Class II · Moderate risk Ongoing
Naproxen Oral Suspension
Reason Chemical contamination; presence of lead and lithium above specification
Naproxen Tablets USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
What was recalled
NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01.
- Recalling firm
- Glenmark Generics Inc., USA
- NDC code
- 68462-190-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1701-2012
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.
Other Naproxen recalls
See all
Class II · Moderate risk Ongoing
Naproxen Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Naproxen Tablets
Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class II · Moderate risk Terminated
Naproxen Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Naproxen Sodium Tablets
Reason CGMP Deviations
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