PlainRecalls
FDA Drug Moderate Class II Terminated

Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01

Reported: August 14, 2013 Initiated: May 21, 2013 #D-856-2013

Product Description

Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01

Reason for Recall

Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.

Details

Recalling Firm
American Health Packaging
Units Affected
48.230 carton units
Distribution
Nationwide.
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01. Recalled by American Health Packaging. Units affected: 48.230 carton units.
Why was this product recalled?
Unit Dose Mispackaging: This recall event is due to a random undetected packaging issue which could increase the potential for a small number of individual unit dose blisters to be packed with more than one tablet.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 14, 2013. Severity: Moderate. Recall number: D-856-2013.