October 2016 FDA Recall Drug by Amerisource Health Services
D-0137-2017 - Failed Dissolution Specifications

This Class III drug recall was voluntarily initiated by Amerisource Health Services on October 27, 2016 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0137-2017

Reason for Recall
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Initiated
10-27-2016
Reported
11-23-2016
Quantity
a) 15,409 bottles b) 5,128 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75581
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.
06-29-2017
Product Description About Product Description
Full technical description of the product.
Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories

Batch or Lot Expiration Information

Lot# : a) M601509, Exp 3/31/2018; M606506, Exp 4/30/2018; b) M601510, Exp 3/31/2018; M604444, Exp 4/30/2018; M606515, Exp 4/30/2018.