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WormGuy

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  1. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm513406.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    Public Notification: Mang Luk Power Slim Detox contains hidden drug ingredient

     

    [7/27/2016] The Food and Drug Administration (FDA) is advising consumers not to purchase or use Mang Luk Power Slim Detox, a product promoted for weight loss. This product was identified by FDA during an examination of international mail shipments.

     

    FDA laboratory analysis confirmed that Mang Luk Power Slim Detox contains sibutramine and desmethylsibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. Desmethylsibutramine is a substance structurally similar to sibutramine. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.

     

    Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

     

    Complete and submit the report online MedWatch Online Voluntary Reporting Form, or:

    Download and complete the form, then submit it via fax at 1-800-FDA-0178.

     

    Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.

     

     

     

    :wormie2:

    John

  2. http://www.fda.gov/Safety/Recalls/ucm515105.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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: JM Exotic Foods, Inc. Recalls Ground Turmeric Due to Elevated Levels of Lead

     

    For Immediate Release

    August 5, 2016

     

    Contact

    Consumers

    Customer Service

    (205) 699-2889

     

    Announcement

    View Product Photos

    http://www.fda.gov/Safety/Recalls/ucm515105.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos

     

    JM Exotic Foods, Inc. is recalling ground turmeric because samples from our supplier were found to contain elevated levels of lead.

     

    This product was solely distributed to a farmer’s market in Doraville, GA from May until August 2016.

     

    While the U.S. Food and Drug Administration (FDA) has not set a specific limit on lead in spices, there is a limit of 0.1 PPM in candy. The Environmental Protections Agency (EPA) has stated that lead levels of 0.015 PPM in drinking water require treatment. Lead can accumulate in the body over time and too much of it can cause serious and sometimes permanent adverse health consequences. No illnesses have been reported to date.

     

    The recalled products:

     

    Ground Turmeric, Item Number 1153, were packaged in 4 oz. clear plastic clamshells with the following codes:

     

    Lot# 16131185

    Lot# 16165184

     

    Customers who have purchased this product are urged not to consume the product and should return it for a full refund. Consumers with questions may contact Customer Service at (205) 699-2889, Monday – Thursday (7am – 5pm CDT).

     

     

     

    :wormie2:

    John

  3. http://www.fda.gov/Safety/Recalls/ucm515328.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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: Gel Spice, Inc. Issues Expanded Recall of Ground Tumeric Powder Due to Elevated Lead Levels

     

    For Immediate Release

    August 5, 2016

     

    Contact

    Consumers

    (201) 564-0435

     

    Announcement

    View Product Photos

    http://www.fda.gov/Safety/Recalls/ucm513844.htm#recall-photos

     

    Gel Spice, Inc. is expanding its recall of ground turmeric powder to include additional brands because of elevated lead levels. Lead can accumulate in the body over time. Too much can cause health problems, including delayed mental and physical development and learning deficiencies. Pregnant women, infants and young children especially should avoid exposure to lead. People concerned about blood lead levels should contact their physician or health clinic to ask about testing.

     

    The additional products being recalled are identified in the table below.

     

    Brand/Description and Net Weight

    Lot/BB code

    UPC NUMBER

     

    Spice Select/8 oz

    03/18/19

    076114007730

     

    Market Pantry/0.95 oz

    05APR2019

    085239211038

     

    Gel/15 oz

    04/18/19

    076114800867

     

    Gel/15 oz

    05/16/19

    076114800867

     

    Clear Value /0.75oz

    04/27/19

    036800354920

     

    Lieber’s/2 oz

    05/13/19

    043427006361

     

    Spice Supreme/2 oz

    05/17/19

    076114364628

     

    The products were distributed by various retailers throughout the United States.

    Sampling and testing of another product, produced from the same bulk turmeric, revealed the elevated level of lead.

     

    No illnesses have been reported to date in connection with this problem.

     

    Consumers who have purchased the ground turmeric powders identified above should discard the product. Consumers with questions about the recalled product may call (201) 564-0435 between the hours of 8 AM to 4 PM Eastern Time, Monday-Friday.

     

    Original FDA Recall Page

    http://www.fda.gov/Safety/Recalls/ucm513844.htm

     

     

     

    :wormie2:

    John

  4. http://www.fda.gov/Safety/Recalls/ucm515304.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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.

     

    Beyond Better Foods, LLC Issues Allergy Alert On Undeclared Peanuts In Mislabeled Peanut Butter Chocolate Chip Ice Cream

     

    For Immediate Release

    August 6, 2016

     

    Contact

    Consumers

    Customer Service

    1-800-819-2998

     

    Announcement

    View Product Photos

    http://www.fda.gov/Safety/Recalls/ucm515304.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos

     

    Beyond Better Foods, LLC is recalling select cases from a single production run of Enlightened brand Peanut Butter Chocolate Chip ice cream because they may have been packaged in Mint Chocolate Chip ice cream containers and thus contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

     

    The affected product was distributed nationwide in retail stores. Beyond Better Foods is taking immediate steps to recall all affected product.

     

    This recall is the result of mislabeled product. Specifically, portions of one lot of Peanut Butter Chocolate Chip ice cream was mistakenly filled in pint sized Enlightened brand Mint Chocolate Chip pint containers, and capped with Peanut Butter Chocolate Chip labeled lids. These packages have a base container labeled “Mint Chocolate Chip,” a lid labeled “Peanut Butter Chocolate Chip” and are filled with Peanut Butter Chocolate chip ice cream. The opaque container reveals tan Peanut Butter Chocolate Chip ice cream inside -- not light green Mint Chocolate Chip ice cream. All affected products have a “best by” date of November 18, 2017.

     

    Customers who have purchased mislabeled Peanut Butter Chocolate Chip ice cream in an Enlightened brand Mint Chocolate Chip container are urged to return it to the place of purchase for a full refund. Questions may be directed to 1-800-819-2998 Monday-Friday between 9AM and 5PM Eastern Time.

     

    Investigation regarding the source of this mislabeling is ongoing, though it is believed to be an isolated incident.

     

    To date, no illnesses have been reported related to this recall.

     

     

     

    :wormie2:

    John

  5. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-070-2016-release

     

     

    News Release

     

    Al Shabrawy Meat Incorporated Recalls Meat and Poultry Products Due To Misbranding and Undeclared Allergens

     

    Class I Recall

    070-2016

    Health Risk: High

    Aug 6, 2016

     

    Congressional and Public Affairs

    Richard J. McIntire

    (202) 720-9113

    Press@fsis.usda.gov

     

    WASHINGTON, AUG. 6, 2016 – Al Shabrawy Meat Inc., a South River, N.J. establishment, is recalling an undetermined amount of meat and poultry products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. Some of the products contain pistachio nut and soy, known allergens, which are not declared on the product label.

     

    The beef bologna, beef salami, mortadella and other sausage-like items were produced on various dates between Jan. 1, 2015 and Aug. 4, 2016. The following products are subject to recall:

    View Labels PDF Only

    http://www.fsis.usda.gov/wps/wcm/connect/d25da70f-5a34-46d9-a083-82179448205d/070-2016-labels.pdf?MOD=AJPERES

     

    1-lb. plastic container of “AL SHABRAWY COOKED BEEF SALAMI” with UPC code 4203601235 printed on the label.

     

    16-oz. rolls of “AL SHABRAWY COOKED BEEF BOLOGNA” with UPC code 4203601237 printed on the label.

     

    5-lb. rolls of “AL SHABRAWY COOKED BEEF BOLOGNA” with UPC code 4203601236 printed on the label.

     

    1-lb. plastic container of “AL SHABRAWY COOKED BEEF MORTADELLA” with UPC code 4203601236 printed on the label.

     

    5-lb. plastic container of “AL SHABRAWY COOKED BEEF SALAMI PLAIN” with UPC code 4203601235 printed on the label.

     

    20-lb. cases, containing five pieces of “AL SHABRAWY BASTERMA” with UPC code 4203601231 printed on the label.

     

    1-lb. plastic container of “BAROODY COOKED BEEF SALAMI” with UPC code 4203601235 printed on the label.

     

    1-lb. plastic container of “BAROODY MAKANEK (Raw)” with UPC code 4203601223 printed on the label.

     

    .75-lb. plastic container of “BAROODY SOUJOUK (Dried Beef Sausage)” with UPC code 4203601222 printed on the label.

     

    The products subject to recall bear establishment number “EST. 19160” inside the USDA mark of inspection. These items were shipped to retail locations and wholesalers in California, Florida, Illinois, New Jersey, New York and Pennsylvania.

     

    The problem was discovered during an on-going FSIS investigation at the establishment following a complaint to the agency. The major public health concerns include listing hydrolyzed plant protein in the ingredient statement of the beef bologna and beef mortadella, but not specifying that soy, an allergen, is the source of that protein. Also, the beef mortadella products did not declare pistachio nut, an allergen, on individual package ingredient statements, although some cases of the product display a sticker stating “Pistachio” was in the product. FSIS also found that beef salami and beef bologna products contained poultry ingredients and a sausage product tested positive for Red Dye #40, which is not declared on product labels. Additionally, raw beef trim, designated for cooking only, was used in raw non-intact finished products.

     

    There have been no confirmed reports of adverse reactions 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 and the company are concerned that some product may be frozen and in consumers' freezers.

     

    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 and media with questions about the recall can contact Medhat Mechaeil, company owner, at (732) 238-0428.

     

     

     

    :wormie2:

    John

  6. http://www.cdc.gov/salmonella/reading-08-16/index.html

     

     

     

    Multistate Outbreak of Salmonella Reading and Salmonella Abony Infections Linked to Alfalfa Sprouts

     

    Posted August 5, 2016 4:15 PM ET

    Highlights

     

    Read the Advice to Retailers and Consumers

    http://www.cdc.gov/salmonella/reading-08-16/advice.html

     

    CDC, several states, and the U.S. Food and Drug Administration (FDA) are investigating a multistate outbreak of Salmonella Reading and Salmonella Abony infections.

     

    30 people infected with the outbreak strains of Salmonella Reading or Salmonella Abony have been reported from nine states.

     

    Five ill people have been hospitalized. No deaths have been reported.

    Epidemiologic and traceback evidence available at this time indicate that alfalfa sprouts supplied by Sprouts Extraordinaire of Denver, Colorado are the likely source of this outbreak.

    On August 5, 2016, Sprouts Extraordinaire recalled alfalfa sprout products from the market due to possible Salmonella contamination.

    Recalled alfalfa sprouts were sold in 5-pound boxes and labeled "Living Alfalfa Sprouts."

    CDC recommends that consumers do not eat and restaurants and other retailers do not sell or serve recalled alfalfa sprouts supplied by Sprouts Extraordinaire.

    This investigation is ongoing, and we will update the public when more information becomes available.

     

    Initial Announcement

    Introduction

     

    CDC is collaborating with public health officials in several states and the U.S. Food and Drug Administration (FDA) to investigate a multistate outbreak of Salmonella Reading and Salmonella Abony infections.

     

    Public health investigators are using the PulseNet system to identify illnesses that may be part of this outbreak. PulseNet, coordinated by CDC, is the national subtyping network of public health and food regulatory agency laboratories. PulseNet performs DNA fingerprinting on Salmonella bacteria isolated from ill people by using techniques called pulsed-field gel electrophoresis (PFGE) and whole genome sequencing (WGS). CDC PulseNet manages a national database of these DNA fingerprints to identify possible outbreaks.

     

    Thirty people infected with the outbreak strains have been reported from nine states. Of those ill people, 24 were infected with Salmonella Reading, 1 was infected with Salmonella Abony, and 5 were infected with both. A list of the states and the number of cases in each can be found on the Case Count Map page.

     

    Illnesses started on dates ranging from May 21, 2016 to July 20, 2016. Ill people range in age from less than 1 year to 72, with a median age of 30. Fifty-three percent of ill people are female. Five ill people have been hospitalized, and no deaths have been reported.

