Drug product
hydrOXYzine PAMOATE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555032402.
D-951-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 800 Capsules
- Official record key
drug-enforcement:D-951-2014
Official wording
Reason: Labeling: Label Mixup: hydrOXYzine PAMOATE, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), NDC 00904506260, AD46257_43, EXP: 5/15/2014; guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: W002734, EXP: 6/6/2014; guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: W003689, EXP: 6/26/20
Code information: hydrOXYzine PAMOATE, Capsule, 100 mg has the following codes: Pedigree: AD46265_28, EXP: 5/15/2014; Pedigree: W002735, EXP: 6/6/2014; Pedigree: W003690, EXP: 6/26/2014; Pedigree: AD21790_61, EXP: 5/1/2014; Pedigree: AD60272_67, EXP: 5/22/2014; Pedigree: W003008, EXP: 6/11/2014; Pedigree: W003332, EXP: 6/18/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled