PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 14, 2013 Initiated: June 6, 2013 #D-846-2013

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

Reason for Recall

Defective container: products are packaged in pouches which may not have been fully sealed

Details

Recalling Firm
Novartis Consumer Health
Units Affected
472,000 pouches
Distribution
Nationwide, Puerto Rico, Brazil and Panama
Location
Lincoln, NE

Frequently Asked Questions

What product was recalled?
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. Recalled by Novartis Consumer Health. Units affected: 472,000 pouches.
Why was this product recalled?
Defective container: products are packaged in pouches which may not have been fully sealed
Which agency issued this recall?
This recall was issued by the FDA Drug on August 14, 2013. Severity: Moderate. Recall number: D-846-2013.