FDA Drug Recalls

Recalls / Class II

Class IID-954-2014

Product

BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00574010603.

Affected lot / code info
BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg has the following codes: Pedigree: AD68010_4, EXP: 5/28/2014; Pedigree: AD73525_40, EXP: 5/30/2014.

Why it was recalled

Labeling: Label Mixup: BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg may have potentially been mislabeled as one of the following drugs: BENAZEPRIL HCL, Tablet, 40 mg, NDC 65162075410, Pedigree: AD68010_1, EXP: 5/28/2014; THIORIDAZINE HCL, Tablet, 50 mg, NDC 00378061601, Pedigree: AD73525_28, EXP: 5/30/2014.

Recalling firm

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

Distribution

Quantity
63 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-954-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.