Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Chemical contamination; presence of lead and lithium above specification
Reason CGMP Deviations
Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Reason CGMP Deviations
Reason CGMP Deviations
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