Merck Animal Health Recalls Banamine/Banamine-S Injection

Merck Animal Health, affiliated to drug major Merck & Co., Inc., has recalled three batches of Banamine/Banamine-S (flunixin meglumine injection) 50 mg/mL in the United States citing the presence of particulate matter.

Flunixin meglumine is a potent, non-narcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity.

The U.S. Food and Drug Administration noted that the prescription product is used for injection in cattle, swine and horses.

It is approved in the US only for intravenous use in beef and dairy cattle, for intravenous and intramuscular use in horses and for intramuscular use in swine.

The agency noted that particulates were observed during routine quality testing and reviews for the three batches.

The administration of the product with particulate matter may result in local irritation, swelling or infection. After intravenous administration in large animals, such as cattle or horses, particulate matter could travel to the lungs and result in local tissue damage.

However, the Rahway, New Jersey has not received reports of any adverse events for the recalled batches to date.

The recalled batches include BANAMINE 100mL, UIN 065474, NDC 00061-0851-03, Batch 2834102, exp Oct. 2024 with distribution dates of March 6, 2023, to May 3, 2023; and BANAMINE 250mL, UIN 065476, NDC 00061-0851-04, Batch 2864102, exp Nov. 2024 with distribution dates of June 21, 2023, to July 11, 2023.

The recall also includes BANAMINE-S 100mL, UIN 065477, NDC 0061-1838-30, Batch 2834103, exp Oct. 2024 with distribution dates: March 20, 2023, to May 16, 2023.

Customers who have received BANAMINE and BANAMINE-S from the recalled batches are asked to stop using the products and refer to their recall letter for product return instructions.

In recent recalls for animal products, Inmar Supply Chain Solutions, LLC in late August recalled various FDA regulated products stored at its Arlington, Texas Facility citing poor conditions including rodents and higher than required heat. The FDA regulated products include food, and over the counter or OTC human or animal drugs, among others.

In early August, Ozona, Texas -based Ozona Organics, LLC called back select Dog, Cat, Equine, and Swine Probiotic products citing potential to become contaminated with microbial growth.

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