Medicine recalls
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| The United States: Scynexis issues a voluntary nationwide recall of BREXAFEMME® (ibrexafungerp tablets) due to potential for cross contamination with a non-antibacterial beta-lactam drug substance |
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The US Food and Drug Administration (FDA) announces that Scynexis, Inc. is conducting a voluntary nationwide recall of 2 lots of BREXAFEMME® (ibrexafungerp 150mg tablets) (lot number: LF21000008, LF22000051) to the consumer level in the US market due to potential cross contamination with a non-antibacterial beta-lactam drug substance in the ibrexafungerp citrate used to manufacture the BREXAFEMME® tablets. During a review of manufacturing equipment and cleaning activities at a supplier, Scynexis was made aware of potential cross-contamination risk with a non-antibacterial beta-lactam drug substance.
The potential cross contamination with a non-antibacterial beta-lactam drug substance could lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis, a potentially life-threatening adverse reaction. To date, Scynexis has not received any reports of adverse events established to be due to the possible beta-lactam cross contamination.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/scynexis-issues-voluntary-nationwide-recall-brexafemmer-ibrexafungerp-tablets-due-potential-cross
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Sep 29, 2023
Issued at HKT 14:00
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