     

    This outbreak can be illustrated with a chart showing the number of people who became ill each day. This chart is called an epidemic curve or epi curve. Illnesses that occurred after July 12, 2016, might not yet be reported due to the time it takes between when a person becomes ill and when the illness is reported. This takes an average of 2 to 4 weeks. Please see the Timeline for Reporting Cases of Salmonella Infection for more details.

     

    Investigation of the Outbreak

     

    Epidemiologic and traceback evidence available at this time indicate that alfalfa sprouts supplied by Sprouts Extraordinaire of Denver, Colorado are the likely source of this outbreak.

     

    In interviews, ill people answered questions about the foods they ate and other exposures in the week before they became ill. Of the 27 ill people who were interviewed, 17 (63%) reported eating or possibly eating alfalfa sprouts in the week before illness started. This proportion is significantly higher than results from a 2006 survey of healthy people, in which 3% reported eating sprouts on a sandwich in the week before they were interviewed. Ill people in the current outbreak reported eating raw alfalfa sprouts on sandwiches from several different restaurants.

     

    Federal, state, and local health and regulatory officials performed a traceback investigation from five restaurants where ill people reported eating alfalfa sprouts. This investigation indicated that Sprouts Extraordinaire supplied alfalfa sprouts to all five of these locations.

     

    On August 5, 2016, Sprouts Extraordinaire recalled its alfalfa sprout products from the market due to possible Salmonella contamination. These products were sold in 5-pound boxes labeled "Living Alfalfa Sprouts". CDC recommends that restaurants and other retailers do not sell or serve and consumers do not eat recalled alfalfa sprouts supplied by Sprouts Extraordinaire. Read the Advice to Retailers and Consumers.

     

    This investigation is ongoing, and we will update the public when more information becomes available. CDC and state and local public health partners are continuing laboratory surveillance through PulseNet to identify additional ill people and to interview those people about foods they ate before they got sick.

     

     

     

    :wormie2:

    John

  7. 0.25 Percent Bupivacaine Hydrochloride Injection, USP by Hospira: Recall - Particulate Matter

    AUDIENCE: Pharmacy, Risk Manager, OBGYN, Dentistry

     

    ISSUE: Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017) at the hospital/retail level due to the presence of particulate matter within a single vial. In the event that the particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate.

     

    BACKGROUND: 0.25% Bupivacaine Hydrochloride Injection, USP is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.

     

    The product is packaged 50 units of 30 mL Single-use Teartop Vials per case, (25 Bottles per tray, two trays per case). The lot was distributed nationwide in the U.S. to wholesalers and hospitals between December 2015 and January 2016. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

     

    RECOMMENDATION: Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Inform Healthcare Professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital/retail level.

     

    Healthcare professionals and patients 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 a link to the firm's press release, at:

    http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm515233.htm

     

     

     

    :wormie2:

    John

  8. http://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm490246.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    FDA Releases Final Environmental Assessment for Genetically Engineered Mosquito

     

    Update

    August 5, 2016

     

    The FDA has completed the environmental review for a proposed field trial to determine whether the release of Oxitec Ltd.’s genetically engineered (GE) mosquitoes (OX513A) will suppress the local Aedes aegypti mosquito population in the release area at Key Haven, Florida. After considering thousands of public comments, the FDA has published a final environmental assessment (EA) and finding of no significant impact (FONSI) that agrees with the EA’s conclusion that the proposed field trial will not have significant impacts on the environment.

     

    FDA’s finalization of the EA and FONSI does not mean that Oxitec’s GE mosquitos are approved for commercial use. Oxitec is responsible for ensuring all other local, state, and federal requirements are met before conducting the proposed field trial, and, together with its local partner, the Florida Keys Mosquito Control District, to determine whether and when to begin the proposed field trial in Key Haven, Florida.

     

    May 16, 2016

    The public comment period for the draft Environmental Assessment and preliminary Finding of No Significant Impact concerning investigational use of Oxitec OX513A mosquitoes was extended for 30 days and closed on May 13, 2016. The FDA is thoroughly reviewing all public comments and information submitted before determining its next steps. Oxitec will not conduct the field trial of its OX513A mosquito until the FDA has had the opportunity to review public comments on the draft EA and determined whether it will finalize the EA and FONSI or prepare an Environmental Impact Statement.

     

    March 11, 2016

    The FDA is releasing for public comment a draft environmental assessment (EA) submitted by Oxitec, Ltd., that assesses the potential environmental impacts of a field trial of the company’s genetically engineered (GE) Aedes aegypti mosquitoes (OX513A) in Key Haven, Florida. Ae. aegypti is known to transmit potentially debilitating human viral diseases, including Zika, dengue, yellow fever and chikungunya.

     

    The National Environmental Policy Act (NEPA) requires federal agencies to assess the environmental impacts of certain actions. Pursuant to FDA regulations, sponsors opening an Investigational New Animal Drug (INAD) file must submit either a draft EA or a claim of categorical exclusion from the EA requirement.

     

    The FDA is also releasing a preliminary finding of no significant impact (FONSI) that agrees with the draft EA’s conclusion that the field trial of such GE mosquitoes will not result in significant impacts on the environment.

     

    Oxitec will not conduct the field trial of its OX513A mosquito until the FDA has had the opportunity to review public comments on the draft EA, and subsequently has issued either a final EA and FONSI or an environmental impact statement.

     

    The FDA is accepting public comments on the draft EA and preliminary FONSI for 30 days from the date of publication in the Federal Register. To submit your comments electronically to the docket, go to www.regulations.gov and type FDA-2014-N-2235 in the search box. While comments are welcome at any time, you should submit them by the closing date to ensure FDA considers your comments.

     

    To submit your comments to the docket by mail, use the following address. Be sure to include docket number FDA-2014-N-2235 on each page of your written comments.

