Drug Enforcement D-897-2014

Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as one of the following drugs: NEBIVOLOL HCL, Tablet, 5 mg, NDC 00456140530, Pedigree: AD73611_7, EXP: 5/30/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: W003022, EXP: 6/12/2014; ISOSORBIDE DINITRATE, Tablet, 5 mg, NDC 00781163501, Pedigree: W003474, EXP: 6/20/2014; HYDROCORTISONE, Tabl

Status

Terminated

Classification

Class II

Report Date

January 29, 2014

Termination Date

February 7, 2014

Product Information

Product description
LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378180701.
Product quantity
600 Tablets
Reason for recall
Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 88 mcg may have potentially been mislabeled as one of the following drugs: NEBIVOLOL HCL, Tablet, 5 mg, NDC 00456140530, Pedigree: AD73611_7, EXP: 5/30/2014; MELATONIN, Tablet, 3 mg, NDC 08770140813, Pedigree: W003022, EXP: 6/12/2014; ISOSORBIDE DINITRATE, Tablet, 5 mg, NDC 00781163501, Pedigree: W003474, EXP: 6/20/2014; HYDROCORTISONE, Tabl
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-897-2014
Event ID
65690
Recall initiation date
July 2, 2013
Center classification date
January 20, 2014
Code info
LEVOTHYROXINE SODIUM, Tablet, 88 mcg has the following codes: Pedigree: AD73652_10, EXP: 5/30/2014; Pedigree: W003047, EXP: 6/12/2014; Pedigree: W003476, EXP: 6/20/2014; Pedigree: W002967, EXP: 6/11/2014; Pedigree: AD42584_1, EXP: 5/14/2014.
More code info