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 (NYSE:MRK), is voluntarily recalling four additional batches of BANAMINE® / BANAMINE®-S (flunixin meglumine injection) 50 mg/mL in the United States, used for injection in cattle, swine and horses due to the presence of particulate matter. These batches are in addition to the BANAMINE® / BANAMINE®-S recall of three batches dated Sept. 1, 2023 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, exp Dec. 2024
- Distribution dates: May 16, 2023, to August 8, 2023
- BANAMINE 100mL, UIN 065474, NDC 00061-0851-03, Batch 3511104, exp Dec. 2024
- Distribution dates: August 4, 2023, to August 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
A photo of the bottle of each batch number (lot number) that is part of the recall can be found at the end of this press release. 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 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. We are notifying our distributors and customers directly and are arranging for the return of all recalled product.
Consumers with technical questions regarding this recall should call 1-800-221-3573 (Monday through Friday 8 a.m. – 5 p.m. CDT). 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 at http://www.FDA.gov/reportanimalae.
This recall is being made with the knowledge of the Food and Drug Administration.
The health and well-being of animals is the foremost priority at Merck Animal Health. We place the utmost emphasis on product quality at every step in the manufacturing and supply chain process.
The post Merck Expands Voluntary Banamine Recall To Include New Batches Of Injectable Product appeared first on Horse Racing News | Paulick Report.
