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Flushmate Expands Recall of Flushmate III Pressure-Assisted Flushing Systems Due to Impact and Laceration Hazards
Recall date: JULY 14, 2016
Recall number: 16-223
Recall Summary
Name of product: Flushmate® III Pressure-Assist Flushing Systems
Hazard: The system can burst at or near the vessel weld seam releasing stored pressure. This pressure can lift the tank lid and shatter the tank, posing impact and laceration hazards to consumers and property damage.
Consumer Contact:
Flushmate at (800) 303-5123 between 8 a.m. and 10 p.m. ET Monday through Friday and between 8 a.m. and 6:30 p.m. ET Saturday, or online at www.flushmate.com and click on “Flushmate III Recall” in the black box on the top left of the page for more information.
Recall Details
In conjunction with
Canada Flag
Units
About 453,000 in the U.S. (in addition, about 12,000 in Canada) (The Series 503 Flushmate III was previously recalled January 2014 and June 2012.)
Description
This recall is for Series 503 Flushmate III Pressure Assist flushing systems installed inside toilet tanks that were manufactured from July 2009 through April 2011. The units are rectangular, black, two-piece vessels made of injection molded plastic. Previously recalled systems were manufactured from October 1997 through June 2009. Recalled units have a date code/serial number that is 16 characters long and is located on the label on the top of the Flushmate III. The first six numerals of the serial number are the date code. The date code range for units included in this recall in MMDDYY format is 070109 (July 1, 2009) through 043011 (April 30, 2011). The date code range for previously recalled systems in MMDDYY format was 101497 (October 14, 1997) through 063009 (June 30, 2009). Units included in this recall were sold individually and installed in toilets manufactured by American Standard, Copperfit, Crane, Ecotech, Eljer, Gerber, Kohler, Lamosa, Mancesa, Mansfield, Orion, St. Thomas, Universal Rundle, Vitra, Vitromex, Vortens and Western Pottery.
Incidents/Injuries
Flushmate has received two reports of the units included in this recall bursting, resulting in property damage, including one report of a minor injury.
Remedy
Consumers should immediately stop using the recalled Flushmate III systems, turn off the water supply to the units, flush the toilet to release the internal pressure and contact the firm to request a free repair kit.
Sold at
Home Depot and Lowe’s stores, toilet manufacturers, distributors and plumbing contractors nationwide from 2009 through 2011 for about $108 for the units without toilets.
Manufacturer(s)
Flushmate, of New Hudson, Mich., a division of Sloan Valve Company
Manufactured in
U.S.
John
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WEN by Chaz Dean Cleansing Conditioners: FDA Statement - Investigation of Adverse Event Reports
AUDIENCE: Consumer, Family Practice, Dermatology
ISSUE: The FDA is investigating reports of hair loss, hair breakage, balding, itching, and rash associated with the use of WEN by Chaz Dean Cleansing Conditioner products.
While the FDA continues its investigation, consumers should be aware of reactions reported in association with the use of WEN by Chaz Dean Cleansing Conditioner products. Consumers who experience a reaction after using WEN by Chaz Dean Cleansing Conditioner products should stop using the product and consult with their dermatologist or other health care provider. The agency also urges consumers to report to FDA any reactions they may have experienced when using these products.
The FDA has not yet determined a possible cause for the adverse events that have been reported, and will provide additional updates as new information becomes available.
BACKGROUND: As of July 7, 2016, the FDA had received 127 adverse event reports directly from consumers about WEN by Chaz Dean Cleansing Conditioner products, the largest number of reports ever associated with any cosmetic hair cleansing product, including cleansing conditioners. FDA is also investigating more than 21,000 complaints reported directly to Chaz Dean, Inc. and Guthy Renker, LLC that FDA learned of during inspections of manufacturing and distribution facilities.
The FDA has not yet determined a possible cause for the adverse events that have been reported, and today has called on the company to “provide any data that might help us to better understand the reports of hair loss associated with the use of WEN by Chaz Dean Cleansing Conditioner products.” The FDA also has reached out to physicians and other health care providers asking them to notify their patients of hair loss and other complaints associated with the use of these products and to report adverse events to the agency.
RECOMMENDATION: While the FDA continues its investigation, consumers should be aware of reactions reported in association with the use of WEN by Chaz Dean Cleansing Conditioner products. Consumers who experience a reaction after using WEN by Chaz Dean Cleansing Conditioner products should stop using the product and consult with their dermatologist or other health care provider.
See the “Dear Healthcare Provider letter” and “FDA Information for Consumers” for additional information.
Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including links to the FDA Statement, Dear Healthcare Provider letter, and Consumer Information, at:
*More information
WEN by Chaz Dean Cleansing Conditioners: FDA Statement - Investigation of Adverse Event Reports
[Posted 07/19/2016]
AUDIENCE: Consumer, Family Practice, Dermatology
ISSUE: The FDA is investigating reports of hair loss, hair breakage, balding, itching, and rash associated with the use of WEN by Chaz Dean Cleansing Conditioner products.
While the FDA continues its investigation, consumers should be aware of reactions reported in association with the use of WEN by Chaz Dean Cleansing Conditioner products. Consumers who experience a reaction after using WEN by Chaz Dean Cleansing Conditioner products should stop using the product and consult with their dermatologist or other health care provider. The agency also urges consumers to report to FDA any reactions they may have experienced when using these products.
The FDA has not yet determined a possible cause for the adverse events that have been reported, and will provide additional updates as new information becomes available.
BACKGROUND: As of July 7, 2016, the FDA had received 127 adverse event reports directly from consumers about WEN by Chaz Dean Cleansing Conditioner products, the largest number of reports ever associated with any cosmetic hair cleansing product, including cleansing conditioners. FDA is also investigating more than 21,000 complaints reported directly to Chaz Dean, Inc. and Guthy Renker, LLC that FDA learned of during inspections of manufacturing and distribution facilities.
The FDA has not yet determined a possible cause for the adverse events that have been reported, and today has called on the company to “provide any data that might help us to better understand the reports of hair loss associated with the use of WEN by Chaz Dean Cleansing Conditioner products.” The FDA also has reached out to physicians and other health care providers asking them to notify their patients of hair loss and other complaints associated with the use of these products and to report adverse events to the agency.
RECOMMENDATION: While the FDA continues its investigation, consumers should be aware of reactions reported in association with the use of WEN by Chaz Dean Cleansing Conditioner products. Consumers who experience a reaction after using WEN by Chaz Dean Cleansing Conditioner products should stop using the product and consult with their dermatologist or other health care provider.
See the “Dear Healthcare Provider letter” and “FDA Information for Consumers” for additional information.
Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
[07/19/2016 - Statement - FDA]
http://www.fda.gov/Cosmetics/ProductsIngredients/Products/ucm511626.htm
[07/19/2016 - Dear Health Care Provider Letter - FDA]
http://www.fda.gov/Cosmetics/ProductsIngredients/Products/ucm511636.htm
[07/19/2016 - FDA Information for Consumers About WEN by Chaz Dean Cleansing Conditioners - FDA]
http://www.fda.gov/Cosmetics/ProductsIngredients/Products/ucm511631.htm
[07/19/2016 - FDA Authority Over Cosmetics – FDA]
http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074162.htm
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Theo Chocolate Issues Allergy Alert on Undeclared Milk in Salted Almond 70% Dark Chocolate
For Immediate Release
July 18, 2016
Contact
Consumers
Theo Chocolate
1-206-632-5100 x1001
Media
Dennis Macray
1-206-632-5100 x1001
Announcement
View Product Photos
Theo Chocolate of Seattle, Washington is voluntarily recalling 3 ounce Salted Almond 70% Dark Chocolate bars because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
Salted Almond 70% Dark Chocolate was distributed to retail stores in AZ, CA, CO, GA, IA, ID, FL, MI, MT, ND, NH, OR, NJ, NY, PA, TX, WA, and WI.
The Theo Chocolate Salted Almond 70% Dark Chocolate bars have the affected lot 3037431 and the expiration date 05/2017 and they are found on the back side of the bar.
Theo Chocolate Salted Almond 70% Dark Chocolate bars are wrapped in a white paper envelope, weighs 3 oz., UPC is 8 74492 00170 4, and stored at room temperature.
No illnesses have been reported to date.
The voluntary recall was initiated after the firm received a consumer complaint and discovered that the actual product inside the wrapper was milk salted almond bar and it contains milk. This product was mis-labeled as Salted Almond 70% Dark Chocolate and did not reveal the presence of milk.
This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.
Consumers who have an allergy or severe sensitivity to milk are urged not to consume this product and should return it to the place of purchase for a full refund.
