FDAClass IIJanuary 22, 2014

Cholecalciferol recall: Labeling Error

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

Why was Cholecalciferol recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

CHOLECALCIFEROL, Capsule, 5000 units has the following codes Pedigree: AD70629_19, EXP: 5/29/2014; Pedigree: W003541, EXP: 6/21/2014; Pedigree: AD52993_22, EXP: 5/20/2014.

Product
CHOLECALCIFEROL, Capsule, 5000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 0904598660
Recalling firm
Aidapak Services, LLC
Quantity
300 Capsules
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls