Drug product
chlordiazePOXIDE HCl, Capsule, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555015902.
D-950-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,101 Capsules
- Official record key
drug-enforcement:D-950-2014
Official wording
Reason: Labeling: Label Mixup: chlordiazePOXIDE HCl, Capsule, 25 mg may have potentially been mislabeled as one of the following drugs: FLECAINIDE ACETATE, Tablet, 50 mg, NDC 65162064110, Pedigree: AD46414_16, EXP: 5/16/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD49463_1, EXP: 5/16/2014; LACTOBACILLUS GG, Capsule, 0 mg, NDC 49100036374, Pedigree: W003173, EXP: 6/13/2014.
Code information: chlordiazePOXIDE HCl, Capsule, 25 mg has the following codes: Pedigree: AD46333_4, EXP: 5/16/2014; Pedigree: AD49426_1, EXP: 5/16/2014; Pedigree: W003194, EXP: 6/13/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled