D-691-2014 Class II Terminated
FDA drug recall D-691-2014 was initiated by Aidapak Services, LLC on July 2, 2013 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated February 7, 2014). Affected quantity: 402 Tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- January 22, 2014
- Initiation Date
- July 2, 2013
- Termination Date
- February 7, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 402 Tablets
Product Description
ZOLPIDEM TARTRATE, Tablet, 2.5 mg (1/2 of 5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 64679071401
Reason for Recall
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.
Distribution Pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Code Information
ZOLPIDEM TARTRATE Tablet, 2.5 mg (1/2 of 5 mg) has the following code Pedigree: AD28355_1, EXP: 5/8/2014.