FDAFDA · Food and drugs·Recall number D-0632-2020
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Published January 8, 2020 · Recall initiated: December 13, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- RANITIDINE
- Manufacturer
- Granules India Limited
- Distributor
- OR, NY, NJ
- Lot
- 7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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