Status
Terminated
Drug Enforcement D-744-2014
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Classification
Class III
Report Date
January 22, 2014
Termination Date
November 4, 2014
Product Information
- Product description
- Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.
- Product quantity
- 2,978,000/2-caplet packages
- Reason for recall
- Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
Location & Firm
- Recalling firm
- Novartis Consumer Health
- Address
-
10401 Hwy 6
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-744-2014
- Event ID
- 65181
- Recall initiation date
- May 15, 2013
- Center classification date
- January 16, 2014
- Code info
- Lot# 10118234 Exp 05/13 Lot# 10120254 Exp 05/13 Lot# 10123513 Exp 08/13 Lot#10125262 Exp 09/13
- More code info
- —