FDA Drug Recalls

Recalls / Class II

Class IID-524-2014

Product

SIMVASTATIN Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714068303

Affected lot / code info
SIMVASTATIN, Tablet, 20 mg has the following code Pedigree: W003580, EXP: 6/24/2014.

Why it was recalled

Labeling: Label Mixup; SIMVASTATIN Tablet, 20 mg may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: W003591, EXP: 6/24/2014.

Recalling firm

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

Distribution

Quantity
1,000 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-524-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.