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| The United States: Darmerica LLC issues voluntary nationwide recall of Quinacrine Dihydrochloride due to a labeling error (English Only) |
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The US Food and Drug Administration (FDA) announces that Darmerica LLC is voluntarily recalling two lots, DR4654A and DL4654A (expiration date of April 27, 2021), of Quinacrine Dihydrochloride, bulk API powder packaged in amber HDPE bottles to the consumer level. This product is being recalled due to a label mix-up. Product intended for further compounding use by pharmacies labeled as Quinacrine API was tested and identified as Artemisinin API.
Receiving artemisinin rather than quinacrine could lead to deterioration of disease that is being treated, serious adverse reactions, due to prolonged exposure to artemisinin, which would need medical or surgical intervention as well as mistaken evaluation and remediation of adverse reactions. To date, Darmerica LLC 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/darmerica-llc-issues-voluntary-nationwide-recall-quinacrine-dihydrochloride-due-labeling-error
In Hong Kong, the above product is not a registered pharmaceutical substance.
Ends/Monday, Sep 16, 2019
Issued at HKT 18:00
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