Recalls You Should Be Aware Of—Week of September 2, 2018

We’ve rounded up a list of important US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) recalls from this past week:

J.T.M. Provisions Recalls Cooked Ground Beef Products Potentially Contaminated with Listeria Monocytogenes

J.T.M. Provisions Co., a Harrison, Ohio establishment, is recalling approximately 960 pounds of cooked ground beef patty products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The affected product are 20-lb. cases containing four 5-lb sealed pouches of “COOKED BEEF PATTY CRUMBLES” with case code “47860” and a Julian date of “18137.” The products were produced on May 17, 2018.

USDA- Food Safety and Inspection Service (FSIS) inspection program personnel discovered the problem on August 31, 2018 during routine inspection duties. The product was tested by the establishment and found to be positive for L. monocytogenes under their sampling program.

For more information on this recall, check out the company’s statement.

Bahar LLC Issues Recall for Frozen Beef Dumpling Products Produced without Benefit of Inspection

Bahar LLC., a Clifton, N.J. establishment, is recalling approximately 2,344 pounds of frozen, raw beef dumplings products that were produced without the benefit of federal inspection, the FSIS announced today.

The frozen, raw beef dumpling items were produced from May 2, 2018 to August 29, 2018. The following products are subject to recall:

• Various weight sealed plastic packages containing “Bahar MANTI Gourmet Mediterranean Brand Beef Dumplings” and “EXP. DATE” of 05/20/19 through 08/29/19.
• 1-lb. square plastic sealed packages containing “Bahar MANTI Gourmet Mediterranean Brand Beef Dumplings” and “EXP. DATE” of 05/20/19 through 08/29/19.

There have been no confirmed reports of adverse reactions linked to this recall so far.

For more details on this class I recall, read the official announcement.

Wayne Farms, LLC Recalls Cooked Chicken Products Potentially Contaminated with Foreign Objects

Wayne Farms, LLC, a Decatur, Ala. establishment, is recalling approximately 438,960 pounds of frozen, fully cooked chicken products that may be contaminated with extraneous materials, specifically metal pieces, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The frozen, ready-to-eat, fully cooked chicken products were produced on various dates from July 4 through July 17, 2018. The following products that are subject to recall can be found here.

There have been no confirmed reports of adverse reactions or injury due to consumption of these products thus far.

To learn more about this recall, check out the press release.

Vyaire Medical Recalls Tri-Flo Subglottic Suction System Due to Breakage Risk

Vyaire Medical, Inc is recalling the Tri-Flo Subglottic Suction System because there is a risk that the distal soft tip of the catheter may break off and enter the patient's lungs.

Health care providers typically place endotracheal tubes into a patient's airway (trachea) to help establish and maintain their airway and to ensure the adequate exchange of oxygen and carbon dioxide. Health care providers use the Tri-Flo Subglottic Suction System to remove liquids or semisolids that block an adult patient's airway when an endotracheal tube is in place.

The FDA has identified this as a Class I recall, the most serious type of recall, to learn more consult the recall statement.

Beaumont Bio Med, Inc Recalls all Homeopathic Aqueous/Alcohol Based Medicines Produced by King Bio Due to Microbial Contamination

Beaumont Bio Med, Inc. is voluntarily recalling its entire aqueous/alcohol-based product line for human use, within expiry, to the consumer level. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

Risk Statement: The administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention and could result in infections that could be life threatening to certain individuals. To date, Beaumont Bio Med has not received any reports of adverse events related to this recall.

For a complete list of products affected by this recall, consult the recall statement.

SCA Pharmaceuticals Issues Recall of Furosemide 100mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

Administration of a drug product that may contain precipitate has the potential to result in serious adverse events due to dosages that may be lower than intended and could lead to therapeutic failures. Intravenous administration of a product with the precipitate can result in blockage of blood vessels and/or catheter occlusions which could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to permanent lung damage.

For details associated with the recalled lots, check out the recall announcement.