Naproxen Sodum Tablets USP 220 mg recalled over manufacturing violations
- Recall date
- August 11, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Granules USA, Inc. recalls Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A,…
- Recall number
- D-0777-2021
- FDA classification
- Class II
- Brand / firm
- Granules USA, Inc.
- Sold / distributed
- NY
Why it was recalled
CGMP Deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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
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