Consumers with questions may contact Theo Chocolate at 1-206-632-5100 x1001 from 8:30am until 5:30pm PST, Monday-Friday.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
PharmaTech LLC Issues Voluntary Nationwide Recall of Diocto Liquid Distributed by Rugby Laboratories Due to Product Contamination
For Immediate Release
July 15, 2016
Contact
Consumers
Rugby®'s Customer Support Department
1-800-645-2158
Media
Brett Ludwig
(215) 970-0153
Announcement
View Product Photos
PharmaTech LLC of Davie, FL, the manufacturer of the Rugby® - branded product, is voluntarily recalling all lots within the expiry of Diocto Liquid, a docusate sodium solution due to a risk of product contamination with Burkholderia cepacia. Use of docusate sodium liquid contaminated with B. cepacia may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
As part of its commitment to patient safety, Rugby® Laboratories is working with PharmaTech LLC to notify customers who may be in possession of Diocto Liquid NDC 0536-0590-85; 50 mg/5 mL for all lots within the expiration period.
Diocto Liquid is used as a stool softener and is packaged in one pint (473 mL) bottles. All lots with NDC 0536-0590-85 are included in the recall. Diocto Liquid was distributed nationwide to wholesale and retail facilities including hospitals and pharmacies. The company learned of the potential issue through the receipt of two isolated complaints regarding this product. FDA has informed PharmaTech and Rugby that it received several adverse event reports of B. cepacia infections in patients. Additionally, some of these reports identify liquid docusate products manufactured by companies other than PharmaTech.
PharmaTech is notifying its distributors and customers by recall letter and is arranging for return of all recalled products. Consumers, pharmacies, and healthcare facilities that have product which is being recalled should stop using and dispensing them immediately.
Consumers with questions regarding this recall should contact Rugby®'s Customer Support Department at 1-800-645-2158, available Monday through Friday 8a – 8p EST. Consumers can contact their physician or healthcare provider if they have additional questions about this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre- addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the full knowledge of the U.S. Food and Drug Administration.
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Monday, July 18, 2016
HIV therapy for breastfeeding mothers can virtually eliminate transmission to babies
For HIV-infected mothers whose immune system is in good health, taking a three-drug antiretroviral regimen during breastfeeding essentially eliminates HIV transmission by breast milk to their infants, according to results from a large clinical trial conducted in sub-Saharan Africa and India.
These findings from the ongoing Promoting Maternal and Infant Survival Everywhere (PROMISE) study, funded by the National Institutes of Health, support the World Health Organization (WHO) guidelines introduced in 2015 that recommend lifelong antiretroviral therapy for all pregnant and breastfeeding women living with HIV. PROMISE investigators found that both three-drug maternal antiretroviral therapy and daily infant nevirapine were safe and effective at preventing HIV transmission during breastfeeding. Overall, infant mortality in the study was extremely low, with nearly all babies surviving their first year of life.
“These findings add to the considerable body of evidence confirming the benefits of antiretroviral therapy for every person living with HIV,” said Anthony S. Fauci, M.D., director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID). “Maternal antiretroviral therapy safely minimizes the threat of HIV transmission through breast milk while preserving the health advantages of breastfeeding, as the high infant survival in this study underscores.”
PROMISE is funded by NIAID and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), both part of NIH, and is conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trials network. Researchers will present the new results in a poster at the 21st International AIDS Conference in Durban, South Africa, on July 19. The findings also were presented at the pre-conference 8th International Workshop on HIV Pediatrics on July 16.
PROMISE, which began in 2010, is a multi-component study that aims to determine how best to safely reduce the risk of HIV transmission from HIV-infected women to their babies during pregnancy, delivery and after childbirth, while preserving the health of both mother and child. Study results reported in 2014 identified the superiority of a three-drug regimen for the mother over other regimens for preventing perinatal HIV transmission during pregnancy and delivery.
The new findings stem from a component of PROMISE that compares the safety and efficacy of two antiretroviral regimens for preventing mother-to-child transmission of HIV during breastfeeding. This component included mother-infant pairs living in resource-limited settings where breastfeeding is common and recommended for infant health. HIV-infected mothers in areas that lack safe, clean water may be encouraged to breastfeed because of the health benefits for the infant and the risk for infants from mixing formula with an unsafe water supply. Breastfeeding helps prevent malnutrition, and antibodies from breast milk protect babies against potentially life-threatening diarrheal and respiratory infections.
The researchers enrolled 2,431 pairs of HIV-infected mothers and their HIV-uninfected infants at clinical research sites in South Africa, Malawi, Tanzania, Uganda, Zambia, Zimbabwe and India between June 2011 and October 2014. On average, the women were asymptomatic and had relatively high CD4+ cell levels — a marker of good immune system health. Investigators randomly assigned the mothers and their newborns to one of two regimens. One regimen included triple-drug antiretroviral therapy for the mother that continued through the period of study follow up and daily doses of nevirapine for the infant until 6 weeks after birth. The second regimen consisted of triple-drug antiretroviral therapy for the mother until 1 week after delivery and daily doses of nevirapine for the infant beginning from the first week after birth and continuing through completion of study follow up. The participants were followed for 18 months or until the mother stopped breastfeeding (on average 15 months after childbirth), whichever came first.
The researchers found that maternal three-drug antiretroviral therapy, as well as infant nevirapine, offered protection against HIV transmission from mother to child. The rate of perinatal transmission did not differ between the two study arms and was very low — 0.3 percent at 6 months of age and 0.6 percent at 1 year of age. The longer an HIV-infected mother breastfeeds, the greater the risk for HIV transmission to the infant. In comparison, in the absence of any intervention, rates of HIV transmission from a HIV-infected mother to her child during either pregnancy, labor, delivery or breastfeeding historically have ranged from 15 to 45 percent, according to WHO. Adverse events in mothers and babies occurred at a similarly low rate in both study arms. Infant mortality in resource-limited countries can be high, but in this study, nearly 99 percent of babies lived to see their first birthday.
“HIV-infected mothers in low and middle income countries, who may not have access to alternative feeding methods, can be reassured that breastfeeding is a safe option for their infants,” said Nahida Chakhtoura, M.D., of the Maternal and Pediatric Infectious Disease Branch at NICHD.
“The PROMISE team and the PROMISE mothers were gratified with the extremely low rates of infant infection and excellent infant survival with the use of maternal antiretroviral therapy,” said Protocol Chair Mary Glenn Fowler, M.D., M.P.H. “These results show the importance of mothers continuing to take antiretroviral therapy to reduce risk of mother-to-child transmission during breastfeeding.”
Infant nevirapine also offers a safe and effective alternative if the mother has difficulty adhering to or tolerating antiretroviral therapy, the researchers suggest.
Another component of PROMISE, also presenting results at AIDS 2016, followed 1,652 HIV-positive non-breastfeeding women with relatively strong immune system health who were randomly assigned to either continue antiretroviral therapy or stop antiretroviral therapy postpartum. While both groups of study participants showed similar, low rates of AIDS-defining and serious non-AIDS events, other HIV-related illnesses were significantly lower among the women who continued antiretroviral therapy. These findings provide further evidence from a large international randomized clinical trial of the benefits of antiretroviral therapy for women.
For more information, visit ClinicalTrials.gov using study identifier NCT01061151 and NCT00955968.
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD conducts and supports research in the United States and throughout the world on fetal, infant and child development; maternal, child and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit NICHD’s website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIH…Turning Discovery Into Health®
References
TE Taha et al. Comparing maternal triple antiretrovirals and infant nevirapine prophylaxis for the prevention of mother-to-child transmission of HIV during breastfeeding. Oral presentation at the 8th International Workshop on HIV Pediatrics and poster presentation at the 21st International AIDS Conference (AIDS 2016) Durban, South Africa.
J Currier et al. Randomized Trial of Stopping or Continuing ART among Post-partum women with Pre-ART CD4 >400 cells/mm3 (PROMISE 1077HS). Oral presentation at the 21st International AIDS Conference (AIDS 2016) Durban, South Africa.
John
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U.S. Food and Drug Administration is alerting health care professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.
PharmaTech manufactures the oral liquid docusate sodium, which is distributed nationwide by Rugby with a Rugby label in one pint (473 mL) bottles.
In addition, FDA has received several adverse event reports of B. cepacia infections in patients. Some of these reports identify liquid docusate sodium products manufactured by companies other than PharmaTech. FDA and the Centers for Disease Control and Prevention continue to investigate the extent of this issue in order to identify other potentially contaminated liquid docusate sodium products.
Patient safety is our top priority. FDA joins CDC in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose.
FDA and CDC will provide additional information when it is available.
FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of oral liquid docusate sodium products to FDA’s MedWatch Adverse Event Reporting program:
For more information, please visit: Diocto Liquid.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Update: Tippin’s Gourmet Pies, LLC Announces the Recall of Tippin’s Key Lime Pie for the Presence of Undeclared Peanut Residue Due to Supplier Recall
For Immediate Release
July 15, 2016
Contact
Consumers
toll-free hotline
1-800-435-3382
Announcement
View Product Photos
http://www.fda.gov/Safety/Recalls/ucm507525.htm#recall-photos
UPDATE (Effective July 15, 2016): As an update to the June 21, 2016 recall announcement, Tippin’s is expanding the recall to include lot number 05-31-16. Additionally, lot numbers 04-21-16, 04-25-16, 05-05-16, and 05-11-16 are not affected by this recall. No related illness or allergic reaction involving this product has been reported. Consumers should continue to check the product lot number before consumption to ensure it is not part of the recalled lots listed below.
