United States
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. To date, no adverse event reports have been received for the recalled batches.
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
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.
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 the affected products should stop using them 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.
Company name: Merck Animal Health
Brand name: Merck Animal Health
Product recalled: Banamine; Banamine-S
Reason of the recall: Potential presence of particulate matter
FDA Recall date: September 01, 2023
Source:
www.fda.gov
