Drug product
ZOLPIDEM TARTRATE, Tablet, 2.5 mg (1/2 of 5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 64679071401
D-691-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 402 Tablets
- Official record key
drug-enforcement:D-691-2014
Official wording
Reason: Labeling: Label Mixup; ZOLPIDEM TARTRATE Tablet, 2.5 mg (1/2 of 5 mg) may be potentially mislabeled as TEMAZEPAM, Capsule, 7.5 mg, NDC 00378311001, Pedigree: AD22861_7, EXP: 5/8/2014.
Code information: ZOLPIDEM TARTRATE Tablet, 2.5 mg (1/2 of 5 mg) has the following code Pedigree: AD28355_1, EXP: 5/8/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled