Rx 'Reformulation' In Herbal Sleep Aid Gives FDA A Nightmare
FDA inspects Belmora's website and product labeling in March and issues a warning letter that firm’s Elavil OTC Sleep Aid is an unapproved new drug with inadequate directions for its intended use.
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FDA alerts consumers and health care providers to 13 products found in examinations of international mail shipments to contain sildenafil and one with the banned drug sibutramine.
This comprehensive table provides key facts at a glance for every one of the 1,276 drug recalls FDA reported last year, grouped into seven main problem areas. For each recall, it says what product was recalled and how much of it was recalled, what company manufactured it and recalled it, how seriously FDA rated the health threat the recalled product posed, and what reason the company gave for recalling the product.
Five firms' “representations create a false impression that [their] products have been authorized for emergency use by FDA and are misleading," states FDA's medical device center.