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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet), Rx only, Distributed by: AidaPak Service, LLC, NDC 55253080130
Recall Number D-623-2014
Classification Class II
Code Info MODAFINIL Tablet, 50 mg (1/2 of 100 mg Tablet) has the following code Pedigree: AD21787_4, EXP: 5/1/2014.
Product Distributed Qty 60 Tablets
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.

Event Detail

Event Id 65707
Product Type Drugs
Status Ongoing
Recalling Firm Aidapak Services, LLC
City Vancouver
State WA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-02
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Repacked drugs were distributed in Arizona, California, Oregon, and Washington.