Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031
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: Firm went out of business and could no longer continue stability studies.
Reason Supterpotent Drug
Reason Subpotent Drug: Out of specification for assay (stability testing)
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