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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Product Detail

Product Description Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign packaging do not have NDC number This product was only distributed to Novartis Brazil by the recalling firm
Recall Number D-846-2013
Classification Class II
Code Info Lot # 10121996, Exp 7/13
Product Distributed Qty 472,000 pouches
Reason For Recall Defective container: products are packaged in pouches which may not have been fully sealed

Event Detail

Event Id 65422
Product Type Drugs
Status Ongoing
Recalling Firm Novartis Consumer Health
City Lincoln
State NE
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide, Puerto Rico, Brazil and Panama