March 31

Category: 

Animal & Veterinary Recalls

Midwestern Pet Foods Voluntarily Recall Due to Possible Salmonella Health Risk

Midwestern Pet Foods, Evansville, Indiana is issuing a voluntary recall of specific expiration dates of certain dog and cat food brands including CanineX, Earthborn Holistic, Venture, Unrefined, Sportmix Wholesomes, Pro Pac, Pro Pac Ultimates, Sportstrail, Sportmix and Meridian brands produced at its Monmouth, Illinois Production Facility because they have the potential to be contaminated with Salmonella.

Drug Recalls

Bit & Bet LLC Issues Voluntary Nationwide Recall of Thumbs Up 7 Blue 69K Due to Presence of Undeclared Sildenafil and Tadalafil

Bit & Bet LLC is voluntarily recalling all lots of Thumbs Up 7 Blue 69K capsules to consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and tadalafil in Thumbs Up 7 Blue 69K capsules make them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Consumers with underlying medical issues who take Thumbs Up 7 Blue 69K capsules with undeclared sildenafil and tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Bit & Bet has not received any reports of adverse events related to this recall.

Antoto-K Issues Voluntary Nationwide Recall of Thumbs Up 7 Red 70K Due to the Presence of Undeclared Sildenafil and Tadalafil

Manassas, VA, Antoto-K is voluntarily recalling all lots of Thumbs Up 7 Red 70K, 10 capsules to consumer level. FDA analysis has found the product to contain undeclared Sildenafil and Tadalafil. Sildenafil and Tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of Sildenafil and Tadalafil in Thumbs Up 7 Red 70K, 10 capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Consumers with underlying medical issues who take Thumbs Up 7 Red 70K, 10 capsules with undeclared Sildenafil and Tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.

Namoo Enterprise LLC Issues Voluntary Nationwide Recall of PremierZen Black 5000 Due to the Presence of Undeclared Sildenafil and Tadalafil

Little Ferry, NJ, Namoo Enterprise LLC is voluntarily recalling all lots within expiry of PremierZen Black 5000 capsules to the consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil, known as phosphodiesterase (PDE-5) inhibitors, are found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and tadalafil in PremierZen Black 5000 products makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall.

Zydus Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Acyclovir Sodium Injection, 50 mg/mL Due to Crystallization

Pennington, NJ, Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, to the Hospital/User level after receiving several complaints of crystallization in vials.

Administration of crystalized Acyclovir Sodium Injection, 50 mg/mL has a potential of life-threatening adverse consequences including injection site inflammation of a vein and local reactions, damage and/or obstruction of blood vessels, which could induce clots, particularly in the lungs, the passage of the particulate matter into the bloodstream may lead to clots resulting in stroke, heart attack, decreased liver or kidney function or death of tissues or cells.

S&B Shopper LLC Issues Voluntary Nationwide Recall of Imperial Extreme 2000mg Due to Presence of Undeclared Sildenafil and Tadalafil

S&B Shopper LLC is voluntarily recalling all lots of Imperial Extreme 2000mg capsules, to the consumer level. FDA analysis has found this product to contain undeclared sildenafil and tadalafil. Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and tadalafil in Imperial Extreme 2000mg capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore, subject to recall.

Alembic Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Telmisartan Tablets, USP, 20 mg Due to Label Mix-Up

Bridgewater, NJ, Alembic Pharmaceuticals, Inc is voluntarily recalling one lot of Telmisartan Tablets, USP, 20 mg, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level. The product is being recalled due to a market complaint received which stated that one bottle labelled as 30-count Telmisartan Tablets, USP, 20 mg incorrectly contained 30 tablets of Telmisartan Tablets, USP, 40mg.

Durisan Hand Sanitizer Recall Due to Microbial Contamination

Sanit Technologies LLC d/b/a Durisan announces a voluntary recall of Durisan Antimicrobial Hand Sanitizer, Non-Alcohol products in various sizes listed. The products are being recalled due to microbial contamination. Specifically, out of specification results for bacterial count for Burkholderia cepacia complex and Ralstonia pickettii.

BD Expands Voluntary Recall of ChloraPrep™ 3 mL Applicator Nationwide to Include All U.S. States

BD (Becton, Dickinson and Company), a leading global medical technology company, has revised its press release dated March 19, 2021 relating to an expanded voluntary recall that was initiated on June 23, 2020 for specified catalog numbers of the ChloraPrep™ 3 mL applicator due to possible fungal contamination under certain environmental conditions.

