Granules USA, Inc.: Drug Recall
Recall #D-0777-2021 · 08/11/2021
Class II: Risk
Recall Details
- Recall Number
- D-0777-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Granules USA, Inc.
- Status
- Terminated
- Date Initiated
- 08/11/2021
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,450,000 tablets
Reason for Recall
CGMP Deviations
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
Distribution Pattern
NY
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.