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
Reported: September 8, 2021 Initiated: August 11, 2021 #D-0777-2021
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
Details
- Recalling Firm
- Granules USA, Inc.
- Units Affected
- 11,450,000 tablets
- Distribution
- NY
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Granules USA, Inc.. Units affected: 11,450,000 tablets.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 8, 2021. Severity: Moderate. Recall number: D-0777-2021.
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