Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations
Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-179-01
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 Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
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