November 2013 FDA Recall Drug by Wockhardt Usa Inc.
D-1042-2014 - Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.

This Class II drug recall was voluntarily initiated by Wockhardt Usa Inc. on November 27, 2013 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications; 12 month acid dissolution test results were above upper limit specifications.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1042-2014

Reason for Recall
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Initiated
11-27-2013
Reported
02-05-2014
Quantity
1129 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67238
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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 including Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-29-2015
Product Description About Product Description
Full technical description of the product.
Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02.

Batch or Lot Expiration Information

Lot# Lot: #: DM12286, Expiry: 06/14.