One of the 10 firms with US approval to make 75- or 150-mg ranitidine tablets provided as OTC private labels or store brands, Apotex Corp., is recalling its products due to the presence of potentially carcinogenic contaminant, N-nitrosodimethylamine (NDMA).
Apotex First In US To Recall OTC Ranitidine Tablets Due To NDMA Impurity
Apotex recalls 13 OTC ranitidine tablet products it provided to Walmart, Walgreens and Rite Aid. FDA has no information on plans by nine other firms that, like Apotex, have approved ANDAs for copies of Zantac 75- and 150-mg tablets, which also remain available.
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