Drug Enforcement D-594-2014

Labeling: Label Mixup; traZODone HCl Tablet, 150 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 00135051001, Pedigree: AD21858_1, EXP: 5/1/2014; SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: W003256, EXP: 6/17/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
traZODone HCl Tablet, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111044101
Product quantity
300 Tablets
Reason for recall
Labeling: Label Mixup; traZODone HCl Tablet, 150 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 00135051001, Pedigree: AD21858_1, EXP: 5/1/2014; SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: W003256, EXP: 6/17/2014.
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-594-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
traZODone HCl, Tablet, 150 mg has the following codes Pedigree: AD21858_7, EXP: 5/1/2014; Pedigree: W003245, EXP: 6/17/2014.
More code info