Class II
Ongoing
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
This recall is currently active, issued January 8, 2020. It was issued by Granules India Limited.
- Company
- Granules India Limited
- Recall Initiated
- December 13, 2019
- Posted
- January 8, 2020
- Recall Number
- D-0632-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 23,090,000 tablets
- Firm Location
- Qutbullapur Mandal, Ranga Redd, India
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Distribution
OR, NY, NJ
Lot / Code Info
7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A
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