     

    The Division of Dockets Management

    HFA-305

    Food and Drug Administration

    5630 Fishers Lane, Room 1061

    Rockville, MD 20852

     

     

     

    Additional Information

    Oxitec Mosquito

    http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm446529.htm

     

    Oxitec Mosquito - Final Environmental Assessment (PDF - 3MB)

    http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/UCM514698.pdf

     

    Oxitec Mosquito - Finding of No Significant Impact (PDF - 198KB)

    http://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/UCM514699.pdf

     

    Notice of Availability; Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning Investigational Use of Oxitec OX513A Mosquitoes

    https://www.federalregister.gov/articles/2016/03/14/2016-05622/draft-environmental-assessment-and-preliminary-finding-of-no-significant-impact-concerning

     

     

     

    :wormie2:

    John

  9. VentStar Oxylog 3000 Pediatric Patient Breathing Circuit by Dräger: Class I Recall - Potential Valve Leakage

     

    AUDIENCE: Emergency Medicine, Risk Manager, Patient

     

    ISSUE: Dräger discovered that the check valve on the circuit may leak. This could result in the patient re-breathing exhaled gas with reduced oxygen concentration and increased carbon dioxide levels. This can lead to serious health consequences, including excessive carbon dioxide in the bloodstream (hypercapnia) and increased acidity in the blood (acidosis), which could lead to death.

     

    This issue pertains only to the VentStar Oxylog 3000 Disposable Pediatric Patient Circuit. There is no issue or problem with the Oxylog 3000/3000 plus ventilator.

     

    BACKGROUND: The VentStar Oxylog 3000 disposable pediatric patient breathing circuit is used with the Dräger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators for pediatric patients who require ventilation.

     

    RECOMMENDATION: On May 31, 2016, the firm notified consignees of the problem via an Urgent Medical Device Recall letter. The letter directed consignees to identify and dispose of the affected products.

     

    Healthcare professionals and patients 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 a link to the FDA Class I Recall Notice, at:

    http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm515152.htm

     

     

     

    :wormie2:

    John

     

  10. http://www.fda.gov/Safety/Recalls/ucm515116.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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.

     

    Mann Packing Voluntarily Issuing Class 1 Recall Of O Organics Organic Vegetable Tray With Creamy Ranch Dressing Dip Due To Mislabeled Ingredients That May Pose An Allergen Risk

     

    For Immediate Release

    August 4, 2016

     

    Contact

    Consumers

    Mann Packing

    info@mannpacking.com

    1-800-285-1002

     

    Media

    Lorri Koster | Mann Packing Co., Inc.

    lorri.koster@mannpacking.com

    831-594-4156

     

    Announcement

    View Product Photos

    http://www.fda.gov/Safety/Recalls/ucm515116.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos

     

    Mann Packing is voluntarily recalling 844 cases of 18 ounce O Organics Organic Vegetable Tray with Creamy Ranch Dressing Dip because the product ingredients label does not identify ingredients that could pose an allergen risk; specifically egg, milk and soy.

     

    The recalled product has a Best If Used By date of August 11, 2016 and an incorrect UPC barcode: 21130 98428. No illnesses have been reported in association with the recall to date. No other Mann Packing or O Organics products are affected by the recall. Mann Packing is taking the extra precautionary measure of issuing this recall so that consumers who may have purchased the product are properly made aware.

     

    The recalled product is carried at Albertsons, ACME, Carrs, Haggen, Pavilions, Pak ‘N Save, Safeway, Shaw’s, Star Market,

     

    Tom Thumb and Vons stores in the following states: Alaska, Arizona, Arkansas, California, Connecticut, Delaware, Hawaii, Idaho, Louisiana, Maine, Maryland, Massachusetts, Nevada, New Hampshire, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Rhode Island, Texas, Utah, Vermont and Washington.

     

    Consumers who have the recalled product in their possession and are allergic to egg, milk and soy, should not consume the item. The product can be returned to the place of purchase for a full refund. Consumers with questions should contact Mann Packing at 1-800-285-1002 Monday through Friday from 8 am to 5 pm Pacific Standard Time or via info@mannpacking.com. Customers can also call Albertsons Companies Customer Service at 1-877-723-3929 at any time.

     

    The following product with the Best if Used By date of Aug 11 is subject to this recall. The best if used by date can be found in the upper left corner.

     

    Mann Packing representatives are contacting retail customers who received the item and asking that they remove the product from their store shelves and inventories.

     

    About Mann Packing Company

    Founded in 1939, Mann Packing is an industry leading, third-generation supplier of premium fresh vegetables. Headquartered in Salinas, California, Mann’s is one of the largest suppliers of western vegetables, Broccoli® and sugar snap peas in North America. The firm holds the distinguished Women’s Owned Business Certification from the Women’s Business Enterprise National Council - the most widely recognized and respected certification in the United States for women’s business enterprises. Leading the way in product innovation, environmental sustainability and green supply chain management practices, Mann Packing is consistently vigilant in food safety, employee wellness and quality assurance, making for one of the most trusted brands in the industry.

     

     

     

    :wormie2:

    John

  11. http://www.fda.gov/Safety/Recalls/ucm515105.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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: JM Exotic Foods, Inc. Recalls Ground Turmeric Due to Elevated Levels of Lead

     

    For Immediate Release

    August 5, 2016

     

    Contact

    Consumers

    Customer Service

    (205) 699-2889

     

    Announcement

    View Product Photos

    http://www.fda.gov/Safety/Recalls/ucm515105.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos

     

    JM Exotic Foods, Inc. is recalling ground turmeric because samples from our supplier were found to contain elevated levels of lead.

     

    This product was solely distributed to a farmer’s market in Doraville, GA from May until August 2016.

     

    While the U.S. Food and Drug Administration (FDA) has not set a specific limit on lead in spices, there is a limit of 0.1 PPM in candy. The Environmental Protections Agency (EPA) has stated that lead levels of 0.015 PPM in drinking water require treatment. Lead can accumulate in the body over time and too much of it can cause serious and sometimes permanent adverse health consequences. No illnesses have been reported to date.

