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US FDA Requests Ranitidine Removals

Also Encourages Research For Stable Formulations

Executive Summary

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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EMA Set To Discuss Safety Of Ranitidine

Following the announcement in the US that ranitidine drugs must be withdrawn from the market, the European Medicines Agency told the Pink Sheet it would decide on the fate of these medicines in the EU after wrapping up its own inquiry.

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.

DeLauro Renews Push To Give FDA Mandatory Recall Authority For Drugs

"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.

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