FDA recall D-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

Reason for recall

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

Distribution

Nationwide, Puerto Rico, Brazil and Panama

Key facts

Status

Terminated

Initiation date

2013-06-06

Report date

2013-08-14

Termination date

2014-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lincoln, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-846-2013