FDA Drug Recalls

Recalls / Class II

Class IID-794-2014

Product

CALCIUM ACETATE, Capsule, 667 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00054008826.

Affected lot / code info
CALCIUM ACETATE, Capsule, 667 mg has the following codes: Pedigree:AD30180_1, EXP: 5/8/2014; Pedigree:AD62865_4, EXP: 5/23/2014; Pedigree:W003045, EXP:6/12/2014; Pedigree: AD52412_11, EXP: 5/17/2014; Pedigree: AD54587_1, EXP: 5/21/2014; Pedigree: AD62986_1, EXP: 5/23/2014; Pedigree: AD73623_1, EXP: 5/30/2014; Pedigree: W003469, EXP: 6/20/2014; Pedigree: AD42592_1, EXP: 5/14/2014; Pedigree: AD52778_10, EXP: 5/20/2014; Pedigree: W003460, EXP: 6/20/2014; Pedigree: AD49463_1, EXP: 5/16/2014.

Why it was recalled

Labeling: Label Mixup: CALCIUM ACETATE, Capsule, 667 mg may be potentially mislabeled as one of the following drugs: ZOLPIDEM TARTRATE, Tablet, 2.5 mg (1/2 of 5 mg), NDC 64679071401, Pedigree: AD28355_1, EXP: 5/8/2014; acetaZOLAMIDE, Tablet, 250 mg, NDC 51672402301, Pedigree: AD62865_1, EXP: 5/23/2014; ZINC GLUCONATE, Tablet, 50 mg, NDC 00904319160, Pedigree: W003028, EXP: 6/12/2014; PROPRANO

Recalling firm

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

Distribution

Quantity
3600 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-794-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.