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Merck Animal Health voluntarily recalls three lots of Banamine/Banamine-S in US due to presence of particulate matter

Rahway, New Jersey
Monday, September 4, 2023, 14:00 Hrs  [IST]

Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, New Jersey, USA., is voluntarily 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 US.  

Particulates were observed during routine quality testing and reviews for the following batches: Banamine 100mL, UIN 065474, NDC 00061-0851-03, Batch 2834102, exp October 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 October 2024 -- Distribution dates: March 20, 2023, to May 16, 2023.

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. We are notifying our distributors and customers directly and are arranging for the return of all recalled product.

This recall is being made with the knowledge of the US 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.

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: The company use the power of leading-edge science to save and improve lives around the world. For more than a century, we’ve been at the forefront of research, bringing forward medicines, vaccines and innovative health solutions for the world’s most challenging diseases.


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