Class III
Terminated
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
This recall has been terminated (originally issued November 21, 2018).
- Recall Initiated
- November 6, 2018
- Posted
- November 21, 2018
- Recall Number
- D-0279-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9,193 bottles
- Firm Location
- Boca Raton, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: 5599.008A, 5599.009A, 5599.010A, Exp. 04/2019; 5599.012A, 5599.013A, Exp. 11/2019; 5599.014A, Exp. 01/2020
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