Reported Nov 21, 2018 · Terminated
Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical,…
Breckenridge Pharmaceutical, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Breckenridge Pharmaceutical, Inc. · 6111 Broken Sound Pkwy NW Ste 170 · Boca Raton, FL · 33487-2875
Is this the product you have?
- Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only
- Distributed byBreckenridge Pharmaceutical, Inc. Boca Raton, FL 33487
- Manufactured byPharmaceutics International Inc. Hunt Valley, MD 21031
- Lot codes and dates
Lot #: 5599.008A5599.009A5599.010AExp. 04/20195599.012A5599.013AExp. 11/20195599.014AExp. 01/2020
- Amount recalled
- 9,193 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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