Medicine recalls
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| The United States: KVK Tech Inc., Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg／5mL Due to Temperature Abuse |
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The US Food and Drug Administration (FDA) announces that KVK Tech, Inc., is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mL (lot number: 16653A, 16654A) to the consumer level. The recall is based on customer complaints of unusual grittiness in the product, which KVK has determined was most probably caused by prolonged exposure of these product lots to extremely cold weather during shipment.
Exposure of Atovaquone Oral Suspension to extremely low temperatures, during shipment (the product is required to be protected from freezing temperatures), may result in changes to the effectiveness, appearance, taste and thickness of the liquid. Severely immunocompromised patients who receive less effective Atovaquone Oral Suspension may experience inadequate treatment of serious and life-threatening infections. To date, KVK Tech is not aware of any adverse events associated with this problem.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kvk-tech-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5ml-due
In Hong Kong, the above product is not registered pharmaceutical products.
Ends/ Saturday, August 07, 2021
Issued at HKT 12:30
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