     

    The recalled products:

     

    Ground Turmeric, Item Number 1153, were packaged in 4 oz. clear plastic clamshells with the following codes:

     

    Lot# 16131185

    Lot# 16165184

     

    Customers who have purchased this product are urged not to consume the product and should return it for a full refund. Consumers with questions may contact Customer Service at (205) 699-2889, Monday – Thursday (7am – 5pm CDT).

     

     

     

    :wormie2:

    John

  12. http://www.fda.gov/Safety/Recalls/ucm515115.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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.

     

    JML Ingredients Recalls IQF Cut Green Beans Because Of Possible Health Risk

     

    For Immediate Release

    July 22, 2016

     

    Contact

    Consumers

    JML Ingredients

    717-569-2141

     

    Announcement

    JML Ingredients, Inc. of East Petersburg, PA is recalling IQF Cut Green Beans, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

     

    IQF Cut Green Beans was distributed to manufacturers in Massachusetts, New York, and Pennsylvania.

     

    No illnesses have been reported to date.

     

    The recall was the result of a routine sampling program by a manufacturer who used the product in their finished product. JML Ingredients has ceased the distribution of the product as FDA and the company continue their investigation as to what caused the problem.

     

    Products being recalled are as follows:

     

    Brand

    Product

    Lot Number

    Expiration Date

    Product size/container

     

    ICAPP

    IQF CUT GREEN BEANS

    110815 / 15649

    August 10, 2017

    20 lb. / 9.070 kg. bulk case

     

    ICAPP

    IQF CUT GREEN BEANS

    120815 / 15650

    August 11, 2017

    20 lb. / 9.070 kg. bulk case

     

    ICAPP

    IQF CUT GREEN BEANS

    050915 / 15651

    September 4, 2017

    20 lb. / 9.070 kg. bulk case

     

    ICAPP

    IQF CUT GREEN BEANS

    200915 / 15652

    September 19, 2017

    20 lb. / 9.070 kg. bulk case

     

    Consumers who have purchased ICAPP IQF CUT GREEN BEANS are urged to return it to the place of purchase for a full refund. Consumers with questions may contact JML Ingredients at 717-569-2141.

     

     

     

    :wormie2:

    John

  13. http://www.fda.gov/Safety/Recalls/ucm514967.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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.

     

    Grassfields Cheese Recall Affects Select Whole Foods Market Locations; Grocer Recalls Product from Cheese Departments

     

    For Immediate Release

    August 3, 2016

     

    Contact

    Consumers

    Grassfields Cheese

    Grassfieldscheese@gmail.com

    616-997-8251

     

    Announcement

    AUSTIN, Texas - In response to Grassfields Cheese LLC’s organic cheese recall, Whole Foods Market is voluntarily recalling the product from select stores in the Midwest and South out of an abundance of caution. Grassfields Cheese issued the recall due to possible contamination with Shiga toxin-producing E. coli (STEC), a bacteria that can cause serious illness in humans.

     

    E.coli infection symptoms vary by individual, but often include severe stomach cramps, diarrhea (often bloody), and vomiting. If there is fever, it usually is not very high (less than 101˚F/less than 38.5˚C). Most people get better within 5–7 days. Some infections are very mild, but others are severe or even life-threatening. Around 5–10% of those diagnosed with Shiga-toxin producing E.coli infections develop a potentially life-threatening complication known as hemolytic uremic syndrome (HUS). Signs that a person is developing HUS include decreased frequency of urination, feeling very tired, and losing pink color in cheeks and inside the lower eyelids.

     

    The recall includes the following types of Grassfields Cheeses: Gouda, Onion ‘n Garlic, Country Dill, Leyden, Edam, Lamont Cheddar, Fait Gras and Polkton Corners which were cut and packaged in clear plastic wrap with scale labels beginning with PLU codes that ranged from 0206151 to 0206159 and "sell by" dates through 9/2/2016.

     

    The products were sold at Whole Foods Market stores in the following states: Alabama, Georgia, Illinois, Iowa, Indiana, Michigan, Minnesota, Missouri, Nebraska, North Carolina, South Carolina, Tennessee and Wisconsin. Not all products were sold in all stores.

     

    The potential for contamination was identified during an ongoing investigation of seven cases of human illnesses occurring between March and July 2016 caused by a same type of STEC. The Michigan Department of Agriculture and Rural Development’s Geagley Laboratory confirmed the presence of STEC bacteria in a sample of Grassfields cheese collected by MDARD food and dairy inspectors.

     

    Consumers who have purchased any of these recalled products can return them to the store for a full refund. Consumers with questions may contact Grassfields Cheese at 616-997-8251 Monday – Friday, 8am - 5pm EST or Grassfieldscheese@gmail.com.

     

     

     

    :wormie2:

    John

  14. The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

     

     

    On August 3, 2016, the U.S. Food and Drug Administration approved the first generic version of Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B ) in patients two weeks of age and older who have had flu symptoms for no more than 48 hours; and prevention of the flu in patients one year of age and older. Tamiflu was approved in 1999.

     

    The FDA is committed to improving patient access to safe and effective generic drugs. Generic drugs approved by the FDA have the same high-quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.

     

    The most common side effects reported by people using oseltamivir phosphate in clinical trials included nausea and vomiting.

     

    Patients must use oseltamivir phosphate as directed by their health care provider. Oseltamivir phosphate does not take the place of receiving a flu vaccination. Talk to your health care provider about when you should receive an annual flu vaccination.

     

    Oseltamivir phosphate does not treat or prevent illness caused by infections other than the influenza virus, and oseltamivir phosphate does not prevent bacterial infections that may happen with the flu. The FDA does not know if oseltamivir phosphate is effective in people who start treatment after two days of developing symptoms, or have weakened immune systems.

     

    Patients and health care providers may find more information on oseltamivir phosphate in the drug label.

