Tag Archives: FDA

Mylan Provides Update on Meridian Medical Technologies’, a Pfizer Company, Expanded Voluntary Worldwide Recall of EpiPen® Auto-Injector

Posted on by

Mylan N.V. today announced that Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen® Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA).

This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). Both reports are related to the single lot that was previously recalled. The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.

The recalled product was manufactured by Meridian Medical Technologies, a Pfizer company, and distributed by Mylan Specialty between December 2015 and July 2016. The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America.

The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies.

U.S. Impacted Lots:

Product/Dosage NDC Number Lot Number Expiration Date
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg 49502-501-02 5GN767 April 2017
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg 49502-501-02 5GN773 April 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 5GM631 April 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 5GM640 May 2017
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg 49502-501-02 6GN215 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM082 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM072 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM081 September 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM088 October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM199 October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM091 October 2017
EpiPen 2-Pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM198 October 2017
EpiPen 2-pak® Auto-Injectors, 0.3 mg 49502-500-02 6GM087 October 2017

Mylan is committed to replacing recalled devices at no cost and Mylan would like to reassure patients that there will be no additional replacement-related financial burden to them as a result of this recall. Patients, customers and distributors are being notified and should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions. We are asking patients to keep their existing product until their replacement product can be secured.

Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability. The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector.

It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device.

To return your product please contact Stericycle at 877-650-3494. If you have any additional questions regarding this recall, please contact Mylan Customer Relations at 800-796-9526 or customer.service@mylan.com.

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.

This voluntary recall is being conducted with the knowledge of FDA.

Epinephrine is the first-line treatment for a life-threatening allergic reaction (anaphylaxis) and access to this product is critical in the event of an emergency. Delays in epinephrine administration have been associated with negative health consequences.

More information about the risks and benefits of EpiPen® Auto-Injector can be found at EpiPen.com.

Please see the full Prescribing Information and Patient Information.

Conagra Brands Recalls Hunt’s Chili Kits

Posted on by

Conagra Brands, Inc., announced today it is voluntarily recalling a limited amount of Hunt’s Chili Kits due to the potential presence of Salmonella in the chili seasoning packet contained in the kit. The chili seasoning used in the packet originated from a supplier who informed the company of the potential presence of Salmonella in a raw material used in the chili seasoning. Although no Salmonella was found in the finished product supplied to Conagra Brands, the company has decided out of an abundance of caution to recall the product.

There have been no reports of adverse reactions or injuries due to consumption of this product to date. Salmonella is a bacterium that can cause diarrhea, fever and abdominal cramps. Most individuals recover without treatment. In some cases, diarrhea may be so severe that the patient needs to be hospitalized. The elderly, infants and those with impaired immune systems are more likely to have a severe illness.

The product covered by this recall was distributed in retail stores, military commissaries and online nationwide in the U.S.; the specific product information is listed below. The product code information is stated on the bottom of the kit below the barcode. No other Hunt’s products or Conagra Brands’ products are impacted by this recall.

Item Description UPC MFG/Lot Code Best By Date
HUNT’S CHILI KIT 44.8OZ 20-0-27000-42063-2 3534619500 Apr 04, 2018
HUNT’S CHILI KIT 44.8OZ 20-0-27000-42063-2 3534622200 May 01, 2018
HUNT’S CHILI KIT 44.8OZ 20-0-27000-42063-2 3534619600 Apr 05, 2018

Consumers who have purchased this item are advised not to consume it and return it to the store where originally purchased. Conagra Brands is cooperating with the FDA on this recall and is working with customers to ensure the packages are removed from store shelves and are no longer distributed. Consumers with questions should call our Consumer Affairs hotline at 1-800-921-7404, open 9 am through 5 pm CDT, Monday through Friday.

Pro Sports Club Recalls Yogurt Peanut Crunch Bar Because of Possible Health Risk

Posted on by

Pro Sports Club of Bellevue, WA is recalling 36,957 Yogurt Peanut Crunch bars because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS). HUS is most likely to occur in young children and the elderly. The condition can lead to serious kidney damage and even death.

The Yogurt Peanut Crunch Bar was sold directly to clients at the PRO Sports facilities in Washington (Bellevue, Redmond and Seattle cities) between August 8, 2016 and March 10, 2017. Product was also sold to internet customers through www.2020lifestyles.com.

This recalled Yogurt Peanut Crunch Bars has a brand name 20/20 Life Styles, lot code B.B. 22JUL17 (means best by July 22, 2017), net weight 2 oz., UPC Code 78571 00052.

