Drug recall D-0279-2019

Class III Terminated reported Nov 21, 2018

Product

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

Reason for recall

Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.

Lots and codes

Lot #: 5599.008A, 5599.009A, 5599.010A, Exp. 04/2019; 5599.012A, 5599.013A, Exp. 11/2019; 5599.014A, Exp. 01/2020

Recall details

Recalling firm
Breckenridge Pharmaceutical, Inc., Boca Raton, FL
Quantity
9,193 bottles
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
November 6, 2018
Terminated
November 26, 2019