FDA Drug Recalls

Recalls / Class II

Class IID-922-2014

Product

LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527134601.

Affected lot / code info
LEVOTHYROXINE SODIUM, Tablet, 112 mcg has the following codes: Pedigree: AD60272_22, EXP: 5/22/2014.

Why it was recalled

Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled as the following drug: RALTEGRAVIR, Tablet, 400 mg, NDC 00006022761, Pedigree: AD60272_19, EXP: 5/22/2014.

Recalling firm

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

Distribution

Quantity
100 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-922-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.