No illnesses related to the consumption of the Yogurt Peanut Crunch Bars have been reported to date.

The recall was initiated after our manufacturer notified us that the ingredient used in the Yogurt Peanut Crunch Bars was recalled by supplier Soy Nut Butter Company of Glenview, Illinois because it was found to contain E. Coli O157:H7.

This recall is being made with the knowledge of the U.S. Food and Drug Administration.

Consumers who have purchased Yogurt Peanut Crunch Bars are urged not to consume and to return any remaining product to the place of purchase for a full refund.

Consumers with questions may contact the company at 1-425-895-6533 Monday through Friday, 9AM-5PM PST.

Lakes Farm Raised Catfish, Inc. Recalls Siluriformes Fish Products Due To Possible Adulteration

Posted on by

WASHINGTON – Lakes Farm Raised Catfish Inc., a Dundee, Miss. establishment, is recalling approximately 1,695 pounds of siluriformes fish (catfish) products that may be adulterated with residues of public health concern, specifically Malachite Green and Leucomalachite Green, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The siluriformes (catfish) products were produced on March 14 through 17, 2017. The following products are subject to recall: [View Labels (PDF Only)]

  • 15-lb. cardboard boxes of frozen raw “catfish” fillets identified as LAKE’S FARM RAISED CATFISH and having lot codes T-14, T-15, T-16, and T-17.
  • 15-lb. cardboard boxes of frozen raw “catfish” nuggets identified as LAKE’S FARM RAISED CATFISH and having lot codes T-14, T-15, T-16, and T-17.
  • 15-lb. cardboard boxes of frozen raw “catfish” steaks identified as LAKE’S FARM RAISED CATFISH and having lot codes T-14, T-15, T-16, and T-17.
  • 15-lb. cardboard boxes of frozen raw whole “catfish” identified as LAKE’S FARM RAISED CATFISH and having lot codes T-14, T-15, T-16, and T-17.

The products subject to recall bear establishment number “EST. 48150” inside the USDA mark of inspection. These items were shipped to institutional and retail locations in Mississippi and Tennessee.

The problem was discovered on March 23, 2017, after routine FSIS sampling results revealed violative levels of the chemicals Malachite Green and Leucomalachite Green in the 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.

Consumers and media with questions about the recall can contact Earl Lake, President, at (662) 363-1847.

Nutiva Expanded Voluntary Recall In All Lots of Organic Plant Based Protein Superfood 30 Shake

Posted on by

Nutiva, an Organic Superfoods company, has decided to expand its initial voluntary product recall of the Organic Plant Based Protein Superfood 30 Shake – Vanilla to include all lots of both Vanilla and Chocolate flavored products after identifying that this product may contain trace amounts peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product. “We are choosing to voluntarily recall all of our Organic Plant Based Protein Superfood 30 Shakes as a precautionary measure to provide the safest products for our customers,” states John W. Roulac, Nutiva’s CEO.

The affected products include:

Product # Description Packaging Packet UPC/
Caddy UPC		 Master Case UPC Lot Code Expiration Date Range
PBP101 Organic Plant Based Protein
Superfood 30 Shake –Chocolate		 10 – 1.2 OZ (34g) Packets 6-92752-10713-9
6-92752-10714-6		 6-92752-10715-3 24MAY2016 – 11NOV2016 24 MAY 2018 – 11 NOV 2018
Product # Description Packaging Packet UPC/
Caddy UPC		 Master Case UPC Lot Code Expiration Date Range
PBP105 Organic Plant Based Protein
Superfood 30 Shake -Chocolate		 21.6 OZ
HDPE Jar		 6-92752-10709-2 6-92752-10710-8 03MAY2016 – 11JAN2017 03 MAY 2018 – 11 JAN 2019
Product # Description Packaging Packet UPC/
Caddy UPC		 Master Case UPC Lot Code Expiration Date Range
PBP201 Organic Plant Based Protein
Superfood 30 Shake -Vanilla		 10 – 1.2 OZ (34g) Packets 6-92752-10716-0
6-92752-10717-7		 6-92752-10718-4 06MAY2016– 10NOV2016 06 MAY 2018 – 10 NOV 2018
Product # Description Packaging Packet UPC/
Caddy UPC		 Master Case UPC Lot Code Expiration Date Range
PBP205 Organic Plant Based Protein
Superfood 30 Shake -Vanilla		 21.6 OZ
HDPE Jar		 6-92752-10711-5 6-92752-10712-2 03MAY2016 – 02MAR2017 03 MAY 2018 – 02 MAR 2019

These items were sold on the internet and through distributors in Alabama, California, Colorado, Connecticut, Florida, Georgia, Indiana, Iowa, Kansas, Kentucky, Nevada, New Hampshire, New Jersey, New York, North Carolina, Oregon, Pennsylvania, Texas, Virginia, Washington, and Wisconsin.

