Reported Jan 22, 2014 · Terminated
Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan…
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?
- Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula
- Distributed byNovartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2084-24
- Lot codes and dates
- Lot# 10117243 Exp 06/13 Lot# 10119333 Exp 07/13
- Amount recalled
- 38,856/24-caplet package
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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