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FDA Alerts

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. 4/13/2019 12:15:00 AM

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. 4/11/2019 10:15:00 PM

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. 4/10/2019 9:55:00 PM

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 4/8/2019 7:18:00 PM

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 4/7/2019 12:07:00 AM

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. 3/30/2019

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. 3/29/2019 12:29:00 PM

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. 3/28/2019 10:15:00 PM

USA LESS, is voluntarily recalling all lots of LEOPARD Miracle Honey, to the consumer level. FDA analysis has found LEOPARD Miracle Honey to be tainted with sildenafil. 3/25/2019 6:43:00 PM

Henry Avocado Corporation is voluntarily recalling California-grown whole avocados sold in bulk at retail stores because they have the potential to be contaminated with Listeria monocytogenes. Henry Avocado is issuing this voluntary recall out of an abundance of caution due to positive test results on environmental samples taken during a routine government inspection at its California packing facility. There are no reported illnesses associated with this recall. 3/24/2019 2:02:00 AM

Ata Int. Inc. is voluntarily recalling all lots within expiry of BLUEFUSION Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin and daidzein. Sildenafil and tadalafil are FDA approved drugs for the treatment of male erectile dysfunction and are in a class of drugs called phosphodiesterase (PDE-5) inhibitors. Desmethyl carbodenafil and dithiodesmethyl carbodenafil are analogues of PDE-5 inhibitors and are likely to have the same pharmacological activity as PDE-5 inhibitors and thus carry the same clinical risks. Scutellarin and daidzein are derived from plants or herbs. 3/21/2019 6:35:00 PM

Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL to the consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC. 3/18/2019 8:59:00 PM

Legacy Pharmaceutical Packaging, LLC is recalling 3 repackaged lots of Losartan Tablets USP 50mg to the consumer level. This recall was prompted due to Torrent Pharmaceuticals LTD issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer). 3/16/2019 12:05:00 AM

Earth City, MO, Legacy Pharmaceutical Packaging, LLC is recalling 40 repackaged lots of Losartan Tablets USP 25mg, 50mg, and 100mg to the consumer level. This recall was prompted due to Camber Pharmaceuticals, Inc. issuing a Voluntary Nationwide Recall of Losartan Tablets, USP, due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, (API manufacturer). 3/15/2019 11:27:00 PM

Hospira, Inc., a Pfizer company, is voluntarily recalling lot numbers 79-238-EV, 79-240-EV and 80-088-EV, NDC# 0409-6625-02, of 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL), to the Hospital/Institution level. The recall was initiated due to the presence of particulate matter, confirmed as glass. 3/15/2019 9:57:00 PM

Stokes Healthcare Inc. is voluntarily recalling 1 lot of 81 units of Pilocarpine 0.1% Ophthalmic Solution, to the consumer and veterinarian office levels. The ophthalmic solution has been found to contain a higher level of the preservative benzalkonium chloride than is typical. 3/13/2019 9:27:00 PM

Out of an abundance of caution, today Claire?s Stores, Inc., announced a voluntary recall of three cosmetic products: Claire?s Eye Shadows, Claire?s Compact Powder and Claire?s Contour Palette. We initiated this voluntary recall after testing by the U.S. Food and Drug Administration indicated the possible presence of asbestos fibers in product samples from one lot of each product. Inhalation of asbestos over time has been linked to serious adverse health consequences. 3/12/2019 6:47:00 PM

Norbrook Laboratories Limited of Newry, Northern Ireland is recalling two lots of Enroflox? 100 Injection (enrofloxacin), two lots of Noromectin? Injection (ivermectin) and two lots of Ivermax? 1% Injection (ivermectin) to the veterinarian/consumer level as a precautionary measure as product sterility cannot be assured. There is a concern that if the sterility of these products has been compromised, use of these products could result in introduction of infectious agents to the animal. This may result in the need for medical intervention(s) including, but not limited to the need for supportive care, antibiotics, and/or antifungal drugs. 3/7/2019 10:59:00 PM

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. This recall is being initiated in response to the recall by the manufacturer (Aurobindo Pharma USA, Inc.), which included the affected lot that was repackaged by American Health Packaging. 3/7/2019 6:37:00 PM

McDaniel Life-Line LLC is voluntarily recalling all lots of Life-Line Water to the consumer level. This product is being recalled because FDA analysis found the product to be contaminated with Pseudomonas aeruginosa. 3/6/2019 10:22:00 PM

Weston, Florida, Apotex Corp. is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP to the patient /user level. The four recalled lots of Drospirenone and Ethinyl Estradiol Tablets, USP may possibly contain defective blisters with incorrect tablet arrangements and/or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. LLC. Oman under the subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany. 3/4/2019 4:48:00 PM

Springfield, OR, Sunstone Organics is voluntarily recalling two lots of Sunstone Organics Kratom. These two lots include Sunstone Organics White Vein Kratom Lot 119 and Sunstone Organics Maeng Da Kratom Lot 124A in both capsules and powder form and in all sizes. The products have been found to potentially be contaminated with salmonella. 3/1/2019 9:35:00 PM

Torrent Pharmaceuticals Limited is voluntarily recalling 60 lots of Losartan potassium tablets USP and 54 lots of 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. 3/1/2019 8:50:00 PM

AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. This recall is an expansion of the recall initiated 12/31/18 The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. The expansion relates to lots distributed under the labels for AurobindoPharma USA, Inc. and Acetris Health, LLC. To date, AurobindoPharma USA, Inc. has not received any reports of adverse events related to this recall. 3/1/2019 4:53:00 PM

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit - I (API manufacturer). 3/1/2019 12:01:00 AM

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