Despite FDA Request, Consumer Alert, Firm Won't Recall Spiked Supplement
FDA warns Wave Miami that its Lipro Dietary Capsule weight loss product contains tadalafil and the firm has not recalled it despite requests from the agency. FDA says the firm makes claims including helping users lose 30 pounds in 30 days.
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"FDA’s failure to stop companies from selling ranitidine makes the United States government complicit in exposing infants and adults to the risk of cancer," says Rep. DeLauro in letter to FDA and HHS. She also re-introduced legislation proposing FDA have mandatory recall authority for drugs.
HBW Regulatory Roundup: Spiked 'Vitamin C' Found, SC Johnson Facility GMP Problems, AHPA Labeling Guidance
Fitoterapia USA recalls 190,000 bottles of Metro Macho Artificial Passion Fruit Flavored Vitamin C Liquid Supplement tainted with tadalafil; FDA sends GMP warning letter to SC Johnson facility making antimicrobial hand soaps ; and AHPA revises its herbal supplement labeling guidance.
FDA's suggestions in voluntary recalls draft guidance largely track with advice attorneys long have offered consumer health product firms. Instead, on top of November guidance on mandatory recall authority and February guidance on recall public notifications, FDA is making clear its expectations for firms' preparedness for recalls and their responses when faced with removing products from store shelves.