FDAFDA · Food and drugs·Recall number D-742-2014
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.
Published January 22, 2014 · Recall initiated: May 15, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Novartis Consumer Health
- Distributor
- Distribution was made nationwide and foriegn distribution was made--Mexicio, Panama, Ecuador and Venezuela.
- Lot
- 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
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.