Recalls / Class II
Class IID-780-2014
Product
TOLTERODINE TARTRATE ER, Capsule, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00009519001.
- Affected lot / code info
- TOLTERODINE TARTRATE ER, Capsule, 2 mg has the following codes: Pedigree: AD65478_1, EXP: 5/29/2014; Pedigree: W002724, EXP: 6/6/2014.
Why it was recalled
Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 2 mg may be potentially mislabeled as one of the following drugs: RANOLAZINE ER , Tablet, 500 mg, NDC 61958100301, Pedigree: AD62995_7, EXP: 5/29/2014; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe), NDC 00904759160, Pedigree: W002717, EXP: 6/6/2014.
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-780-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.