FDA-Drug2021-09-08Class II

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

Granules USA, Inc.
Hazard

CGMP Deviations

Sold states
NY
Affected count
11,450,000 tablets
Manufactured in
35 Waterview Blvd Fl 3, N/A, Parsippany, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0777-2021

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