Drug Enforcement D-500-2014

Labeling: Label Mixup; NIACIN TR, Tablet, 250 mg may be potentially mislabeled as SOLIFENACIN SUCCINATE, Tablet, 5 mg, NDC 51248015001, Pedigree: W003755, EXP: 6/26/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
NIACIN TR, Tablet, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 10939043533
Product quantity
101 Tablets
Reason for recall
Labeling: Label Mixup; NIACIN TR, Tablet, 250 mg may be potentially mislabeled as SOLIFENACIN SUCCINATE, Tablet, 5 mg, NDC 51248015001, Pedigree: W003755, EXP: 6/26/2014.
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-500-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
NIACIN TR, Tablet, 250 mg has the following code Pedigree: W003756, EXP: 5/31/2014.
More code info