The recall comes one week after Sandoz halted worldwide distribution of its generic versions of Zantac after regulators disclosed the pills contain a high-level of a cancer-causing impurity.
When news broke about the detection of the impurity known as N-nitrosodimethylamine, the company recalled the products in some European countries and Canada, but held off on recalling the products in the U.S.
The company began internal testing of its generic versions of Zantac and found that the products contained “above levels established by the FDA” in some batches, according to STAT.
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