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FDADecember 2, 2019drug

Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations: Presence of NDMA impurity detected in product.

What to do

FDA enforcement status: Terminated

Brands named

preferred pharmaceuticalspreferred

UPCs

6878870780368788707806

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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