FDA recall D-897-2014

Aidapak Services, LLC · Class II · drug

Product

LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378180701.

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

Distribution

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Key facts

Status
Terminated
Initiation date
2013-07-02
Report date
2014-01-29
Termination date
2014-02-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Vancouver, WA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-897-2014