Food and Drugs Administration--Recalls/Safety Alerts

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency (Fri, 22 May 2020 15:00:00 EDT) Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amo

New Hoque and Sons, Inc. Recalls Radhuni Curry Powder Because of Possible Health Risk (Thu, 21 May 2020 14:14:00 EDT) New Hoque and Sons, Inc. of Maspeth, NY is recalling Radhuni Curry Powder, contained in 400g plastic bottles, 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 wi

Biota Biosciences Issues Voluntary Nationwide Recall of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables Because They Were Marketed Without FDA Approval (Wed, 20 May 2020 00:00:00 EDT) Biota Biosciences is voluntarily recalling the following lots in the table below of Cannabidiol (CBD) Complex, Curcumin Complex, and Cannabidiol + Curcumin Injectables to the customer level.

Kent Nutrition Group Recalls Home Fresh Starter Amp Crumble Because of Elevated Salt Levels (Wed, 20 May 2020 00:00:00 EDT) Kent Nutrition Group (KNG) of Muscatine, Iowa is voluntarily recalling 27- 25 lb.bags of Home Fresh Starter AMP Crumble from a single batch due to elevated salt levels, which can present illness or death to poultry.

Ramar Foods Recalls Mint Chocolate Chip With Hidden Spinach Ice Cream Because of Possible Health Risk (Thu, 14 May 2020 21:51:00 EDT) Ramar Foods of Pittsburg, CA, is recalling its 14 ounce packages of Peekaboo branded Mint Chocolate Chip with Hidden Spinach Ice Cream product out of an abundance of caution because of the potential contamination of Listeria monocytogenes, an organism which can cause serious and sometimes fatal infe

Mellace Family Brands California Inc. (Johnvince Foods) Recalls Wegmans Semi-Sweet Chocolate nonpareils, 18.5oz (1lb 2.5oz) 524g Due to Undeclared Milk Allergen (Thu, 14 May 2020 00:00:00 EDT) MELLACE FAMILY BRANDS CALIFORNIA INC. (JOHNVINCE FOODS),located at 655 North River Road, Unit C, Warren Ohio 44483-2254, is recalling Wegmans Semi-Sweet Chocolate nonpareils, 18.5oz (1lb 2.5oz) 524g because it has undeclared MILK allergen on the retail label. People who have an allergy or severe sen

Summitt Labs Issues Voluntary Nationwide Recall of KORE ORGANIC Watermelon CBD Oil Due to High Lead Results (Tue, 12 May 2020 09:36:00 EDT) Summitt Labs is voluntarily recalling Batch#730 Lot#K018 of KORE ORGANIC Watermelon CBD Oil Tincture, 30 ml bottle, 15mg 450x to the consumer level. The Florida Department of Agriculture and Consumer Services tested a random sample and found the product to contain lead levels at 4.7 ppm.

UNFI Voluntarily Recalls Wild Harvest® Organic Basil Due to Possible Health Risk (Mon, 11 May 2020 00:00:00 EDT) United Natural Foods, Inc. (UNFI) is initiating a voluntary recall of a limited quantity of Wild Harvest® Organic Basil distributed out of UNFI’s Hopkins, MN distribution center to select retailers in Minnesota between 4/18/2020-5/8/2020. UNFI’s recall is issued out of an abundance of caution becaus

ICU Medical Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP Due to the Presence of Particulate Matter (Fri, 08 May 2020 13:25:00 EDT) ICU Medical, Inc. is voluntarily recalling one single lot of Lactated Ringer's Injection, USP. The products are being recalled to the hospital/user level due to the presence of particulate matter identified as iron oxide. ICU Medical became aware of this issue through a single customer complaint

Zilk’s Plus Resources Issues Allergy Alert on Undeclared Milk, Soy, and Wheat in Select 12 Oz Bottled Sauces (Fri, 08 May 2020 00:00:00 EDT) Zilk’s Plus Resources, LLC of Austin, TX announces a voluntary recall for select 12 oz bottles of Pluckers World Famous Wing Sauces because they may contain undeclared allergens.

