Breckenridge Pharmaceutical, Inc. recalls Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical,…
- Recall date
- November 6, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0279-2019
- FDA classification
- Class III
- Brand / firm
- Breckenridge Pharmaceutical, Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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