FDA Gets Final With Guidance On Recall Public Warnings, Notifications
There may be fewer recalls, but they are getting more publicity, in part because of FDA warnings that one recalcitrant firm said “decimated” sales.
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Recent developments confirm the laser focus of the US FDA and the pharmaceutical industry on managing quality risks such as potentially carcinogenic impurities, product mix-ups and microbial contamination. But they also underscored opportunities like global regulatory harmonization, assay development and responses to negative pre-approval inspections.
EpiPens get new lease on life, though not like nationally stockpiled AtroPens got, while B. Cepacia humbles King Bio and valsartan impurity rouses science to action. More drug recalls, more warning letters, more import alerts are announced, while a new counterfeit detector makes its debut.
Dr. King's brand homeopathic Aquaflora Candida HP9, Lymph Detox and Baby Teething liquids are recalled after FDA found microbial contaminants. MyNicNaxs, which was shut down in March, is recalling all supplements it sold for five years. Gaia Ethnobotanical is latest firm recalling kratom-containing supplements due to salmonella.