Perrigo's Recall Flushes Ranitidine OTC Private Label And Store Brand Products From US Market
Also added to FDA recalls database are multiple variations of GSK's Advil line found not to include required safety warning information; a California contract manufacturer's 12 protein products due to an unapproved herbicide; and cosmetics firm Tween Brands' third recall in nine months due to an unapproved colorant.
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Sedgwick reported US OTC drug recalls in 2020 doubled to 61 driven by methanol contamination and GMP deviations in hand sanitizers. Once FDA resumes full inspection schedule, enforcement will be “more frequent, penalties will be harsher and cross-agency collaboration” will be welcome.
Switch consultant Susan Levy suggests drug firms temper enthusiasm for Rx-to-OTC switches with considering the costs NDAs generate and the histories of switches that haven’t been successes.
Attorneys and recall consultants say any firm distributing products associated with COVID-19 should expect to receive the highest level of scrutiny as the US FDA resumes inspections and uses its enforcement muscle to prohibit companies from making adulterated products, such as hand sanitizers, or making fraudulent claims.