D-0777-2021 Class II Terminated
FDA drug recall D-0777-2021 was initiated by Granules USA, Inc. on August 11, 2021 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated February 16, 2023). Affected quantity: 11,450,000 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- September 8, 2021
- Initiation Date
- August 11, 2021
- Termination Date
- February 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,450,000 tablets
Product Description
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
Reason for Recall
CGMP Deviations
Distribution Pattern
NY
Code Information
7620060a