Food and Drug Administration--Recalls/Safety Alerts

Legacy Pharmaceutical Packaging, LLC Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity Found in the Active Pharmaceutical Ingredient (API) (Wed, 24 Apr 2019 20:13:00 -0400) Legacy Pharmaceutical Packaging, LLC is expanding its consumer-level recall of 3 repackaged lots Losartan Tablets USP 50mg to include one additional lot.

Jurox Incorporated is Voluntarily Recalling Two Lots of Alfaxan Unpreserved, an Intravenous Injectable Anaesthetic (Wed, 24 Apr 2019 17:24:00 -0400) This recall has been initiated due to an out of specification result for clarity observed in the stability program. The presence of the aluminum phosphate precipitate presents a potential risk that intravascular (I.V.) injection of product containing this precipitate could result in blood vessel in

Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling (Sun, 21 Apr 2019 14:26:00 -0400) Alvogen, Inc. is voluntarily recalling two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level.

Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium/Hydrochlorothiazide Tablets, USP (Thu, 18 Apr 2019 17:55:00 -0400) Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The Recall is expanded to include an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP

Weis Markets Issues Recall for Undeclared Egg Allergen In WQ Banana Puddin Ice Cream (Wed, 17 Apr 2019 19:06:00 -0400) Weis Markets today said it has issued a recall for its Weis Quality Banana Puddin Ice Cream (48oz) since the product’s ingredient label fails to list an egg allergen due to a supplier error. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products. There have been no reports of illness from customer’s consuming this product to date.

Mondelēz Global LLC Conducts Voluntary Recall of Certain Chewy Chips Ahoy 13oz Due to Unexpected Solidified Ingredient in Product in the US (Wed, 17 Apr 2019 14:37:00 -0400) Mondelēz Global LLC announced today a limited voluntary recall in the United States of certain Chewy Chips Ahoy 13oz cookies. This voluntary recall is being conducted because of the potential for certain product to contain an unexpected solidified ingredient. Some reports of potential adverse health effects have been received.

Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with <em>Salmonella</em> (Tue, 16 Apr 2019 16:45:00 -0400) Jensen Tuna of Louisiana is Voluntarily Recalling Frozen Ground Tuna Imported from JK Fish, Because it may Potentially be Contaminated with Salmonella. The frozen product, individually packaged in clear plastic one-pound bags, is sold in white wax 20 lb. boxes. The product is only sold as a wholesale case with twenty bags in each case. The lot numbers are z266, z271 and z272.

Hercules Candy LLC Issues Allergy Alert on Undeclared Peanuts in Cashew Brittle Bits (Tue, 16 Apr 2019 12:40:00 -0400) Hercules Candy LLC . of East Syracuse, NY, is recalling its 4 ounce packages of Cashew Brittle Bits because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product. The recalled Cashew Brittle Bits were distributed from the brick and mortar retail in East Syracuse and nationally through the website www.herculescandy.com.

Unilever Issues Allergy Alert on Undeclared Tree Nut in Limited Quantities of Ben & Jerry’s Coconut Seven Layer Bar Bulk and Chunky Monkey Pint (Tue, 16 Apr 2019 12:39:00 -0400) Unilever is voluntarily recalling a limited quantity of Ben & Jerry’s Coconut Seven Layer Bar bulk and Ben & Jerry’s Chunky Monkey pints, which may inadvertently contain tree nuts including almonds, Brazil nuts, and hazelnuts that are not declared in the ingredient list or allergy information list. Both affected products include a “Contains Walnuts” and a “May contain other tree nuts” label on the back of the pack. Persons who have an allergy or severe sensitivity to these undeclared tree nuts run the risk of a serious or life-threatening allergic reaction if they consume the recalled products.

Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Product Because of Possible Health Risk (Fri, 12 Apr 2019 20:15:00 -0400) Caito Foods is voluntarily recalling fresh cut watermelon, fresh cut honeydew melon, fresh cut cantaloupe and fresh cut mixed fruit containing one of these melons, produced at the Caito Foods facility in Indianapolis because these products have the potential to be contaminated with Salmonella Carrau, 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, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

SD Import Issues Voluntary Nationwide Recall of Aphrodisiac Capsules Due to Presence of Undeclared Sildenafil (Thu, 11 Apr 2019 18:15:00 -0400) SD Import, LLC is voluntarily recalling all lots of Aphrodisiac, Capsules to the consumer level. The products have been found to be tainted with sildenafil. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an active pharmaceutical ingredient in FDA approved product used in the treatment of erectile dysfunction. The presence of sildenafil in Aphrodisiac capsules renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Great American Marketing Company Recalls Ready To Eat Products Because of Possible Health Risk (Wed, 10 Apr 2019 17:55:00 -0400) Great American Marketing Company of Houston, Texas is recalling Ready to Eat Sandwiches, Wraps and Salads because they have the potential to be contaminated with LISTERIA MONOCYTOGENES , an organism which can cause serious and sometimes fatal infections in young children, frail and elderly people and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria Infection can cause miscarriages and still births among pregnant women.

