Drug Enforcement D-563-2014

Labeling: Label Mixup; METHYLERGONOVINE MALEATE Tablet, 0.2 mg may be potentially mislabeled as ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701, Pedigree: AD52778_31, EXP: 5/20/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: W003476, EXP: 6/20/2014.

Status

Terminated

Classification

Class II

Report Date

January 22, 2014

Termination Date

February 7, 2014

Product Information

Product description
METHYLERGONOVINE MALEATE Tablet, 0.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386014028
Product quantity
112 Tablets
Reason for recall
Labeling: Label Mixup; METHYLERGONOVINE MALEATE Tablet, 0.2 mg may be potentially mislabeled as ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701, Pedigree: AD52778_31, EXP: 5/20/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: W003476, EXP: 6/20/2014.
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-563-2014
Event ID
65707
Recall initiation date
July 2, 2013
Center classification date
January 16, 2014
Code info
METHYLERGONOVINE MALEATE, Tablet, 0.2 mg has the following codes Pedigree: AD52778_40, EXP: 5/20/2014; Pedigree: W003477, EXP: 6/20/2014.
More code info