WormGuy
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News Release
Al Shabrawy Incorporated Recalls Meat and Poultry Products Due To Misbranding and Undeclared Allergens
Class I Recall
070-2016 EXP
Health Risk: High
Aug 10, 2016
Distribution List PDF
Congressional and Public Affairs
Benjamin A. Bell
(202) 720-9113
EDITORS NOTE: This release is being reissued as an expansion of the August 6, 2016 recall to include additional products. The first recall 070-2016 on August 6, 2016, recalled an undetermined amount of basterma, sausage, soujouk, salami, mortadella, makanek, and bologna products due to misbranding and undeclared allergens. The expansion of the recall is based on evidence provided by FSIS that all package sizes and brands of the products produced during the initial recall dates of January 1, 2015 to August 4, 2016 are misbranded as described in the initial recall.
WASHINGTON, Aug. 10, 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 basterma, sausage, soujouk, salami, mortadella, makanek, bologna, Lahmajun (meat pie) 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
“TAZAH, SULTAN, & YORUK SLICED BASTERMA” – cryovaced and weighed at the time of sale
“AL MARAAI, AL HALU, BAROODY, & AL SHABRAWY SLICED AND WHOLE BASTERMA” – cryovaced and weighed at the time of sale
“AL SHABRAWY, TAZAH, & BAROODY MAKANEK” – cryovaced and weighed at the time of sale
“TAZAH EGYPTIAN STYLE FRESH SAUSAGE” – cryovaced and weighed at the time of sale
“AL SHABRAWY FRESH SAUSAGE” – cryovaced and weighed at the time of sale
“BAROODY & SULTAN DRIED SOUJOUK” – cryovaced and weighed at the time of sale
“SEVAN LAHMAJUN” – cryovaced and weighed at the time of sale
1-lb. plastic tubes (chubs) of “AL SHABRAWY PLAIN, OLIVE, & BLACK PEPPER SALAMI”
5-lb. plastic tubes (chubs) of “AL SHABRAWY PLAIN, OLIVE, & BLACK PEPPER SALAMI”
1-lb. plastic tubes (chubs) of “AL SHABRAWY OLIVE & PISTACHIO MORTADELLA”
5-lb. plastic tubes (chubs) of “AL SHABRAWY OLIVE & PISTACHIO MORTADELLA”
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.
Details of the first recall are: 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:
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.
John
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During the years around menopause (a time called perimenopause or menopausal transition), some women have hot flashes, night sweats, difficulty sleeping, or other troublesome symptoms. Can natural products or other complementary approaches help? See what the science says.
See what effect complementary approaches may have on symptoms of menopause.
http://nihseniorhealth.gov/complementaryhealthapproaches/faq/faq24.html
See “What You Can Do for Hot Flashes and Other Menopausal Symptoms” from the National Institute on Aging (NIA) at NIH.
John
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News Release
Green Bay Dressed Beef Recalls Beef Products Due To Possible Specified Risk Materials Contamination
Class II Recall
073-2016
Health Risk: Low
Aug 24, 2016
Congressional and Public Affairs
Benjamin A. Bell
(202) 720-9113
WASHINGTON, Aug. 24, 2016 – Green Bay Dressed Beef, LLC, doing business as American Foods Group, LLC, a Green Bay, Wis. establishment, is recalling approximately 7,420 pounds of beef brain products that may be contaminated with specified risk materials (SRM) the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The beef brains were produced on various dates between April 24, 2016, and August, 11, 2016. The following products are subject to recall:
View Label PDF Only
15-unit cases containing beef brains labeled “AMERICAN FOODS GROUP BEEF BRAINS <30” and bearing packaging code 06400.
The products subject to recall bear establishment number “EST. 410” inside the USDA mark of inspection. These items were shipped to a distributor in California.
The problem was discovered while FSIS inspectors were conducting verification activities.
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 and media with questions about the recall can contact Jennifer Dibbern at (800) 829-2838.
John
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http://www.foxbusiness.com/markets/2016/08/24/ford-to-recall-91000-cars-to-fix-fuel-pump-issue.html
FOLKS I HAD TO HACK THIS ARTICLE REALLY BAD TO GET IT UNDER THE 50 % LIMIT
Ford to Recall 91,000 Cars
About 91,000 vehicles to replace faulty fuel-pump parts that could potentially cause a car to stall without warning.
Ford would replace fuel-pump control modules in about 88,151 vehicles, including 2013-15 Ford Taurus sedans, Ford Flex crossover utility vehicles, Lincoln MKS sedans, Lincoln MKT SUVs and Ford Police Interceptor sedans.
2,472 Ford Transit vans to replace fuel-injection pumps in 2015-16.
23,150 Ford Escape SUVs of 2017 to update power-window software.
John
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http://www.cpsc.gov/en/Recalls/2016/Dorel-Juvenile-Recalls-Safety-1st-Strollers/
Dorel Juvenile Recalls Safety 1st Strollers Due to Fall Hazard
Recall date: AUGUST 24, 2016
Recall number: 16-249
Recall Summary
Name of product: Safety 1st Step and Go Travel Systems
Hazard: The stroller tray folding mechanism can partially disengage on one side when used with an infant car seat attached to the stroller, posing a fall hazard.
Consumer Contact:
Safety 1st toll-free at 866-762-3036 from 8 a.m. to 5 p.m. ET Monday through Friday, email at stepandgo@djgusa.com or online at www.safety1st.com and click on “Safety Notices” for more information.
Recall Details
In conjunction with
Canada Flag
Units
About 20,000 (in addition, 5,800 were sold in Canada)
Description
This recall involves Step and Go Travel Systems sold under the Safety 1st brand and manufactured by Dorel Juvenile. The stroller has a step-to-open design that opens by stepping on the pedal. It was sold in a variety of colors along with the OnBoard 35 infant car seat. Safety 1st is imprinted on the front of the stroller tray. Model number TR314 is printed on a white label on the back of the stroller seat.
Incidents/Injuries
The firm has received 30 reports of the front stroller tray that supports the infant car seat disengaging on one side. No injuries reported.
Remedy
Consumers should immediately stop using the recalled strollers with the infant car seat and contact Safety 1st for a free repair kit.
Sold at
Babies R Us and other retailers nationwide and online at amazon.com, babiesrus.com and Walmart.com from May 2015 through June 2016 for between $250 and $300.
Importer(s)
Dorel Juvenile, of Columbus, Ind.
Distributor(s)
Dorel Juvenile, of Columbus, Ind.
Manufactured in
China
John
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FDA Announcement
FDA Investigates Outbreak of Hepatitis A Illnesses Linked to Raw Scallops
For Immediate Release
August 24, 2016
Contact
Consumers
1-888-SAFEFOOD
Announcement
Please find more information about the Outbreak of Hepatitis A Illnesses Linked to Raw Scallops here:
http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm517289.htm
John
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Did you know that the National Park Service turns 100 tomorrow? And to celebrate this big birthday, entrance to all national parks will be free from August 25 to August 28. Learn more about the centennial celebrations.
Looking to visit a park close to you? Check out some of our own staff's favorites, and find out why they made the list!
John
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What to Know When Buying or Using a Breast Pump
Download PDF (140 K)
http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM335280.pdf
If you’re giving your baby breast milk, you probably know there can be times when a breast pump can come in handy.
Breast pumps are medical devices regulated by the U.S. Food and Drug Administration. They can be used to maintain or increase a woman’s milk supply, relieve engorged breasts and plugged milk ducts, or pull out flat or inverted nipples so a nursing baby can latch on more easily.
And there are important safety considerations if you use one.
What kinds of breast pumps are available?
A. Breast shield: Cone-shaped cup that fits over the nipple and surrounding area.
B. Milk container: Detachable container that fits below the breast shield and collects milk as it is pumped.
C. Pump: Creates the vacuum that expresses milk. The pump may be attached to the breast-shield or have plastic tubing to connect the pump to the breast shield.
Breast pumps include a breast shield that fits over the nipple, a pump that creates a vacuum to express (or pump) milk, and a detachable container for collecting milk.
Pumps can be manual or powered. Powered pumps can use batteries or a cord that plugs into an electrical outlet. Some pumps even have an adapter for use in the car. (Obviously not while you’re driving, however!)
Double pumps extract milk from both breasts at the same time, while single pumps extract milk from one breast. (Find food safety tips for babies, including breast milk storage tips, on the FDA’s website.)
The Affordable Care Act requires most insurance plans to cover the cost of a breast pump as part of women’s preventive health services. You can talk to your insurance company about its coverage.
Is it safe to rent or share a breast pump?
Renting or sharing these devices can be dangerous if pumps are not designed for multiple users.
“Consumers should be aware of the hazards of renting or sharing a breast pump that is not designed for multiple users—even with family and friends,” says H. Paige Lewter, an electrical engineer and device reviewer in the FDA’s Obstetrics and Gynecology Devices branch. “Contaminated breast pumps could cause you and your baby to develop an infection.”
“Even if a used device looks really clean, potentially infectious particles may survive in the breast pump and/or its accessories for a surprisingly long time,” adds Michael Cummings, M.D., an FDA obstetrician-gynecologist.
Key points:
Manual breast pumps are designed for one user only (single use) and should never be rented or shared for safety reasons.
Powered breast pumps that are designed for single users should never be rented or shared.
Sharing a breast pump may violate the manufacturer’s warranty, which means you may not be able to get help from the manufacturer if you have a problem with the pump.
The FDA does not recognize the term “hospital grade,” so this term doesn’t mean a pump is safe.
The bottom line for sharing breast pumps designed for single users? Don’t do it.
And if you rent or share from an authorized provider (such as a hospital, lactation consultant, or specialty medical supply store), do so only if the pump is designed for multiple users. And do so only if you have your own accessories kit to avoid contamination. The accessories kit typically includes the milk container, breast-shield, and tubing.
“Multiple-user pumps are designed so that the breast milk can never touch the working parts of the pump that are shared,” says Lewter. “The only part of a multiple-user breast pump that you can safely share is the pump itself.”
