Recalls / Class II

Class IID-488-2014

Product

CHOLECALCIFEROL, Tablet, 2000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904615760

Affected lot / code info

CHOLECALCIFEROL, Tablet, 2000 units has the following codes Pedigree: AD46312_37, EXP: 5/16/2014; Pedigree: AD65311_1, EXP: 5/24/2014; Pedigree: W003539, EXP: 6/21/2014; Pedigree: W003744, EXP: 6/26/2014; Pedigree: AD54586_10, EXP: 5/21/2014.

Why it was recalled

Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 2000 units may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD46312_34, EXP: 5/16/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 13811051410, Pedigree: AD65314_1, EXP: 5/24/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003538, EXP: 6/21/2014; LEVOTHYROXINE SODIUM, Tablet, 175

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity

2,998 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-488-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.