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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 guaiFENesin ER Tablet, 600 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824000834
Recall Number D-683-2014
Classification Class II
Code Info guaiFENesin ER, Tablet, 600 mg has the following codes Pedigree: AD62834_4, EXP: 5/24/2014; Pedigree: AD62834_7, EXP: 5/24/2014; Pedigree: W003514, EXP: 6/21/2014; Pedigree: W003574, EXP: 6/24/2014; Pedigree: W003850, EXP: 6/27/2014; Pedigree: W003931, EXP: 6/28/2014; Pedigree: AD46429_1, EXP: 5/15/2014; Pedigree: AD73592_1, EXP: 5/31/2014.
Product Distributed Qty 480 Tablets
Reason For Recall Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: AD62829_18, EXP: 5/24/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD62834_4, EXP: 5/24/2014; diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: W003513, EXP: 6/21/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375701, Pedigree: W003558, EXP: 6/24/2014; LOSARTAN POTASSIUM, Tablet, 25 mg, NDC 16714058102, Pedigree: W003845, EXP: 6/27/2014; TERAZOSIN HCL, Capsule, 5 mg, NDC 00781205301, Pedigree: W003913, EXP: 6/28/2014; ATORVASTATIN CALCIUM, Tablet, 80 mg, NDC 00378212277, Pedigree: AD46300_1, EXP: 5/15/2014; IRBESARTAN, Tablet, 150 mg, NDC 65862063830, Pedigree: AD73686_7, 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.