Contamination In Common OTC Antacid Adds To FDA's API Impurity Concerns
Executive Summary
FDA assessing contamination of Rx and OTC H2 blocker ranitidine to determine steps it should take. The contaminant, NDMA, is dangerous when consumed in large quantities, but has been found in H2 blockers at levels that don't pose a risk, FDA says.
You may also be interested in...
US FDA Details Trials To Evaluate New Drugs' Potential Interactions With Heartburn Remedies
Draft guidance on testing investigational drugs for drug-drug interactions with ingredients used in antacids, histamine H2-receptor antagonists and proton pump inhibitors points to including labels warnings on the new drugs about their concomitant use with the heartburn remedies.
Perrigo's Recall Flushes Ranitidine OTC Private Label And Store Brand Products From US Market
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.
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.