November 2016 FDA Recall Bupropion by Zydus Pharmaceuticals Usa Inc
D-0207-2017 - Failed Dissolution Specifications; 6 month time point

This Class III drug recall was voluntarily initiated by Zydus Pharmaceuticals Usa Inc on November 2, 2016 for the product Bupropion. The FDA reported the reason for recall as failed dissolution specifications; 6 month time point. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0207-2017

Reason for Recall
Failed Dissolution Specifications; 6 month time point
Initiated
11-02-2016
Reported
12-28-2016
Quantity
16,356 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
75764
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.
Zydus Pharmaceuticals USA 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2020
Product Description About Product Description
Full technical description of the product.
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534

Batch or Lot Expiration Information

Lot# a) MS1667 exp 01/2018; M601708, exp 03/2018; b) MS1667, MS1668, MS1669, exp 01/2018; M601515, M601516, exp 03/2018; M602920, M602921, M605399, M602937, M602938, M602939, exp 04/2018; M603988, exp 06/2018

Affected Packages Involved in this Recall

68382-354-06 Bupropion
68382-354-16 Bupropion
68382-354-05 Bupropion
68382-354-10 Bupropion
68382-353-06 Bupropion
68382-353-16 Bupropion
68382-353-05 Bupropion
68382-353-10 Bupropion