Key Takeaway

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., Pars by Novartis Consumer Health was recalled on June 6, 2013. The hazard: Defective container: products are packaged in pouches which may not have been fully sealed

FDA Drug Class II Terminated

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., Pars

Recalled: June 6, 2013 ~a) 4,178,000 pouches; b) 101,300 boxes and c) & d) 38,235 pouches and boxes (combined) units affected D-843-2013

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.

Hazard / Reason

Defective container: products are packaged in pouches which may not have been fully sealed

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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., Pars

Drugs

Company Information

Novartis Consumer Health

Lincoln, NE, United States

View all 60 recalls by Novartis Consumer Health →

Distribution

Nationwide, Puerto Rico, Brazil and Panama

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Frequently Asked Questions

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Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

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