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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 FLUoxetine HCl Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714035103
Recall Number D-517-2014
Classification Class II
Code Info FLUoxetine HCl, Capsule, 10 mg has the following code Pedigree: AD70585_13, EXP: 5/29/2014.
Product Distributed Qty 100 Capsules
Reason For Recall Labeling: Label Mixup; FLUoxetine HCl, Capsule, 10 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD70585_10, EXP: 5/29/2014.

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.