Merck Recalls Three Batches of Injectable Banamine

Edited Press Release, Comments Off on Merck Recalls Three Batches of Injectable Banamine
Merck Animal Health is voluntarily recalling three batches of injectable Banamine/Banamine-S due to particulates that were observed during routine quality testing. Read on for more:

Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, 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 U.S.

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)

A photo of the bottle of each batch number (lot number) that is part of the recall can be found below. The lot number (LOT) and expiry date (EXP) is located at the bottom right part of the bottle label.

Banamine 100 mL

Banamine 250 mL

Banamine-S 100mL

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.

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.

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.

About Merck Animal Health
At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We 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. Merck Animal Health, a division of Merck & Co., Inc., Rahway, N.J., USA, is the global animal health business of Merck. Through its commitment to The Science of HealthierAnimals®, Merck Animal Health offers veterinarians, farmers, producers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of connected technology that includes identification, traceability and monitoring products. Merck Animal Health is dedicated to preserving and improving the health, well-being and performance of animals and the people who care for them. It invests extensively in dynamic and comprehensive R&D resources and a modern, global supply chain. Merck Animal Health is present in more than 50 countries, while its products are available in some 150 markets. For more information, visit Merck Animal Health and connect with us on LinkedIn, Facebook, Twitter, and Instagram.