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
Stanozolol (50 mg/ml and 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 CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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