Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility
SELENIUM 200MCG/ML (PF), 10ML Vials, MEDAUS PHARMACY
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 CGMP Deviations: Stability data does not support expiry date.
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Reason Lack of Assurance of Sterility
Reason Lack of sterility assurance.
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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