What kind of breast pump should you buy?
If you purchase a pump, consider your needs. For instance, if you’ll use the pump only at home, one that plugs into the wall may be fine. But if you’ll pump at work or otherwise away from home, you may want to consider a device that’s easy to carry and battery-powered.
Key points:
You should never buy a previously used or “pre-owned” pump designed for single users. That’s because these pumps sold secondhand also can expose you and your baby to contamination.
Buying a used pump may violate the manufacturer’s warranty.
If you’re not sure which pump or accessories to get, talk to a health care professional who has expertise in breastfeeding.
How should you clean a breast pump?
Contamination can happen even to your personal pump if it is not cleaned properly.
“Correct use and cleaning helps protect you and your baby,” says Lewter.
The FDA recommends cleaning and disinfection between uses. You should read the manufacturer’s instructions for specific information on how to keep your pump clean.
In general, steps for cleaning include:
Rinsing each piece that comes into contact with breast milk in cool water as soon as possible after pumping;
Washing each piece separately using liquid dishwashing soap and plenty of warm water;
Rinsing each piece thoroughly with hot water for 10 to 15 seconds; and Placing the pieces on a clean paper towel or in a clean drying rack and allowing them to air dry.
“Wiping the pump body with ethanol or isopropyl alcohol at 70 to 90 percent concentration—or boiling the breast pump parts in water—generally is also acceptable,” Lewter notes. “If the tubing looks moldy or cloudy, stop use and replace the tubing immediately.”
If you’re renting or buying a multiple-user device, ask the person providing the pump to make sure all components (including internal tubing), have been cleaned and disinfected according to the manufacturer’s instructions.
How can you report problems with these devices?
If a breast pump is not working as it should—for instance, if there are electrical problems or issues with suction—you can contact the manufacturer for recommendations on what to do with your device.
If you’re injured while using a breast pump or have pain, contact your health care provider. The FDA also encourages you to report injuries or problems with regulated devices to the agency. You can file a voluntary report by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program.
This article appears on the FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Published: January 14, 2013
Updated: August 24, 2016
For More Information
Breast Pumps
Food Safety for Moms to Be: Once Baby Arrives
http://www.fda.gov/Food/FoodborneIllnessContaminants/PeopleAtRisk/ucm089629.htm
HealthCare.gov: Breastfeeding Benefits
https://www.healthcare.gov/coverage/breast-feeding-benefits/
John
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Alex Toys Recalls Infant Building Play Sets Due to Choking Hazard
Recall date: AUGUST 23, 2016
Recall number: 16-248
Recall Summary
Name of product: ALEX Jr. Baby Builder, First Pops and First Snaps
Hazard: Small parts of the plastic toy building sets can detach, posing a choking hazard to young children.
Consumer Contact:
ALEX toll-free at 844-310-6691 anytime or online at www.alexbrands.com and click on the “Recall Information” link beneath the carousel for more information.
Recall Details
In conjunction with
Canada Flag
Units
About 91,000
Description
This recall involves three ALEX Jr. branded sets of infant building toys, the Baby Builder, model 1982, First Pops, model 1981P, and the First Snaps, model 1981S produced prior to November 2010. The sets include an assortment of plastic shapes in bright colors. The pieces are designed to be pulled, pushed, snapped and twisted and come in stackable plastic jars. They were sold in sets of 14 and 26 pieces.
The recalled First Snaps sets’ containers have the following batch codes, on a sticker above the UPC code on the container.
P0002073
P0001713
P0001330
P0000954
P0002107
P0001628
P0001009
P00000814
P0001948
P0001536
P0001098
P0001677
P0001427
P0000983
Incidents/Injuries
There have been 22 reports of the ends of small parts detaching from the building sets. No injuries have been reported.
Remedy
Consumers should immediately take the recalled building sets away from children and contact ALEX for a prepaid shipping envelope to return the product(s). ALEX will send consumers a full refund upon receipt of returned sets.
Sold at
Barnes & Noble and Land of Nod and online at www.Zulily.com. The Baby Builders were sold from December 2009 through June 2016 for about $28, First Pops sold from March 2009 through June 2016 for about $18, and First Snaps distributed from March 2009 through October 2010 for about $18.
Importer(s)
ALEX Toys, New Jersey
Manufactured in
China
John
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http://www.cpsc.gov/en/Recalls/2016/Crownplace-Brands-Recalls-Kerosene-Lamp-Burners/
Crownplace Brands Recalls Kerosene Lamp Burners Due to Burn and Fire Hazards
Recall date: AUGUST 23, 2016
Recall number: 16-246
Recall Summary
Name of product: Lamp burners
Hazard: The burner’s threads can disengage, allowing the burner to disconnect from the base, posing burn and fire hazards to the user.
Consumer Contact:
Crownplace Brands at 800-457-5267 from 9 a.m. to 4:30 p.m. ET Monday through Friday, via email at info@aladdinlamps.com or online at www.aladdinlamps.com for more information.
Recall Details
Units
About 500
Description
This recall involves Crownplace Brands’ Aladdin MaxBrite kerosene lamp burners. The solid brass lamp burners measure about four inches tall and three inches in diameter. The burner thread is about 3/8 inches long (about 9mm). “Aladdin MAXBrite500” is printed on the burner knob. The patent number is 3551086. “Aladdin” and the patent number are printed on the barrel of the burner.
Incidents/Injuries
The firm has received one report of thread failure, resulting in a first degree burn.
Remedy
Consumers should immediately stop using the recalled lamp burners and contact Crownplace Brands for a free replacement.
Sold at
Hardware and antique stores nationwide and online at www.amazon.com from July 2015 through July 2016 for between $100 and $400. The lamp burners were sold separately and as part of a lamp assembly.
Distributor(s)
Crownplace Brands Ltd, of Dalton, Ohio
Manufactured in
China
John
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http://www.cpsc.gov/en/Recalls/2016/McDonalds-Recalls-Step-iT-Activity-Wristbands/
McDonald’s Recalls “Step-iT” Activity Wristbands Due to Risk of Skin Irritation or Burns
Recall date: AUGUST 23, 2016
Recall number: 16-247
Recall Summary
Name of product: “Step-iT” Activity Wristbands
Hazard: The recalled wristbands can cause skin irritation or burns to children.
Consumer Contact:
McDonald’s at 800-244-6227 from 7 a.m. to 7 p.m. CT daily, or online at www.mcdonalds.com and click on “Safety Recall” for more information.
Recall Details
In conjunction with
Health Canada link
Units
About 29 million units in the U.S. (in addition, about 3.6 million units in Canada)
Description
This recall involves “Step-iT” activity wristbands, which come in two styles—“Activity Counter” and a motion-activated “Light-up Band.” The Activity Counter comes in translucent plastic orange, blue or green and features a digital screen that tracks a child’s steps or other movement. The Light-up Band comes in translucent plastic red, purple, or orange and blinks light with the child’s movement. Both styles of activity wristbands have a square face with the words “STEP-iT” printed on them and a button to depress and activate the wristband. The back of the square face contains the etched words “Made for McDonald’s.”
Incidents/Injuries
McDonald’s has received more than 70 reports of incidents, including seven reports of blisters, after wearing the wristbands.
Remedy
Consumers should immediately take the recalled wristbands from children and return them to any McDonald’s for a free replacement toy and either a yogurt tube or bag of apple slices.
Sold at
Distributed exclusively by McDonald’s restaurants nationwide from August 9, 2016 to August 17, 2016 with Happy Meals and Mighty Kids Meals.
Distributor(s)
McDonald’s Corp., of Oakbrook, Ill.
Manufactured in
China
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
August 17, 2016
Contact
Consumers
Snack Factory® Consumer Affairs
(888) 683-5400
Announcement
View Product Photos
Baptista’s Bakery, Inc. announced a voluntary recall of a limited number of 7.2 oz. Snack Factory® Original Pretzel Crisps® and 7.2 oz Snack Factory® Sriracha Lime 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 the following products:
Snack Factory® Original Pretzel Crisps®
7.2 oz packages
UPC code: 049508006008
Best By Date: 07-01-17
Snack Factory® Sriracha Lime Pretzel Crisps®
7.2 oz packages
UPC code: 049508006060
Best By Date: 07-01-17
No other Snack Factory® Original Pretzel Crisps® or Snack Factory® Sriracha Lime 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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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 Expands Voluntary Worldwide Recall of Specific Lots of Topical Skin Products Due to Potential Microbial Contamination - Second Expansion
For Immediate Release
August 19, 2016
Contact
Consumers
Sage Products Customer Service
1-800-421-6556
Media
Michael Nygren
815-455-4700
Announcement
View Product Photos
Cary, IL, Sage Products announced today it is expanding its voluntary worldwide recall to include specific lots of impregnated cloth topical skin products at the distributor, healthcare facility, retail and consumer/user levels. The recall is being initiated due to potential 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. The recalled products were distributed to distributors, healthcare facilities and retailers in the United States, Canada, El Salvador, Singapore, Saudi Arabia, Portugal, the Netherlands, Malaysia, Mexico, Australia, Ireland, Honduras, United Kingdom, Denmark, Germany, Bahrain, and United Arab Emirates. The recalled products contain single-use, disposable cloths and were distributed between August 2014 and August 2016. The list of affected products and their corresponding lot numbers are indicated below.
