Recalls / Class II
Class IID-781-2014
Product
TOLTERODINE TARTRATE ER, Capsule, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00009519101.
- Affected lot / code info
- TOLTERODINE TARTRATE ER, Capsule, 4 mg has the following codes: Pedigree: AD49448_1, EXP: 5/17/2014; Pedigree: AD73686_1, EXP: 5/31/2014.
Why it was recalled
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.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 60 Capsules
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-20
- Posted by FDA
- 2014-01-29
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-781-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.