FDA recall D-0632-2020
Granules India Limited · Class II · drug
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
Distribution
OR, NY, NJ
Key facts
- Status
- Ongoing
- Initiation date
- 2019-12-13
- Report date
- 2020-01-08
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Qutbullapur Mandal, Ranga Redd, N/A, India
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0632-2020