Comfort Shield® Barrier Cream Cloths
Lot #
Product Code
Description
Expiry
NDC
45489
7503
COMFORT SHIELD 3-PACK
8/23/16
53462-915-50
45537
7503
COMFORT SHIELD 3-PACK
8/25/16
53462-915-50
45631
7503
COMFORT SHIELD 3-PACK
9/1/16
53462-915-50
45781
7503
COMFORT SHIELD 3-PACK
9/10/16
53462-915-50
46345
7503
COMFORT SHIELD 3-PACK
10/18/16
53462-915-50
46708
7503
COMFORT SHIELD 3-PACK
11/9/16
53462-915-50
46763
7503
COMFORT SHIELD 3-PACK
11/11/16
53462-915-50
47378
7503
COMFORT SHIELD 3-PACK
1/5/17
53462-915-50
47723
7503
COMFORT SHIELD 3-PACK
1/27/17
53462-915-50
48347
7503
COMFORT SHIELD 3-PACK
3/4/17
53462-915-50
49057
7503
COMFORT SHIELD 3-PACK
4/18/17
53462-915-50
49498
7503
COMFORT SHIELD 3-PACK
5/16/17
53462-915-50
49576
7503
COMFORT SHIELD 3-PACK
5/19/17
53462-915-50
49869
7503
COMFORT SHIELD 3-PACK
6/8/17
53462-915-50
51306
7503
COMFORT SHIELD 3-PACK
9/10/17
53462-915-50
51309
7503
COMFORT SHIELD 3-PACK
9/10/17
53462-915-50
51720
503
COMFORT SHIELD 3-PACK
10/6/17
53462-915-50
52187
7503
COMFORT SHIELD 3-PACK
11/7/17
53462-915-50
52216
7503
COMFORT SHIELD 3-PACK
11/8/17
53462-915-50
52226
7503
COMFORT SHIELD 3-PACK
11/8/17
53462-915-50
52235
7503
COMFORT SHIELD 3-PACK
11/9/17
53462-915-50
52239
7503
COMFORT SHIELD 3-PACK
11/9/17
53462-915-50
52415
7503
COMFORT SHIELD 3-PACK
11/19/17
53462-915-50
52694
7503
COMFORT SHIELD 3-PACK
12/8/17
53462-915-50
52702
7503
COMFORT SHIELD 3-PACK
12/8/17
53462-915-50
52711
7503
COMFORT SHIELD 3-PACK
12/9/17
53462-915-50
52722
7503
COMFORT SHIELD 3-PACK
12/9/17
53462-915-50
52968
7503
COMFORT SHIELD 3-PACK
1/4/18
53462-915-50
53000
7503
COMFORT SHIELD 3-PACK
1/5/18
53462-915-50
53957
7503
COMFORT SHIELD 3-PACK
3/6/18
53462-915-50
54543
7503
COMFORT SHIELD 3-PACK
4/10/18
53462-915-50
54597
7503
COMFORT SHIELD 3-PACK
4/12/18
53462-915-50
55814
7503
COMFORT SHIELD 3-PACK
6/20/18
53462-915-50
45408
7905
COMFORT SHIELD 8-PACK
8/17/16
53462-915-80
45427
7905
COMFORT SHIELD 8-PACK
8/18/16
53462-915-80
45451
7905
COMFORT SHIELD 8-PACK
8/19/16
53462-915-80
45468
7905
COMFORT SHIELD 8-PACK
8/20/16
53462-915-80
45483
7905
COMFORT SHIELD 8-PACK
8/21/16
53462-915-80
45557
7905
COMFORT SHIELD 8-PACK
8/26/16
53462-915-80
45650
7905
COMFORT SHIELD 8-PACK
9/2/16
53462-915-80
45768
7905
COMFORT SHIELD 8-PACK
9/9/16
53462-915-80
45893
7905
COMFORT SHIELD 8-PACK
9/17/16
53462-915-80
45998
7905
COMFORT SHIELD 8-PACK
9/23/16
53462-915-80
46169
7905
COMFORT SHIELD 8-PACK
10/5/16
53462-915-80
46432
7905
COMFORT SHIELD 8-PACK
10/22/16
53462-915-80
46512
7905
COMFORT SHIELD 8-PACK
10/27/16
53462-915-80
46551
7905
COMFORT SHIELD 8-PACK
10/29/16
53462-915-80
46608
7905
COMFORT SHIELD 8-PACK
11/2/16
53462-915-80
46647
7905
COMFORT SHIELD 8-PACK
11/4/16
53462-915-80
46669
7905
COMFORT SHIELD 8-PACK
11/6/16
53462-915-80
46841
7905
COMFORT SHIELD 8-PACK
11/17/16
53462-915-80
46851
7905
COMFORT SHIELD 8-PACK
11/17/16
53462-915-80
46970
7905
COMFORT SHIELD 8-PACK
11/29/16
53462-915-80
47058
7905
COMFORT SHIELD 8-PACK
12/2/16
53462-915-80
47115
7905
COMFORT SHIELD 8-PACK
12/7/16
53462-915-80
47202
7905
COMFORT SHIELD 8-PACK
12/14/16
53462-915-80
47309
7905
COMFORT SHIELD 8-PACK
12/20/16
53462-915-80
47420
7905
COMFORT SHIELD 8-PACK
1/8/17
53462-915-80
47436
7905
COMFORT SHIELD 8-PACK
1/10/17
53462-915-80
47512
7905
COMFORT SHIELD 8-PACK
1/13/17
53462-915-80
47560
7905
COMFORT SHIELD 8-PACK
1/17/17
53462-915-80
47800
7905
COMFORT SHIELD 8-PACK
2/2/17
53462-915-80
47837
7905
COMFORT SHIELD 8-PACK
2/3/17
53462-915-80
48134
7905
COMFORT SHIELD 8-PACK
2/19/17
53462-915-80
48154
7905
COMFORT SHIELD 8-PACK
2/21/17
53462-915-80
48928
7905
COMFORT SHIELD 8-PACK
4/9/17
53462-915-80
48943
7905
COMFORT SHIELD 8-PACK
4/11/17
53462-915-80
49149
7905
COMFORT SHIELD 8-PACK
4/25/17
53462-915-80
49222
7905
COMFORT SHIELD 8-PACK
4/29/17
53462-915-80
49386
7905
COMFORT SHIELD 8-PACK
5/9/17
53462-915-80
49466
7905
COMFORT SHIELD 8-PACK
5/12/17
53462-915-80
49600
7905
COMFORT SHIELD 8-PACK
5/20/17
53462-915-80
49926
7905
COMFORT SHIELD 8-PACK
6/13/17
53462-915-80
50578
7905
COMFORT SHIELD 8-PACK
7/27/17
53462-915-80
50585
7905
COMFORT SHIELD 8-PACK
7/27/17
53462-915-80
50596
7905
COMFORT SHIELD 8-PACK
7/28/17
53462-915-80
50600
7905
COMFORT SHIELD 8-PACK
7/28/17
53462-915-80
50910
7905
COMFORT SHIELD 8-PACK
8/15/17
53462-915-80
51204
7905
COMFORT SHIELD 8-PACK
9/6/17
53462-915-80
51260
7905
COMFORT SHIELD 8-PACK
9/8/17
53462-915-80
51268
7905
COMFORT SHIELD 8-PACK
9/8/17
53462-915-80
51293
7905
COMFORT SHIELD 8-PACK
9/9/17
53462-915-80
51344
7905
COMFORT SHIELD 8-PACK
9/13/17
53462-915-80
51438
7905
COMFORT SHIELD 8-PACK
9/19/17
53462-915-80
51522
7905
COMFORT SHIELD 8-PACK
9/23/17
53462-915-80
51527
7905
COMFORT SHIELD 8-PACK
9/23/17
53462-915-80
51531
7905
COMFORT SHIELD 8-PACK
9/23/17
53462-915-80
51755
7905
COMFORT SHIELD 8-PACK
10/7/17
53462-915-80
51824
7905
COMFORT SHIELD 8-PACK
10/13/17
53462-915-80
52016
7905
COMFORT SHIELD 8-PACK
10/26/17
53462-915-80
52079
7905
COMFORT SHIELD 8-PACK
10/29/17
53462-915-80
52083
7905
COMFORT SHIELD 8-PACK
10/31/17
53462-915-80
52263
7905
COMFORT SHIELD 8-PACK
11/10/17
53462-915-80
52308
7905
COMFORT SHIELD 8-PACK
11/14/17
53462-915-80
52397
7905
COMFORT SHIELD 8-PACK
11/18/17
53462-915-80
52407
7905
COMFORT SHIELD 8-PACK
11/18/17
53462-915-80
52538
7905
COMFORT SHIELD 8-PACK
11/29/17
53462-915-80
52614
7905
COMFORT SHIELD 8-PACK
12/5/17
53462-915-80
52615
7905
COMFORT SHIELD 8-PACK
12/5/17
53462-915-80
52644
7905
COMFORT SHIELD 8-PACK
12/6/17
53462-915-80
52659
7905
COMFORT SHIELD 8-PACK
12/6/17
53462-915-80
52661
7905
COMFORT SHIELD 8-PACK
12/7/17
53462-915-80
52676
7905
COMFORT SHIELD 8-PACK
12/7/17
53462-915-80
52737
7905
COMFORT SHIELD 8-PACK
12/12/17
53462-915-80
52946
7905
COMFORT SHIELD 8-PACK
1/3/18
53462-915-80
53359
7905
COMFORT SHIELD 8-PACK
1/25/18
53462-915-80
53624
7905
COMFORT SHIELD 8-PACK
2/14/18
53462-915-80
53724
7905
COMFORT SHIELD 8-PACK
2/20/18
53462-915-80
53849
7905
COMFORT SHIELD 8-PACK
2/27/18
53462-915-80
53850
7905
COMFORT SHIELD 8-PACK
2/27/18
53462-915-80
54498
7905
COMFORT SHIELD 8-PACK
4/6/18
53462-915-80
54544
7905
COMFORT SHIELD 8-PACK
4/10/18
53462-915-80
54653
7905
COMFORT SHIELD 8-PACK
4/17/18
53462-915-80
54693
7905
COMFORT SHIELD 8-PACK
4/18/18
53462-915-80
54734
7905
COMFORT SHIELD 8-PACK
4/20/18
53462-915-80
54769
7905
COMFORT SHIELD 8-PACK
4/22/18
53462-915-80
54771
7905
COMFORT SHIELD 8-PACK
4/24/18
53462-915-80
54856
7905
COMFORT SHIELD 8-PACK
4/28/18
53462-915-80
54922
7905
COMFORT SHIELD 8-PACK
5/3/18
53462-915-80
54945
7905
COMFORT SHIELD 8-PACK
5/4/18
53462-915-80
55365
7905
COMFORT SHIELD 8-PACK
5/30/18
53462-915-80
55629
7905
COMFORT SHIELD 8-PACK
