FDA recall D-487-2014

Aidapak Services, LLC · Class II · drug

Product

CHOLECALCIFEROL, Capsule, 5000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 0904598660

Reason for recall

Labeling: Label Mixup; CHOLECALCIFEROL, Capsule, 5000 units may be potentially mislabeled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: AD70629_16, EXP: 5/29/2014; CHOLECALCIFEROL, Tablet, 400 units, NDC 00904582360, Pedigree: W003540, EXP: 6/21/2014; THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD52993_16, EXP: 5/20/2014.

Distribution

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-22
Termination date: 2014-02-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Vancouver, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-487-2014