August 2016 FDA Recall Drug by Amerisource Health Services
D-1501-2016 - Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.

This Class III drug recall was voluntarily initiated by Amerisource Health Services on August 4, 2016 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1501-2016

Reason for Recall
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Initiated
08-04-2016
Reported
09-21-2016
Quantity
2626 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75030
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.
Amerisource Health Services
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-17-2017
Product Description About Product Description
Full technical description of the product.
buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03

Batch or Lot Expiration Information

Lot# : MS1509, Exp 12/17