March 2012 FDA Recall Drug by Aurobindo Pharma Ltd
D-041-2013 - Adulterated Presence of Foreign Tablets

This Class II drug recall was voluntarily initiated by Aurobindo Pharma Ltd on March 9, 2012 for the product Drug. The FDA reported the reason for recall as adulterated presence of foreign tablets. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-041-2013

Reason for Recall
Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg
Initiated
03-09-2012
Reported
11-14-2012
Quantity
23,616 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62113
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.
Aurobindo Pharma LTD
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.
FAX
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-21-2013
Product Description About Product Description
Full technical description of the product.
Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India

Batch or Lot Expiration Information

Batch# Batch Number ZPSB11054-A Exp. 05/13