PlainRecalls
FDA Drug Moderate 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., 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.

Reported: August 14, 2013 Initiated: June 6, 2013 #D-843-2013

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.

Reason for Recall

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

Details

Recalling Firm
Novartis Consumer Health
Units Affected
a) 4,178,000 pouches; b) 101,300 boxes and c) & d) 38,235 pouches and boxes (combined)
Distribution
Nationwide, Puerto Rico, Brazil and Panama
Location
Lincoln, NE

Frequently Asked Questions

What product was recalled?
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.. Recalled by Novartis Consumer Health. Units affected: a) 4,178,000 pouches; b) 101,300 boxes and c) & d) 38,235 pouches and boxes (combined).
Why was this product recalled?
Defective container: products are packaged in pouches which may not have been fully sealed
Which agency issued this recall?
This recall was issued by the FDA Drug on August 14, 2013. Severity: Moderate. Recall number: D-843-2013.