June 17, 2016
Kansas City, KS – Tippin’s Gourmet Pies, LLC today is voluntarily recalling select Key Lime Pies because they may contain flour with undeclared peanut residue. Tippin’s initiated the recall after we became aware that our supplier, Kellogg Company, was conducting a recall of graham cracker crumbs because they may contain undeclared peanut residue. The graham cracker crumbs were used to make the crust for our Key Lime Pies identified below.
While consumers with severe peanut allergies should avoid the recalled product, the FDA has stated that the amount of peanut exposure from the flour is low and not expected to cause adverse health effects in the vast majority of peanut allergic consumers. Tippin’s has received no notice of related illness or allergic reactions involving this product to date, and is taking this action out of an abundance of caution.
This recall applies only to the product listed. This recall does not affect any other Tippin’s brand products.
BRAND / PRODUCT NAME
SIZE
UPC
LOT NUMBER
Tippin’s Key Lime Pie
8 inch
680816050057
04-26-16
04-27-16
05-03-16
05-04-16
05-17-16
05-31-16
This product was sold to distributers throughout Kansas, Missouri, Texas, Oklahoma, Arizona, and Illinois. Tippin’s Gourmet Pies will work with its customers to ensure that the recalled products are no longer available for sale or distribution.
In the event that consumers believe they have purchased the listed product and have an allergy concern, they should return the product to the store they purchased it from for a full refund, or discard the product. Consumers are urged to contact the store they purchased product from for questions concerning if your product is affected by this recall.
For questions or concerns regarding information about this recall, consumers may visit http://tippins.net or leave a message on our 24 hour toll-free hotline at 1-800-435-3382. Calls received Monday through Friday will be followed the next business day.
More information about the recall can be found on the FDA’s website at:
http://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm504002.htm.
Previous Posting
http://www.fda.gov/Safety/Recalls/ucm507525.htm
John
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News Release
ConAgra Foods Recalls Frozen Chicken and Beef Products Due to Possible Foreign Matter Contamination
Class I Recall
056-2016 EXP
Health Risk: High
Jul 15, 2016
Congressional and Public Affairs
Veronika Medina
Sarah R. Lichtman
(202) 720-9113
EDITORS NOTE: This release is being reissued as an expansion of the July 6, 2016, release to include additional products and production dates. The initial recall included 3,806 pounds of product. This expansion includes an additional 191,791 pounds of product, for a total of 195,597 pounds of product. Details of this release were also updated to reflect a change in distribution area.
WASHINGTON, July 15, 2016 – ConAgra Foods, a Russellville, Ark. establishment, is recalling approximately 195,597 pounds of frozen chicken and beef entrée products that may be contaminated with extraneous materials, specifically metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The metal fragments range in size between 2 and 9 millimeters (mm) in diameter, and are curled, malleable and shiny. The metal fragments may be embedded in the sauce contained within the frozen entrée products.
The frozen chicken and beef entrée items were produced on various dates between May 31, 2016 and June 22, 2016. The following products are subject to recall:
View Labels PDF Only
22-oz. plastic bagged meal packages of “P.F. Chang’s Home Menu Signature Spicy Chicken” with “Use By” date of 6/08/17 and case code 5006616500.
22-oz. plastic bagged meal packages of “P.F. Chang’s Home Menu Mongolian Style Beef” with “Use By” date of 6/17/17 and case code 5006617400.
22-oz. plastic bagged meal packages of “P.F. Chang’s Home Menu Mongolian Style Beef” with “Use By” date of 6/1/17 and case code 5006615800.
22-oz. plastic bagged meal packages of “P.F. Chang’s Home Menu Beef with Broccoli” with “Use By” date of 6/4/17 and case code 5006616100.
22-oz. plastic bagged meal packages of “P.F. Chang’s Home Menu Sweet & Sour Chicken” with “Use By” date of 6/3/17 and case code 5006616000.
22-oz. plastic bagged meal packages of “P.F. Chang’s Home Menu General Chang’s Chicken” with “Use By” date of 6/3/17 and case code 5006616000.
22-oz. plastic bagged meal packages of “P.F. Chang’s Home Menu Garlic Chicken with Dan Dan Noodles” with “Use By” date of 6/8/17 and case code 5006616500.
22-oz. plastic bagged meal packages of “P.F. Chang’s Home Menu Grilled Chicken Teriyaki with Lo Mein Noodles” with “Use By” date of 6/10/17 and case code 5006616700.
22-oz. plastic bagged meal packages of “P.F. Chang’s Home Menu Signature Spicy Chicken” with “Use By” date of 5/26/17 and case code 5006615200.
The products subject to recall bear establishment number “EST. 233” or “EST. P-115” inside the USDA mark of inspection. These items were shipped to distributors and retail locations nationwide.
The problem was initially discovered on July 1, 2016, when an establishment employee observed metal fragments while dispensing sugar from a supplier for sauce formulation during processing. The resulting sauce is a component in the frozen entrée products. On July 14, 2016, ConAgra Foods was notified by the supplier of an FDA recall involving multiple production lots of sugar due to potential metal contamination. The recall action involved additional lots of sugar potentially used in FSIS regulated products at ConAgra Foods, and resulted in this expansion of the initial recall action.
There have been no confirmed reports of adverse reactions or injuries due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers with questions about the recall can contact 1-800-252-0634. Members of the media with questions about the recall can contact Kristine Mulford, Manager of Communications, ConAgra Foods, at (312) 549-5522.
John
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http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm499157.htm
FDA Investigated Listeria Outbreak Linked to Frozen Vegetables
July 15, 2016
*NOTE: Everything listed under “On this page" is a link. If you wish to visit those links go to the link above.
On this page:
Update
What was the Problem and What was Done About It?
What are the Symptoms of Listeriosis?
Who is at Risk?
What Specific Products were Recalled?
What Do Restaurants and Retailers Need To Do?
What Do Consumers Need To Do?
Who Should be Contacted?
Additional Information
The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC), state, and local officials, investigated listeriosis linked to frozen vegetables.
Update:
The FDA facilitated the recall of at least 456 products related to this outbreak. CRF Frozen Foods recalled 358 products and at least 98 other products were recalled by firms that received CRF- recalled products. On July 15, 2016, CDC declared the outbreak investigation over.
What was the Problem and What was Done About It?
The FDA, CDC, state, and local officials investigated a multi-state outbreak of listeriosis identified in March 2016.
The CDC reports that nine people infected with the outbreak strains of Listeria monocytogenes have been reported from four states (California, Connecticut, Maryland, and Washington) from September 2013 to May 2016. Ill people ranged in age from 56 to 91, with a median age of 76. Epidemiology and laboratory evidence indicated that frozen vegetables produced by CRF Frozen Foods of Pasco, Washington, and sold under various brand names are one likely source of illnesses in this outbreak. As discussed further below, CRF Frozen Foods initiated a recall of certain products.
As part of a routine product sampling program, the Ohio Department of Agriculture collected packages of frozen vegetable products from a retail location and isolated Listeria monocytogenes from True Goodness by Meijer brand frozen organic white sweet cut corn and frozen organic petite green peas. Both products were produced by CRF Frozen Foods.
Whole genome sequencing showed that the Listeria monocytogenes isolated from the frozen corn was closely related genetically to eight bacterial isolates from ill people, and the Listeria monocytogenes isolate from the frozen peas was closely related genetically to one isolate from another ill person. This close genetic relationship provides additional evidence that the people in this outbreak became ill from eating frozen vegetables produced by CRF Frozen Foods.
Based on the positive findings by the Ohio Department of Agriculture, on April 22, 2016, CRF Frozen Foods ceased production at its Pasco, WA facility and recalled 11 frozen vegetable products because they may be contaminated with Listeria monocytogenes. On May 2, 2016, following a conversation between FDA, CDC, and the firm, CRF Frozen Foods expanded its recall to include all of its frozen organic and traditional fruit and vegetable products manufactured or processed in its Pasco facility since May 1, 2014. Approximately 358 consumer products sold under 42 separate brands were recalled. Recalled products were sold nationwide and in the following Canadian Provinces: British Columbia, Alberta, Manitoba, and Saskatchewan. Pulsed-field gel electrophoresis (PFGE) of recalled product samples collected from ill people in California and Idaho revealed the presence of Listeria monocytogenes matching the outbreak strain.
Additionally, March 2016 environmental samples collected by FDA from Oregon Potato Company, located in Pasco, WA, were found to be closely related genetically to eight of the isolates of ill people associated with this outbreak. Based on this information, Oregon Potato Company voluntarily recalled wholesale onion products, which led to subsequent downstream customer recalls, one disclaimer icon of which publicly disclosed Oregon Potato Company as its product source. FDA worked to identify other parts of the relevant supply chain and facilitated recalls where necessary. However, FDA is prohibited by law from releasing publicly certain information about supply chains, which may constitute confidential commercial information.
