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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 DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904789159
Recall Number D-491-2014
Classification Class II
Code Info DOCUSATE SODIUM, Capsule, 250 mg has the following codes Pedigree: AD68028_1, EXP: 5/28/2014; Pedigree: AD68022_1, EXP: 5/28/2014; Pedigree: AD37072_1, EXP: 5/13/2014; Pedigree: AD37072_4, EXP: 5/13/2014; Pedigree: AD56924_1, EXP: 5/21/2014; Pedigree: W003671, EXP: 6/25/2014; Pedigree: W002920, EXP: 6/10/2014.
Product Distributed Qty 4,318 Capsules
Reason For Recall Labeling: Label Mixup; DOCUSATE SODIUM, Capsule, 250 mg may be potentially mislabeled as ATROPINE SULFATE/DIPHENOXYLATE HCL, Tablet, 0.025 mg/2.5 mg, NDC 00378041501, Pedigree: AD65475_13, EXP: 5/28/2014; VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD68025_1, EXP: 5/28/2014; PANTOPRAZOLE SODIUM DR, Tablet, 40 mg, NDC 64679043402, Pedigree: AD37063_10, EXP: 5/13/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00904789159, Pedigree: AD37072_1, EXP: 5/13/2014; ISOSORBIDE DINITRATE, Tablet, 5 mg, NDC 00781163501, Pedigree: AD56882_1, EXP: 5/21/2014; LACTOBACILLUS, Tablet, NDC 64980012950, Pedigree: W003623, EXP: 10/31/2013; NEBIVOLOL HCL, Tablet, 5 mg, NDC 00456140530, Pedigree: W002930, EXP: 6/10/2014.

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.