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The Quality Lowdown: FDA's Enhanced Drug Recall Authority

 
• By Bowman Cox

Opioid crisis gives US FDA something heparin crisis couldn’t: more drug recall authority in some cases. Meanwhile, Hanlim warning letter and Mercury Labs and Recipharm EU GMP non-compliance statements prove illuminating.

detailed illustration of a compass with Recall text, eps10 vector

This year’s congressional response to the US opioid crisis has succeeded in an area where the response to the heparin crisis of a decade earlier had failed: it delivered mandatory drug recall authority for FDA, though only for controlled substances.

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