Drug Enforcement D-557-2014

Labeling: Label Mixup; LIOTHYRONINE SODIUM Tablet, 25 mcg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD46414_22, EXP: 5/16/2014; BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603, Pedigree: AD68010_4, EXP: 5/28/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
LIOTHYRONINE SODIUM, Tablet 25 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 42794001902
Product quantity
200 Tablets
Reason for recall
Labeling: Label Mixup; LIOTHYRONINE SODIUM Tablet, 25 mcg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD46414_22, EXP: 5/16/2014; BROMOCRIPTINE MESYLATE, Tablet, 2.5 mg, NDC 00574010603, Pedigree: AD68010_4, EXP: 5/28/2014.
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-557-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
LIOTHYRONINE SODIUM Tablet, 25 mcg has the following codes Pedigree: AD46414_35, EXP: 5/16/2014; Pedigree: AD68010_11, EXP: 5/28/2014.
More code info