Drug 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.
D-744-2014
Product summary
- Event
- Event 65181
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,978,000/2-caplet packages
- Official record key
drug-enforcement:D-744-2014
Official wording
Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Code information: Lot# 10118234 Exp 05/13 Lot# 10120254 Exp 05/13 Lot# 10123513 Exp 08/13 Lot#10125262 Exp 09/13
Distribution pattern: Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Derived failure modes
-
Unknown
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing