FDA Drug Recalls

Recalls / Class II

Class IID-939-2014

Product

CALCIUM POLYCARBOPHIL, Tablet, 625 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536430611.

Affected lot / code info
CALCIUM POLYCARBOPHIL, Tablet, 625 mg has the following codes: Pedigree: AD73592_11, EXP: 5/31/2014.

Why it was recalled

Labeling: Label Mixup: CALCIUM POLYCARBOPHIL, Tablet, 625 mg may have potentially been mislabeled as the following drug: CAFFEINE, Tablet, 100 mg (1/2 of 200 mg), NDC 24385060173, Pedigree: ADWA00002146, EXP: 5/31/2014.

Recalling firm

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

Distribution

Quantity
90 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-939-2014. 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