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

D-844-2013

June 06, 2013

Class II

Product summary

Firm: Novartis Consumer Health
Event: Event 65422
Status: Terminated
Classification: Class II
Quantity: 10,624,000 pouches
Official record key: drug-enforcement:D-844-2013

Official wording

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

Code information: Lot # a) 10116809, Exp 5/13 Foreign: Lot #s b) 10115644 Exp 5/13; 10118226 Exp 5/13; 10118227 Exp 6/13; 10118228 Exp 6/13; 10121956 Exp 8/13 and 10121957 Exp 8/13

Distribution pattern: Nationwide, Puerto Rico, Brazil and Panama

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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