6/12/18
53462-915-80
55781
7905
COMFORT SHIELD 8-PACK
6/19/18
53462-915-80
56255
7905
COMFORT SHIELD 8-PACK
7/18/18
53462-915-80
56263
7905
COMFORT SHIELD 8-PACK
7/19/18
53462-915-80
56273
7905
COMFORT SHIELD 8-PACK
7/19/18
53462-915-80
56353
7905
COMFORT SHIELD 8-PACK
7/24/18
53462-915-80
56410
7905
COMFORT SHIELD 8-PACK
7/27/18
53462-915-80
56413
7905
COMFORT SHIELD 8-PACK
7/27/18
53462-915-80
56532
7905
COMFORT SHIELD 8-PACK
8/3/18
53462-915-80
46225
7502
COMFORT SHIELD 3-PACK
10/8/16
53462-915-51
46554
7502
COMFORT SHIELD 3-PACK
10/29/16
53462-915-51
46915
7502
COMFORT SHIELD 3-PACK
11/22/16
53462-915-51
49296
7502
COMFORT SHIELD 3-PACK
5/3/17
53462-915-51
49343
7502
COMFORT SHIELD 3-PACK
5/5/17
53462-915-51
50105
7502
COMFORT SHIELD 3-PACK
6/23/17
53462-915-51
50626
7502
COMFORT SHIELD 3-PACK
7/30/17
53462-915-51
50634
7502
COMFORT SHIELD 3-PACK
7/30/17
53462-915-51
50639
7502
COMFORT SHIELD 3-PACK
7/30/17
53462-915-51
51310
7502
COMFORT SHIELD 3-PACK
9/12/17
53462-915-51
51313
7502
COMFORT SHIELD 3-PACK
9/12/17
53462-915-51
51340
7502
COMFORT SHIELD 3-PACK
9/13/17
53462-915-51
52388
7502
COMFORT SHIELD 3-PACK
11/17/17
53462-915-51
52395
7502
COMFORT SHIELD 3-PACK
11/18/17
53462-915-51
52403
7502
COMFORT SHIELD 3-PACK
11/18/17
53462-915-51
52421
7502
COMFORT SHIELD 3-PACK
11/19/17
53462-915-51
52912
7502
COMFORT SHIELD 3-PACK
12/21/17
53462-915-51
52915
7502
COMFORT SHIELD 3-PACK
12/22/17
53462-915-51
52918
7502
COMFORT SHIELD 3-PACK
12/22/17
53462-915-51
53508
7502
COMFORT SHIELD 3-PACK
2/6/18
53462-915-51
54815
7502
COMFORT SHIELD 3-PACK
4/26/18
53462-915-51
56307
7502
COMFORT SHIELD 3-PACK
7/20/18
53462-915-51
56311
7502
COMFORT SHIELD 3-PACK
7/21/18
53462-915-51
56316
7502
COMFORT SHIELD 3-PACK
7/21/18
53462-915-51
56457
7502
COMFORT SHIELD 3-PACK
7/29/18
53462-915-51
56561
7502
COMFORT SHIELD 3-PACK
8/4/18
53462-915-51
53304
7508
COMFORT SHIELD 8-PACK
1/23/18
53462-915-81
53339
7508
COMFORT SHIELD 8-PACK
1/24/18
53462-915-81
53342
7508
COMFORT SHIELD 8-PACK
1/24/18
53462-915-81
53357
7508
COMFORT SHIELD 8-PACK
1/25/18
53462-915-81
55784
7508
COMFORT SHIELD 8-PACK
6/19/18
53462-915-81
50806
7524
COMFORT SHIELD 24-PACK
2/7/17
53462-915-60
52305
7524
COMFORT SHIELD 24-PACK
5/15/17
53462-915-60
48066
7526
COMFORT SHIELD 24-PACK
8/18/16
53462-915-62
48110
7526
COMFORT SHIELD 24-PACK
8/20/16
53462-915-62
48596
7526
COMFORT SHIELD 24-PACK
9/20/16
53462-915-62
48668
7526
COMFORT SHIELD 24-PACK
9/23/16
53462-915-62
49249
7526
COMFORT SHIELD 24-PACK
11/1/16
53462-915-62
49335
7526
COMFORT SHIELD 24-PACK
11/4/16
53462-915-62
49535
7526
COMFORT SHIELD 24-PACK
11/16/16
53462-915-62
50614
7526
COMFORT SHIELD 24-PACK
1/28/17
53462-915-62
50702
7526
COMFORT SHIELD 24-PACK
2/2/17
53462-915-62
50988
7526
COMFORT SHIELD 24-PACK
2/21/17
53462-915-62
51288
7526
COMFORT SHIELD 24-PACK
3/11/17
53462-915-62
51715
7526
COMFORT SHIELD 24-PACK
4/6/17
53462-915-62
51745
7526
COMFORT SHIELD 24-PACK
4/8/17
53462-915-62
51749
7526
COMFORT SHIELD 24-PACK
4/8/17
53462-915-62
51754
7526
COMFORT SHIELD 24-PACK
4/8/17
53462-915-62
51765
7526
COMFORT SHIELD 24-PACK
4/9/17
53462-915-62
51870
7526
COMFORT SHIELD 24-PACK
4/18/17
53462-915-62
52484
7526
COMFORT SHIELD 24-PACK
5/26/17
53462-915-62
52864
7526
COMFORT SHIELD 24-PACK
6/20/17
53462-915-62
53095
7526
COMFORT SHIELD 24-PACK
7/13/17
53462-915-62
53398
7526
COMFORT SHIELD 24-PACK
8/1/17
53462-915-62
54081
7526
COMFORT SHIELD 24-PACK
9/12/17
53462-915-62
54373
7526
COMFORT SHIELD 24-PACK
9/29/17
53462-915-62
55537
7526
COMFORT SHIELD 24-PACK
12/7/17
53462-915-62
56020
7526
COMFORT SHIELD 24-PACK
1/4/18
53462-915-62
56107
7526
COMFORT SHIELD 24-PACK
1/9/18
53462-915-62
Incontinence Clean-Up Cloth
Lot#
Product Code
Description
Expiry
NDC
52588
7505
INCONTINENCE CLEAN-UP CLOTH
N/A - COSMETIC
N/A
52596
7505
INCONTINENCE CLEAN-UP CLOTH
N/A - COSMETIC
N/A
52603
7505
INCONTINENCE CLEAN-UP CLOTH
N/A - COSMETIC
N/A
52607
7505
INCONTINENCE CLEAN-UP CLOTH
N/A - COSMETIC
N/A
53401
7505
INCONTINENCE CLEAN-UP CLOTH
N/A - COSMETIC
N/A
53425
7505
INCONTINENCE CLEAN-UP CLOTH
N/A - COSMETIC
N/A
54432
7505
INCONTINENCE CLEAN-UP CLOTH
N/A - COSMETIC
N/A
55892
7505
INCONTINENCE CLEAN-UP CLOTH
N/A - COSMETIC
N/A
M-care™ Meatal Cleansing Cloths for the Foley Catheterized Patient
Lot #
Product Code
Description
Expiry
NDC
46651
7952
M-CARE CLEANSING CLOTH 2-PACK
N/A - COSMETIC
N/A
47524
7952
M-CARE CLEANSING CLOTH 2-PACK
N/A - COSMETIC
N/A
49247
7952
M-CARE CLEANSING CLOTH 2-PACK
N/A - COSMETIC
N/A
49782
7952
M-CARE CLEANSING CLOTH 2-PACK
N/A - COSMETIC
N/A
50894
7952
M-CARE CLEANSING CLOTH 2-PACK
N/A - COSMETIC
N/A
50899
7952
M-CARE CLEANSING CLOTH 2-PACK
N/A - COSMETIC
N/A
50904
7952
M-CARE CLEANSING CLOTH 2-PACK
N/A - COSMETIC
N/A
51181
7952
M-CARE CLEANSING CLOTH 2-PACK
N/A - COSMETIC
N/A
52169
7952
M-CARE CLEANSING CLOTH 2-PACK
N/A - COSMETIC
N/A
53283
7952
M-CARE CLEANSING CLOTH 2-PACK
N/A - COSMETIC
N/A
54171
7952
M-CARE CLEANSING CLOTH 2-PACK
N/A - COSMETIC
N/A
54956
7952
M-CARE CLEANSING CLOTH 2-PACK
N/A - COSMETIC
N/A
55721
7952
M-CARE CLEANSING CLOTH 2-PACK
N/A - COSMETIC
N/A
56302
7952
M-CARE CLEANSING CLOTH 2-PACK
N/A - COSMETIC
N/A
47528
7954
M-CARE CLEANSING CLOTH 4 2-PACKS
N/A - COSMETIC
N/A
48233
7954
M-CARE CLEANSING CLOTH 4 2-PACKS
N/A - COSMETIC
N/A
51197
7954
M-CARE CLEANSING CLOTH 4 2-PACKS
N/A - COSMETIC
N/A
52174
7954
M-CARE CLEANSING CLOTH 4 2-PACKS
N/A - COSMETIC
N/A
53297
7954
M-CARE CLEANSING CLOTH 4 2-PACKS
N/A - COSMETIC
N/A
54189
7954
M-CARE CLEANSING CLOTH 4 2-PACKS
N/A - COSMETIC
N/A
55754
7954
M-CARE CLEANSING CLOTH 4 2-PACKS
N/A - COSMETIC
N/A
56327
7954
M-CARE CLEANSING CLOTH 4 2-PACKS
N/A - COSMETIC
N/A
Comfort Bath® Cleansing Washcloths
Lot #
Product Code
Description
Expiry
NDC
50777
7803
ESSENTIAL BATH 8-PACK
N/A - COSMETIC
N/A
50812
7803
ESSENTIAL BATH 8-PACK
N/A - COSMETIC
N/A
50832
7803
ESSENTIAL BATH 8-PACK
N/A - COSMETIC
N/A
50852
7803
ESSENTIAL BATH 8-PACK
N/A - COSMETIC
N/A
47226
7805
ESSENTIAL BATH 8-PACK
N/A - COSMETIC
N/A
47972
7805
ESSENTIAL BATH 8-PACK
N/A - COSMETIC
N/A
48823
7805
ESSENTIAL BATH 8-PACK
N/A - COSMETIC
N/A
47178
7815
DEODORANT BATH 5-PACK
N/A - COSMETIC
N/A
47463
7815
DEODORANT BATH 5-PACK
N/A - COSMETIC
N/A
48186
7815
DEODORANT BATH 5-PACK
N/A - COSMETIC
N/A
49194
7815
DEODORANT BATH 5-PACK
N/A - COSMETIC
N/A
49181
7818
DEODORANT BATH 8-PACK
N/A - COSMETIC
N/A
46097
7855
COMFORT BATH 5-PACK
N/A - COSMETIC
N/A
47127
7855
COMFORT BATH 5-PACK
N/A - COSMETIC
N/A
47845
7855
COMFORT BATH 5-PACK
N/A - COSMETIC
N/A
48796
7855
COMFORT BATH 5-PACK
N/A - COSMETIC
N/A
48126
7856
ESSENTIAL BATH 5-PACK
N/A - COSMETIC
N/A
49056
7856
ESSENTIAL BATH 5-PACK
