October 3, 2023
Merck Animal Health is voluntarily recalling four additional batches of Banamine / Banamine-S (flunixin meglumine injection) 50 mg/mL in the United States due to the presence of particulate matter. These batches are in addition to the recall of three batches dated Sept. 1, 2023, due to the presence of particulate matter.
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 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.
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 said it is working with its distributor partners to ensure that unused product is no longer in distribution or with customers. Distributors and customers are being notified directly in order to arrange for the return of all recalled product.
“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 company stated.
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.
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