Consumers who have purchased these items and have an allergy or severe sensitivity to peanuts are urged to not eat the product, and to dispose of it or return it for refund to where it was originally purchased. Nutiva has taken these steps strictly as a precautionary measure to assure our customers of our commitment to quality. No other Nutiva items are impacted by this recall.

Customers with questions may contact (800) 993-4367 between the hours of 8:00 a.m. – 3:00 p.m., Monday – Friday, or email help@nutiva.com.

Wellpet Voluntarily Recalls a Limited Amount of One Recipe of Canned Topper For Dogs

Posted on by

WellPet has initiated a voluntary recall of a limited amount of one canned topper product due to potential elevated levels of naturally occurring beef thyroid hormone.

Recalled Product Details:

Wellness 95% Beef Topper for Dogs – 13.2 oz, Can UPC: 0 76344 89450 6
Best-By Dates of 02 FEB 19, 29 AUG 19 and 30 AUG 19, located on the bottom of the can

Three best-by date codes of one recipe have the potential to contain elevated levels of naturally occurring beef thyroid hormone. Elevated levels may affect a dog’s metabolism and can be associated with anxiousness, increased thirst, increased urinary output and weight loss. However, with prolonged consumption these symptoms may increase in severity and may include vomiting, diarrhea, and rapid or difficulty breathing. Although multiple studies indicate that, for the vast majority of pets, symptoms are reversible once the pet stops eating product with elevated thyroid hormone, if your pet has consumed this product and has exhibited any of these symptoms, please contact your veterinarian.

The recipe is a mixer or topper and is intended for intermittent or supplemental feeding only; the likelihood of a dog being affected is remote. Even though the chance of a dog being affected is unlikely, WellPet is voluntarily recalling this recipe with these three best-by dates. No other Wellness products are affected. Affected products were distributed at pet specialty retailers throughout North America and online.

Although the WellPet Consumer Affairs team has received no reports of any health problems to date as a result of feeding this recipe, the FDA advised WellPet of three dogs that were affected. WellPet immediately initiated an investigation, and based on follow-up research, decided to recall the lots in question. The dogs are now fully recovered and doing well.

“Please know that safeguarding the health and wellbeing of pets is of the utmost importance to us,” said Camelle Kent, chief executive officer of WellPet, the maker of Wellness products. “We fully intend on maintaining the trust you have placed in us to keep your pets healthy and happy, and are removing this product as part of our ongoing commitment to quality and food safety.”

If you have any of the 13.2 oz recipe with these three best-by dates, please email WellPet at wecare@wellpet.com or call 1-877-227-9587. For more information, please visit WellPet’s website for a letter from the CEO.

Blue Buffalo Voluntarily Recalls One Lot of BLUE Wilderness® Rocky Mountain Recipe Wet Food

Posted on by

Blue Buffalo Company is voluntarily recalling one production lot of BLUE Wilderness® Rocky Mountain RecipeTM Red Meat Dinner Wet Food for Adult Dogs, as the product has the potential to contain elevated levels of naturally- occurring beef thyroid hormones.

Dogs ingesting high levels of beef thyroid hormones may exhibit symptoms such as increased thirst and urination, weight loss, increased heart rate and restlessness. These symptoms may resolve when the use of the impacted food is discontinued. However, with prolonged consumption these symptoms may increase in severity and may include vomiting, diarrhea, and rapid or difficulty breathing. Should these symptoms occur, contact your veterinarian immediately.

Although the Blue Buffalo Customer Care Resource Team has not received any reports of dogs exhibiting these symptoms from consuming this product, the FDA advised Blue Buffalo of a single consumer who reported symptoms in one dog, who has now fully recovered. Blue Buffalo immediately began an investigation, however, and after working with the FDA, Blue Buffalo decided it would be prudent to recall the one production lot in question.

The voluntary recall is limited to one production lot of the following product:

Product Name UPC Code Best Buy Date
BLUE Wilderness Rocky Mountain
Recipe Red Meat Dinner Wet
Food for Adult Dogs 12.5 oz can		 840243101153 June 7, 2019 (found
on the bottom of the can)

Affected products were distributed nationally through pet specialty and on-line retailers.

