Status
Terminated
Drug Enforcement D-742-2014
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
- Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-6438-24), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622.
- Product quantity
- 98,024/8-caplet packages and 557,548/24-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-742-2014
- Event ID
- 65181
- Recall initiation date
- May 15, 2013
- Center classification date
- January 16, 2014
- Code info
- a) 08 caplets: Lot# 10121228 exp 08/13. b) 24caplets: Lot# 10114814 exp 05/13 Lot# 10117233 exp 05/13 Lot# 10117811 exp 06/13 Lot# 10119338 exp 07/13 Lot# 10121470 exp 07/13 Lot# 10123892 exp 09/13 Lot# 10124161 exp 10/13
- More code info
- —