Drug product
Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043, Telangana, INDIA. NDC 62207-762-36
D-0777-2021
Product summary
- Event
- Event 88475
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,450,000 tablets
- Official record key
drug-enforcement:D-0777-2021
Official wording
Reason: CGMP Deviations
Code information: 7620060a
Distribution pattern: NY
Derived failure modes
-
Manufacturing or process control
CGMP Deviations