FDA recall D-0777-2021

Granules USA, Inc. · Class II · drug

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

Distribution

Key facts

Status: Terminated
Initiation date: 2021-08-11
Report date: 2021-09-08
Termination date: 2023-02-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Parsippany, NJ, United States

Primary source

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