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

Recall Number: D-0279-2019

Firm: Breckenridge Pharmaceutical, Inc.

Classification: Class III

Status: Terminated

Report Date: 20181121

Initiation Date: 20181106

Termination Date: 20191126

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