Recalls / Class II

Class IID-486-2014

Product

CHOLECALCIFEROL, Tablet, 1000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582460

Affected lot / code info

CHOLECALCIFEROL, Tablet, 1000 units has the following codes Pedigree: W003464, EXP: 6/20/2014; Pedigree: AD33897_37, EXP: 5/9/2014; Pedigree: W002779, EXP: 6/6/2014; Pedigree: W003626, EXP: 6/25/2014; Pedigree: W003827, EXP: 6/27/2014; Pedigree: AD33897_34, EXP: 5/9/2014.

Why it was recalled

Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 1000 units may be potentially mislabeled as ASPIRIN, Chew Tablet, 81 mg, NDC 00536329736, Pedigree: W003459, EXP: 6/20/2014; MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 37205018581, Pedigree: AD32328_8, EXP: 5/9/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W002715, EXP: 6/5/2014; GLYCOPYRROLATE, Tablet, 2 mg, NDC 49884006601

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

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

Distribution

Quantity

2,399 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-486-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.