Drug Enforcement D-592-2014

Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as DEXAMETHASONE, Tablet, 1 mg, NDC 00054418125, Pedigree: AD37088_1, EXP: 5/9/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD54498_4, EXP: 5/20/2014; guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: AD39611_1, EXP: 4/30/2014.

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 50111043301
Product quantity
400 Tablets
Reason for recall
Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as DEXAMETHASONE, Tablet, 1 mg, NDC 00054418125, Pedigree: AD37088_1, EXP: 5/9/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD54498_4, EXP: 5/20/2014; guanFACINE HCl, Tablet, 1 mg, NDC 00591044401, Pedigree: AD39611_1, EXP: 4/30/2014.
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-592-2014
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 codes Pedigree: AD37088_4, EXP: 5/9/2014; Pedigree: AD54562_1, EXP: 5/20/2014; Pedigree: AD39611_4, EXP: 5/14/2014.
More code info
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