Recalls / Class II
Class IID-846-2013
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
- Affected lot / code info
- Lot # 10121996, Exp 7/13
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
- 472,000 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-846-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.