The Recall Desk

FDA (Drugs) recall action 71013

Reckitt Benckiser LLC recalled 7 products on 2015-09-02

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
2015-09-02
Critical
0
Units
3,331,344

Why these products were recalled

Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–7 of 7

  • SevereFDA (Drugs)··2015-09-02

    Mucinex Fast-Max Cold & Sinus Recalled for Missing Drug Facts Labeling

    Reckitt Benckiser is recalling Mucinex Fast-Max Cold & Sinus liquid because the back of the bottle is missing active ingredients and safety warnings.

    Product
    Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-016-66,
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2015-09-02

    Mucinex Fast Max Liquid Recalled for Missing Drug Facts Labeling

    Reckitt Benckiser is recalling Mucinex Fast Max liquid bottles where the back label is missing active ingredients and safety warnings.

    Product
    Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 638
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2015-09-02

    Mucinex Fast-Max Recalled for Missing Drug Facts Labeling

    Reckitt Benckiser is recalling Mucinex Fast-Max liquid bottles because the back label is missing active ingredients and safety warnings.

    Product
    MUCINEX FAST-MAX (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2015-09-02

    Mucinex Fast Max Liquid Recalled for Missing Drug Facts Labeling

    Reckitt Benckiser is recalling Mucinex Fast Max Night Time Cold & Flu liquid bottles because the back label is missing active ingredients and safety warnings.

    Product
    Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl Antihistamine/Cough Suppressant, Phenylephrine HCl Nasal Decongestant, 6 fl oz. (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2015-09-02

    Mucinex Fast Max Liquid Recalled for Missing Drug Facts Labeling

    Reckitt Benckiser is recalling Mucinex Fast Max liquid bottles because the back label is missing active ingredients and safety warnings.

    Product
    Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2015-09-02

    Mucinex Fast-Max Liquid Recalled for Missing Drug Facts Labeling

    Reckitt Benckiser is recalling Mucinex Fast-Max liquid bottles because the back label is missing active ingredients and safety warnings.

    Product
    Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bottles Total -12 fl oz (360 mL), For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-526-22
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2015-09-02

    Mucinex Fast-Max DM Max Recalled for Missing Drug Facts Labeling

    Reckitt Benckiser is recalling Mucinex Fast-Max DM Max bottles because the back label is missing active ingredients and safety warnings.

    Product
    MUCINEX FAST-MAX DM MAX AND MUCINEX NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE)
    Category
    Distribution
    0 states
Reckitt Benckiser LLC recalled 7 products on 2015-09-02 · The Recall Desk