N/A - COSMETIC
N/A
51203
7856
ESSENTIAL BATH 5-PACK
N/A - COSMETIC
N/A
52547
7856
ESSENTIAL BATH 5-PACK
N/A - COSMETIC
N/A
47899
7903
COMFORT BATH 8-PACK
N/A - COSMETIC
N/A
56429
7903
COMFORT BATH 8-PACK
N/A - COSMETIC
N/A
46024
7907
COMFORT BATH 4-PACK
N/A - COSMETIC
N/A
47290
7907
COMFORT BATH 4-PACK
N/A - COSMETIC
N/A
47298
7907
COMFORT BATH 4-PACK
N/A - COSMETIC
N/A
48019
7907
COMFORT BATH 4-PACK
N/A - COSMETIC
N/A
48862
7907
COMFORT BATH 4-PACK
N/A - COSMETIC
N/A
49719
7907
COMFORT BATH 4-PACK
N/A - COSMETIC
N/A
49742
7907
COMFORT BATH 4-PACK
N/A - COSMETIC
N/A
51277
7907
COMFORT BATH 4-PACK
N/A - COSMETIC
N/A
52560
7907
COMFORT BATH 4-PACK
N/A - COSMETIC
N/A
53166
7907
COMFORT BATH 4-PACK
N/A - COSMETIC
N/A
54080
7907
COMFORT BATH 4-PACK
N/A - COSMETIC
N/A
54866
7907
COMFORT BATH 4-PACK
N/A - COSMETIC
N/A
54909
7907
COMFORT BATH 4-PACK
N/A - COSMETIC
N/A
55627
7907
COMFORT BATH 4-PACK
N/A - COSMETIC
N/A
56223
7907
COMFORT BATH 4-PACK
N/A - COSMETIC
N/A
45811
7942
DEODORANT BATH 8-PACK
N/A - COSMETIC
N/A
47167
7942
DEODORANT BATH 8-PACK
N/A - COSMETIC
N/A
47439
7942
DEODORANT BATH 8-PACK
N/A - COSMETIC
N/A
48169
7942
DEODORANT BATH 8-PACK
N/A - COSMETIC
N/A
49148
7942
DEODORANT BATH 8-PACK
N/A - COSMETIC
N/A
51109
7942
DEODORANT BATH 8-PACK
N/A - COSMETIC
N/A
45841
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
47190
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
47471
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
47505
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
48196
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
49208
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
49770
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
50865
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
51139
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
51173
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
52085
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
52117
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
52122
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
52130
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
52137
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
53206
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
53241
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
54114
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
54918
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
55679
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
56256
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
56451
7943
DEODORANT CLEAN-UP BATH 3-PACK
N/A - COSMETIC
N/A
45952
7956
COMFORT BATH 5-PACK
N/A - COSMETIC
N/A
47243
7956
COMFORT BATH 5-PACK
N/A - COSMETIC
N/A
47999
7956
COMFORT BATH 5-PACK
N/A - COSMETIC
N/A
48849
7956
COMFORT BATH 5-PACK
N/A - COSMETIC
N/A
51263
7956
COMFORT BATH 5-PACK
N/A - COSMETIC
N/A
49128
7959
BATH CLOTHS 5-PACK
N/A - COSMETIC
N/A
46068
7982
BATH CLOTHS 8-PACK
N/A - COSMETIC
N/A
47306
7982
BATH CLOTHS 8-PACK
N/A - COSMETIC
N/A
47818
7982
BATH CLOTHS 8-PACK
N/A - COSMETIC
N/A
48743
7982
BATH CLOTHS 8-PACK
N/A - COSMETIC
N/A
45975
7987
IMPREVA BATH 5-PACK
N/A - COSMETIC
N/A
46601
7987
IMPREVA BATH 5-PACK
N/A - COSMETIC
N/A
47263
7987
IMPREVA BATH 5-PACK
N/A - COSMETIC
N/A
48090
7987
IMPREVA BATH 5-PACK
N/A - COSMETIC
N/A
48586
7987
IMPREVA BATH 5-PACK
N/A - COSMETIC
N/A
48693
7987
IMPREVA BATH 5-PACK
N/A - COSMETIC
N/A
48023
7988
IMPREVA BATH 8-PACK
N/A - COSMETIC
N/A
48595
7988
IMPREVA BATH 8-PACK
N/A - COSMETIC
N/A
48649
7988
IMPREVA BATH 8-PACK
N/A - COSMETIC
N/A
51307
9775
COMFORT BATH 2-PACK
N/A - COSMETIC
N/A
54475
9775
COMFORT BATH 2-PACK
N/A - COSMETIC
N/A
47304
7800-MC
ESSENTIAL BATH 8-PACK
N/A – COSMETIC
N/A
47816
7800-MC
ESSENTIAL BATH 8-PACK
N/A - COSMETIC
N/A
53717
9702-P
COMFORT BATH 2-PACK
N/A - COSMETIC
N/A
54483
9702-P
COMFORT BATH 2-PACK
N/A - COSMETIC
N/A
2% Chlorhexidine Gluconate Cloths
Lot #
Product Code
Description
Expiry
NDC
50749
9705
2% CHLORHEXIDINE GLUCONATE 2-PACK
9/29/16
53462-705-20
50765
9705
2% CHLORHEXIDINE GLUCONATE 2-PACK
9/30/16
53462-705-20
50771
9705
2% CHLORHEXIDINE GLUCONATE 2-PACK
9/30/16
53462-705-20
50773
9705
2% CHLORHEXIDINE GLUCONATE 2-PACK
10/1/16
53462-705-20
52839
9705
2% CHLORHEXIDINE GLUCONATE 2-PACK
2/9/17
53462-705-20
52843
9705
2% CHLORHEXIDINE GLUCONATE 2-PACK
2/9/17
53462-705-20
52855
9705
2% CHLORHEXIDINE GLUCONATE 2-PACK
2/10/17
53462-705-20
52861
9705
2% CHLORHEXIDINE GLUCONATE 2-PACK
2/10/17
53462-705-20
53840
9705
2% CHLORHEXIDINE GLUCONATE 2-PACK
4/21/17
53462-705-20
54760
9705 (9701-P)
2% CHLORHEXIDINE GLUCONATE 2-PACK
6/15/17
53462-705-20
54763
9705 (9780)
2% CHLORHEXIDINE GLUCONATE 2-PACK
6/16/17
53462-705-20
56081
9705
2% CHLORHEXIDINE GLUCONATE 2-PACK
9/1/17
53462-705-20
56513
9705
2% CHLORHEXIDINE GLUCONATE 2-PACK
9/26/17
53462-705-20
Sage Products is notifying distributors, healthcare facilities, retailers and consumers by letter, and they are being provided instructions to discontinue use and return product to Sage Products.
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. and 5:00 p.m., CDT.
Customers with questions regarding this recall, or requiring replacement product, should call Sage Products customer service at 1-800-421-6556, Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m., CDT. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products.
Any adverse reactions or quality problems experienced with the use of these products 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
Original Release
http://www.fda.gov/Safety/Recalls/ucm514358.htm
First Expansion
http://www.fda.gov/Safety/Recalls/ucm516950.htm
John
-
Monday, August 22, 2016
NIH researchers discover otulipenia, a new inflammatory disease
Rare and sometimes lethal disease affects young children
The just-discovered otulipenia is a rare and sometimes lethal inflammatory disease that causes fever, skin rashes, diarrhea and joint pain in young children. NHGRI National Institutes of Health researchers have discovered a rare and sometimes lethal inflammatory disease — otulipenia — that primarily affects young children. They have also identified anti-inflammatory treatments that ease some of the patients’ symptoms: fever, skin rashes, diarrhea, joint pain and overall failure to grow or thrive.
Otulipenia is caused by the malfunction of OTULIN, a single gene on chromosome 5. When functioning properly, OTULIN regulates the development of new blood vessels and mobilization of cells and proteins to fight infection. NIH researchers published their findings Aug. 22, 2016, in the early edition of the Proceedings of the National Academy of Sciences.
