FDA (Drugs) recall action 63707
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.
Product Lacks Stability: These lots are being recalled due to the failure to meet the particle size distribution specification.
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 Advair HFA inhalers because they failed to meet particle size distribution specifications.
GlaxoSmithKline is recalling 18,676 units of Advair HFA inhalers because they failed to meet particle size distribution specifications.