The FDA facilitated the recall of at least 456 products related to this outbreak. CRF Frozen Foods recalled 358 products and at least 98 other products were recalled by firms that received CRF-recalled products. For a complete list of recalls linked to CRF Frozen Foods, see http://www.foodsafety.gov/recalls/recent/listeria.html.
On July 15, 2016, CDC declared the outbreak investigation over.
What are the Symptoms of Listeriosis?
Listeriosis is a rare but serious illness usually caused by eating food contaminated with the bacteria called Listeria monocytogenes. Anyone who experiences fever and muscle aches, sometimes preceded by diarrhea or other gastrointestinal symptoms, or develops fever and chills while pregnant after eating any of the recalled products listed below, should seek medical care and tell their health care provider about eating the potentially contaminated frozen vegetables. Symptoms can appear from a few days up to a few weeks after consumption of the contaminated food.
Who is at Risk?
Listeriosis can be fatal, especially in certain high-risk groups. These groups include the elderly, and people with weakened immune systems and certain chronic medical conditions (such as cancer). In pregnant women, listeriosis can cause miscarriage, stillbirth, premature labor, and serious illness or death in newborn babies.
What Specific Products were Recalled?
On April 22, 2016, CRF Frozen Foods recalled 11 frozen vegetable products because they may be contaminated with Listeria. On May 2, 2016, CRF Frozen Foods expanded its recall to include all frozen organic and traditional fruit and vegetable products manufactured or processed in CRF Frozen Foods’ Pasco facility since May 1, 2014. These products have “best by” dates of April 26, 2016, through April 26, 2018, and may have been purchased in all fifty U.S. states and the following Canadian Provinces: British Columbia, Alberta, Manitoba, and Saskatchewan.
The FDA facilitated the recall of at least 456 products related to this outbreak. CRF Frozen Foods recalled 358 products and at least 98 other products were recalled by firms that received CRF-recalled products. For a complete list of recalls linked to CRF Frozen Foods, see http://www.foodsafety.gov/recalls/recent/listeria.html.
Additionally, FDA has established a Major Product Recalls page for CRF Frozen Foods related recalls.
What Do Restaurants and Retailers Need To Do?
Retailers and restaurants should not serve or sell any of the recalled products and should dispose of them. If they do not know the source of their frozen vegetable products, they should check with the supplier.
Wash and sanitize display cases and refrigerators where potentially contaminated products were stored.
Wash and sanitize cutting boards, surfaces, and utensils used to cut, serve, or store potentially contaminated products.
Wash hands with warm water and soap following the cleaning and sanitation process.
Retailers, restaurants, and other food service operators who have processed and packaged any potentially contaminated products need to be concerned about cross-contamination of cutting surfaces and utensils through contact with the potentially contaminated products.
Regular frequent cleaning and sanitizing of cutting boards and utensils used in processing may help to minimize the likelihood of cross-contamination.
Listeria can grow at refrigeration temperatures in foods. Listeria can also cross-contaminate other food cut and served on the same cutting board or stored in the same area.
Retailers, restaurants, and other food service operators may wish to consider whether other foods available for sale could have been cross-contaminated from the potentially contaminated products, and should be discarded.
Firms who have re-labeled, re-packed, or used the recalled products to produce new products that have not received a thermal kill step should contact the FDA Recall Coordinator in your state to determine whether or not you should initiate a new recall of your product(s). FDA District Recall Coordinators for each state are listed at: http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129334.htm).
What Do Consumers Need To Do?
The FDA urges consumers to not eat any of the recalled products and to check their homes for the recalled fruit and frozen vegetable products. CRF Frozen Foods directs any consumers who have purchased any of the recalled products to return them to the place of purchase for a full refund, or discard them.
Further, for frozen foods not listed in the recall, consumers should thoroughly cook them and follow microwave or conventional oven cooking instructions found on the package. Only thorough cooking will kill bacteria that can cause foodborne illness. It is not recommended to cook recalled product because of the risk that bacteria from the recalled food could cross-contaminate the food preparation area and utensils.
Consumers should follow these simple steps:
Wash hands with warm water and soap for at least 20 seconds before and after handling food.
Wash the inside walls and shelves of the refrigerator, cutting boards and countertops; then sanitize them with a solution of one tablespoon of chlorine bleach to one gallon of hot water; then dry with a clean cloth or paper towel that has not been previously used.
Wipe up spills in the refrigerator immediately and clean the refrigerator regularly.
Always wash hands with warm water and soap following the cleaning and sanitization process.
Additional recommendations for preventing listeriosis are available at the CDC Listeria website: http://www.cdc.gov/listeria/prevention.html.
Who Should be Contacted?
Consumers who have questions about the CRF Frozen Foods recall may call the company’s consumer hotline at 844-483-3866, Monday through Friday, 8:00 am to 8:00 pm Eastern Standard Time.
The FDA also encourages consumers with questions about food safety to call 1-888-SAFEFOOD Monday through Friday between 10 a.m. and 4 p.m. Eastern time, or to consult the fda.gov website: http://www.fda.gov.
John
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FDA Approves an Increase to the Amount of Vitamin D for Milk and Milk Alternatives
July 15, 2016
The U.S. Food and Drug Administration today approved an increase to the amount of vitamin D that may be added as an optional ingredient to milk, and approved the addition of vitamin D to beverages made from edible plants intended as milk alternatives, such as beverages made from soy, almond, and coconut, and edible plant-based yogurt alternatives. Vitamin D was already authorized for use in soy beverages, but today’s approval increases the authorized amount for such beverages that are intended as milk alternatives.
Under the law, the FDA may approve the use of a food additive only after conducting a scientific safety review of the information provided in the petition to ensure that use of ingredients added to foods are safe for the general population. In this case, the FDA evaluated the projected human dietary exposure to vitamin D from foods and dietary supplements, safety data, and other relevant information and found these uses of vitamin D to be safe.
Vitamin D is a fat-soluble vitamin that is essential for human health. It comes in many forms. The two major forms are vitamin D2 and vitamin D3. Vitamin D without a subscript represents either vitamin D2 or vitamin D3 or both. The major function of vitamin D is to help with the absorption of calcium and phosphorus in the small intestine. Vitamin D deficiency can lead to abnormalities in bone metabolism, such as rickets in children or osteomalacia in adults. Excess intake of vitamin D can also be harmful, elevating calcium levels in the blood (hypercalcemia).
The approval, which amends existing food additive regulations, will allow manufacturers to voluntarily add up to 84 IU/100g of vitamin D3 to milk, 84 IU/100g of vitamin D2 to plant-based beverages intended as milk alternatives, and 89 IU/100g of vitamin D2 to plant-based yogurt alternatives.
Manufacturers may begin using the new amounts on July 18, 2016.
For more information:
FR Notice: Food Additives Permitted for Direct Addition to Food for Human Consumption: Vitamin D2 and Vitamin D3
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Monogram Appetizers Issues Allergy Alert On Undeclared (Egg) In Poppers Brand Mozzarella Cheese
For Immediate Release
July 14, 2016
Contact
Consumers
Monogram Foods
1-855-556-1351
Media
DeWayne McVey
901-259-6642
Announcement
View Product Photos
Monogram Appetizers of Plover, Wisconsin is recalling approximately 5000 cases of Poppers Brand Mozzarella Cheese Sticks, because it may contain undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products.
The recalled Poppers Brand Mozzarella Cheese Sticks were distributed nationwide in retail stores. The product comes in a 32 ounce, clear plastic package marked with UPC 4670488920 and code numbers.
No illnesses have been reported to date in connection with this problem.
The recall was initiated after it was discovered that the product was distributed in packaging that did not reveal the presence of egg. The problem was discovered during a routine quality check, which revealed that egg was inadvertently omitted during a recent graphics change.
The use of this product packaging has been suspended and placed on Hold.
Consumers who have purchased 32 ounce packages of Poppers Mozzarella Cheese Sticks with code numbers as referenced above are urged to return them to the place of purchase for a full refund. Consumers with questions may contact Monogram Foods at 1 (855) 556-1351 Monday - Friday 8am - 5pm CST.
John
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News Release
Haring Catfish, Inc. Recalls Siluriformes Fish Products Due To Possible Adulteration
Class II Recall
060-2016
Health Risk: Low
Jul 14, 2016
Congressional and Public Affairs
Benjamin Bell
(202) 720-9113
EDITORS NOTE: This release is being reissued to edit product descriptions.
WASHINGTON, July 14, 2016 – Haring Catfish, Inc., a Wisner, La. establishment, is recalling approximately 21,521pounds of siluriformes fish (catfish) products that may be adulterated with a residue of public health concern, specifically gentian (crystal) violet, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The siluriformes (catfish) products items were produced on June 28 and 29, 2016. The following products are subject to recall:
View Labels PDF Only
11-lb. Cardboard boxes of ice packed “catfish” tails in plastic wrapping identified as HARING CATFISH and having Lot Code 2140 printed on the label.
