Drug product
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.
D-742-2014
Product summary
- Event
- Event 65181
- Status
- Terminated
- Classification
- Class III
- Quantity
- 98,024/8-caplet packages and 557,548/24-caplet packages
- Official record key
drug-enforcement:D-742-2014
Official wording
Reason: Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
Code information: 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
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