Contributing to the work were researchers from the National Human Genome Research Institute (NHGRI), the National Institute of Allergy and Infectious Diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Heart, Lung, and Blood Institute and the NIH Clinical Center, all part of NIH, along with their colleagues in Turkey and the United Kingdom.
“The results have been amazing and life changing for these children and their families,” said Daniel Kastner, M.D., Ph.D., co-author and NHGRI scientific director and head of NHGRI’s Inflammatory Disease Section. “We have achieved the important goal of helping these young patients and made progress in understanding the biological pathways and proteins that are important for the regulation of the immune system’s responses.” Cells use biological pathways to send and receive chemical cues in reaction to injury, infection or stress.
Otulipenia is one of several inflammatory diseases that occur when the immune system attacks the host’s own tissues. Inflammation is the body’s natural response to invading bacteria or viruses. The body releases chemicals that cause blood vessels to leak and tissues to swell in order to isolate a foreign substance from further contact with the body’s tissues. Inflammatory diseases affecting the whole body are caused by mutations in genes like OTULIN that are part of a person’s innate immunity (the cells and proteins present at birth that fight infections).
An international network of scientists studying inflammatory diseases identified four children from Pakistani and Turkish families with unexplained skin rashes and inflamed joints. NIH scientists then searched for disease-causing genes using next-generation DNA sequencing, technology that allows researchers to sequence DNA quickly and economically.
Once they found that the OTULIN gene was abnormal in the sick children, they studied the immune pathway in order to understand the mechanisms of disease and to improve treatment of these patients. They discovered a problem in the processing of a small protein, ubiquitin, which is critical to the regulation of many other proteins in the body, including immune molecules. In the affected children, the inability to remove the ubiquitin proteins from various molecules resulted in an increased production of chemical messengers that lead to inflammation (inflammatory cytokines).
The researchers determined that the children with otulipenia might respond to drugs that turned off tumor necrosis factor, a chemical messenger involved in systemic inflammation. Inflammation subsided in the children who had been treated with anti-tumor necrosis factor drugs (TNF inhibitors). TNF inhibitors are also used to treat chronic inflammatory diseases such as rheumatoid arthritis.
“The malfunction in this protein has not been previously linked to clinical disorders of the human immune system,” said Ivona Aksentijevich, M.D., staff scientist in NHGRI's Medical Genetics Branch and study co-author. “This discovery suggests a direction that can be explored for development of new therapies for patients with a wide range of inflammatory diseases.”
This study together with NIH’s 2016 identification of haploinsufficiency of A20 (HA20), suggests a new category of human inflammatory diseases caused by impaired ubiquitination, according to the researchers.
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.
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 at www.niaid.nih.gov.
The mission of the NIAMS, a part of the U.S. Department of Health and Human Services' National Institutes of Health (NIH), is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases; the training of basic and clinical scientists to carry out this research; and the dissemination of information on research progress in these diseases. For more information about the NIAMS, call the information clearinghouse at (301) 495-4484 or (877) 22-NIAMS (free call) or visit the NIAMS website at www.niams.nih.gov
Part of the National Institutes of Health, the National Heart, Lung, and Blood Institute (NHLBI) plans, conducts, and supports research related to the causes, prevention, diagnosis and treatment of heart, blood vessel, lung and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children and other topics. NHLBI press releases and other materials are available online at http://www.nhlbi.nih.gov.
The NIH Clinical Center is the nation's largest hospital devoted entirely to clinical research. Clinician-investigators translate scientific observations and laboratory discoveries into new approaches to diagnosing, treating, and preventing disease. http://clinicalcenter.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
-
http://www.emergencyemail.org/newsemergency/anmviewer.asp?a=6411&z=63
RECALL: Assorted Donuts
King Soopers Recalls Assorted Donuts Due to Undeclared Peanut, Pecan and Coconut Allergens
DENVER, Aug. 19, 2016 /PRNewswire/ -- King Soopers has recalled boxes of Bakery Fresh Goodness Assorted Donuts with Toppings sold in its retail stores because the product contains peanuts, pecans and coconut not listed on the ingredient label.
People who are allergic to peanuts, pecans or coconut run the risk of a serious or life-threatening reaction if they consume this product. For consumers who are not allergic to these items, there is no safety issue with the product. One customer illness has been reported at this time. King Soopers was notified by a customer contact.
All stores operating under the King Soopers and City Market in Colorado, New Mexico, Wyoming and Utah are included in this recall.
King Soopers has removed this item from store shelves and initiated its customer recall notification system that alerts customers who may have purchased recalled products through register receipt tape messages and phone calls.
King Soopers is recalling the following item:
Product
UPC
Codes
Size
BAKERY FRESH GOODNESS
ASSORTED DONUTS WITH TOPPINGS
00235864-0XXXX
Sell By Dates 8/21 and before
Varied
Customers allergic to peanuts, pecans or coconut who have purchased the above product should not consume it and should return them to a store for a full refund or replacement.
Customers who have questions may contact Kroger at 1-800-KROGERS, Monday through Friday 8:00 am to 12:00 am EDT and Saturday through Sunday 8:00 am to 9:00 pm ET.
About King Soopers:
King Soopers operates 149 stores, 145 pharmacies and 78 fuel centers in Colorado. For more than 65 years, King Soopers has emphasized a customer-first approach to providing quality products, value pricing, outstanding service and an exceptional shopping experience. We are dedicated to making a difference in the communities we serve by supporting hunger relief, education, health and wellness, military families and diversity programs. For more information about King Soopers, download the free King Soopers mobile app or connect on King Soopers.com, Facebook, Twitter or Instagram.
SOURCE King Soopers
John
-
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
Congressional and Public Affairs
Sarah R. Lichtman
(202) 720-9113
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
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.
John
-
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.
Honeywell Issues Voluntary Nationwide Recall Of One Lot Of Eyesaline Eyewash Solution Due To Microbial Contamination
For Immediate Release
August 19, 2016
Contact
Consumers
Honeywell Customer Care
1-800-430-5490
Media
Don Galman
1(847)955-8389
Announcement
View Product Photos
In cooperation with the U.S. Food and Drug Administration (FDA), Honeywell is voluntarily recalling one production lot of 32-ounce bottles of Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury.
Although no injuries have been reported and we have not found any contamination in our batch testing, the voluntary recall is a precautionary measure due to a low risk of product contamination with Klebsiella pneumoniae. Although found in the normal flora of the mouth and skin, if the contaminant were present in a bottle, there is a potential for it to result in infections that may be sight-threatening.
Eyesaline Eyewash is sold through industrial sales distributors. Approximately 9,700 32-ounce bottles with lot number F16091-61 are subject to recall. No other lot number of the product is subject to this recall.
All of Honeywell’s distributors who received this lot have been notified by phone, e-mail and certified mail, and have been instructed to notify their customers. See instructions below on how to find the lot number to determine if your supply is covered by this voluntary recall.
Distributors must stop distribution of the affected product and return it to Honeywell for credit or replacement. Commercial-industrial users of the product should also check whether their Eyesaline Eyewash is subject to recall. If it is, customers should stop using the solution and contact their distributor for replacement or credit.
The affected product and lot number can be identified as follows:
Product: 32 ounce Eyesaline Eyewash
Lot number: F16091-61 (no other lot number is subject to recall)
The lot number can be found on the outside of the product case, shown at left, and on individual bottles, as shown on the right below.
Customers with questions regarding this recall can contact their distributor or Honeywell Customer Care at 1-800-430-5490, Monday – Friday, and 8:00 am – 6:30 pm EST. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using 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.
John
-
News Release
Panna Café Express To Go Inc. Recalls Various Meat and Poultry Products Produced Without Benefit of Inspection
Class I Recall
072-2016
Health Risk: High
Aug 21, 2016
Congressional and Public Affairs
Julie Schwartz
(202) 720-9113
Press@fsis.usda.gov
WASHINGTON, AUG. 21, 2016 – Panna Café Express To Go Inc., a North Miami Beach, Fla., establishment, is recalling approximately 1,951 pounds of various meat and poultry products that were produced without the benefit of federal inspection and used the USDA marks of inspection without authorization, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The various heat-treated, not fully cooked, not shelf stable meat and poultry products were produced and packed on various dates between June 2, 2016 and Aug. 17, 2016. The following products are subject to recall:
View Labels PDF Only
7.6-lb. tray packages containing 20 units of raw “ZERPA’S ANTOJOS CRIOLLOS CACHITOS HAM FILLED BREAD” with best by dates of Feb. 15, 16, 17, or 23, 2017 and bearing UPC code 854631003448.
2.2-lb. tray packages containing 6 units of heat and serve “PANNA NEW LATINO FOOD EMPANADA VENEZOLANA POLLO CHICKEN” with best by dates of Dec. 2, 3, 8, 2016, or Feb. 15, 16, 17, 2017 and bearing UPC code 820103507561.
1.4-lb. tray packages containing 6 units of heat and serve “PANNA NEW LATINO FOOD EMPANADA ARGENTINA POLLO CHICKEN” with best by dates of Feb. 15 or 17, 2017 and bearing UPC code 820103507509.
1.25-lb. tray packages containing 3 units of heat and serve “MISTER FOOD CACHITOS HAM/JAMON” with best by dates of Feb. 15, 16, or 17, 2017 and bearing UPC code 856305006038.
1.25-lb. tray packages containing 3 units of heat and serve “PANNA TO GO CACHITO DE JAMON Y QUESO HAM AND CHEESE CACHITO” with best by dates of Feb. 15, 16, or 17, 2017 and bearing UPC code 815026020174.
60-unit cases of raw “MISTER FOOD CACHITO DE JAMON Y QUESO HAM & CHEESE WRAPPED IN DOUGH” with best by dates of Feb. 15, 16, 17, or 23, 2017 and bearing UPC code 856305000006.
30-unit cases of pre-baked “MISTER FOOD CACHITO DE JAMON Y QUESO HAM & CHEESE WRAPPED IN DOUGH” with best by dates of Feb. 15, 16 or 17, 2017 and bearing UPC code 856305000013.
