FDA Drug Recalls

Recalls / Class II

Class IID-786-2014

Product

PROGESTERONE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032170801.

Affected lot / code info
PROGESTERONE, Capsule, 100 mg has the following codes: Pedigree: AD46320_1, EXP: 5/15/2014.

Why it was recalled

Labeling: Label Mixup: PROGESTERONE, Capsule, 100 mg may be potentially mislabeled as the following drug: LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), NDC 00527134101, Pedigree: AD46265_40, EXP: 5/15/2014.

Recalling firm

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

Distribution

Quantity
500 Capsules
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-786-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.