Drug product
TEMAZEPAM, Capsule, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378311001.
D-905-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 Capsules
- Official record key
drug-enforcement:D-905-2014
Official wording
Reason: Labeling: Label Mixup: TEMAZEPAM, Capsule, 7.5 mg may have potentially been mislabeled as one of the following drugs: CALCIUM CITRATE, Tablet, 200 mg Elemental Calcium, NDC 00904506260, Pedigree: AD28333_1, EXP: 5/8/2014; VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD49414_7, EXP: 5/17/2014.
Code information: TEMAZEPAM, Capsule, 7.5 mg has the following codes: Pedigree: AD22861_7, EXP: 5/8/2014; Pedigree: AD49418_1, EXP: 5/17/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled