Reported Jan 22, 2014 · Terminated
Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg ,…
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 Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-6437-08) b) 24 coated caplets (NDC 0067-6438-24)
- Distributed byNovartis Consumer Health, Inc., Parsippany, NJ. 07054-0622
- Lot codes and dates
- a) 08 capletsLot# 10121222 exp 07/13
- b) 24 capletsLot# 10117231 exp 06/13 Lot# 10117814 exp 06/13 Lot# 10119341 exp 07/13 Lot# 10123425 exp 08/13 Lot# 10124156 exp 10/13
- Amount recalled
- 3,768/8-caplet packages and 300,580/24-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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Novartis Consumer Health recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.