FDA Drug Recalls

Recalls / Class II

Class IID-842-2014

Product

SIMVASTATIN, Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093715598.

Affected lot / code info
SIMVASTATIN, Tablet, 40 mg has the following codes: Pedigree: AD22845_4, EXP: 5/2/2014.

Why it was recalled

Labeling: Label Mixup: SIMVASTATIN, Tablet, 40 mg may have potentially been mislabeled as the following drug: METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304057901, Pedigree: AD21790_67, EXP: 5/1/2014.

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-842-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.