FDA recall D-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

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2018-11-06

Report date

2018-11-21

Termination date

2019-11-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boca Raton, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0279-2019