FDA recall D-898-2014

Aidapak Services, LLC · Class II · drug

Product

LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378181101.

Reason for recall

Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 112 mcg may have potentially been mislabeled as one of the following drugs: ZINC SULFATE, Capsule, 220 mg (50 mg Elem Zn), NDC 00904533260, Pedigree: AD57624_1, EXP: 5/9/2014; hydrALAZINE HCl, Tablet, 50 mg, NDC 50111032801, Pedigree: AD52778_28, EXP: 5/20/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W003828, EXP: 6/

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-898-2014