FDAClass IIJanuary 22, 2014

Cholecalciferol recall: Labeling Error

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

Why was Cholecalciferol 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

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, 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.

Product
CHOLECALCIFEROL, Tablet, 1000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582460
Recalling firm
Aidapak Services, LLC
Quantity
2,399 Tablets
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