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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 Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d) Cibalenaa (250 mg Acetaminophen, 250 mg Aspirin, 65 mg Caffeine), boxes of 48/4-ct pouches Foreign packaging do not have NDC numbers.
Recall Number D-843-2013
Classification Class II
Code Info Lot #s a) 10120190, Exp 6/13 and 10121628, Exp 7/13; Lot #s b) 10115658, Exp 5/13; 10116807, Exp 5/13; 10121630, Exp 7/13 and 10125253, Exp 9/13 Foreign Lot #s c) 10120192, Exp 7/13; d)10120272, Exp 7/13, 10121528 Exp 7/13 and 10121958 Exp 8/13
Product Distributed Qty a) 4,178,000 pouches; b) 101,300 boxes and c) & d) 38,235 pouches and boxes (combined)
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