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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 Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2081-24.
Recall Number D-739-2014
Classification Class III
Code Info Lot # 10119267 exp 07/13 Lot # 10123857 exp 07/13 Lot # 10123888 exp 09/13
Product Distributed Qty 32,256/24-caplet packages
Reason For Recall Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Event Detail

Event Id 65181
Product Type Drugs
Status Ongoing
Recalling Firm Novartis Consumer Health
City Lincoln
State NE
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-15
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.