FDA recall D-844-2013

Novartis Consumer Health · Class II · drug

Product

Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702 Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin 250 mg and 65 mg Caffeine) 2-ct pouches. The foreign packaging do not have NDC numbers

Reason for recall

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

Distribution

Nationwide, Puerto Rico, Brazil and Panama

Key facts

Status: Terminated
Initiation date: 2013-06-06
Report date: 2013-08-14
Termination date: 2014-11-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lincoln, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-844-2013