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FDA Alerts

Plainsboro, New Jersey, Jacobus Pharmaceutical Company Inc. is voluntarily recalling 3 lots of Ruzurgi? (amifampridine) 10 mg tablets to the consumer level. The products have been found to be contaminated with yeast, mold, and aerobic bacteria based on laboratory test results. Oral products heavily 9/13/2021

Velvet Ice Cream has issued a voluntary recall of its 56oz Raspberry Fudge Cordial Ice Cream because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts could experience a serious or life-threatening allergic reaction if they consume this product. The impac 9/13/2021

Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of conventional Curly Leaf Parsley. The product being recalled is Dole? Curly Leaf Parsley, with harvest dates of August 18, 2021, and August 19, 2021. A random, routine regulatory sample collected in Michigan tested po 9/10/2021 6:38:00 PM

McKee Foods of Collegedale, Tenn., is recalling 25 cases of Little Debbie? Mini Nutty Buddy Cookie Bites Sandwich Cookies, because they may contain undeclared pecans. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they cons 9/10/2021 12:47:00 PM

Wilmington, MA, Azurity Pharmaceuticals, Inc. (?Azurity?) is voluntarily recalling one lot of Firvanq? (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit (?Firvanq??) to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omepraz 9/8/2021

ICU Medical, Inc. is voluntarily recalling one lot (2,112 units) of Aminosyn II, 15%, An Amino Acid Injection, Sulfite Free intravenous (IV) solution to the hospital/user level due to the presence of visible particulate matter identified as fibers, hair, and proteinaceous material along with other 9/3/2021 5:12:00 PM

Weis Markets today announced it has issued a recall for its in-store $7 Crab Cake Meal for not declaring milk as an allergen on its label. Food allergies are an immune system reaction that occurs soon after eating a food containing an allergen. Even a tiny amount of the allergy-causing food can tri 9/2/2021 5:17:00 PM

The Baking Institute Bakery Co. of Northbrook, Illinois is recalling ?Carrot Cake? because it may contain undeclared walnuts and coconut. People who have an allergy or severe sensitivity to walnuts and coconut run the risk of serious or life-threatening allergic reaction if they consume these produc 9/2/2021 4:34:00 PM

Rocky Top Farms of Ellsworth, MI, is recalling its 10-ounce jars of "Cherry Butter" fruit butter because they may contain undeclared milk. People who have an allergy or a severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. 8/26/2021 12:24:00 PM

Top Quality Dog Food of Hyattsville, MD is recalling ?Beef HVM? 1-pound packages due to the potential of Salmonella spp., Listeria monocytogenes. Salmonella, Listeria, can affect animals eating the product and there is risk to humans handling contaminated products, especially if they have not thor 8/26/2021

KBF Inc. of Astoria, NY, is recalling its 8.11 ounce packages of ?Banoful Top Orange Biscuit? food treats because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product 8/25/2021 3:30:00 PM

Jimbo?s Kitchen, DBA New England Cupboard is recalling Jimbo?s Bloody Mary Mix because it contains undeclared soy, wheat and sulfites. People who have an allergy or severe sensitivity to soy, wheat and sulfites run the risk of serious or life-threatening allergic reaction if they consume these produ 8/24/2021

Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for all Spectrum IQ infusion pumps to reinforce important safety information when customers implement changes to their network configuration and server systems. Baxter previously communicated this informatio 8/24/2021

Loki Fish Company of Seattle, Washington is recalling 4 oz. packages of Keta Salmon Lox (UPC code 92103 00111) because it has the potential to be contaminated with Listeria monocytogenes 8/23/2021

Pfizer is voluntarily recalling an additional four lots of Chantix 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level. 8/16/2021

8/14/2021, Mai Franchising Inc., of Allentown, PA is voluntarily recalling 103 packs of sushi containing cocktail shrimp for products purchased in the state of California only.in relation to the Shrimp recall expansion initiated by Avanti Frozen Foods Pvt. Ltd, due to potential salmonella contaminat 8/14/2021

8/14/2021, Mai Cuisine Inc., of Allentown, PA is voluntarily recalling 67 packs of 12pc Shrimp Tempura Kabuki Roll WR purchased in the state of California only in relation to the Shrimp recall expansion initiated by Avanti Frozen Foods Pvt. Ltd, due to potential salmonella contamination in frozen sh 8/14/2021

8/14/2021, Genji Pacific LLC., of Allentown, PA is voluntarily recalling 1490 packs of sushi containing cocktail shrimp for products purchased in the state of California only, in relation to the Shrimp recall expansion initiated by Avanti Frozen Foods Pvt. Ltd, due to potential salmonella contaminat 8/14/2021

Avanti Frozen Foods Pvt. Ltd, is voluntarily expanding a prior recall issued on June 25,2021 to include certain consignments of various sizes of frozen cooked, peeled, deveined, shrimp (with some packaged with cocktail sauce) sold in various unit sizes, because it has the potential to be contaminate 8/13/2021

August 13, 2021, Wet Noses Natural Dog Treat Company of Monroe, Washington is recalling approximately 51,000 packages of Simply Nourish frozen dog food, due to it containing elevated levels of Vitamin D. Consumers should stop feeding the products listed below to their dogs. Dogs ingesting elevated 8/13/2021

RMH Foods, LLC in Morton IL is voluntarily recalling 583 cases of Gordon Choice? Deli Style Tuna and Chicken Salads packed in 4lb rigid tubs because of undeclared wheat and tuna allergens. People who have an allergy or severe sensitivity to wheat or tuna run the risk of a serious or life-threatening 8/13/2021

Hostess Brands, LLC (?Hostess Brands?) is voluntarily recalling certain Hostess? Soft White Hamburger Buns and Soft White Hot Dog Buns due to the potential for the products to be contaminated with Listeria monocytogenes and Salmonella. Hostess Brands is recalling the impacted products out of an abun 8/13/2021

Jimmy?s Cookies LLC of Clifton is recalling LOT# 1133 Marketside Chocolate Candy Cookie Cake from certain Walmart stores, because it 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 cons 8/12/2021 3:35:00 PM

Frito-Lay today issued a voluntary recall of a limited number - 31 bags - of 7 3/4 oz. Wavy Lay?s Original Potato Chips as they may contain undeclared milk ingredients. The recall is the result of an investigation following a consumer contact. Those with an allergy or severe sensitivity to milk run 8/11/2021

[eBay Seller ID: jongu 4308] is voluntarily recalling all lots of Hydro Pineapple Burn to consumer level. FDA analysis has found the product to contain undeclared sibutramine. Sibutramine was an FDA approved drug used as an appetite suppressant for weight loss but was withdrawn from the market beca 8/11/2021

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