March 2015 FDA Recall Drug by Wockhardt Usa Inc.
D-0975-2015 - Failed Tablet/Capsule Specifications

This Class II drug recall was voluntarily initiated by Wockhardt Usa Inc. on March 12, 2015 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0975-2015

Reason for Recall
Failed Tablet/Capsule Specifications: out of specification for thickness.
Initiated
03-12-2015
Reported
05-13-2015
Quantity
93,393 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70740
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-14-2017
Product Description About Product Description
Full technical description of the product.
Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA

Batch or Lot Expiration Information

Lot# s: a) LM10525, Exp 03/15; LM10727, Exp 04/15; LM11519, Exp 08/15; LN10008, Exp 11/15; LN10121, Exp 12/15; LN10887, Exp 04/16; LM11248, Exp 06/16
Lot# s: b) LM10522, Exp 03/15; LM10726, Exp 04/15; LN10007, Exp 11/15; LN10116, Exp 12/15; LN10888, Exp 04/16; LN11281 Exp 07/16