Recalls / Class II

Class IID-856-2013

Product

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

Affected lot / code info

Lot #: 114215, Exp 7/13; 114216, Exp 7/13; 114217, Exp 7/13; 120087, Exp 9/13; 120295, Exp 9/13; 121573, Exp 6/14; 123572, Exp 9/14; 123983, Exp 9/14; 130071, Exp 2/15

Why it was 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.

Recalling firm

Firm

American Health Packaging

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188

Distribution

Quantity

48.230 carton units

Distribution pattern

Nationwide.

Timeline

Recall initiated

2013-05-21

FDA classified

2013-08-08

Posted by FDA

2013-08-14

Terminated

2013-12-24

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-856-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.