No other Blue Buffalo products are impacted by this issue.

If your pet has consumed the product listed above and has exhibited any of these symptoms, please discontinue feeding and contact your veterinarian.  Consumers who have purchased the product subject to this recall should dispose of it or return it to the place of purchase for full refund.

Consumers with questions may contact Blue Buffalo at 866-201-9072 from 8 AM to 5 PM Eastern Time Monday through Friday, or by email at  CustomerCare@bluebuffalo.com for more information.

EuroCan Manufacturing Voluntarily Recalling Barnsdale Farms® Pig Ears

Posted on by

EuroCan Manufacturing is voluntarily recalling Lot Number 84 consisting of it’s individually shrink-wrapped, 6-pack, 12-pack and 25-pack bags of Barnsdale Farms®, HoundsTooth® and Mac’s Choice® Pig Ears because they have the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is a risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.

Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare provider.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The pig ears were distributed throughout the United States and Canada. The pig ears were packaged as individually shrink-wrapped, 6-pack, 12-pack and 25-pack bags in the Barnsdale Farms®, Barnsdale Farms®-Select, Houndstooth® and Mac’s Choice® brands. The lot number being recalled is 84. No illnesses of any kind have been reported to date.

The potential for contamination was noted after routine testing revealed the presence of Salmonella in the product. The company has suspended distribution of the product while FDA and the company continue their investigation as to the source of the problem. Consumers who have purchased any of the above-described Barnsdale Farms® pig ears should return product to the place of purchase for a refund. Consumer with questions may contact the company Monday – Friday from 9:00 am to 5:00 pm Eastern Standard Time at (888) 290-7606.

The J.M. Smucker Company Announces a Limited Voluntary Recall on Certain Lots of Canned Cat Food

Posted on by

Orrville, OH – The J.M. Smucker Company today announced a limited voluntary recall on certain lots of 9LivesTM, EverPetTM, and Special KittyTM canned cat food due to possible low levels of thiamine (Vitamin B1).

The issue was discovered by the Quality Assurance team during review of production records at the manufacturing facility. No illnesses related to this issue have been reported to date and the product is being recalled out of an abundance of caution.

Cats fed diets low in thiamine for several weeks may be at risk for developing a thiamine deficiency. Thiamine is essential for cats. Symptoms of deficiency displayed by an affected cat can be gastrointestinal or neurological in nature. Early signs of thiamine deficiency may include decreased appetite, salivation, vomiting, and weight loss. In advanced cases, neurological signs can develop, which include ventroflexion (bending towards the floor) of the neck, wobbly walking, circling, falling, and seizures. Contact your veterinarian immediately if your cat is displaying any of these symptoms. If treated promptly, thiamine deficiency is typically reversible.

The affected product was distributed to a limited number of retail customers from December 20 through January 3, 2017.
Continue reading →

Kraft Heinz Recalls Ready-To-Eat Lunchables Ham and American Cracker Stackers

Posted on by

lunch-1WASHINGTON D.C. — Kraft Heinz Company, a Fullerton, Calif. establishment, is recalling approximately 959 pounds of ready-to-eat “Lunchables Ham and American Cracker Stackers” packaged lunch products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains wheat and soy, known allergens, which are not declared on the product label.

The ready-to-eat meat and cheese packaged lunch items were produced on September 21, 2016. The following products are subject to recall:

3.4-oz. boxes containing four-compartment plastic trays of “Lunchables Ham and American Cracker Stackers,” with a “USE BY” date of 25 DEC 2016 and production times ranging from 9:13 to 10:00 stamped on the side of the plastic container.

The products subject to recall bear establishment number “EST. 537K” inside the USDA mark of inspection. These items were shipped to retail locations in Utah and California.
lunch-2
lunch-3
The problem was discovered on October 6, 2016, when the firm received a consumer complaint. There were no illnesses associated with the complaint.

The establishment determined that the “Lunchables Ham and American Cracker Stackers” products were incorrectly labeled with the back label for a “Nacho Lunchable” product. The back label contains the product ingredient statements and as such, the “Lunchables Ham and American Cracker Stackers” products that were mislabeled do not declare wheat and soy on the label.

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

Consumers who have purchased this product are urged not to consume it. This product should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

Consumers with questions about the recall can contact the Kraft Heinz Consumer Relations Center, at 1-800-573-3877. Members of the media with questions about the recall can contact Lynne Gaila, Corporate Affairs Director, Kraft Heinz Company, at (847) 646-4396 or lynne.galia@kraftheinzcompany.com.