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Food and Drug Administration--Recalls/Safety Alerts

Recall Information from FDA

Ata Int. Inc. Issues Voluntary Nationwide Recall of BLUEFUSION Capsules, due to presence of Undeclared Sildenafil, Tadalafil, Desmethyl carbodenafil, Dithiodesmethyl carbodenafil, Scutellarin and Daidzein

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.

Hill’s Pet Nutrition Expands Voluntary Recall of Select Canned Dog Food for Elevated Vitamin D

Hill’s Pet Nutrition today announced it is expanding its recall of select canned dog food products due to elevated levels of vitamin D.

Better Made Snack Foods Issues Allergy Alert on Undeclared Milk In 10 Ounce $3.99 Original Potato Chips

The recall was initiated after it was discovered that a package of 10-ounce Original Potato Chips dated 10 AUG 2019 did not contain Original Potato Chips but instead contained Cheddar and Sour Cream Potato Chips which contain milk. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes which may have affected 660 bags of 10-ounce Original Potato Chips.

Century Snacks LLC Recalls Snak Club Honey Bliss Nut Mix Due to Undeclared Allergen

Century Snacks, LLC of Commerce, CA is recalling all packages of 3-oz. and 5.75-oz. SNAK CLUB HONEY BLISS NUT MIX due to undeclared MILK. People who have an allergy or severe sensitivity to MILK run the risk of serious or life-threatening allergic reaction if they consume these products.

Kingston Pharma, LLC RECALLS " DG™/health NATURALS baby Cough Syrup + Mucus” Because of Possible Health Risk

Kingston Pharma, LLC of Massena, NY is recalling Lot KL180157 of its 2-fluid ounce (59 mL) bottles of DG™/health NATURALS baby Cough Syrup + Mucus” because it has the potential to be contaminated with Bacillus cereus/ Bacillus circulans. Bacillus cereus in food products has the potential to produce two forms of gastrointestinal illness, one being a syndrome primarily of vomiting, and the other of diarrhea. Most often, illnesses are mild and self-limiting, although more serious and even lethal cases have occurred. Individuals at risk for more severe forms of illness include infants, young children, and others with weakened immune systems. No illnesses have been reported to date in connection with this problem with the use of DG™/health NATURALS baby Cough Syrup + Mucus.

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

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.

Legacy Pharmaceutical Packaging, LLC Issues 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)

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).

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg 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)

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).

Hospira, Inc. Issues a Voluntary Nationwide Recall of 8.4% Sodium Bicarbonate Injection, USP Due to the Presence of Particulate Matter

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.

Surtidoras Bakery Inc. Issues Allergy Alert on Undeclared Milk in Marble Muffin, Banana Muffin, and Blueberry Muffin

Surtidoras Bakery Inc. of Auburn, Washington is recalling Marble Muffin, Banana Muffin, and Blueberry Muffin because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

Stokes Healthcare Inc. Issues Voluntary Nationwide Recall of Pilocarpine 0.1% Ophthalmic Solution Due to a High Level of Preservative

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.

Hometown Food Company Recalls Two Production LOT Codes of Pillsbury® Unbleached All-Purpose 5lb Flour Due to Possible Health Risk

Please be advised the Hometown Food Company initiated a limited, voluntary retail-level recall on two specific lot codes of its Pillsbury® Unbleached All-Purpose 5 lb Flour (UPC 51500-22241) because it may be contaminated with Salmonella. Only Best If Used By Dates APR 19 2020 and APR 20 2020 are impacted.

Claire’s Stores, Inc., Announces Voluntary Recall of Three Make-Up Products

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.

Fullei Fresh Recalls Organic Bean Sprouts Because of Possible Health Risk

Fullei Fresh of Miami, Florida is voluntarily recalling Organic Bean Sprouts because it has the potential to 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.

Norbrook Laboratories Limited Recalls Veterinary Products for Health Risk

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.

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

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.

McDaniel Life-Line LLC Issues Voluntary Worldwide Recall of Life-Line Water

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.

Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement

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.

Sunstone Organics Issues Voluntary Nationwide Recall of Select Kratom Products Due to Potential Contamination by Salmonella

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.

Updated: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium /Hydrochlorothiazide Tablets, USP

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.