The Recall Desk

FDA (Drugs) recall action 65181

Novartis Consumer Health recalled 7 products on 2014-01-22

The FDA (Drugs) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2014-01-22
Critical
0
Units
—

Why these products were recalled

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

The agency’s own wording, quoted from the enforcement report.

1–7 of 7

  • ModerateFDA (Drugs)··2014-01-22

    Novartis Recalls Excedrin Sinus Headache Caplets Due to Unknown Degradant

    Novartis Consumer Health is recalling Excedrin Sinus Headache caplets because an unknown degradant was found during stability testing.

    Product
    Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2014-01-22

    Novartis Recalls Comtrex Nighttime Cold and Cough Due to Unknown Degradant

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Nighttime Cold & Cough because an unknown degradant was found during stability testing.

    Product
    Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula *includes antihistamine, Distributed by: Novartis Consumer Health, Inc., Parsipp
    Category
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    0 states
  • LowFDA (Drugs)··2014-01-22

    Novartis Recalls Maximum Strength Comtrex Day/Night Flu Therapy

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Day/Night Flu Therapy due to an unknown degradant found during stability testing.

    Product
    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 by: Novartis Consumer Health
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2014-01-22

    Novartis Recalls Theraflu Nighttime Warming Relief Due to Unknown Degradant

    Novartis Consumer Health is recalling Theraflu Nighttime Warming Relief caplets because an unknown degradant was found during stability testing.

    Product
    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 by: Novartis Consume
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2014-01-22

    Novartis Recalls Comtrex Cold and Cough Caplets Due to Unknown Degradant

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Day/Night Cold & Cough caplets because an unknown degradant was found during stability testing.

    Product
    Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula and 16 coated caplets nighttime formula *includes antihistamine Distributed by: No
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2014-01-22

    Novartis Recalls Theraflu Warming Relief Due to Unknown Degradant

    Novartis Consumer Health is recalling Theraflu Warming Relief caplets because an unknown degradant was found during stability testing.

    Product
    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. 07054-06
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2014-01-22

    Novartis Recalls Maximum Strength Comtrex Due to Unknown Degradant

    Novartis Consumer Health is recalling specific lots of Maximum Strength Comtrex Severe Cold & Sinus because an unknown degradant was found during stability testing.

    Product
    Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime formula. Novartis, distributed by: Novartis Consumer Health, Inc., Parsippany, N
    Category
    Distribution
    0 states