Drug product
TOLTERODINE TARTRATE ER, Capsule, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00009519101.
D-781-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 Capsules
- Official record key
drug-enforcement:D-781-2014
Official wording
Reason: Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 4 mg may be potentially mislabeled as one of the following drugs: HYDRALAZINE HCL, Tablet, 25 mg, NDC 50111032701, Pedigree: AD49610_4, EXP: 5/16/2014; PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, 0 mg, NDC 51991056601, Pedigree: AD73597_1, EXP: 5/31/2014.
Code information: TOLTERODINE TARTRATE ER, Capsule, 4 mg has the following codes: Pedigree: AD49448_1, EXP: 5/17/2014; Pedigree: AD73686_1, EXP: 5/31/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled