FDA Drug Recalls

Recalls / Class II

Class IID-835-2014

Product

PIOGLITAZONE HCL, Tablet, 15 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093204856.

Affected lot / code info
PIOGLITAZONE HCL, Tablet, 15 mg has the following codes: Pedigree: AD52778_70, EXP: 5/21/2014; Pedigree: W003264, EXP: 6/17/2014.

Why it was recalled

Labeling: Label Mixup: PIOGLITAZONE HCL, Tablet, 15 mg may have potentially been mislabeled as one of the following drugs: DOXYCYCLINE MONOHYDRATE, Capsule, 100 mg, NDC 49884072703, Pedigree: AD52778_25, EXP: 5/20/2014; LOVASTATIN, Tablet, 20 mg, NDC 00185007201, Pedigree: W003263, EXP: 6/17/2014.

Recalling firm

Firm
Aidapak Services, LLC
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity
90 Tablets
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-835-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.