Merck Animal Health announced on Friday, September 29 that it has voluntarily recalled an additional four 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. This latest step follows a separate Merck recall on September 1, 2023 for three batches of Banamine/Banamine-S Injection for the same reason.
Banamine/Banamine-S is used for injection in cattle, swine, and horses and is a prescription product in the U.S.
The FDA defines particulates as “mobile, undissolved particles (metal, glass, dust, fiber, rubber, polymer, mold, degradant precipitate) other than gas bubbles that are unintentionally present in an injectable product.” Particulates were observed during routine quality testing and reviews for the following batches:
- BANAMINE 100mL, UIN 065474, NDC 00061-0851-03, Batch 3511101, exp Dec. 2024
- Distribution dates: May 16, 2023 to August 8, 2023
- BANAMINE-S 100mL, UIN 065474, NDC 0061-1851-03, Batch 3511104, exp Dec. 2024
- Distribution dates: August 4-17, 2023
- BANAMINE 250mL, UIN 065476, NDC 00061-0851-04, Batch 3522101, exp Dec. 2024
- Distribution dates: July 14, 2023, to August 17, 2023
- BANAMINE-S 100mL, UIN 065477, NDC 0061-1838-30, Batch 3511103, exp Dec. 2024
- Distribution dates: May 3, 2023, to August 16, 2023
The lot number (LOT) and expiry date (EXP) is located at the bottom right part 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.
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.