November 2018 FDA Recall Drug by Breckenridge Pharmaceutical, Inc.
D-0279-2019 - Failed Stability Specifications

This Class III drug recall was voluntarily initiated by Breckenridge Pharmaceutical, Inc. on November 6, 2018 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0279-2019

Reason for Recall
Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing.
Initiated
11-06-2018
Reported
11-21-2018
Quantity
9,193 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81523
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Breckenridge Pharmaceutical, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-26-2019
Product Description About Product Description
Full technical description of 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

Batch or Lot Expiration Information

Lot# : 5599.008A, 5599.009A, 5599.010A, Exp. 04/2019; 5599.012A, 5599.013A, Exp. 11/2019; 5599.014A, Exp. 01/2020