15-lb. Cardboard boxes of IQF (Individually Quick Frozen) “catfish” steaks, filets, irregular filets, whole fish, strips and nuggets in plastic wrapping identified as HARING CATFISH and having Lot Code 2140 printed on the label.
30-lb. Cardboard boxes of ice packed “catfish” steaks, filets, irregular filets, whole fish, strips, nuggets, and gutted fish in plastic wrapping identified as HARING CATFISH and having Lot Code 2140 printed on the label.
The products subject to recall bear establishment number “EST. 51217” inside the USDA mark of inspection. These items were shipped to retail locations and hotels, restaurants, and institutions in Arkansas, California, Louisiana, Mississippi, Oklahoma, and Texas.
The problem was discovered on July 11, 2016, after routine FSIS sampling results revealed a violative level of the chemical gentian (crystal) violet in the product.
There have been no confirmed reports of adverse reactions, injury, or illness due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers with questions about the recall can contact Dottie Walker, at (318) 724-6133 ext. 119. Media with questions about the recall can contact Dawn Payne, at (318) 724-6654.
John
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News Release
U.S. Cado Holdings, Inc. Recalls Imported Siluriformes Fish Products Distributed Without Meeting Fsis Requirements
Class I Recall
052-2016 EXP-2
Health Risk: High
Jul 14, 2016
Congressional and Public Affairs
Nina A. Anand
(202) 720-9113
EDITORS NOTE: This release is being reissued as an expansion of the June 20, 2016 and June 25, 2016 recalls to include additional products, production dates, and distribution area. The first recall 052-2016 on June 20, 2016 involved 25,760 pounds of frozen swai fillet products. The recall expansion on June 25, 2016 involved an additional 2,235 pounds of Individually Quick Frozen (IQF) Swai fillet products. The second recall expansion on July 14, 2016 involved an additional 1,650 pounds of frozen Swai Fillets. The combined number of recalled product from June 20, 2016 to July 14, 2016 is 29,645 pounds of frozen Swai imported from Vietnam.
WASHINGTON, July 14, 2016 – U.S. Cado Holdings, Inc., a Santa Ana, Calif. establishment, is recalling approximately 1,650 pounds of imported, frozen Swai fillets products that were distributed into U.S. commerce without meeting federal importation requirements, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
View Labels PDF Only)
The Deep Water Sea Food brand Frozen Swai fillets were produced on April 5, 2016. The following products are subject to recall:
15-lb. boxes containing bulk pieces of “Frozen Swai Fillets” with the label DEEP WATER SEA FOOD, “Production Date: 04/05/2016,” and “Best Before Date: 10/05/2017.” The products subject to recall bear the Factory Number UCH001 on the box and bear the lot number 1683475. These items were shipped to institutional locations in Puerto Rico. The boxes are marked as “9/11 oz.”
The problem was discovered when the customer and import establishment notified FSIS personnel of Swai products entering U.S. commerce without meeting FSIS regulatory requirements for imported Siluriformes. The products were imported from Vietnam and failed to comply with FSIS requirements concerning residue sampling and testing prior to entry into United States commerce. There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.
Details of the first expansion are: June 25, 2016— U.S. Cado Holdings, Inc., a Santa Ana, Calif. establishment recalled approximately 2,235 pounds of imported, frozen Swai fillets produced and packed on March 1, 9, and 16, 2016 in Vietnam by Golden Quality Seafood Corporation. The following products are subject to recall:
15-lb. boxes containing individually wrapped pieces of “Skinless and Boneless Swai Fillets” with the label DELTA’S BEST BASA BRAND and the lot number 023015 and 023021, and best by dates of 03-01-2018, 03-09-2018, and 03-16-2018.
The products subject to recall bear no plant number on the box, but do bear the lot number 023015 and 023021, and best by dates of 03-01-2018, 03-09-2018, and 03-16-2018. These items were shipped to retail locations in Louisiana, Mississippi, and Texas.
The problem was discovered when the customer and imported establishment notified FSIS personnel of Swai products entering U.S. commerce without meeting FSIS regulatory requirements for imported Siluriformes. The products were imported from Vietnam and failed to comply with FSIS requirements concerning residue sampling and testing prior to entry into United States commerce. There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.
Details of the first recall are: June 20, 2016– U.S. Cado Holdings, Inc., a Santa Ana, Calif. establishment, recalled approximately 25,760 pounds of imported, frozen Swai fillets products that were distributed into U.S. commerce without meeting federal requirements.
The skinless and boneless Sea Queen brand Swai Fillet items were produced and packed on March 30, 2016, in Vietnam by Golden Quality Seafood Corporation. The following products are subject to recall:
2-lb. (32-oz.) packages containing individually wrapped pieces of “Skinless and Boneless Swai Fillets.”
The products subject to recall bear plant number FN1158, lot number SW1601-02-16090, and have a “best by” date of March 30, 2018. These items were shipped to Aldi distribution centers in Connecticut, Georgia, Maryland, Pennsylvania, and Tennessee.
The problem was discovered when the customer and import establishment notified FSIS personnel of Swai products entering U.S. commerce without meeting FSIS regulatory requirements for imported Siluriformes. The products were imported from Vietnam and failed to comply with FSIS requirements concerning residue sampling and testing prior to entry into United States commerce. There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about a reaction should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase. Consumers and Media with questions about the recall can contact Paul Nguyen, U.S. Cado Holdings Inc., Manager, at (714) 973-2272.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Under the Federal Meat Inspection Act and implementing regulations, the Food Safety and Inspection Service (FSIS) ensures that Siluriformes fish and fish products in foreign and domestic commerce are safe, wholesome, and not adulterated or misbranded. FSIS samples imported product for drug, pesticide, and other chemical residues. For more information, please visit: http://www.fsis.usda.gov/wps/portal/fsis/topics/inspection/siluriformes/operations-inspection under Hold-and-Test Sampling Protocol for Shipments of Siluriformes Fish/Fish Products from Foreign Establishments that Export Product that Contains a Violative Chemical Residue(s) as Identified by FSIS Border Sampling and Testing.
John
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Thursday, July 14, 2016
High levels of urinary paracetamol may impair male fertility, NIH study suggests
Couples in which the male partner had high levels of paracetamol in his urine took longer to achieve pregnancy than couples in which the male had lower levels of the compound, according to a preliminary study by researchers at the National Institutes of Health.
Paracetamol, also known as acetaminophen, is a non-prescription drug widely used as a pain reliever and fever reducer. It also is one of the compounds produced when the body breaks down aniline, a chemical used to make rubber, pesticides, and coloring agents used in food, cosmetics and clothing. The study was published online in Human Reproduction.
“At this point, our findings need to be corroborated by future research, and there is no cause for alarm,” said Melissa Smarr, Ph.D., the study’s first author, a postdoctoral fellow in the Division of Intramural Population Health Research at NIH’s Eunice Kennedy ShriverNational Institute of Child Health and Human Development.
Dr. Smarr explained that the high levels of paracetamol in the urine of certain men in the study were unlikely to result only from taking medications and were more consistent with those seen from environmental exposure, either to aniline or paracetamol or a combination of the two. The findings could have implications for the amount of paracetamol exposure that is considered acceptable.
The current finding results from the latest analysis of data from the Longitudinal Investigation of Fertility and the Environment (LIFE) study, established to examine how lifestyle and exposure to environmental chemicals may affect fertility. The LIFE study encompasses fertility data from 501 couples enrolled in four counties in Michigan and 12 counties in Texas from 2005 to 2009.
The women taking part in the study ranged from 18 to 44 years of age, and the men were over 18. Each participant provided a single urine sample upon joining the study, which was analyzed to measure its paracetamol concentration.
Women had a higher average level of paracetamol (26.6 ng/mL) than the men (13.2 ng/mL). A high level of paracetamol for the female partner was not associated with reduced chances for pregnancy. However, couples in which the males had high levels of paracetamol (more than 73.5 ng/ml) were 35 percent less likely to achieve a pregnancy, compared to couples in which the males had low levels (less than 5.4 ng/ml.).
The authors stressed that their findings need to be confirmed by larger studies that can better identify the sources of paracetamol, the duration of time the participants are exposed, and the amount of the compound to which they are exposed.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): NICHD conducts and supports research in the United States and throughout the world on fetal, infant and child development; maternal, child and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit NICHD’s website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
John
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Juvenile Arthritis: Discoveries Lead to Newer Treatments
On this page:
Biologics: New Treatments for Juvenile Arthritis
Expanding Use of New Treatments to Children
Arthritis is a disease that mostly affects older people, right? Not necessarily.
Juvenile arthritis is one of the most common chronic illnesses affecting children. In fact, nearly 300,000 youngsters nationwide have been diagnosed with the disease. The most common symptoms include joint pain, inflammation (swelling), tenderness and stiffness. One early sign may be limping in the morning.
Nikolay Nikolov, a rheumatologist and clinical team leader at the Food and Drug Administration (FDA), says that children with juvenile arthritis and their parents have reason to be optimistic. In the last several years, new therapies have been developed by drug companies and approved by the FDA that moderate the effects and control the disease, likely preventing significant disability in later years.
