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Safety Report: Merck Animal Health Banamine/Banamine-S Update - recalled due to presence of particulate matter, USA

11 months ago •source fda.gov

Recall notice

Merck Animal Health Banamine/Banamine-S Update - recalled due to presence of particulate matter photo #1

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 4 additional batches of BANAMINE® / BANAMINE®-S (flunixin meglumine injection) 50 mg/mL in the United States, used for injection in cattle, swine and horses due to the presence of particulate matter. These batches are in addition to the BANAMINE® / BANAMINE®-S recall of three batches dated Sept. 1, 2023 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 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.

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 its distributor partners to ensure that unused product is no longer in distribution or with customers. They are notifying their distributors and customers directly and are arranging for the return of all recalled products. Customers who may need to arrange return of product should contact their point of purchase.

In case you experience harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc.
Brand name: Merck Animal Health
Product recalled: Banamine; Banamine-S
Reason of the recall: Potential presence of particulate matter
FDA Recall date: September 29, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/merck-animal-health-expands-voluntary-recall-four-additional-lots-banaminer-banaminer-s-flunixin

#recall #drugs #us

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