BD has determined that storage of the ChloraPrep™ 3 mL Applicator in regions of the world with high heat and humidity, where product may be exposed to temperatures of 30 degrees Celsius (86 degrees Fahrenheit) and 75% relative humidity, allows the growth of Aspergillus penicillioides.

The Aspergillus penicillioides within the packaging can contaminate the surface of the applicator and/or gloved hands of the health care professional and then consequently the sterile field. Since the applicator is used for site preparation prior to an invasive procedure, a contaminated applicator can result in direct inoculation of the fungus into tissues.

Food & Beverage Recalls

Harris Teeter Announces Voluntary Recall of Fresh Foods Market Cookies & Crème Cakes Due to Undeclared Hazelnut

Harris Teeter announced today the voluntary recall of Fresh Foods Market items due to undeclared hazelnut.

The items included in the recall are:

Harris Teeter Fresh Foods Market 8-inch Three-Layer Cookies & Creme Cake UPC: 0007203695224

Harris Teeter Fresh Foods Market Cookies & Creme Cake Halves UPC: 0007203695846

Harris Teeter Fresh Foods Market Cookies & Creme Cake Slices UPC: 0007203695862

Sabra Dipping Company Issues Limited Voluntary Recall of a Single SKU of Classic Hummus

Today Sabra Dipping Company, LLC announced that, in partnership with the FDA, it is voluntarily recalling approximately 2,100 cases of 10 oz Classic Hummus because it was potentially contaminated with Salmonella, that was discovered by a routine screen of a single tub by the FDA. The recall is limited to 1 SKU of 10 oz Classic Hummus produced on Friday, February 10, 2021 between the hours of 6:00 PM and 12:00 midnight with a “Best Before” date of April 26.

The voluntary recall is limited only to 10 oz Classic Hummus. No other Sabra products are affected by this recall. This product was distributed to 16 states. The product is over halfway through its shelf life. It’s unlikely you’ll find this product on the shelf.

Trident Seafoods Recalling Pacific Salmon Burger - Public Notice

Trident Seafoods Corporation is issuing a voluntary recall of a single lot number of Pacific Salmon Burgers, Net Wt. 3 lbs. (48 oz.), because it may contain small pieces of metal. Consumption of these products may pose a choking hazard or other physical injury. If you have any remaining product with Lot Number GC101431 and a Best By 01/14/2023, please discontinue use and return item to your local Costco for a full refund.

Kareem Mart Recalls “Halva” Because of Possible Health Risk

Kareem Mart of Garden City, MI,is recalling its 1lb and 2lb Kareem Chef brand “Halva”, “Halva with Pistachio”, and “Halva with Chocolate” food treats because they have the potential to be contaminated with salmonella, an organism which can cause serious and sometimes fatal infection in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, producing more severe illnesses infections.

The recalled “Halva” were distributed through Mediterranean food stores and wholesalers in Michigan, Illinois, Missouri, New York, Ohio, North Carolina and Pennsylvania.  Between March 2020 to Feb 2021.

GK Foods USA Announces Voluntary Recall of a Batch of La Fe Peppers and Onions

GraceKennedy Foods (USA) LLC (GK Foods USA) has announced a voluntary recall of a batch of its La Fe Peppers and Onions, due to the probable presence of extraneous material.

Derrick Reckord, President and CEO of GK Foods USA, owner of the La Fe brand, explained that the Voluntary Class 2 Recall has been initiated because there possibly could be small pieces of blue plastic in the product. If consumed, these plastic pieces could cause adverse health consequences. A Class 2 recall is issued when there is a remote probability of adverse health effects from the consumption of a product.

Real Water, Inc., Issues Precautionary Recall of All Sizes of Real Water Brand Drinking Water Due to a Possible Health Risk

Real Water, Inc. of Mesa, AZ and Henderson, NV, has issued a voluntary recall of all sizes of its Real Water brand drinking water, because it may be linked to certain instances of non-viral hepatitis which were reported in or about November, 2020 in the Las Vegas, NV area.

Bobo’s Issues a Voluntarily Allergy Alert on Undeclared Peanuts in Product

Bobo’s of Boulder, Colorado is issuing a voluntary recall of Bobo’s Maple Pecan Oat Bars because they may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

Maple Pecan Bars were distributed through retail stores nationwide and through online orders at www.eatbobos.com.

The product can be identified by the lot code found on a stamp on the back of the bar: 0L30112B, Best By 7/30/21 or 7/31/21. The bars are 3oz and may be a single bar or in a box of 12. UPC Code: 829262000210