August 2016 FDA Recall Bupropion by Zydus Pharmaceuticals Usa Inc
D-0149-2017 - Failed Dissolution Specifications
This Class III drug recall was voluntarily initiated by Zydus Pharmaceuticals Usa Inc on August 3, 2016 for the product Bupropion. 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-0149-2017
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
08-03-2016
11-30-2016
2,472 units
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
07-12-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, NDC 68382-354-05
Batch or Lot Expiration Information
Lot# : MR3365, Exp. Feb 17
