On Friday, Sept. 29, Merck Animal Health announced it is voluntarily recalling four additional batches of Banamine/Banamine-S (flunixin meglumine injection) 50 mg/mL in the United States, used for injection in horses, cattle and swine due to the presence of particulate matter. These batches are in addition to the three batches of Banamine/Banamine S that Merck recalled in early September due to the presence of particulate matter. Banamine/Banamine S (flunixin meglumine injection) is a prescription product in the U.S.
Particulates were observed during routine quality testing and reviews for the following additional batches:
- BANAMINE 100mL, UIN 065474, NDC 00061-0851-03, Batch 3511101, expires December 2024
- Distribution dates: May 16, 2023, to Aug. 8, 2023
- BANAMINE 100mL, UIN 065474, NDC 00061-0851-03, Batch 3511104, expires December 2024
- Distribution dates: Aug. 4-17, 2023
- BANAMINE 250mL, UIN 065476, NDC 00061-0851-04, Batch 3522101, expires December 2024
- Distribution dates: July 14-Aug. 17, 2023
- BANAMINE-S 100mL, UIN 065477, NDC 0061-1838-30, Batch 3511103, expires December 2024
- Distribution dates: May 3-Aug.16, 2023
A photo of the bottle of each batch number (lot number) that is part of the recall can be found below. The lot number (LOT) and expiry date (EXP) is located in the bottom right portion of the bottle label.
The administration of 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.
Flunixin meglumine is a potent, non-narcotic, nonsteroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is approved in the U.S. 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. Merck Animal Health is working with distributors to ensure that unused product is no longer in distribution or with customers. The company is notifying our distributors and customers directly and arranging for the return of all recalled product.
Consumers with technical questions regarding this recall should call 1-800-221-3573 (8 a.m. – 5 p.m. weekdays Central Time). Customers who may need to arrange return of product should contact their point of purchase.
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.
This recall is being made with the knowledge of the Food and Drug Administration.