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Shuttered US Supplement Firm Meets Recall Deadline, But Schumer Says FDA Late Cleaning Up Industry

Executive Summary

While contract manufacturer ABH Nature' complied with consent decree, Sen. Chuck Schumer says FDA is late in enforcing against noncompliant firms across the supplement sector. Other recent consumer health recalls include more OTC ranitidine tablets due to the potential carcinogen NDMA found in the heartburn ingredient and four versions of Sure 48HR Anti-Perspirant & Deodorant with labeling errors.

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US Supplement Firm Shut Down By Decree After Using Ingredient On FDA ‘Advisory List'

FDA's decree of permanent injunction with Fusion Health and Vitality filed same day the firm announced recall of its Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 products found to contain hordenine HCl.

Ranitidine’s US Future In Limbo As Tests Continue; ‘Glow-Boosting’ Mask Also Among Recent Recalls

Zantac marketer Sanofi says it’s unclear whether the product eventually will relaunch. In other recent consumer health and beauty recalls in US, a vitamin C-containing face mask is recalled following a “spike in complaints” about skin irritation and the insides of tubes of sodium chloride ophthalmic ointments made for Walgreens and CVS were found with materials used to make the containers.

New York Supplement Firm Shut Down On GMP Violations Repeated Since 2010

ABH Nature’s and its owner, Mohammed Jahirul Islam, agree to a consent decree recently barring them from distributing adulterated and misbranded supplements and unapproved and misbranded drugs and requiring remedial action before restarting production. FDA records indicate its s inspections of the facilities began in 2010 and at least one GMP violation found in later inspections was noted in the first.

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