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

FDA recall notice · announced January 8, 2020 · Granules India Limited

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

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

Notes

Distribution: OR, NY, NJ
Lot/code information: 7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A
Quantity: 23,090,000 tablets
Status: Ongoing
Products in this recall event:
- RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32 (D-0632-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.