FDA Drug Recalls

Recalls / Class II

Class IID-715-2014

Product

rifAXIMin Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 65649030103

Affected lot / code info
rifAXIMin Tablet, 200 mg has the following code Pedigree: AD54587_10, EXP: 4/30/2014.

Why it was recalled

Labeling:Label Mixup; rifAXIMin Tablet, 200 mg may be potentially mislabeled as CapsuleTOPRIL, Tablet, 25 mg, NDC 00143117201, Pedigree: AD52778_19, EXP: 5/20/2014.

Recalling firm

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

Distribution

Quantity
30 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-715-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls