EXPANDED – Merck Animal Health Issues Recalls Three Lots of BANAMINE and BANAMINE-S
Animal Recalls
Recalled Banamine Products
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 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
o Distribution dates: March 6, 2023, to May 3, 2023
- BANAMINE 250mL, UIN 065476, NDC 00061-0851-04, Batch 2864102, exp Nov. 2024
o Distribution dates: June 21, 2023, to July 11, 2023
- BANAMINE-S 100mL, UIN 065477, NDC 0061-1838-30, Batch 2834103, exp Oct. 2024
o Distribution dates: March 20, 2023, to May 16, 2023
September 29th 2023 additionally recalled items.
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
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 distributor partners to ensure that unused product is no longer in distribution or with customers. The company is notifying distributors and customers directly and are arranging for the return of all recalled product.
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. "
Source and more images: FDA
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Consumer Contact: -
Consumers with questions regarding this recall should call 1-800-521-5767 (Monday through Friday 8 a.m. – 5 p.m. CDT).
NEW INFORMATION:-
Consumers with technical questions regarding this recall should call 1-800-221-3573 (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.
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