Recalls That Should Be on Your Radar—Week of March 17

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Procesadora La Hacienda, Inc. Issues Recall for Beef Potentially Contaminated with Foreign Matter

Procesadora La Hacienda, Inc., a San Lorenzo, Puerto Rico establishment, is recalling approximately 4,940 pounds of ready-to-eat (RTE) corned beef products that may be contaminated with extraneous materials, specifically pieces of metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The products subject to recall bear establishment number “EST. 21217A” inside the USDA mark of inspection. These items were shipped to institutions in Puerto Rico. While the product was distributed to schools, it resulted from a commercial sale and was not part of food provided by the USDA for the National School Lunch Program.

The problem was discovered on March 7, 2019 when the establishment received a consumer complaint from the School Program of Puerto Rico. Specifically, the establishment reported receiving a complaint indicating that a school found a piece of metal embedded in a chub of corned beef.

More information about this recall can be found here.

La Rosita Fresh Market, Inc. Issues Recall for Ground Beef Possibly Contaminated With E coli

La Rosita Fresh Market Inc., a Mt. Prospect, Ill. retail store, is recalling approximately 54 pounds of raw ground beef products that may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The raw ground beef items are ground in the store and packaged for consumers behind the meat counter in varying weights. The raw ground beef items were packed on March 13, 2019 and March 14, 2019.

These items were only sold in the La Rosita Fresh Market Inc. retail store, located at 1805 W. Algonquin Rd., Mt. Prospect, IL, 60056.

Details about this recall can be found in the press release.

Ata Int. Inc, Issues Recall of BLUEFUSION Capsules

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.

The presence of the undeclared active ingredients renders the product an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.

BLUE FUSION capsules were marketed as a dietary supplement for male enhancement and is packaged in 1-count blister packs, UPC code — 7.48252. 66460.0. All lots within expiry are being recalled. Product was distributed Nationwide in the USA between January 2015 and March 2019 to Retail stores and through the internet.

Learn more about this recall here.

Kingston Pharma, LLC, Issues Recall for Baby Cough Syrup Potentially Contaminated with Bacillus cereus/circulans

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.

The recalled DG™/health NATURALS baby Cough Syrup + Mucus” bottles were distributed nationwide in Dollar General retail stores. The product comes in a carton labeled DG™/health baby Cough Syrup + Mucus in 2-fluid ounce bottles marked with Lot KL180157 Expiration date 11/20 on the bottom of the carton and back of the bottle label; UPC Code 8 54954 00250 0.

For information on this recall, visit the FDA’s recall website.

Hospira, Inc. Issues Recall of 8.4% Sodium Bicarbonate Injection Due to Presence of Glass

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.

The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

Additional information on this recall can be found here.

Legacy Pharmaceuticals Issues Recall of Losartan Tablets

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).

NMBA is a potential human carcinogen. To date, Legacy has not received any reports of adverse events related to this recall.

Losartan Potassium USP is a prescription medication used to treat high blood pressure and congestive heart failure and is packaged in 30ct bottles.

More details on Losartan related recalls can be found here.

Mylan Institutional LLC Issues Recall for Levoluecovorin Injection Due to Presence of Copper Salts

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. The Levoleucovorin Injection is being recalled due to the presence of particulate matter identified as copper salts. The particulate matter was discovered during 12-month stability testing.

Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. Intravenous administration of a solution containing particulates could lead to local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. To date, Mylan has not received any reports of adverse events related to this recall.

Additional information on this recall can be found here.

Cook Medical, Inc. Issues Recall for Transseptal Needle Due to Risk of Detached Plastic Fragments

Cook Medical is recalling one lot of the Transseptal Needle due to a manufacturing error that resulted in some needle tips missing the back bevel that creates a sharp tip. Without a back bevel, the needle tip could damage the inside of the introducer sheath during insertion of the needle resulting in detached plastic fragments. These fragments could potentially enter the patient’s bloodstream and result in serious adverse health consequences such as a longer procedure to retrieve the plastic pieces, injury to blood vessel walls, embolism, stroke, or death.

Read the MedWatch statement here.

Tyson Foods, Inc. Issues Recall for Chicken Strips Due to Possible Contamination With Metal

Tyson Foods, Inc., a Rogers, Ark. establishment, is recalling approximately 69,093 pounds of frozen, ready-to-eat chicken strip products that may be contaminated with extraneous materials, specifically pieces of metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen, ready-to-eat chicken strip items were produced on November 30, 2018.

The products subject to recall bear establishment number “P-7221” on the back of the product package. For product clarification, the last two digits of the product case codes correspond to the hour produced and will match the first two numbers of the time stamp (as depicted on the label). These items were shipped to retail locations nationwide and for institutional use in locations in Michigan and Washington.

More information can be found here.