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Apotex First In US To Recall OTC Ranitidine Tablets Due To NDMA Impurity

 
• By Malcolm Spicer

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.

Apotex exterior

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).

The US business of Canadian firm Apotex Inc. is recalling 13 OTC tablet products with the ingredient indicated for heartburn that it provided to chain retailers [Wal-Mart Stores Inc

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