FDA-Drug2018-11-21Class III
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
Breckenridge Pharmaceutical, Inc.
Hazard
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Sold states
Nationwide within the United States
Affected count
9,193 bottles
Manufactured in
6111 Broken Sound Pkwy NW Ste 170, Boca Raton, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0279-2019Don't want to check this manually?
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