Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP
Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc Chesapeake, VA 23320
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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