药 物 回 收
|
| |
| The United States: Merck Animal Health issues voluntary recall for three batches of BANAMINE® / BANAMINE®-S (flunixin meglumine injection) in the US due to presence of particulate matter (English only) |
| |
The US Food and Drug Administration (FDA) announces that Merck Animal Health is voluntarily recalling three batches of BANAMINE®/BANAMINE®-S (flunixin meglumine injection) 50mg/ml in the United States, used for injection in cattle, swine and horses to the consumer level due to the presence of particulate matter. Particulates were observed during routine quality testing and reviews for the following batches:
- BANAMINE® 100ml (batch number: 2834102)
- BANAMINE® 250ml (batch number: 2864102)
- BANAMINE®-S 100ml (batch number: 2834103)
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/merck-animal-health-issues-voluntary-recall-three-lots-banaminer-banaminer-s-flunixin-meglumine
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by Health Canada, and was posted on the Drug Office website on 25 Aug 2023.
Ends/Monday, Sep 4, 2023
Issued at HKT 15:30
|
| |
|
