FDAClass IIJanuary 29, 2014

Cholecalciferol recall: Labeling Error

CHOLECALCIFEROL, Capsule, 2000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536379001.

Why was Cholecalciferol recalled?

Labeling: Label Mixup: CHOLECALCIFEROL, Capsule, 2000 units may have potentially been mislabeled as one of the following drugs: DOXYCYCLINE HYCLATE, Tablet, 100 mg, NDC 53489012002, Pedigree: AD30993_8, EXP: 5/9/2014; VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD60211_20, EXP: 5/21/2014; lamoTRIgine, Tablet, 50 mg (1/2 of 100 mg), NDC 13668004701, Pedigree: A

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, 2000 units has the following codes: Pedigree: AD30028_7, EXP: 5/8/2014; Pedigree: AD60240_4, EXP: 5/22/2014; Pedigree: ADWA00002136, EXP: 5/31/2014; Pedigree: W002666, EXP: 6/5/2014; Pedigree: W003016, EXP: 6/12/2014; Pedigree: W003017, EXP: 6/12/2014; Pedigree: W003712, EXP: 6/26/2014; Pedigree: W003713, EXP: 6/26/2014; Pedigree: W003828, EXP: 6/27/2014; Pedigree: AD21846_4, EXP: 5/1/2014; Pedigree: AD46257_7, EXP: 5/15/2014; Pedigree: AD73521_7, EXP: 5/30/2014; Pedigree: W002691, EXP: 6/5/2014; Pedigree: W003314, EXP: 6/18/2014.

Product
CHOLECALCIFEROL, Capsule, 2000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536379001.
Recalling firm
Aidapak Services, LLC
Quantity
18,282 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls