FDA Registration Assistance Blog

Supercore Products Group, Inc. Issues Voluntary Worldwide Recall of Hard Steel Capsules & Gold Hard Steel Plus Liquid Due to the Presence of Sildenafil and Acetaminophen FOR IMMEDIATE RELEASE – 7/10/2024 – Atlanta, GA, Supercore Products Group is voluntarily recalling of Hard Steel Capsules & Gold Hard Steel Plus Liquid to the consumer level. FDA analysis has found these products to be tainted with Sildenafil and acetaminophen. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found in FDA … Continue reading “Supercore Products Group, Inc. Issues Voluntary Worldwide Recall of Hard Steel Capsules & Gold Hard Steel Plus Liquid Due to the Presence of Sildenafil and Acetaminophen”

Baxter Issues Urgent Medical Device Recall for Life2000 Ventilator Due to Potential Battery Charger Dongle Damage DEERFIELD, Ill., July 10, 2024 – Baxter International Inc. (NYSE:BAX) announced today it has issued an Urgent Medical Device Recall for Life2000 ventilators with an attached battery charger dongle. The recall is due to reports that the devices are not properly charging when there is damage to the battery charger dongle. Baxter has received one serious injury complaint potentially related to this issue and … Continue reading “Baxter Issues Urgent Medical Device Recall for Life2000 Ventilator Due to Potential Battery Charger Dongle Damage”

Reser’s Fine Foods Announces Voluntary Recall of Hill Country Fare Mustard Potato Salad With a Use By Date of JUL/26/24 Beaverton, OR July 2, 2024 Out of an abundance of caution, Reser’s Fine Foods is voluntarily recalling Hill Country Fare Mustard Potato Salad 48oz (3LB) with a Use By Date of JUL/26/24 due to the possibility of pieces of hard plastic foreign material in the package. No injuries have been reported. This item was produced at a regional facility by … Continue reading “Reser’s Fine Foods Announces Voluntary Recall of Hill Country Fare Mustard Potato Salad With a Use By Date of JUL/26/24”

Urban Spirits Issues Voluntary Recall of Urban Spirits Non-Alcoholic Drink Mixes Due to Potential Under-Processing 07/02/2024Urban River Spirits, LLC Urgent Safety Recall2114 Main St. Forest Grove OR 97116(503) 475-9765 Dear Consumer, Urban River Spirits is issuing a voluntary recall of the products listed below due to additional shelf stability testing requirements from the Oregon Department of Agriculture. This recall is being conducted due to a potential safety concern. To date, we have not received any reports of illnesses related to … Continue reading “Urban Spirits Issues Voluntary Recall of Urban Spirits Non-Alcoholic Drink Mixes Due to Potential Under-Processing”

Vitakraft Sun Seed Recall of Sun Seed Vita Prima Hedgehog Food Due to Possible Salmonella Health Risk Vitakraft Sun Seed Inc. of Weston, OH is working closely with our colleagues at the FDA and MN Department of Agriculture and out of an abundance of caution has elected to expand the recall to include the following lots of Sun Seed Vita Prima Hedgehog Food and Vitakraft Vita Smart Hedgehog Food because it has the potential to be contaminated with Salmonella. Salmonella … Continue reading “Vitakraft Sun Seed Recall of Sun Seed Vita Prima Hedgehog Food Due to Possible Salmonella Health Risk”

Viva Raw Issues Voluntary Recall of Dog and Cat Food Including Select Viva Turkey Recipes (Lot 21244) Due to Potential Listeria Monocytogenes Health Risk to People and Pets July 1, 2024 – Viva Raw LLC, Hillsborough, NC is voluntarily recalling dog and cat foods, including the Viva Turkey for Dogs Ground, Viva Turkey for Dogs Chunked, Viva Turkey for Cats, Viva Pure Turkey, and Viva Beef & Turkey for Puppies all manufactured under Lot 21244 because this lot, which includes … Continue reading “Viva Raw Issues Voluntary Recall of Dog and Cat Food Including Select Viva Turkey Recipes (Lot 21244) Due to Potential Listeria Monocytogenes Health Risk to People and Pets”

Sunco & Frenchie LLC. Recalls Terrafina Brand Macadamia in the Raw Because of Possible Health Risk Sunco and Frenchie LLC of Pine Brook, New Jersey is recalling Terrafina brand Macadamia in the Raw packed in 6 oz plastic containers, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, … Continue reading “Sunco & Frenchie LLC. Recalls Terrafina Brand Macadamia in the Raw Because of Possible Health Risk”

Prophet Premium Blends Recalls Diamond Shruumz Products Because of Possible Health Risk Prophet Premium Blends of Santa Ana, California is recalling Diamond Shruumz Infused Cones, Chocolate Bars, and Gummies (Micro- and Mega/Extreme-Dose), because such products contain Muscimol, a chemical found in mushrooms of the genus Amanita; Muscimol could be a potential cause of symptoms consistent with those observed in persons who became ill after eating Diamond Shruumz products. Reported symptoms have included those linked to seizures, agitation, involuntary muscle contractions, … Continue reading “Prophet Premium Blends Recalls Diamond Shruumz Products Because of Possible Health Risk”

Solata Foods Recalls Fresh Spinach and Spinach Products Due to Possible Health Risk Solata Foods LLC. of Newburgh, NY, is recalling its “Fresh Spinach” listed below because they may 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 persons may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, L. monocytogenes infection … Continue reading “Solata Foods Recalls Fresh Spinach and Spinach Products Due to Possible Health Risk”

American Health Packaging on Behalf of BluePoint Laboratories Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution FOR IMMEDIATE RELEASE – June 25, 2024 – American Health Packaging on behalf of BluePoint Laboratories is voluntarily recalling 21 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution. Risk Statement: The failed dissolution of potassium chloride … Continue reading “American Health Packaging on Behalf of BluePoint Laboratories Issues Voluntary Nationwide Recall for Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K Due to Failed Dissolution”