     

    For more information:

     

    Tamiflu’s label

    http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021087s068,021246s051lbl.pdf?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

    First-Time Generic Drug Approvals

    http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ANDAGenericDrugApprovals/?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

     

    :wormie2:

    John

  15. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-068-2016-release

     

     

    News Release

     

    Santana’s Black Label Gourmet Beef Jerky Recalls Beef Jerky Products Produced Without Benefit of Inspection

     

    Class I Recall

    068-2016

    Health Risk: High

    Jul 29, 2016

     

    Distribution List PDF

    http://www.fsis.usda.gov/wps/wcm/connect/344b496e-e7e3-4837-a871-da21ea292798/RC-068-2016-Retail-List.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=344b496e-e7e3-4837-a871-da21ea292798

     

    Congressional and Public Affairs

    Sarah R. Lichtman

    (202) 720-9113

    Press@fsis.usda.gov

     

    WASHINGTON, JULY 29, 2016 – Santana’s Black Label Gourmet Beef Jerky, a Glendale, Ariz. establishment, is recalling approximately 295 pounds of beef jerky products that were produced without the benefit of federal inspection and used the USDA mark of inspection without authorization, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

     

    The beef jerky items were produced on May 25, 2016, June 1, 2016 and June 26, 2016. The following products are subject to recall:

    Labels PDF Only

    http://www.fsis.usda.gov/wps/wcm/connect/ea65c360-987b-4ffd-80ad-9c4c84929fbe/068-2016.pdf?MOD=AJPERES

     

    2.8-oz. plastic bag packages containing “Santana’s Black Label Beef Jerky Heaven” with a “BEST BY” date of May 25, 2017, June 1, 2017 or July 1, 2017.

     

    2.8-oz. plastic bag packages containing “Santana’s Black Label Beef Jerky Smokey Robinson” with a “BEST BY” date of May 25, 2017, June 1, 2017 or July 1, 2017.

     

    2.8-oz. plastic bag packages containing “Santana’s Black Label Beef Jerky Hatcho .357” with a “BEST BY” date of May 25, 2017, June 1, 2017 or July 1, 2017.

     

    2.8-oz. plastic bag packages containing “Santana’s Black Label Beef Jerky Super Mario” with a “BEST BY” date of May 25, 2017, June 1, 2017 or July 1, 2017.

     

    The products subject to recall bear a false establishment number “EST. 090115” inside the mark of inspection. The firm applied this mark of inspection to the labels of the beef jerky products without authorization. Products produced on June 26, 2016, may not bear the mark of inspection. These items were shipped to distributors and retail locations in Arizona.

     

    FSIS was alerted to the problem by a third party source.

     

    There have been no confirmed reports of adverse reactions, illnesses, or injuries 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.

     

    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 and media with questions about the recall can contact Louis Santana Lopez, Owner, Santana’s Black Label Gourmet Beef Jerky, at (505) 615-6920.

     

     

     

    :wormie2:

    John

  16. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-069-2016-release

     

     

    News Release

     

    Grossglockner Inc. Recalls Pork Products Due To Misbranding

     

    Class II Recall

    069-2016

    Health Risk: Low

    Aug 3, 2016

     

    Congressional and Public Affairs

    Nina Anand

    (202) 720-9113

    Press@fsis.usda.gov

     

    WASHINGTON, Aug. 3, 2016 – Grossglockner Inc., a Canandaigua, N.Y. establishment, is recalling approximately 204 pounds of fully cooked, not shelf stable, pork sausage banger products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The firm affixed the incorrect label to the back of products on the July 6, 2016 packaging date. The products have the “Banger Sausage” front label but have an incorrect ingredients label for “Wiener Products” on the back of the package. The Banger sausages contain breadcrumbs formulated with wheat; however, the back label is not correct and thus, does not sub-list the breadcrumbs. Therefore, wheat is not declared and may elicit allergic reactions in those allergic to wheat products.

     

    The pork sausage items were produced on July 5, 2016. The following product is subject to recall:

    View Labels PDF Only

    http://www.fsis.usda.gov/wps/wcm/connect/981cf310-37e5-4463-982b-df420f167f9d/069-2016-labels.pdf?MOD=AJPERES

     

    16-oz. vacuum-packed packages containing “Handcrafted by Joseph Brunner Wegmans Bangers 8% Bread Crumbs” bearing lot number “18716” and a sell-by date of 08/24/2016.

     

    The products subject to recall bear establishment number “EST. M-6373” inside the USDA mark of inspection. These items were shipped to Wegman’s stores in Pennsylvania, Maryland, New Jersey, and Virginia.

     

    The problem was discovered by Wegman’s store personnel. Wegman’s Corporate Headquarters contacted the establishment, which alerted FSIS personnel of the issue.

     

    There have been no confirmed reports of adverse reactions due to consumption of this product. Anyone concerned about an injury or illness should contact a healthcare provider.

     

    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.

     

    Media and consumers with questions about the recall can contact Elizabeth Brunner, Director of Operations, at (585)-266-4960 ext. 103.

     

     

     

    :wormie2:

    John

  17. http://www.cpsc.gov/en/Recalls/2016/Porta-Recalls-Residential-Elevators/

     

     

    Porta Recalls Residential Elevators Due to Serious Fall Hazard

     

    Recall date: AUGUST 03, 2016

    Recall number: 16-238

     

    Recall Summary

     

    Name of product: Residential elevators with electro mechanical door locks (EMDLs)

     

    Hazard: The plastic locks can allow the landing door to open before the elevator car arrives, posing a serious fall hazard to consumers attempting to board the elevator.

     

    Consumer Contact:

    Consumers should contact their elevator service company. Consumers can also contact Porta Inc. toll-free at 844-719-9037 from 8 a.m. to 1 p.m. CT Monday through Thursday or online at www.emiporta.com and click on “Important Product Safety Notice” for more information. Consumers also can email the firm at emdlinfo@emiporta.com.

     

    Recall Details

     

    Units

    About 60,000

     

    Description

    This recall involves all residential elevators with plastic electro mechanical door locks. The EMDLs are installed as part of a complete residential elevator system. Locks included in this recall have a plastic generation 1, 2, 3 or 4 latch and keeper attached to the upper corner on the elevator side of each landing door. A UL or ETL label affixed to the bottom of the EMDL box has “Porta Inc.” printed on it.

