April 2014 FDA Recall Drug by Wockhardt Usa Inc.
D-0304-2015 - Failed Dissolution Specifications

This Class III drug recall was voluntarily initiated by Wockhardt Usa Inc. on April 17, 2014 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-0304-2015

Reason for Recall
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Initiated
04-17-2014
Reported
12-24-2014
Quantity
1,118,400 extended release tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69506
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.
Wockhardt 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.
08-13-2015
Product Description About Product Description
Full technical description of the product.
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA .

Batch or Lot Expiration Information

Lot# a)
Lot# LN10392; Exp. 12/14 b)
Lot# LN10360; Exp. 12/14