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Recall Observatory FDA recall evidence

Drug product

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

D-0632-2020

December 13, 2019

Class II

Product summary

Firm
Granules India Limited
Event
Event 84522
Status
Ongoing
Classification
Class II
Quantity
23,090,000 tablets
Official record key
drug-enforcement:D-0632-2020

Official wording

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

Code information: 7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A

Distribution pattern: OR, NY, NJ

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Impurity N-nitrosodimethylamine (NDMA
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations