Drug recall D-0777-2021

Class II Terminated reported Sep 8, 2021

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

Reason for recall

CGMP Deviations

Lots and codes

7620060a

Recall details

Recalling firm
Granules USA, Inc., Parsippany, NJ
Quantity
11,450,000 tablets
Distribution
NY
Type
Voluntary: Firm initiated
Recall initiated
August 11, 2021
Terminated
February 16, 2023

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