30-unit cases of pre-baked “PANNA TO GO CACHITO DE JAMON Y QUESO HAM & CHEESE WRAPPED IN DOUGH” with best by dates of Feb. 15, 16 or 17, 2017 and bearing UPC code 815026020013.
30-unit cases of pre-baked “ZERPA’S ANTOJOS CRIOLLOS CACHITO DE JAMON Y QUESO HAM & CHEESE WRAPPED IN DOUGH” with best by dates of Feb. 15, 16 or 17, 2017 and bearing UPC code 854631000013.
60-unit cases of raw “PANNA TO GO CACHITO DE JAMON Y QUESO HAM & CHEESE WRAPPED IN DOUGH” with best by dates of Feb. 15, 16, 17, or 23, 2017 and bearing UPC code 815026020006.
30-unit cases of pre-fried “PANNA TO GO PASTEL DE POLLO TIPO VENEZOLANO VENEZUELAN BRAND CHICKEN PASTEL” with best by dates of Dec. 2, 3, 8, 2016 or Feb. 15, 16, 17, 2017 and bearing UPC code 815026020976.
30-unit cases of pre-fried “MISTER FOOD PASTEL DE POLLO TIPO VENEZOLANO VENEZUELAN BRAND CHICKEN PASTEL” with best by dates of Dec. 2, 3, 8, 2016 or Feb. 15, 16, 17, 2017 and bearing UPC code 856305000976.
60-unit cases of pre-baked “PANNA TO GO EMPANADA DE POLLO TIPO ARGENTINA ARGENTINIAN BRAND CHICKEN EMPANADA” with best by dates of Feb. 15 or 17, 2017 and bearing UPC code 815026020686.
30-unit cases of pre-baked “MISTER FOOD EMPANADA DE POLLO TIPO ARGENTINA ARGENTINIAN BRAND CHICKEN EMPANADA” with best by dates of Feb. 15 or 17, 2017 and bearing UPC code 856305000068.
30-unit cases of pre-baked “PANNA TO GO EMPANADA DE POLLO TIPO ARGENTINA ARGENTINIAN BRAND CHICKEN EMPANADA” with best by dates of Feb. 15 or 17, 2017 and bearing UPC code 815026020068.
25-unit cases of pre-baked “PAN & PLUS EMPANADA DE POLLO CHICKEN EMPANADA” with best by dates of Feb. 15 or 17, 2017 and bearing UPC code 815026021423.
6-unit cases of raw “ZERPA’S ANTOJOS CRIOLLOS CACHITO DE JAMON Y QUESO HAM & CHEESE WRAPPED IN DOUGH” with best by dates of Feb. 15, 16, 17, or 23, 2017 and bearing UPC code 854631003431.
60-unit cases of raw “ZERPA’S ANTOJOS CRIOLLOS CACHITO DE JAMON Y QUESO HAM & CHEESE WRAPPED IN DOUGH” with best by dates of Feb. 15, 16, 17, or 23, 2017 and bearing UPC code 854631000006.
The products subject to recall bear establishment number “EST. 40245 or P-40245” inside the USDA mark of inspection. These items were shipped to food service, distributors, and retail locations in Florida.
The problem was discovered when FSIS personnel visited the uninspected facility following their application for a federal grant of inspection that had not yet been approved.
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.
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 Luis Villegas, Plant Manager, at (786) 218 – 1802.
John
-
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.
Cambridge Farms, LLC Recalls Three Brands Of Frozen Cut Corn Because Of Possible Health Risk
For Immediate Release
August 19, 2016
Contact
Consumers
Steve Davis
1-717-945-5178
Announcement
View Product Photos
Cambridge Farms, LLC of Lancaster, PA is recalling the below products because they have 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.
The Specific products / production codes included in this recall are:
Laura Lynn Frozen Cut Corn in a 16 oz. Polybag - UPC 8685401734
Code SWFF/R10312, Best by 4/11/18
Code SWFFR/10452, Best by 5/09/18
Code SWFF/R10609, Best by 6/6/18
Laura Lynn Frozen Cut Corn in a 32 oz. Polybag - UPC 8685401717
Code SWFF/R 10482, Best by 5/10/18
Key Food Frozen Cut Corn in a 16 oz. Polybag - UPC 7329607091
Code SWFF/R10320, Best by 4/11/18
Code SWFF/R10405, Best by 5/2/18
Better Valu Frozen Cut Corn in a 14 oz. Polybag - UPC 7980124561
Code SWFF/R10308, Best by 4/11/18
The above codes will be on the back of the retail package.
The above products were distributed in the following states: NC, SC, TN, AL, GA, VA, NY, CT, NJ, PA, OH, WV, KY, MD and FL. These products are sold thru retail supermarkets.
No illnesses have been reported to date.
The recall was the result of a routine sampling program by the North Carolina Department of Agriculture which revealed that the finished product they sampled from a retail store contained the bacteria. In an abundance of caution, the company has included all cut corn products which may have been produced using the same lot of cut corn. Cambridge Farms, LLC has ceased the production and distribution of the product and continues their investigation as to what caused the problem.
Consumers who have purchased any of the above items are urged to not consume it and to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-717-945-5178 Monday through Friday during the hours of 8:00AM to 5:00PM Eastern Daylight Time.
John
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http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm517289.htm
FDA Investigates Outbreak of Hepatitis A Illnesses Linked to Raw Scallops
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating an outbreak of hepatitis A illnesses linked to raw scallops.
Fast Facts
The FDA and CDC are supporting the Hawaii Department of Health (DOH) in an investigation of hepatitis A virus (HAV) infections linked to scallops supplied by Sea Port Products Corp. On August 17, 2016, Hawaii Department of Health reported that 206 people have been confirmed to have become ill with hepatitis A in that state.
On August 17, 2016, the FDA, Hawaii DOH, CDC and state partners informed Sea Port Products Corp that epidemiological, laboratory and traceback information indicates their scallops are the likely source of illnesses. On August 18, 2016, Sea Port Products Corp initiated a voluntary recall of frozen Bay Scallops produced on November 23, 2015 and 24, 2015. The products were distributed to California, Hawaii, and Nevada. According to Sea Port Products Corp, the recalled products are not intended for retail sale. The FDA is working with the recalling firm to ensure their recall is effective and that recalled product is removed from the market.
Restaurants and other retailers should not sell or serve the recalled Bay Scallops. According to Sea Port Products Corp, the recalled products are not intended for retail sale. Consumers should ask the restaurant or retailer where their scallops came from to make sure they do not eat recalled Bay Scallops from Sea Port Products Corp.
What is the Problem and What is Being Done About It?
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention (CDC) are supporting the State of Hawaii in an investigation of hepatitis A illnesses linked to raw scallops.
According to the Hawaii Department of Health (DOH), 206 people have been confirmed to have become ill with hepatitis A. Illnesses started on dates ranging from June 12, 2016 to August 9, 2016. All cases have been in adults and 51 have required hospitalization.
The FDA’s traceback investigation involved working with Hawaii DOH to trace the path of food eaten by those made ill back to a common source. The traceback investigation determined that Sea Port Products Corp imported the scallops that were later supplied to certain Genki Sushi locations in Hawaii, where ill people reported eating.
On August 17, 2016, FDA laboratory analysis of two scallop samples, which were collected on August 11, 2016, were confirmed positive for hepatitis A. These samples were imported by Sea Port Products Corp.
The FDA, CDC and state partners immediately informed Sea Port Products Corp that epidemiological, laboratory and traceback information indicates their scallops are the likely source of illnesses. On August 18, 2016, Sea Port Products Corp initiated a voluntary recall of frozen Bay Scallops produced on November 23, 2015 and 24, 2015. The products were distributed to California, Hawaii, and Nevada. According to Sea Port Products Corp, the recalled products are not intended for retail sale. The FDA is working with the recalling firm to ensure their recall is effective and that recalled product is removed from the market.
What is Hepatitis A?
Hepatitis A is a contagious liver disease that results from infection with the Hepatitis A virus (HAV). It can range in severity from a mild illness lasting a few weeks to a severe illness lasting several months. Hepatitis A is usually spread when a person ingests fecal matter — even in microscopic amounts — from contact with objects, food, or drinks contaminated by the feces of an infected person (fecal-oral route).
What are the Symptoms of Hepatitis A?
Illness occurs within 15 to 50 days of exposure and in adults includes fatigue, abdominal pain, jaundice, abnormal liver tests, dark urine and pale stool.
Who is at Risk?
Hepatitis A is a disease that originates in and is spread by people, rather than animals. It can occur when an infected food handler prepares food without appropriate hand hygiene. However, food (as is suspected in this outbreak) or water contaminated with HAV can cause outbreaks of disease.
In rare cases, particularly in patients with pre-existing severe illness or who are immunocompromised, HAV infection can progress to liver failure and death. People who have underlying liver conditions or pre-existing severe illness, or who are immunocompromised, should be vaccinated for HAV.
What Specific Products were Recalled?
On August 18, 2016, Sea Port Products Corp initiated a voluntary recall of frozen Bay Scallops produced on November 23, 2015 and 24, 2015. The products were distributed to California, Hawaii, and Nevada. According to Sea Port Products Corp, the recalled products are not intended for retail sale.
What Do Restaurants and Retailers Need To Do?
Retailers and other food service operators should not sell or serve the recalled products. These operations should also:
Wash and sanitize display cases and refrigerators where potentially contaminated products were stored.
Wash and sanitize cutting boards, surfaces, and utensils used to prepare, serve, or store potentially contaminated products.
Wash hands with hot 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.
What Do Consumers Need To Do?
Water, shellfish, and salads are the most frequent foodborne sources of hepatitis A. You can avoid Hepatitis A transmission from seafood by thoroughly cooking it. Hepatitis A can be transmitted from person to person. Consumers should always practice safe food handling and preparation measures. Wash hands, utensils, and surfaces with hot, soapy water before and after handling food. Consumers should thoroughly wash their hands after using the bathroom and changing diapers to help protect themselves from hepatitis A, as well as other foodborne diseases.
