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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 Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 075054-0622, NDC 0067-2082-32.
Recall Number D-738-2014
Classification Class III
Code Info Lot # 10116279 exp 05/13 Lot # 10117810 exp 06/13 Lot # 10119274 exp 07/13 Lot # 10121463 exp 07/13
Product Distributed Qty 104,328/32-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.