FDA recall D-623-2014

Aidapak Services, LLC · Class II · drug

Product

MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet), Rx only, Distributed by: AidaPak Service, LLC, NDC 55253080130

Reason for recall

Labeling:Label Mixup; MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet) may be potentially mislabeled as SACCHAROMYCES BOULARDII LYO, Capsule, 250 mg, NDC 00414200007, Pedigree: AD21859_1, EXP: 10/31/2013.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2013-07-02
Report date: 2014-01-22
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-623-2014