While no one knows exactly what causes juvenile arthritis, scientists do know it is an autoimmune disorder. The immune system, which normally helps the body fight infection, attacks the body’s own tissue.
There are several subgroups of juvenile arthritis. Known collectively as Juvenile Idiopathic Arthritis (JIA), these diseases start before age 16 and cause swelling in one or more joints lasting at least six weeks.
JIA affects large joints such as knees, wrists, and ankles as well as small joints. Polyarticular JIA, the largest JIA subgroup, affects many joints. Another subgroup is Systemic JIA, which affects the whole body, and usually causes fever and skin rashes.
In the past, the first line of treatment for children with juvenile arthritis has been to relieve pain and inflammation with non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin and ibuprofen. Children with severe juvenile arthritis have been treated also with drugs that suppress the body’s immune response such as corticosteroids and methotrexate.
But polyarticular and systemic JIA are now also treated with newer medicines called biologics, which are manufactured in or extracted from biological sources.
Biologics: New Treatments for Juvenile Arthritis
“As science at the molecular level has advanced, we’ve learned more about what drives arthritis—the mechanism of the disease—and we are able to identify important targets,” Nikolov says.
These targets include cytokines (molecules that control and drive inflammation in the body) such as tumor necrosis factor (TNF), interleukins (IL), and other naturally occurring proteins involved in stimulating the body’s immune response. Biologics used in the treatment of juvenile arthritis are generally given intravenously or subcutaneously (under the skin), and usually are taken for years. Different biologics tend to work better for different subgroups of the disease. In recent years, FDA has approved several of these treatments. Here are their names, the type of JIA they treat and approval dates:
Humira (adalimumab) for polyarticular JIA, February 2008
Orencia (abatacept) for polyarticular JIA, April 2008
Enbrel (etanercept) for polyarticular JIA, May 1999
Actemra (tocilizumab) for systemic JIA, April 2011 and polyarticular JIA, April 2013
Ilaris (canakinumab) for systemic JIA, May 2013.
“In addition to improving the signs, symptoms and physical functioning of patients, many of these biologics have been shown to reduce joint destruction in adults with rheumatoid arthritis (RA), a disease that is related to juvenile arthritis, and thus to change the natural history of the disease,” Nikolov says.
While researchers don’t yet have a lot of long-term safety information on use of these drugs in children, there is significant experience with their use in adults with RA. Biologics used for the treatment of patients with juvenile arthritis are potent drugs that suppress the immune system and can increase the risk of serious infections, including opportunistic (unusual) infections and tuberculosis.
Expanding Use of New Treatments to Children
When a drug is found to benefit adults with RA in large clinical trials, drug manufacturers may study it in children with juvenile arthritis to find out if the drug works for them too. In addition, FDA considers the known and potential risks of the drug to determine whether its benefits in treating juvenile arthritis outweigh these risks.
“It’s possible that safety issues might come up in kids that we have not found in adults. For example, these drugs may affect the developing body and immune system in children, and that may warrant changes in the labels to let both health care providers and patients know what are the risks involved, and how to recognize and respond to potential problems,” Nikolov says.
Meantime, scientists continue to work on improving existing treatments for children and search for new treatments that will work better with fewer side effects.
“We don’t have a cure for juvenile arthritis—we’re not there yet,” says Nikolov. “But we’re making progress.”
This article appears on FDA’s Consumer Updates page, http://www.fda.gov/ForConsumers/ConsumerUpdates/default.htm which features the latest on all FDA-regulated products.
July 17, 2014
Updated July 14, 2016
John
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Pain in your calves can be caused by peripheral artery disease, or P.A.D., a blood vessel disease that causes plaque to build up in the arteries that carry blood to your head, organs, and limbs.
Learn what puts you at risk for P.A.D.
http://nihseniorhealth.gov/peripheralarterialdisease/faq/faq4.html
See lifestyle changes that can help with P.A.D.
http://nihseniorhealth.gov/peripheralarterialdisease/faq/faq4.html
The information on Peripheral Artery Disease
http://nihseniorhealth.gov/peripheralarterialdisease/whatispad/01.html
was developed for NIHSeniorHealth http://nihseniorhealth.gov/
by the National Heart, Lung, and Blood Institute (NHLBI) at NIH.
http://www.nhlbi.nih.gov/health/health-topics/topics/pad
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
International Commissary Corporation Issues Voluntary Recall of Marie Callender's Cheese Biscuit Mix Due To Possible Health Risk
For Immediate Release
July 13, 2016
Contact
Consumers
Joanna Fraire
408-792-3123
Media
Joanna Fraire
408-792-3123
Announcement
View Product Photos
San Jose, CA. - International Commissary Corporation (ICC) has issued a voluntary recall of certain lots of two retail products: Marie Callender's 7oz & 14oz Cheese Biscuit Mix. The 7 oz recalled product has Best By dates of 3/22/17 and 5/17/17 and was sold in retail stores in the following states - AL, CA, WA, UT, and TX. The 14 oz recalled product has a Best Buy date of 6/17/17 and was sold only in Stockton, CA.
Most strains of E. coli are harmless, however, others can make you sick. E. coli O121 is a potentially deadly bacterium that can cause bloody diarrhea and dehydration. People who experience these symptoms should seek emergency medical care immediately. The very young, seniors, and those with compromised immune systems are the most susceptible to food borne illness. Anyone diagnosed by a physician as having an illness related to E. coli O121 should contact state and local public health authorities.
ICC was notified by a supplier that an ingredient contains flour which was recalled by General Mills because it may be contaminated with E. coli O121. No other Marie Callender Cheese Biscuit Mix Best By dates are affected. Food Safety is our highest priority and we have taken this action out of an abundance of caution, to protect public health. We are unaware of any illnesses to date from the recalled Marie Callender Cheese Biscuit Mix products.
Consumers who have purchased any of the recalled products are urged to throw them away. Retailers who received the recalled products are being contacted. FDA and the Centers for Disease Control (CDC) warn that consumers should refrain from consuming any raw products made with flour. This recall is being made with the knowledge of FDA.
"The quality of Marie Callender's products and the safety of our customers are the upmost important issues said Kevin Greene, VP of Sales At ICC, we care deeply about people, our consumers, our employees and our supplier partners. We are working with our retail customers and the FDA to ensure any affected product is removed from the marketplace immediately. We thank you for your patience, and appreciate your continued trust that we will do the right thing for our consumers. Consumers and media with questions can contact Joanna Fraire at 408-792-3123, Monday through Friday, from 9 AM to 4 PM Pacific or at Joanna@commissary.com
John
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News Release
Simmons Prepared Foods, Inc. Recalls Chicken Products Due To Possible E. Coli O121 Contamination
Class I Recall
058-2016
Health Risk: High
Jul 12, 2016
Distribution List PDF
Congressional and Public Affairs
Gabrielle N. Johnston
(202) 720-9113
WASHINGTON, July 12, 2016 – Simmons Prepared Foods, Inc., a Van Buren, Ark. establishment, is recalling approximately 5,850 pounds of frozen, heat treated, not ready-to-eat (NRTE) chicken products that may be contaminated with E. coli O121, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The frozen, heat treated, not ready-to-eat (NRTE) chicken tenderloin items were produced on Jan. 25, 2016. The following products are subject to recall:
View Labels PDF Only
30-lb. net-weight case containing six, 5-lb. bags in clear film of “Simmons UNCOOKED CHICKEN TENDERLOIN FRITTERS,” with a case code 31473, packaging date code of 6025, and a Use-By date of 01/25/17.
30-lb. net-weight case containing six, 5-lb. bags in clear film of “Simmons UNCOOKED CHICKEN BREAST TENDERLOIN FRITTERS,” with a case code 62331 and a packaging date of 6025.
The products subject to recall bear establishment number “P-5837” inside the USDA mark of inspection. These items were distributed to Arkansas for institutional use.
The problem was discovered on July 7, 2016, when Simmons Prepared Foods, Inc. received notice from a supplier that flour sold to the establishment was recalled by General Mills. The firm used the recalled flour to bread the chicken fritters affected by this recall action. There have been no confirmed reports of adverse reactions or illnesses due to consumption of these Simmons Prepared Foods, Inc. products.
Information on the General Mills’ recall can be found at: http://www.fda.gov/Safety/Recalls/ucm509693.htm.
Many clinical laboratories do not test for non-O157 Shiga toxin-producing E. coli (STEC), such as STEC O121 because it is harder to identify than STEC O157. People can become ill from STECs 2–8 days (average of 3–4 days) after consuming the organism. Most people infected with STEC O121 develop diarrhea (often bloody), and vomiting. Some illnesses last longer and can be more severe. Infection is usually diagnosed by testing of a stool sample. Vigorous rehydration and other supportive care is the usual treatment; antibiotic treatment is generally not recommended.
