Drug Enforcement D-676-2014

Labeling:Label Mixup; CALCITRIOL, Capsule, 0.5 mcg may be potentially mislabeled as NIACIN TR, Tablet, 250 mg, NDC 10939043533, Pedigree: W003756, EXP: 5/31/2014; ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD32757_28, EXP: 5/13/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
CALCITRIOL Capsule, 0.5 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63304024001
Product quantity
500 Capsules
Reason for recall
Labeling:Label Mixup; CALCITRIOL, Capsule, 0.5 mcg may be potentially mislabeled as NIACIN TR, Tablet, 250 mg, NDC 10939043533, Pedigree: W003756, EXP: 5/31/2014; ISONIAZID, Tablet, 300 mg, NDC 00555007102, Pedigree: AD32757_28, EXP: 5/13/2014.
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-676-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
CALCITRIOL, Capsule, 0.5 mcg has the following codes Pedigree: W003730, EXP: 6/26/2014; Pedigree: AD32757_10, EXP: 5/14/2014.
More code info