Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Naproxen 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
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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