FDA (Drugs) recall action 85224
The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
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.
Glaxosmithkline is recalling specific lots of Advil Liqui-Gel Mini because the Drug Facts Panel lacks required safety warning information.
Glaxosmithkline is recalling specific lots of Infants Advil (Ibuprofen) because the Drug Facts Panel lacks required safety warning information.
Glaxosmithkline is recalling 446,628 bottles of Advil Liqui-Gel Minis because certain lots lack required safety warning information in the Drug Facts Panel.
GlaxoSmithKline is recalling specific lots of Advil Allergy and Congestion Relief because the Drug Facts Panel lacks required safety warning information.
Glaxosmithkline is recalling specific lots of Advil Allergy and Congestion Relief tablets because they lack required safety warning information in the Drug Facts Panel.