Medicine recalls
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| The United States: Bionpharma Inc. issues voluntary nationwide recall of Atovaquone Oral Suspension due to bacterial contamination |
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The US Food and Drug Administration (FDA) announces that Princeton, NJ, Bionpharma Inc. is voluntarily recalling one single batch of Atovaquone Oral Suspension 750mg per mL (batch number: 2310083) to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc. The product was found to be contaminated with Cohnella bacteria.
In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as inflammation of the heart and permanent damage to soft tissue. To date, Bionpharma has not received any reports of adverse events related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bionpharma-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-due-bacterial
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Sep 19, 2024
Issued at HKT 15:15
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