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| The United States: Merck Animal Health expands voluntary recall with four additional batches of BANAMINE®／BANAMINE®-S (flunixin meglumine injection) in the US due to presence of particulate matter (English only) |
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The US Food and Drug Administration (FDA) announces that Merck Animal Health is voluntarily recalling four additional batches of BANAMINE®/BANAMINE®-S (flunixin meglumine injection) 50mg/ml in the United States, used for injection in cattle, swine and horses due to the presence of particulate matter. Particulates were observed during routine quality testing and reviews for the following additional batches:
- BANAMINE® 100ml (batch number: 3511101, 3511104)
- BANAMINE® 250ml (batch number: 3522101)
- BANAMINE®-S 100ml (batch number: 3511103)
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/merck-animal-health-expands-voluntary-recall-four-additional-lots-banaminer-banaminer-s-flunixin
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by Health Canada and FDA, and was posted on the Drug Office website on 25 Aug 2023 and 4 Sep 2023.
Ends/Tuesday, Oct 3, 2023
Issued at HKT 16:00
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