Sanitizers Drive 2020 US OTC Drug Recalls To Double 2019 Total
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.
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Compared to FY2019, FDA data show agency inspections of OTC and Rx drug manufacturing facilities in FY2020 fell 60%. As pandemic continues in FY2021, inspection rate will remain depressed, and it remains unclear how the agency will reduce the backlog without resorting to remotely conducted inspections.
JAMA study found under simulated gastric conditions a standard tablet of ranitidine yielded NDMA to three orders of magnitude beyond established exposure limits. Rapid formation of NDMA appears to continue for extended periods in gastric conditions, say researchers from Memorial Sloan Kettering and Valisure.