FDA Drug Recalls

Recalls / Class II

Class IID-519-2014

Product

FINASTERIDE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714052201

Affected lot / code info
FINASTERIDE Tablet, 5 mg has the following codes Pedigree: AD62846_1, EXP: 2/28/2014; Pedigree: W003031, EXP: 2/28/2014.

Why it was recalled

Labeling: Label Mixup; FINASTERIDE, Tablet, 5 mg may be potentially mislabeled as DIGOXIN, Tablet, 0.125 mg, NDC 00115981101, Pedigree: AD62829_8, EXP: 5/23/2014; PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: W003061, 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
120 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-519-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.