Drug product
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
D-846-2013
Product summary
- Event
- Event 65422
- Status
- Terminated
- Classification
- Class II
- Quantity
- 472,000 pouches
- Official record key
drug-enforcement:D-846-2013
Official wording
Reason: Defective container: products are packaged in pouches which may not have been fully sealed
Code information: Lot # 10121996, Exp 7/13
Distribution pattern: Nationwide, Puerto Rico, Brazil and Panama
Derived failure modes
-
Unknown
Defective container: products are packaged in pouches which may not have been fully sealed