     

    Incidents/Injuries

    The firm has received two reports of lock failure. No injuries have been reported.

     

    Remedy

    Consumers should immediately stop using elevators equipped with the electro mechanical door locks and contact their elevator service company to have the plastic locks replaced with metal parts.

     

    Sold at

    Elevator manufacturers nationwide from January 2005 through December 2011 for between $20,000 and $40,000.

     

    Manufacturer(s)

    Porta Inc., of Arlington Heights, Ill.

     

    Manufactured in

    U.S.

     

     

     

    :wormie2:

    John

  18. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm514678.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter

     

    Posted 08/03/2016

    AUDIENCE: Pharmacy, Nursing

     

    ISSUE: Teva Pharmaceuticals announced a voluntary recall of seven lots of Amikacin Sulfate Injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials due to the potential for the presence of glass particulate matter. The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected. See the press release for a listing of affected lot numbers.

     

    BACKGROUND: Amikacin Sulfate Injection USP is used in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, and has also been shown to be effective in staphylococcal infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease.

     

    Amikacin Sulfate Injection 250 mg/mL, 2 mL & 4 mL vials were distributed nationwide through wholesalers, retailers, and pharmacies.

     

    RECOMMENDATION: Teva issued an Urgent Drug Recall Letter to their direct customers. Teva is arranging for impacted product to be returned to Inmar. Anyone with an existing inventory of the recalled lot(s) should stop use and distribution, and quarantine the product immediately. Customers should notify all retail and medical facility accounts. Customers who have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities.

     

    For medical related questions please contact Teva Medical Information at 888-838-2872, option 3, then, option 4. For a customer service related question, please contact Teva Customer Service at 800-545-8800, Monday – Friday; 8:00 AM – 5:00 PM EST. Consumers should immediately contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.

     

    Healthcare professionals and patients 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

     

     

     

    :wormie2:

    John

  19. http://www.cpsc.gov/en/Recalls/2016/BYA-Sports-Recalls-Hammocks/

     

     

    BYA Sports Recalls Hammocks Due to Fall Hazard

     

    Recall date: AUGUST 02, 2016

    Recall number: 16-237

     

    Recall Summary

     

    Name of product: Bring Your Adventure (BYA) Sports hammocks

     

    Hazard: A weld on the ring of the hammocks can fail, allowing the hammock to pull free and fall while in use, posing a fall hazard to the user.

     

    Consumer Contact:

    BYA Sports collect at 303-443-0163 from 8 a.m. to 5 p.m. MT Monday through Friday or online at www.BYAsports.com and click on the Recall Information tab for more information.

     

    Recall Details

     

    Units

    About 760

     

    Description

    This recall involves BYA Sports Double Hammocks sold in blue or orange. The nylon hammocks measure about 12 feet by 6.5 feet with an attached nylon stuff sack and metal ring on the ends. The BYA logo is printed on the front of the stuff sack. Hammocks with the following UPC bar codes printed on the back of the merchandising card attached to the hammock are included in the recall: 7456112010186 (orange) and 7456112010193 (blue). The BYA logo and “DOUBLE HAMMOCK” is printed on the front of the merchandising card.

     

    Incidents/Injuries

    The firm has received two reports of ring failure, including one report of bruising from a fall.

     

    Remedy

    Consumers should immediately stop using the recalled hammocks and contact BYA Sports for a free replacement hammock.

     

    Sold at

    Gander Mountain stores nationwide and online at amazon.com, dicksportinggoods.com, promotive.com and target.com from January 2015 through March 2016 for between $60 and $75.

     

    Manufacturer(s)

    BYA Sports, of Louisville, Colo.

     

    Manufactured in

    China

     

     

     

    :wormie2:

    John

  20. http://www.cpsc.gov/en/Recalls/2016/Starbucks-to-Recall-Stainless-Steel-Beverage-Straws-to-Provide-New-Warnings/

     

     

    Laceration Injuries to Children Prompt Starbucks to Recall Stainless Steel Beverage Straws to Provide New Warnings

     

    Recall date: AUGUST 02, 2016

    Recall number: 16-236

     

    Recall Summary

     

    Name of product: Stainless Steel Straws

     

    Hazard: The stainless steel straws are rigid and can poke children in the mouth, posing a risk of injury.

     

    Consumer Contact:

    Starbucks at 800-782-7282 from 3 a.m. to Midnight PT daily or online at https://news.starbucks.com

    and click on “stainless steel straw warnings” for more information.

     

    Recall Details

     

    In conjunction with

     

     

     

     

    Canada Flag

     

    Units

    About 2.5 million in the U.S. (in addition, about 301,000 were sold in Canada)

     

    Description

    This recall involves reusable stainless steel Cold-to-Go food grade drinking straws in two sizes. The straws were packaged and sold in sets of three and were also sold as a component of two sizes of stainless steel beverage cups: Grande 16-ounce cups and Venti 24-ounce cups. The straws feature a ridge at the bottom that keeps the straw attached to the lid. The Grande straws measure approximately 9.5 inches and the Venti straws measure approximately 10.4 inches.

     

    Incidents/Injuries

    The firm has received three reports of mouth lacerations to young children while drinking.

     

    Remedy

    Consumers should not allow children to handle or use the stainless steel straws.

     

    Sold exclusively at

    Starbucks stores nationwide and online at Starbucks.com from June 2012 through June 2016 for about $6 for a set of three straws. The beverage cups with straws were sold for between $11 and $30.

     

    Importer(s)

    Starbucks Corp., of Seattle, Wash.

     

    Manufactured in

    China

     

     

     

    :wormie2:

    John

  21. http://www.fda.gov/Safety/Recalls/ucm514358.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

     

     

    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.

