Recalls / Class II
Class IID-844-2013
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
- Affected lot / code info
- 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
Why it was recalled
Defective container: products are packaged in pouches which may not have been fully sealed
Recalling firm
- Firm
- Novartis Consumer Health
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10401 Hwy 6, N/A, Lincoln, Nebraska 68517-9626
Distribution
- Quantity
- 10,624,000 pouches
- Distribution pattern
- Nationwide, Puerto Rico, Brazil and Panama
Timeline
- Recall initiated
- 2013-06-06
- FDA classified
- 2013-08-06
- Posted by FDA
- 2013-08-14
- Terminated
- 2014-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-844-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.