D-0279-2019 Class III Terminated
FDA drug recall D-0279-2019 was initiated by Breckenridge Pharmaceutical, Inc. on Nov 6, 2018 and is designated Class III. Reason for recall: Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing. The recall status is terminated (terminated Nov 26, 2019). Affected quantity: 9,193 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 21, 2018
- Initiation Date
- Nov 6, 2018
- Termination Date
- Nov 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,193 bottles
Product Description
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.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 5599.008A, 5599.009A, 5599.010A, Exp. 04/2019; 5599.012A, 5599.013A, Exp. 11/2019; 5599.014A, Exp. 01/2020
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0279-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026