FDA (Drugs) recall action 64041
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.
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
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.
AstraZeneca is recalling Pulmicort Respules because the budesonide concentration may be slightly above or below the specification range.
AstraZeneca is recalling PULMICORT RESPULES because the budesonide content may be slightly above or below the specification range.