US Consumer Health Regulation: Before Warning, Recall For Supplement With COVID-19 Label Claim
Until FDA on 23 June posted report about Golden Nutrition Inc.’s herbal supplement, violative COVID-19 claims had been found online and in advertising through other channels. Other consumer health recalls in US include more than 2.5m bottles of Gaviscon Liquid Antacid missing a safety warning on labels.
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Additional products listed in FDA recall records update include Similac Pro-Advance Infant Formula filled with water, a lidocaine patch linked to potentially deficient manufacturing quality controls and two scents of PS Primer Water that may be contaminated. Number of hand sanitizer products exported from to the US and found containing methanol also continues to climb.
Variety of products advertised with false coronavirus claims also grew in FTC's latest warnings submitted. It warned 21 firms on claims for products including IV drips, ozone therapy and stem cell treatments.
Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals.