Merck Animal Health has voluntarily recalled three batches of Banamine/Banamine-S (flunixin meglumine injection) 50 mg/mL in the United States to the consumer level due to the presence of particulate matter. Banamine/Banamine-S is used for injection in cattle, swine, and horses and is a prescription product in the U.S.
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 lot number (LOT) and expiry date (EXP) is located at the bottom right part of the bottle label. To date, no adverse event reports have been received for the recalled batches.
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.
Consumers with questions regarding this recall should call 1-800-521-5767 (Monday through Friday 8 a.m. – 5 p.m. CDT).
Click here to read the full FDA Recall Alert.