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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 SERTRALINE HCL Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714061204
Recall Number D-523-2014
Classification Class II
Code Info SERTRALINE HCL Tablet, 50 mg has the following codes Pedigree: AD70585_7, EXP: 5/29/2014; Pedigree: W003575, EXP: 6/24/2014; Pedigree: AD46426_1, EXP: 5/15/2014; Pedigree: AD30993_14, EXP: 5/9/2014; Pedigree: W003033, EXP: 6/12/2014.
Product Distributed Qty 500 Tablets
Reason For Recall Labeling: Label Mixup; SERTRALINE HCL Tablet, 50 mg may be potentially mislabeled as NORTRIPTYLINE HCL, Capsule, 10 mg, NDC 00093081001, Pedigree: AD70585_4, EXP: 5/29/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: W003574, EXP: 6/24/2014; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, NDC 11523726503, Pedigree: AD46300_17, EXP: 5/15/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: AD33897_34, EXP: 5/9/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 00603548221, Pedigree: W003032, EXP: 6/12/2014.

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.