Recalls / Class II
Class IID-639-2014
Product
ARIPiprazole Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59148000613
- Affected lot / code info
- ARIPiprazole, Tablet, 2 mg has the following codes Pedigree: AD21790_43, EXP: 5/1/2014; Pedigree: AD30140_25, EXP: 5/7/2014; Pedigree: AD46265_19, EXP: 5/15/2014; Pedigree: AD46414_1, EXP: 5/16/2014; Pedigree: W003004, EXP: 6/11/2014.
Why it was recalled
Labeling:Label Mixup; ARIPiprazole Tablet, 2 mg may be potentially mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD21790_40, EXP: 5/1/2014; ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: AD30140_19, EXP: 5/7/2014; OLANZapine, Tablet, 7.5 mg, NDC 55111016530, Pedigree: AD46265_46, EXP: 5/15/2014; REPAGLINIDE, Tablet, 2 mg, NDC 00169008481, Pedigree: AD464
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 180 Tablets
- Distribution pattern
- Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Timeline
- Recall initiated
- 2013-07-02
- FDA classified
- 2014-01-16
- Posted by FDA
- 2014-01-22
- Terminated
- 2014-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-639-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.