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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 NICOTINE POLACRILEX Lozenge, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 37205098769
Recall Number D-550-2014
Classification Class II
Code Info NICOTINE POLACRILEX Lozenge, 2 mg has the following codes Pedigree: AD52433_4, EXP: 5/17/2014; Pedigree: AD70700_4, EXP: 5/29/2014; Pedigree: AD73623_7, EXP: 5/30/2014; Pedigree: W003823, EXP: 6/27/2014; Pedigree: W003463, EXP: 6/20/2014.
Product Distributed Qty 1,582 Lozenges
Reason For Recall Labeling: Label Mixup; NICOTINE POLACRILEX Lozenge, 2 mg may be potentially mislabeled as ASPIRIN DR EC, Tablet, 81 mg, NDC 00182106105, Pedigree: AD52433_1, EXP: 5/17/2014; chlorproMAZINE HCl, Tablet, 100 mg, NDC 00832030300, Pedigree: AD70700_1, EXP: 5/29/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD73623_1, EXP: 5/30/2014; FOLIC ACID, Tablet, 1 mg, NDC 65162036110, Pedigree: W003822, EXP: 6/27/2014; PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: W003440, EXP: 5/31/2014.

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.