11/10/2023
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.