US FDA Requests Ranitidine Removal But Also Encourages Research For Stable Formulations
FDA requests immediate removal of ranitidine OTC and Rx drugs after third-party testing finds contaminant NDMA increases during storage, especially at higher temperatures. CDER Director Janet Woodcock asks firms to reformulate products to be stable as the ingredient remains approved.
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Also added to FDA recalls database are multiple variations of GSK's Advil line found not to include required safety warning information; a California contract manufacturer's 12 protein products due to an unapproved herbicide; and cosmetics firm Tween Brands' third recall in nine months due to an unapproved colorant.
Concerns over the presence of a probable human carcinogen will likely see marketing of all ranitidine-containing drugs suspended across the European Union.
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.