Drug Enforcement D-488-2014

Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 2000 units may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD46312_34, EXP: 5/16/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 13811051410, Pedigree: AD65314_1, EXP: 5/24/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003538, EXP: 6/21/2014; LEVOTHYROXINE SODIUM, Tablet, 175

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
CHOLECALCIFEROL, Tablet, 2000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904615760
Product quantity
2,998 Tablets
Reason for recall
Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 2000 units may be potentially mislabeled as PYRIDOXINE HCL, Tablet, 50 mg, NDC 00904052060, Pedigree: AD46312_34, EXP: 5/16/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 13811051410, Pedigree: AD65314_1, EXP: 5/24/2014; RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003538, EXP: 6/21/2014; LEVOTHYROXINE SODIUM, Tablet, 175
Recall initiation reason
—
Initial firm notification
Telephone
Distribution pattern
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Location & Firm

Recalling firm
Aidapak Services, LLC
Address
14301 Se 1st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-488-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
CHOLECALCIFEROL, Tablet, 2000 units has the following codes Pedigree: AD46312_37, EXP: 5/16/2014; Pedigree: AD65311_1, EXP: 5/24/2014; Pedigree: W003539, EXP: 6/21/2014; Pedigree: W003744, EXP: 6/26/2014; Pedigree: AD54586_10, EXP: 5/21/2014.
More code info
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