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
Reported: November 21, 2018 Initiated: November 6, 2018 #D-0279-2019
Product Description
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.
Details
- Recalling Firm
- Breckenridge Pharmaceutical, Inc.
- Units Affected
- 9,193 bottles
- Distribution
- Nationwide within the United States
- Location
- Boca Raton, FL
Frequently Asked Questions
What product 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. Recalled by Breckenridge Pharmaceutical, Inc.. Units affected: 9,193 bottles.
Why was this product recalled? ▼
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 21, 2018. Severity: Low. Recall number: D-0279-2019.
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