Information about Merck Banamine voluntary recall

The following information was sent out by the American Horse Council and is being distributed by the National HBPA for informational purposes:

There has been an important voluntary recall from Merck Animal Health.

On September 1, 2023, Merck Animal Health voluntarily recalled three batches of BANAMINE®/BANAMINE®-S (flunixin meglumine injection) 50 mg/mL in the United States, used for injection in cattle, swine and horses to the consumer level due to the presence of particulate matter.

Particulates were observed during routine quality testing and reviews for the following batches:

• BANAMINE 100mL, UIN 065474, NDC 00061-0851-03, Batch 2834102, exp Oct. 2024
  • Distribution dates: March 6, 2023, to May 3, 2023
• BANAMINE 250mL, UIN 065476, NDC 00061-0851-04, Batch 2864102, exp Nov. 2024
  • Distribution dates: June 21, 2023, to July 11, 2023
• BANAMINE-S 100mL, UIN 065477, NDC 0061-1838-30, Batch 2834103, exp Oct. 2024
  • Distribution dates: March 20, 2023, to May 16, 2023

The batch number, also known as the lot number (LOT), and expiry date (EXP) is located at the bottom right part of the bottle label. See the attached images that includes photos of each recalled bottle.

Using an injectable product that contains particulate matter may result in local irritation, swelling or infection in response to the foreign material. After intravenous administration in large animals, such as cattle or horses, particulate matter could travel to the lungs which could result in local tissue damage. To date, no adverse event reports have been received for the recalled batches.

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

Customers who have received BANAMINE® and BANAMINE®-S from the batches being recalled should stop using the products and refer to their recall letter for product return instructions. Horse owners who have BANAMINE® in their barn should contact Merck or their veterinarian for help identifying the lot number and expiry date. Merck Animal Health is working with distributor partners to ensure that unused product is no longer in distribution or with customers. Merck is arranging for the return of all recalled product.

Consumers with questions regarding this recall should contact Merck Animal Health directly at 1-800-521-5767 (Monday through Friday 8 a.m. – 5 p.m. CDT).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA at 1-888-FDA-VETS or online at http://www.FDA.gov/reportanimalae.