Most people recover within a week, but, rarely, some develop a more severe infection. Hemolytic uremic syndrome (HUS) is uncommon with STEC O121 infection. HUS can occur in people of any age but is most common in children under 5 years old, older adults and persons with weakened immune systems. It is marked by easy bruising, pallor, and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.
FSIS and the company are concerned that some product may be frozen and in consumers' freezers.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Media with questions regarding the recall can contact Donny Epp, Director of Communications, at (479) 215-2626 and Kimmie Provost, Executive Assistant and Corporate Affairs Coordinator, at (479) 215-2507. Consumers with questions regarding the recall can contact Vicky Goodman, Customer Service Manager, at (479) 215-2296.
John
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News Release
Michael Angelo's Gourmet Foods, Inc. Recalls Shrimp Scampi Products Due To Misbranding and Undeclared Allergens
Class I Recall
059-2016
Health Risk: High
Jul 13, 2016
Congressional and Public Affairs
Sarah R. Lichtman
(202) 720-9113
WASHINGTON, July 13, 2016 – Michael Angelo’s Gourmet Foods, Inc., an Austin, Texas establishment, is recalling approximately 4,225 pounds of frozen shrimp scampi products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products may be mislabeled and contain chicken, as well as egg and soy, known allergens, which are not declared on the product label.
The following products are subject to recall:
View Label PDF Only
26-oz. boxes, containing plastic trays, labeled, “Michael Angelo’s Uncompromisingly Italian-Style Shrimp Scampi with Linguini Pasta in a Fresh Heirloom Garlic-Butter Sauce” with a packaging date of May 7, 2016, “BEST IF USED BY” date of May 7, 2017 and UPC code 0 37363 98377 0.
Due to a packaging error, products are labeled as, “Michael Angelo’s Uncompromisingly Italian-Style Shrimp Scampi with Linguini Pasta in a Fresh Heirloom Garlic-Butter Sauce;” however, the packages may contain a chicken piccata product, which contains chicken, egg and soy, ingredients not declared on the label. The products subject to recall do not bear the USDA mark of inspection, as shrimp products are regulated by the U.S. Food and Drug Administration (FDA). These items were shipped to distributors in the Southeastern U.S.
The problem was discovered after the firm received a customer complaint.
There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury, illness or allergic reaction should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers with questions about the recall can contact the firm’s consumer hotline, at 1 (877) 482-5426. Media with questions about the recall can contact Richard Price, Vice President of Operations, Michael Angelo’s Gourmet Foods, Inc., at (512) 218-3514.
John
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*NOTE: There is a problem with the distribution link. It does NOT give the correct information. If there is another release on this I will post it.
News Release
Simmons Prepared Foods, Inc. Recalls Chicken Products Due To Possible E. Coli O121 Contamination
Class I Recall
058-2016
Health Risk: High
Jul 12, 2016
Distribution List PDF
Congressional and Public Affairs
Gabrielle N. Johnston
(202) 720-9113
WASHINGTON, July 12, 2016 – Simmons Prepared Foods, Inc., a Van Buren, Ark. establishment, is recalling approximately 5,850 pounds of frozen, heat treated, not ready-to-eat (NRTE) chicken products that may be contaminated with E. coli O121, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The frozen, heat treated, not ready-to-eat (NRTE) chicken tenderloin items were produced on Jan. 25, 2016. The following products are subject to recall:
View Labels PDF Only
30-lb. net-weight case containing six, 5-lb. bags in clear film of “Simmons UNCOOKED CHICKEN TENDERLOIN FRITTERS,” with a case code 31473, packaging date code of 6025, and a Use-By date of 01/25/17.
30-lb. net-weight case containing six, 5-lb. bags in clear film of “Simmons UNCOOKED CHICKEN BREAST TENDERLOIN FRITTERS,” with a case code 62331 and a packaging date of 6025.
The products subject to recall bear establishment number “P-5837” inside the USDA mark of inspection. These items were distributed to Arkansas for institutional use.
The problem was discovered on July 7, 2016, when Simmons Prepared Foods, Inc. received notice from a supplier that flour sold to the establishment was recalled by General Mills. The firm used the recalled flour to bread the chicken fritters affected by this recall action. There have been no confirmed reports of adverse reactions or illnesses due to consumption of these Simmons Prepared Foods, Inc. products.
Information on the General Mills’ recall can be found at: http://www.fda.gov/Safety/Recalls/ucm509693.htm.
Many clinical laboratories do not test for non-O157 Shiga toxin-producing E. coli (STEC), such as STEC O121 because it is harder to identify than STEC O157. People can become ill from STECs 2–8 days (average of 3–4 days) after consuming the organism. Most people infected with STEC O121 develop diarrhea (often bloody), and vomiting. Some illnesses last longer and can be more severe. Infection is usually diagnosed by testing of a stool sample. Vigorous rehydration and other supportive care is the usual treatment; antibiotic treatment is generally not recommended.
Most people recover within a week, but, rarely, some develop a more severe infection. Hemolytic uremic syndrome (HUS) is uncommon with STEC O121 infection. HUS can occur in people of any age but is most common in children under 5 years old, older adults and persons with weakened immune systems. It is marked by easy bruising, pallor, and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.
FSIS and the company are concerned that some product may be frozen and in consumers' freezers.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Media with questions regarding the recall can contact Donny Epp, Director of Communications, at (479) 215-2626 and Kimmie Provost, Executive Assistant and Corporate Affairs Coordinator, at (479) 215-2507. Consumers with questions regarding the recall can contact Vicky Goodman, Customer Service Manager, at (479) 215-2296.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Kerry Inc. Recalls Golden Dipt® Jalapeño Breaders Because of Possible Health Risk
For Immediate Release
July 12, 2016
Contact
Consumers
Kerry, Inc.
1-800-325-3383
Media
Jim Egan
608-299-5100
Announcement
View Product Photos
Kerry Inc. of Beloit, WI is recalling two lots of Golden Dipt® Jalapeño Breader that were sold to foodservice distributors because one of our suppliers recalled an ingredient used in our mix for the potential presence of E. coli O121. Kerry Inc. was notified by our supplier that two of their products, a red bell pepper nugget and a jalapeno nugget, were made with a small percentage of affected flour which was recalled by General Mills because it may be contaminated with E. coli O121.
Most strains of E. coli are harmless, however, others can make you sick. E. coli O121 is a potentially deadly bacterium that can cause bloody diarrhea and dehydration. People who experience these symptoms should seek emergency medical care immediately. The very young, seniors, and those with compromised immune systems are the most susceptible to foodborne illness. Anyone diagnosed by a physician as having an illness related to E. coli 0121 should contact state and local public health authorities.
No illnesses have been reported to date with the Kerry Inc. products. No other Kerry Inc. products are affected by this recall.
These two lot codes of Golden Dipt® Jalapeño Breader were manufactured by Kerry Inc. and sold to foodservice distributors located in Florida, Texas, Oklahoma, Illinois, Minnesota, New Jersey, Missouri and regions of Canada. Product may have been further distributed beyond these locations throughout the foodservice industry and to retail stores open to the general public.
The affected Golden Dipt® Jalapeño Breader is in a white 10 pound bag with the UPC number 763089721548 and Item Number: G5620.690. The recall only affects lots 0414647003 and 0513647003. The lot code is printed along the bottom of the label, as illustrated below.
If you have purchased Golden Dipt® Jalapeno Breader with either of the lot codes noted above, please dispose of the product and seek reimbursement with the distribution group/store where it was purchased. Questions can be directed to Kerry 800-325-3383 between the hours of 8 am to 5 pm CST.
This recall is being made with the knowledge of the U.S. Food and Drug Administration.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
IKEA N.A. Services, LLC Voluntarily Issues Expanded Recall and Allergy Alert on Undeclared Milk, Almond, and/or Hazelnut on Certain IKEA Chocolate Products
For Immediate Release
July 6, 2016
Contact
Consumers
1-888-966-4532
Announcement
View Product Photos
CHOKLAND MÖRK, CHOKLAND MÖRK 70%, CHOKLAD LINGON & BLABAR, CHOKLAD NÖT, GODIS CHOKLADKROKANT, GODIS CHOKLADRAN and CHOKLAD LJUS, are being recalled due to undeclared Milk, Hazelnuts and/or Almond. "All Best Before Dates," Sold from April 30, 2015 to July 1, 2016.
IKEA had samples of chocolate analyzed and found them to contain milk, hazelnut and/or almond. Persons allergic to milk, hazelnuts and/or almonds may have a severe to life-threatening reaction after consuming the dark chocolate.
Products have been distributed Nationwide at IKEA retail stores and sold individually. There has been no complaints or reported incidents in the United States to date. IKEA of Sweden has had one reported complaint in Japan. The chocolate products do carry an advisory statement, which identifies that the chocolate products may contain milk and tree nuts.
Consumers are encouraged to return the affected products to the nearest IKEA store for a full refund, proof of purchase is not required. If you have any questions or concerns please call Customer Service toll free (24/7) at 1-888-966-4532 or www.IKEA-usa.com.
