Drug Enforcement D-526-2014

Labeling: Label Mixup; hydrALAZINE HCl Tablet, 100 mg may be potentially mislabeled as DOXEPIN HCL, Capsule, 150 mg, NDC 49884022201, Pedigree: AD46312_10, EXP: 5/16/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD73652_1, EXP: 5/29/2014; LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD30197_13, EXP: 5/9/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
hydrALAZINE HCl Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 23155000401
Product quantity
400 Tablets
Reason for recall
Labeling: Label Mixup; hydrALAZINE HCl Tablet, 100 mg may be potentially mislabeled as DOXEPIN HCL, Capsule, 150 mg, NDC 49884022201, Pedigree: AD46312_10, EXP: 5/16/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: AD73652_1, EXP: 5/29/2014; LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD30197_13, EXP: 5/9/2014.
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-526-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
hydrALAZINE HCl Tablet, 100 mg has the following codes Pedigree: AD46312_13, EXP: 5/16/2014; Pedigree: AD73652_4, EXP: 5/29/2014; Pedigree: AD30197_7, EXP: 5/9/2014.
More code info
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