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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 63824000815
Recall Number D-682-2014
Classification Class II
Code Info guaiFENesin ER, Tablet, 600 mg has the following codes Pedigree: AD21965_22, EXP: 5/1/2014; Pedigree: AD56917_13, EXP: 5/21/2014; Pedigree: AD73627_23, EXP: 5/30/2014; Pedigree: W003218, EXP: 6/17/2014; Pedigree: W003360, EXP: 6/19/2014; Pedigree: W002660, EXP: 6/5/2014.
Product Distributed Qty 600 Tablets
Reason For Recall Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: AD21965_13, EXP: 5/1/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD56917_7, EXP: 5/21/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD73627_17, EXP: 5/30/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W003216, EXP: 6/14/2014; LACTOBACILLUS GG, Capsule, 15 Billion Cells, NDC 49100036374, Pedigree: W003357, EXP: 6/19/2014; LEFLUNOMIDE, Tablet, 10 mg, NDC 23155004303, Pedigree: W002659, EXP: 6/5/2014.

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.