Recalls / Class II
Class IID-664-2014
Product
QUEtiapine FUMARATE, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 60505313001
- Affected lot / code info
- QUEtiapine FUMARATE, Tablet, 25 mg has the following codes Pedigree: AD33897_25, EXP: 5/9/2014; Pedigree: W003099, EXP: 6/13/2014.
Why it was recalled
Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 58914001460, Pedigree: AD32325_1, EXP: 5/9/2014; ASPIRIN DR EC, Tablet, 81 mg, NDC 00182106105, Pedigree: W003094, EXP: 6/13/2014.
Recalling firm
- Firm
- Aidapak Services, LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14301 Se 1st St, Vancouver, Washington 98684-3501
Distribution
- Quantity
- 400 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-664-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.