Recalls / Class III
Class IIID-0279-2019
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
- Affected 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
Why it was recalled
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Recalling firm
- Firm
- Breckenridge Pharmaceutical, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 6111 Broken Sound Pkwy NW Ste 170, Boca Raton, Florida 33487-2875
Distribution
- Quantity
- 9,193 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2018-11-06
- FDA classified
- 2018-11-20
- Posted by FDA
- 2018-11-21
- Terminated
- 2019-11-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0279-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.