Drug Enforcement D-593-2014

Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100, Pedigree: AD54475_1, EXP: 5/20/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
traZODone HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111043303
Product quantity
2,000 Tablets
Reason for recall
Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100, Pedigree: AD54475_1, EXP: 5/20/2014.
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-593-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
traZODone HCl, Tablet, 50 mg has the following code Pedigree: AD54475_7, EXP: 5/20/2014.
More code info