Reported Jan 22, 2014 · Terminated
Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg,…
Novartis Consumer Health
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Novartis Consumer Health · 10401 Hwy 6 · Lincoln, NE · 68517-9626
Is this the product you have?
- 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 byNovartis Consumer Health, Inc., Parsippany, NJ. 07054-0622
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 Lot# 10121228 exp 08/13. b) 24caplets 2 Lot# 10114814 exp 05/13 3 Lot# 10117233 exp 05/13 4 Lot# 10117811 exp 06/13 5 Lot# 10119338 exp 07/13 6 Lot# 10121470 exp 07/13 7 Lot# 10123892 exp 09/13 8 Lot# 10124161 exp 10/13 - Amount recalled
- 98,024/8-caplet packages and 557,548/24-caplet packages
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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