Brian Richardson DBA “In Tha Pink” Issues Voluntary Nationwide Recall of Kopi Jantan Tradisional Natural Herbs Coffee Due to Presence of Undeclared Sildenafil and Tadalafil (Mon, 08 Apr 2019 15:18:00 -0400) Brian Richardson DBA “In Tha Pink”, is voluntarily recalling lots with the expiration of October 13, 2020 (13/10/2020) of ground Kopi Jantan Tradisional Natural Herbs Coffee to the consumer level. FDA analysis has found the product to be tainted with Sildenafil and Tadalafil

Thogensen Family Farm Recalls Raw Frozen Ground Pet Food (Rabbit; Duck; Llama; Pork) Because of Possible <em>Listeria Monocytogenes</em> Health Risk (Sat, 06 Apr 2019 20:07:00 -0400) Thogersen Family Farm of Stanwood, WA is voluntarily recalling raw frozen ground pet food because it has the potential to be contaminated with Listeria monocytogenes. The following varieties, packaged in two pound packs, are included in this recall: course ground rabbit, course ground mallard duck, ground llama, and ground pork frozen raw pet food

Conagra Brands Announces Recall of a Limited Amount of Hunt’s Tomato Paste Cans Due to Potential Presence of Mold (Thu, 04 Apr 2019 17:45:00 -0400) Conagra Brands, Inc. (NYSE: CAG) is voluntarily recalling a limited amount of Hunt’s Tomato Paste No Salt Added six ounce cans. After the canning process, the final product could have been damaged, creating the potential for mold. Conagra Brands became aware of the issue after receiving calls from consumers.

Wakefern Food Corp. Voluntarily Recalls Wholesome Pantry Organic Nut Butters Because of Possible Health Risk (Tue, 02 Apr 2019 14:14:00 -0400) Wakefern Food Corp. has initiated a voluntary recall of a variety of Wholesome Pantry Organic nut butters 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 individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. No illnesses related to the recall have been reported.

NadaMoo! Voluntarily Recalls Select Pints of Strawberry Cheesecake Due to Undeclared Almond (Mon, 01 Apr 2019 18:55:00 -0400) Little Red Rooster Ice Cream Company, d/b/a NadaMoo! (“NadaMoo!”) announced a limited voluntary recall of approximately 26,000 pints of its Strawberry Cheesecake Non-Dairy Frozen Dessert because they contain an undeclared almond ingredient. People who have an allergy or severe sensitivity to almonds run the risk of a serious or life-threatening allergic reaction if they consume the recalled products.

Nestle Purina PetCare Company Voluntarily Recalls a Limited Amount of Muse Wet Cat Food Natural Chicken Recipe in Gravy in Three-ounce Cans due to the Potential Presence of Rubber Pieces (Fri, 29 Mar 2019 20:00:00 -0400) Out of an abundance of caution, Nestle Purina PetCare Company is voluntarily recalling a limited amount of Muse wet cat food Natural Chicken Recipe in Gravy in three-ounce cans. The product could contain rubber pieces that are translucent yellow with a blue backing, which may present a potential choking hazard.

Thomas Hammer Coffee Roasters Inc. Issues Allergy Alert on Undeclared Egg in Blueberry Bread (Fri, 29 Mar 2019 08:29:00 -0400) Thomas Hammer Coffee Roasters Inc. of Spokane, WA is recalling 15 loaves of Blueberry Bread because it may contain 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 product.

Theo Chocolate Issues Allergy Alert on Undeclared Milk in 3oz Sea Salt 70% Dark Chocolate Bars (Thu, 28 Mar 2019 18:15:00 -0400) Theo Chocolate of Seattle, WA is voluntarily recalling 3oz Sea Salt 70% Dark Chocolate bars (UPC 8 74492 00325 8) because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product.