FDA recall D-923-2014

Aidapak Services, LLC · Class II · drug

Product

LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527135001.

Reason for recall

Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD46265_34, EXP: 5/15/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003008, EXP: 6/11/2014.

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-923-2014