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

FDA recall notice · announced November 21, 2018 · Breckenridge Pharmaceutical

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide within the United States
Lot/code information: Lot #: 5599.008A, 5599.009A, 5599.010A, Exp. 04/2019; 5599.012A, 5599.013A, Exp. 11/2019; 5599.014A, Exp. 01/2020
Quantity: 9,193 bottles
Status: Terminated
Products in this recall event:
- 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. Hun (D-0279-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.