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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 4, 2014 · Data as of Sep 19, 5:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.