FDA-Drug2013-08-14Class II
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.
Novartis Consumer Health
Hazard
Defective container: products are packaged in pouches which may not have been fully sealed
Sold states
Nationwide, Puerto Rico, Brazil and Panama
Affected count
a) 4,178,000 pouches; b) 101,300 boxes and c) & d) 38,235 pouches and boxes (combined)
Manufactured in
10401 Hwy 6, N/A, Lincoln, NE, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-843-2013Don't want to check this manually?
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