We are sorry for any inconvenience this may cause.
IKEA recalls
Product Name
Size
UPC
Undeclared Allergens
CHOKLAD MORK Dark Chocolate Bar
3.5 oz. (100g)
1002939270003
Milk, Almond, Hazelnut
CHOKLAD MORK 70% Dark Chocolate Bars
3.5 0z. (100g)
1203080940009
Milk, Almond, Hazelnut
CHOKLAD LINGON & BLABAR
6.3 0z (180g)
1602184210009
Hazelnut, Almond
GODIS CHOKLADKROKANT Milk chocolate with butterscotch
15.9 oz. (450g)
1202155040002
Hazelnut, Almond
GODIS CHOKLADRAN Wafer filled and covered with chocolate
5.9 oz. (168g)
1202290300009
Hazelnut, Almond
CHOKLAD LJUS Milk Chocolate Bar
3.5 oz. (100g)
1402939250003
Hazelnut, Almond
CHOKLAD NÖT Milk Chocolate with hazelnut
3.5 oz. (100g)
1202939260008
Almond
Original Press Release
http://www.fda.gov/Safety/Recalls/ucm508786.htm
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Baptista's Bakery Issues Allergy Alert on Undeclared Milk in Snack Factory® Original Pretzel Crisps®
For Immediate Release
July 12, 2016
Contact
Consumers
Snack Factory® Consumer Affairs
1-888-683-5400
Media
Laura Villarreal
414-409-2123
Announcement
View Product Photos
Baptista’s Bakery, Inc. announced a voluntary recall of a limited number of 30 oz. Snack Factory® Original Pretzel Crisps® packages because they may contain undeclared milk ingredients. People who have an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume the affected product.
This voluntary recall covers only the following product:
Snack Factory® Original Pretzel Crisps®
30 oz packages
UPC code: 049508250401
Best By Date: 07-01-17
No other Snack Factory® Original Pretzel Crisps® products or sizes were impacted.
We are initiating this recall out of an abundance of caution after determining that seasoned product produced in the same facility may have been commingled with the product listed above.
No illnesses have been reported as a result of this issue. Baptista’s Bakery has informed the U.S. Food & Drug Administration of this voluntary recall.
To locate the Best By date, consumers should look on the bottom of the package. Consumers who have purchased the product listed above should not consume it, but should dispose of it or return it to the store where it was originally purchased. Consumers may also contact Snack Factory® Consumer Affairs for a full refund online at info@pretzelcrisps.com or by calling (888) 683-5400 between 8am and 5pm Central Standard Time. Please direct additional questions or concerns to Laura Villarreal at 414-409-2123 between 8 am and 6pm Central Standard Time.
John
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Tuesday, July 12, 2016
Researchers make advance in possible treatments for Gaucher, Parkinson’s diseases
NIH scientists identify molecule that may impact serious neurological diseases
With assistance from a high tech robot, National Institutes of Health researchers have identified and tested a molecule that shows promise as a possible treatment for the rare Gaucher disease and the more common Parkinson’s disease. Ellen Sidransky, M.D., a senior investigator with NIH’s National Human Genome Research Institute (NHGRI), and her collaborators at the National Institute of Neurological Disorders and Stroke (NINDS) and the National Center for Advancing Translational Sciences (NCATS), published their findings June 12, 2016 in the Journal of Neuroscience.
“Until now, drugs used to treat Gaucher disease have not been able to enter the brain and reach those neurons that are affected in the most severe forms of Gaucher disease or in Parkinson’s disease,” said Dr. Sidransky. “It’s really exciting to have found a molecule that theoretically could be widely available to treat people with these diseases. However, there’s a long distance between identifying this molecule and having an approved drug.” Dr. Sidransky has conducted research on Gaucher disease for the last 28 years and made the connection between Gaucher disease and Parkinson’s disease in 2001.
Gaucher disease occurs when GBA1, the gene that codes for the protein glucocerebrosidase, is mutated. This protein normally helps cells dispose of certain fats (lipids), a type of waste produced by all cells. When a person inherits two mutated copies of GBA1, lipids accumulate and can cause symptoms such as enlargement of the spleen, frequent bleeding and bruising, weakened bones and, in the most severe cases, neurological disease. People with even one mutated copy of GBA1 are at higher risk of developing Parkinson’s disease, a common disorder characterized by tremors, muscular rigidity and slowed movements.
To better understand the connection between Gaucher and Parkinson’s diseases, NHGRI researchers used a labor-intensive technology to develop pluripotent stem cells (unspecialized cells that can develop into various specialized body cells). Elma Aflaki, Ph.D., a research fellow in Sidransky’s lab, created stem cells from the skin cells of Gaucher patients with and without Parkinson’s disease in the lab. She then converted the stem cells into neurons that had features that were identical to those in people with Gaucher disease. Neurons are nerve cells that transmit information via chemical messengers and electrical signals.
The researchers showed that the neurons from Gaucher patients, who also had Parkinson’s disease, showed elevated levels of alpha-synuclein. This is the protein that accumulates in the brains of people with Parkinson’s disease impacting neurons responsible for controlling movement.
The researchers then looked for a molecule that would help patients with mutant GBA1 break down cellular waste. In a process known as high-throughput drug screening, researchers at NCATS Chemical Genomics Center evaluated hundreds of thousands of different molecules. NCATS researchers Juan Marugan, Ph.D., Samarjit Patnaik, Ph.D., Noel Southall, Ph.D., and Wei Zheng, Ph.D., identified a promising molecule, NCGC607, in conjunction with researchers at the University of Kansas, Lawrence, which helps to “chaperone” the mutated protein so that it can still function. In the patients’ stem cell-derived neurons, NCGC607 reversed the lipid accumulation and lowered the amount of alpha-synuclein, suggesting a possible treatment strategy for Parkinson’s disease.
“This research constitutes a major advance,” said Daniel Kastner, M.D., Ph.D., NHGRI scientific director and director of the institute’s Division of Intramural Research. “It demonstrates how insights from a rare disorder such as Gaucher disease can have direct relevance to the treatment of common disorders like Parkinson’s disease.”
Researchers will next test the new molecule to see if it might be developed into an appropriate prototype drug for patients with Gaucher disease and Parkinson’s disease.
Gaucher disease affects an estimated 1 in 50,000 to 1 in 100,000 people in the general population. People of Eastern and Central European (Ashkenazi) Jewish heritage are more likely to get Gaucher disease. Parkinson’s disease affects 1.5-2 percent of people over age 60, and the incidence increases with age. In the United States, about 60,000 new cases are identified each year. Parkinson’s disease affects more than 1 million people in North America and 7-10 million people worldwide.
NHGRI is one of the 27 institutes and centers at the NIH, an agency of the Department of Health and Human Services. The NHGRI Division of Intramural Research develops and implements technology to understand, diagnose and treat genomic and genetic diseases. Additional information about NHGRI can be found at: www.genome.gov.
NINDS is the nation’s leading funder of research on the brain and nervous system. The mission of NINDS is to seek fundamental knowledge about the brain and nervous system and to use that knowledge to reduce the burden of neurological disease.
About the National Center for Advancing Translational Sciences (NCATS): NCATS is a distinctly different entity in the research ecosystem. Rather than targeting a particular disease or fundamental science, NCATS focuses on what is common across diseases and the translational process. The Center emphasizes innovation and deliverables, relying on the power of data and new technologies to develop, demonstrate and disseminate advances in translational science that bring about tangible improvements in human health. For more information, visit https://ncats.nih.gov.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
John
Recall: Floor Lamps
in Pinching Pennies
Posted
http://www.cpsc.gov/en/Recalls/2016/Home-Source-Recalls-Floor-Lamps/
Home Source Recalls Floor Lamps Due to Fire and Shock Hazards
Recall date: JULY 14, 2016
Recall number: 16-224
Recall Summary
Name of product: Floor lamps
Hazard: The lamps can short circuit due to defective sockets, posing fire and shock hazards.
Consumer Contact:
Home Source toll-free at 888-660-5549 from 9 a.m. to 5 p.m. ET Monday through Friday or online at www.homesourceind.com and click on the “Safety Notice” link for more information.
Recall Details
Units
About 2,700
Description
This recall involves brown metal floor lamps with alabaster glass shades. They are illuminated with a single 100-watt light bulb and measure about 70 to 72 inches tall. The model numbers LMP4229, LMP4168 and LMP10771 can be found on the label at the bottom of the lamps.
Incidents/Injuries
Home Source has received three reports of the lamp’s sockets burning and smoking. No injuries have been reported.
Remedy
Consumers should immediately stop using the recalled floor lamps and contact Home Source for information on returning the lamps for a full refund.
Sold at
Small retail stores located in the New York metropolitan area and online at Amazon.com, Houzz.com, Target.com and Wayfair.com from February 2016 to April 2016 for about $60.
Importer(s)
Home Source Industries LLC, of East Rutherford, N. J.
Distributor(s)
Home Source Industries LLC, of East Rutherford, N. J.
Manufactured in
China
John