Why it was recalled
Defective container: products are packaged in pouches which may not have been fully sealed
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide, Puerto Rico, Brazil and Panama
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-844-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 6, 2013
- FDA report date
- Aug 14, 2013
- Quantity
- 10,624,000 pouches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Consumer Health
Original FDA data
Every field from FDA enforcement report D-844-2013, exactly as published.
Show all FDA fields
- City
- Lincoln
- State
- NE
- Status
- Terminated
- Country
- United States
- Event ID
- 65422
- Address
- 10401 Hwy 6
- 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
- Postal code
- 68517-9626
- Report date
- Aug 14, 2013
- Product type
- Drugs
- Recall number
- D-844-2013
- Classification
- Class II
- Recalling firm
- Novartis Consumer Health
- Product quantity
- 10,624,000 pouches
- Termination date
- Nov 4, 2014
- Reason for recall
- Defective container: products are packaged in pouches which may not have been fully sealed
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide, Puerto Rico, Brazil and Panama
- Recall initiation date
- Jun 6, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 6, 2013