Drug Enforcement D-485-2014

Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD37056_10, EXP: 5/10/2014; ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: W002567, EXP: 6/3/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD76686_4, EXP: 5/31/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 0053

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
CHOLECALCIFEROL, Tablet, 400 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904582360
Product quantity
1,199 Tablets
Reason for recall
Labeling: Label Mixup; CHOLECALCIFEROL, Tablet, 400 units may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 500 mcg, NDC 00536355101, Pedigree: AD37056_10, EXP: 5/10/2014; ROSUVASTATIN CALCIUM, Tablet, 5 mg, NDC 00310075590, Pedigree: W002567, EXP: 6/3/2014; PYRIDOXINE HCL, Tablet, 100 mg, NDC 00536440901, Pedigree: AD76686_4, EXP: 5/31/2014; CYANOCOBALAMIN, Tablet, 500 mcg, NDC 0053
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
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Codes & Dates

Recall number
D-485-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
CHOLECALCIFEROL, Tablet, 400 units has the following codes Pedigree: AD37056_13, EXP: 5/10/2014; Pedigree: W002574, EXP: 6/3/2014; Pedigree: AD76686_7, EXP: 5/31/2014; Pedigree: AD60578_27, EXP: 5/29/2014; Pedigree: W003540, EXP: 6/21/2014; Pedigree: AD52993_25, EXP: 5/20/2014; Pedigree: W002715, EXP: 6/5/2014; Pedigree: AD30197_31, EXP: 5/9/2014; Pedigree: AD73592_8, EXP: 5/31/2014; Pedigree: W002642, EXP: 6/4/2014.
More code info
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