Drug 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
D-0279-2019
Product summary
- Event
- Event 81523
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9,193 bottles
- Official record key
drug-enforcement:D-0279-2019
Official wording
Reason: Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Code information: Lot #: 5599.008A, 5599.009A, 5599.010A, Exp. 04/2019; 5599.012A, 5599.013A, Exp. 11/2019; 5599.014A, Exp. 01/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out-of-Specification