FDAClass IIAugust 14, 2013

Zolpidem Tartrate Tablets 5 mg recall

Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC.…

Why was Zolpidem Tartrate Tablets 5 mg 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.…
Recalling firm
American Health Packaging
Quantity
48.230 carton units
Distribution
Nationwide.
Recall date
August 14, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls