Drug Enforcement D-645-2014

Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603, Pedigree: AD73525_40, EXP: 5/30/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003005, EXP: 6/11/2014; carBAMazepine ER, Tablet, 100 mg, NDC 00078051005, Pedigree: W003330, EXP: 6/18/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
MIRTAZAPINE Tablet, 7.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 59762141503
Product quantity
91 Tablets
Reason for recall
Labeling:Label Mixup; MIRTAZAPINE Tablet, 7.5 mg may be potentially mislabeled as BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603, Pedigree: AD73525_40, EXP: 5/30/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003005, EXP: 6/11/2014; carBAMazepine ER, Tablet, 100 mg, NDC 00078051005, Pedigree: W003330, EXP: 6/18/2014.
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-645-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
MIRTAZAPINE, Tablet, 7.5 mg has the following codes Pedigree: AD73525_55, EXP: 5/30/2014; Pedigree: W003012, EXP: 6/11/2014; Pedigree: W003334, EXP: 6/18/2014.
More code info