The Recall Desk

FDA (Drugs) recall action 85848

Glaxosmithkline Consumer Healthcare Holdings recalled 2 products on 2020-07-08

The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2020-07-08
Critical
0
Units
210,468

Why these products were recalled

Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.

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.

1–2 of 2

  • ModerateFDA (Drugs)··2020-07-08

    Children's Robitussin DM Recalled for Missing Dosing Cup Graduations

    Glaxosmithkline is recalling 132,336 bottles of Children's Robitussin DM because the included dosing cups lack age-specific measurement markings.

    Product
    CHILDRENS ROBITUSSIN HONEY COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2020-07-08

    Children's Dimetapp Cold & Cough Recalled for Missing Dosing Cup Graduations

    Glaxosmithkline is recalling Children's Dimetapp Cold & Cough bottles because the included dosing cups are missing graduation marks for certain age groups.

    Product
    Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19.
    Category
    Distribution
    0 states