FDA Drug Recalls

Recalls / Class II

Class IID-679-2014

Product

ATENOLOL Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 63304062101

Affected lot / code info
ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg) has the following codes Pedigree: AD73525_1, EXP: 5/30/2014; Pedigree: AD30140_1, EXP: 5/7/2014.

Why it was recalled

Labeling:Label Mixup; ATENOLOL, Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001, Pedigree: AD73652_19, EXP: 5/30/2014; PIROXICAM, Capsule, 10 mg, NDC 00093075601, Pedigree: AD21836_1, EXP: 3/31/2014.

Recalling firm

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

Distribution

Quantity
398 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-679-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.