Becca Cosmetics voluntarily recalls Light Shifter Brightening Concealer (Thu, 07 May 2020 00:00:00 EDT) Out of abundance of caution, and in line with its commitment to consumer satisfaction and safety, Becca Cosmetics is voluntarily recalling all shades of its Light Shifter Brightening Concealer because a brownish-black material identified as a common household mold was found on the sponge-tip applica

MasterPharm, LLC. Issues Voluntary Nationwide Recall of Finasteride Plus 1.25mg Due to the Presence of an Undeclared Antihypertensive Drug (Wed, 06 May 2020 16:42:00 EDT) MasterPharm, LLC. is voluntarily recalling 1 lot of Finasteride Plus 1.25mg, capsules to the consumer level. The Finasteride Plus capsules have been found to contain undeclared minoxidil, an antihypertensive drug, at levels greater than those found in FDA approved products. The undeclared minoxidil

The Essential Baking Company Issues Allergen Alert on Undeclared Egg in 84 Loaves of 32 Oz. Sliced Columbia Bread (Tue, 05 May 2020 00:00:00 EDT) The Essential Baking Company of Seattle, Washington is recalling 84 loaves of 32 oz. Sliced Columbia Bread, expiration date May 6.20, due to undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this pro

Medifast Inc. Issues Allergy Alert on Undeclared Milk in OPTAVIA Essential Old Fashioned Maple & Brown Sugar Oatmeal (Mon, 04 May 2020 11:04:00 EDT) Medifast, Inc. of Baltimore, Md., is recalling 24,923 boxes of OPTAVIA Essential Old Fashioned Maple & Brown Sugar Oatmeal because the product may contain undeclared traces of milk.

Mondelēz Global LLC Conducts Voluntary Recall of Limited Quantity of RITZ Cheese Cracker Sandwiches Family Size Product in the U.S. Due to Undeclared Peanut on Outer Packaging (Fri, 01 May 2020 00:00:00 EDT) Mondelēz Global LLC announced today a voluntary recall of a limited quantity of RITZ Cheese Cracker Sandwiches Family Size (21.6 oz. carton) product in the United States. This recall is being conducted because the outer packaging indicates that the product is Cheese variety, while the individually-

Condies Foods Issues Allergy Alert on Undeclared Soy Allergen in Chicken Salad on Croissant Single Item# 43237 and Chicken Sandwich on White Single Item# 43559 (Wed, 29 Apr 2020 16:05:00 EDT) Condies Foods of Kearns, UT is recalling 165 units of roll chicken salad on croissant single item# 43237 “USE THRU” 03/6/2020 05/6/2020, and sndw chicken sandwich on white single item# 43559 “USE THRU” 03/6/2020 05/2/2020. There is a possibility that this may contain undeclared soy allergen

GSK Consumer Healthcare Recalls Benefiber Healthy Shape Prebiotic Fiber Supplement and Benefiber Prebiotic Fiber Supplement Due to Possible Plastic Contamination from the Bottle Cap (Tue, 28 Apr 2020 00:00:00 EDT) GSK Consumer Healthcare is voluntarily recalling five lots (listed below) of Benefiber Healthy Shape Prebiotic Fiber Supplement powder and Benefiber Prebiotic Fiber Supplement powder due to the potential for green plastic pieces or shavings from bottle caps to be present in the product. There is a p

CME America Provides Update on Two Previously Announced Voluntary Recalls Related to Ambulatory Infusion Pumps and Sets (Mon, 27 Apr 2020 00:00:00 EDT) CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), a leading global medical technology company, today issued the following update regarding two previously announced voluntary recalls, one related to all models of CMEAmerica BodyGuard® infusion pumps (FDA Recall Number: Z-1

Fresenius Kabi's Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.) (Thu, 23 Apr 2020 00:00:00 EDT) QuVa Pharma, Inc. confirms that is working with the U.S. Food and Drug Administration, and voluntarily recalling all lots of R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) 50 ml in Sodium Chloride-60 ml BD syringe that were prepared using sterile Ketorolac being recalled by Fresenius Kabi

Royal International Trading Inc Issues Alert On Undeclared Sulfites In “Tayni Boctoka Dry Fruits Mix Compot Apple” (Wed, 22 Apr 2020 00:00:00 EDT) ROYAL INTERNATIONAL TRADING Inc of Brooklyn, NY is recalling its 500g (17.63oz) packages of "TAINY BOCTOKA DRY FRUITS MIX COMPOT APPLE" because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they c