Drug product
DILTIAZEM HCL ER Capsule, 240 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 49884083109
D-589-2014
Product summary
- Event
- Event 65707
- Status
- Terminated
- Classification
- Class II
- Quantity
- 180 Capsules
- Official record key
drug-enforcement:D-589-2014
Official wording
Reason: Labeling: Label Mixup; DILTIAZEM HCL ER Capsule, 240 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: AD52433_4, EXP: 5/17/2014; PARoxetine HCl, Tablet, 10 mg, NDC 13107015430, Pedigree: AD52778_67, EXP: 5/20/2014.
Code information: DILTIAZEM HCL ER, Capsule, 240 mg has the following codes Pedigree: AD52375_1, EXP: 5/17/2014; Pedigree: AD56917_1, EXP: 5/21/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled