Why it was recalled
Defective container: products are packaged in pouches which may not have been fully sealed
Product description
Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign packaging do not have NDC number This product was only distributed to Novartis Brazil by the recalling firm
Lot numbers, UPCs & expiration codes
Lot # 10121996, Exp 7/13
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-846-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 6, 2013
- FDA report date
- Aug 14, 2013
- Quantity
- 472,000 pouches
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Consumer Health
Original FDA data
Every field from FDA enforcement report D-846-2013, 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 # 10121996, Exp 7/13
- Postal code
- 68517-9626
- Report date
- Aug 14, 2013
- Product type
- Drugs
- Recall number
- D-846-2013
- Classification
- Class II
- Recalling firm
- Novartis Consumer Health
- Product quantity
- 472,000 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
- Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis Consumer Health S.A., Brazil, for Novartis de Venezuela. The foreign packaging do not have NDC number This product was only distributed to Novartis Brazil by the recalling firm
- Distribution pattern
- Nationwide, Puerto Rico, Brazil and Panama
- Recall initiation date
- Jun 6, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 6, 2013