FDA-Drug2014-01-22Class III

Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.

Novartis Consumer Health
Hazard

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Sold states
Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Affected count
2,978,000/2-caplet packages
Manufactured in
10401 Hwy 6, Lincoln, NE, United States
Products
Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-744-2014

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