Medicine recalls
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| The United States: AvKARE, LLC issues voluntary nationwide recall of Atovaquone Oral Suspension, USP 750mg/5ml due to potential Bacillus cereus contamination |
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The US Food and Drug Administration (FDA) announces that AvKARE, LLC is voluntarily recalling lot number AW0221A of Atovaquone Oral Suspension, USP 750mg/5ml to the consumer/user level due to the potential Bacillus cereus contamination in the product found during stability testing at a third party lab.
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 endocarditis and necrotizing soft tissue infections. To date, AvKARE 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/avkare-llc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5-ml-due
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Apr 2, 2024
Issued at HKT 15:00
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