Consumers should ask the restaurant or retailer where their scallops came from to make sure they do not eat recalled Bay Scallops from Sea Port Products Corp.
The FDA has provided information on selecting and serving fresh and frozen seafood safely. Some people are at greater risk for foodborne illness and should not eat raw or partially cooked fish or shellfish. These susceptible groups include:
Pregnant women
Young children
Older adults
Persons whose immune systems are compromised
Persons who have decreased stomach acidity
If you are unsure of your risk, ask your healthcare provider.
Who Should be Contacted?
Contact your healthcare provider if you think you may have become ill from eating raw scallops.
The FDA 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 http://www.fda.gov.
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.
Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Oxacillin for Injection, USP, 10g Due to Presence of Iron Oxide Particulate Matter
For Immediate Release
August 18, 2016
Contact
Consumers
Customer Call Center
(866) 625-1618
Announcement
Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by Astral SteriTech Private Limited and distributed by Sagent. Sagent has initiated this voluntary recall to the user level due to the receipt of a product complaint for a single vial containing small, dark particulate matter found within the solution after reconstitution. The particulate matter has been identified as iron oxide.
In the event that metal particulate in an injectable product is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, or blockage of blood vessels. Blockage of blood vessels can lead to serious events, which may be life-threatening, such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.
To date, Sagent is not aware of any known adverse patient events resulting from the use of the subject product lot.
The product is packaged in cartons containing 10 x 10 gram Pharmacy Bulk Package bottles identified by NDC 25021-163-99. The lot number being recalled is Lot OXT512 which was distributed to hospitals, wholesalers and distributors nationwide from June 2016 through July 2016. Oxacillin for Injection, USP, 10 g is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. It is available by prescription only.
Customers are being notified by fax, email, FedEx, and/or certified mail that includes arrangements for the return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return the recalled lot of product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com.
Any questions about returning unused product should be directed to the Customer Call Center at (866) 625-1618 M-F 8am-7pm CST. Healthcare workers who have medical questions about Oxacillin for Injection, USP may contact Sagent Medical Affairs (866-625-1618, Option 3) M-F 8am-5pm CST.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using 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
About Sagent Pharmaceuticals, Inc.
Sagent Pharmaceuticals, Inc., founded in 2006, is a leading provider of affordable pharmaceuticals to the hospital market. Sagent has created a unique, global network of resources, comprising rapid development capabilities, sophisticated manufacturing and innovative drug delivery technologies, resulting in an extensive and rapidly expanding pharmaceutical product portfolio that fulfills the evolving needs of patients.
John
-
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.
Voluntary Nationwide Recall of Cetylev® (Acetylcysteine) Effervescent Tablets for Oral Solution Due to an Inadequate Seal of the Blister Pack
For Immediate Release
August 18, 2016
Contact
Consumers
Arbor Pharmaceuticals, LLC
1-866-516-4950
Announcement
Arbor Pharmaceuticals, LLC (Arbor) today announced a voluntary recall of three (3) lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal of the blister pack. An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity which can start the effervescent process. This results in enlarged and swelled tablets which could also completely dissolve within the blister pack.
Three lots of the 500 mg strength (Lot Numbers 005C16, 006C16 and 007C16, expiration date
02/2018) with NDC 24338-700-10 are included in the recall. Healthcare facilities should immediately discontinue use from these lots of product and return all unused Cetylev to Arbor. To date, Arbor has not received any reports of adverse events related to this recall. Product was distributed nationwide to wholesalers and pharmacies.
The improper seal of the product can lead to excess moisture and partial dissolution of the tablets. This can lead to a potentially sub-therapeutic dose as well as potential microbial contamination. Because the effectiveness of acetylcysteine to prevent or lessen hepatic injury after ingestion of acetaminophen is delayed with decreased therapy, sub-therapeutic dosing could lead to increased risk of liver injury. With regards to the potential microbial contamination due to moisture ingress into the tablets, the risk of serious infection is increased in certain patient populations such as children, pregnant women, immunosuppressed patients, and patients on gastric acid suppression therapy such as proton pump inhibitors.
Cetylev (acetylcysteine) effervescent tablets for oral solution are indicated as an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from
repeated supratherapeutic ingestion.
Consumers with questions regarding this recall should contact Arbor Pharmaceuticals, LLC at
1-866-516-4950, Monday through Friday, during business hours of 9:00 am to 5:00 pm, Eastern Standard Time (EST). Please mention this notification when calling. 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.
About Arbor:
Arbor Pharmaceuticals, headquartered in Atlanta, Georgia, is a specialty pharmaceutical company currently focused on the cardiovascular, hospital, pediatric and neurology markets.
Source: Arbor Pharmaceuticals, LLC
John
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http://www.emergencyemail.org/newsemergency/anmviewer.asp?a=6384&z=63
RECALL: Takata Air Bags, Critical Warning
Critical Warning Regarding Certain 2001-2003 Honda and Acura Vehicles with Takata Air Bags
NHTSA urges consumers to not drive these vehicles unless they are going straight to a dealer to have them repaired immediately:
2001-2002 Honda Civic
2001-2002 Honda Accord
2002-2003 Acura TL
2002 Honda CR-V
2002 Honda Odyssey
2003 Acura CL
2003 Honda Pilot
New test data on the defective Takata air bag inflators in these vehicles show a far higher risk of ruptures during air bag deployment than for other recalled Takata air bags.
If you own one of these vehicles, search the Recalls Lookup using your vehicle identification number (VIN) at https://vinrcl.safercar.gov/vin/ to confirm that the vehicle has an unaddressed recall and needs a repair. If it does, immediately call your dealer to schedule a free repair. Replacement parts for these vehicles are available.
John
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http://www.emergencyemail.org/newsemergency/anmviewer.asp?a=6382&z=63
RECALL: Chest of Drawers Due to Serious Hazard
Sauder Woodworking Recalls Chest of Drawers Due to Serious Tip-Over Hazard; Sold Exclusively at Walmart.com (Recall Alert)
The recalled chests are unstable unless they are properly anchored to the wall.
Recall date: August 16, 2016
Recall number: 16-767
Recall Summary
Name of product: Four-drawer chests
Hazard: The recalled chests are unstable unless they are properly anchored to the wall, posing a serious tip-over and entrapment hazard that could result in death or serious injuries to children. Due to a manufacturing problem, these chests do not comply with the voluntary safety standard (ASTM F2057-14).
Consumer Contact:
Sauder Woodworking at 800-523-3987 from 9 a.m. to 5 p.m. ET Monday through Friday or online at www.sauder.com and click on "Public Notices" at the bottom of the page for more information.
Recall Details
Units
About 8,000
Description
This recall involves four-drawer wooden chests sold under the Storybook brand (model 416407). The white laminated chests have a single white wood pull on each drawer. The chests were manufactured between April 2016 and June 2016. A label with the date code in the MM/YYYY format is located on the back of the unit. The chests measure 42.13 inches high by 29.25 inches wide and 16.25 inches deep.
Date code
04/2016
05/2016
06/2016
Incidents/Injuries
None reported
Remedy
Consumers should immediately stop using any recalled chests that are not properly anchored to the wall and place them in an area that children cannot access. Sauder Woodworking is contacting all known purchasers directly and sending free repair kits and wall anchoring kits. If a consumer is unable or unwilling to attach the repair kit, they should contact Sauder Woodworking for a full refund. Consumers who request a refund will be provided instructions by Sauder on how to properly dispose of the chests.
CPSC strongly recommends that all dressers be anchored to the wall. For more information on our Anchor It campaign, please visit http://www.anchorit.gov/
Sold exclusively at
Online at www.walmart.com from April 2016 through June 2016 for about $100.
Distributor(s)
Sauder Woodworking Co., of Archbold, Ohio
Manufactured in
U.S.
John
Recall: Frozen Chicken Entrées
in Pinching Pennies
Posted
http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-074-2016-release
News Release
Sentry Foods Recalls Frozen Chicken Entrées due To Possible Foreign Matter Contamination
Class II Recall
074-2016
Health Risk: Low
Aug 25, 2016
Congressional and Public Affairs
Gabrielle N. Johnston
(202) 720-9113
Press@fsis.usda.gov
WASHINGTON, Aug. 25, 2016 – Sentry Foods, a Tucker, Ga. establishment, is recalling approximately 21,570 pounds of frozen chicken entrées that may be contaminated with extraneous materials, specifically glass or hard plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The frozen chicken entrée items were produced and packaged on March 17, March 18, April 30, and May 13, 2016. The following products are subject to recall:
View Labels PDF Only
http://www.fsis.usda.gov/wps/wcm/connect/343f2d01-8596-479b-b777-04a68272b435/074-2016.pdf?MOD=AJPERES
10-oz. tray pack in box of Saffron Road “LEMONGRASS BASIL CHICKEN WITH BASMATI RICE” with a “Best By” date of “08-19-2017” and lot number 0219-00207-016.
10-oz. tray pack in box of Saffron Road “LEMONGRASS BASIL CHICKEN WITH BASMATI RICE” with a “Best By” date of “10-29-2017” and lot number 0429-00258-016.
10-oz. tray pack in box of Saffron Road “LEMONGRASS BASIL CHICKEN WITH BASMATI RICE” with a “Best By” date of “10-29-2017” and lot number 0429-00207-016.
The products subject to recall bear establishment number “EST. P-19031” inside the USDA mark of inspection or printed on the side of the container. These items were shipped to retail locations in Indiana, Texas, and Pennsylvania.
The problem was discovered through consumer complaints reported to the company who then contacted FSIS. No injuries were reported with the complaints.
FSIS has received no confirmed reports of injury or illness from 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 John William Morris, Assistant Vice President, at (470) 268-8440. Media with questions about the recall can contact John Conard, Director of Quality, at (470) 286-8440.
John