     

    Sage Products Issues Voluntary Nationwide Recall of Comfort Shield Barrier Cream Cloths Due to Microbial Contamination

     

    For Immediate Release

    August 1, 2016

     

    Contact

    Consumers

    Customer Service

    1-800-421-6556

     

    Media

    Michael Nygren, Director of Marketing Communications

    mnygren@sageproducts.com

    815-455-4700

     

    Announcement

    View Product Photos

    http://www.fda.gov/Safety/Recalls/ucm514358.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-photos

     

    CARY, IL, USA July 29, 2016 -- Sage Products announced today it is voluntarily initiating a nationwide recall of one lot of Comfort Shield Barrier Cream Cloths to the distributor and health care facility/user level. The recall is being initiated due to product contamination with the bacteria, Burkholderia cepacia.

     

    Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups. These infections could be life-threatening. To date, no adverse events have been reported associated with the recalled products, which were distributed to distributors and healthcare facilities in the United States. The product, Comfort Shield Barrier Cream Cloths is a non-sterile, topical skin protectant used to treat and prevent moisture associated skin irritation caused by urine and/or stool exposure. The package contains three, single-use, disposable cloths. This recall affects the following lot of Comfort Shield Barrier Cream Cloths:

     

    Product Code

    NDC Number

    Lot Number

    Expiration Date

     

    7503

    53462-915-50

    53957

    3/6/2018

     

    Sage Products notified its distributors and health care facilities by letter, and they were provided instructions to discontinue use and return product to Sage Products. The affected lot was distributed to customers between March 31, 2016 and June 8, 2016.

     

    Customers who received affected products should discontinue use of the affected products and return them to Sage Products for credit by contacting Sage Products customer service at 1-800-421-6556, Monday through Friday, between the hours of 8:00 a.m. to 5:00 p.m., Central Time

     

    Customers with questions regarding this recall, or requiring replacement product, can call Sage Products customer service at 1-800-421-6556, Monday through Friday, between the hours of 8:00 a.m. to 5:00 p.m., Central Time. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

     

    Any 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 knowledge of the U.S. Food and Drug Administration.

     

    About Sage Products

     

    Since 1971, Sage Products has successfully developed and produced innovative prevention products that have significantly improved outcomes for patients and clinicians, while improving efficiency and profitability for healthcare facilities. In 2016, Sage was acquired by Stryker Corporation and is a business within the Stryker Medical Division. Sage is a leading developer of products used to prevent hospital-acquired conditions such as skin injury due to incontinence, pressure ulcers, surgical site infections and healthcare worker injury. To learn more, visit www.sageproducts.com

     

     

     

    :wormie2:

    John

  22. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-059-2016-exp-release

     

     

    News Release

     

    Michael Angelo's Gourmet Foods, Inc. Recalls Shrimp Scampi and Meat Lasagna Products Due To Misbranding and Undeclared Allergens

     

    Class I Recall

    059-2016 EXP

    Health Risk: High

    Aug 1, 2016

     

    Congressional and Public Affairs

    Sarah R. Lichtman

    (202) 720-9113

    Press@fsis.usda.gov

     

    EDITORS NOTE: This release is being reissued as an expansion of the July 13, 2016 release to include additional products and production dates. The initial recall included 4,225 pounds of shrimp scampi product. This expansion includes an additional 1,452 pounds of meat lasagna product, for a total of 5,677 pounds of product.

     

    WASHINGTON, Aug. 1, 2016 – Michael Angelo’s Gourmet Foods, Inc., an Austin, Texas establishment, is recalling approximately 5,677 pounds of frozen shrimp scampi and meat lasagna 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, soy or shrimp, known allergens, which are not declared on the product label.

     

    The following products are subject to recall:

    View Labels PDF Only

    http://www.fsis.usda.gov/wps/wcm/connect/dad7f577-2d18-4595-a74d-ac2be91f2043/059-2016-exp-labels.pdf?MOD=AJPERES

     

    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.

     

    11-oz. boxes, containing plastic trays, labeled, “Michael Angelo’s Uncompromisingly Italian-Style Lasagna with Meat Sauce” with a packaging date of July 11, 2016, “BEST IF USED BY” date of July 11, 2017 and UPC code 0 37363 00612 7.

     

    Due to a packaging error, the products labeled as, “Michael Angelo’s Uncompromisingly Italian-Style Shrimp Scampi with Linguini Pasta in a Fresh Heirloom Garlic-Butter Sauce” may contain a chicken piccata product, which contains chicken, egg and soy, ingredients not declared on the label. These 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).

     

    The products labeled as “Michael Angelo’s Uncompromisingly Italian-Style Lasagna with Meat Sauce” may contain a shrimp scampi product, which contains shrimp, an ingredient not declared on the product label. These products bear the establishment number “1009A” within the USDA mark of inspection.

     

    These items were shipped to distributors in the southern U.S.

     

    The problem was discovered after the firm received customer complaints.

     

    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.

     

     

     

    :wormie2:

    John

  23. I saw this the other day.

     

     

     

    http://www.fooddive.com/news/what-nobody-is-telling-the-public-about-a-large-sugar-recall/423541/

     

     

    *Snip

     

     

    What nobody is telling the public about a large sugar recall

    By Carolyn Heneghan | July 29, 2016

     

    Manufacturers may be able to find relief knowing that the FDA abides by corporate confidentiality laws. However, the main problem here is not facing regulators — it's facing consumers.

     

    In a statement to Food Safety News, the FDA said, "We are still gathering information and working to identify other parts of the relevant supply chain and facilitate recalls where necessary. However, FDA is prohibited by law from releasing publicly certain information about supply chains, which may constitute confidential commercial information."

     

    The questions in this recall are often answered upfront by the company and FDA in news releases made available to the public. That nobody—not the sugar supplier itself, the FDA nor the companies that purchase the sugar—has come forward to identiifiy the supplier could suggest a larger recall is looming in the near future.

    Recommended Reading

     

    Food Safety News: FDA cites corporate confidentiality laws in secret sugar recall

    http://www.foodsafetynews.com/2016/07/fda-cites-corporate-confidentiality-laws-in-secret-sugar-recall/#.V58njTXnPvr

     

     

     

    :wormie2:

    John

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