Recalls / Class II
Class IID-0632-2020
Product
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
- Brand name
- Ranitidine
- Generic name
- Ranitidine
- Active ingredient
- Ranitidine Hydrochloride
- Route
- Oral
- NDCs
- 62207-773, 62207-774
- FDA application
- ANDA210243
- Affected lot / code info
- 7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A
Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm
- Firm
- Granules India Limited
- Manufacturer
- Granules India Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Plot No. 160/A, 161/E, 162 and 174/A, Gagillapur Village, Qutbullapur Mandal, Ranga Redd, N/A N/A, India
Distribution
- Quantity
- 23,090,000 tablets
- Distribution pattern
- OR, NY, NJ
Timeline
- Recall initiated
- 2019-12-13
- FDA classified
- 2019-12-29
- Posted by FDA
- 2020-01-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0632-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.