Drug 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
D-856-2013
Product summary
- Event
- Event 65495
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48.230 carton units
- Official record key
drug-enforcement:D-856-2013
Official wording
Reason: 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.
Code information: 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
Distribution pattern: Nationwide.
Derived failure modes
-
Labeling or packaging
Mispackaging