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FDADecember 13, 2019drug

RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32

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

The hazard

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

What to do

FDA enforcement status: Ongoing

Brands named

granules indiagranules

Recall history

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

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RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32 — Recall Details · AllClear