Merck Animal Health Recalls Three Lots of BANAMINE® / BANAMINE®-S Due to Presence of Particulate Matter
Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA, is recalling 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. 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 batches:
- Distribution dates: March 6, 2023, to May 3, 2023
- Distribution dates: June 21, 2023, to July 11, 2023
- 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.
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. 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. Merck Animal Health is working with our distributor partners to ensure that unused product is no longer in distribution or with customers.
Consumers with questions regarding this recall should call 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.