Recalls / Class III
Class IIID-744-2014
Product
Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.
- Affected lot / code info
- Lot# 10118234 Exp 05/13 Lot# 10120254 Exp 05/13 Lot# 10123513 Exp 08/13 Lot#10125262 Exp 09/13
Why it was recalled
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Recalling firm
- Firm
- Novartis Consumer Health
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10401 Hwy 6, Lincoln, Nebraska 68517-9626
Distribution
- Quantity
- 2,978,000/2-caplet packages
- Distribution pattern
- Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Timeline
- Recall initiated
- 2013-05-15
- FDA classified
- 2014-01-16
- Posted by FDA
- 2014-01-22
- Terminated
- 2014-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-744-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.