FDA (Drugs) recall action 83327
The FDA (Drugs) publishes a recall like this one as 6 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 6 pages.
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
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.
Deva Holding AS is recalling Temozolomide Capsules due to manufacturing deviations that allowed possible cross-contamination with beta-lactam products.
Deva Holding AS is recalling Temozolomide Capsules due to manufacturing deviations that allowed possible cross-contamination with beta-lactam products.
Deva Holding AS is recalling Temozolomide capsules because manufacturing deviations allowed possible cross-contamination with beta-lactam products.
Deva Holding AS is recalling Temozolomide Capsules because manufacturing deviations allowed for possible cross-contamination with beta-lactam products.
Deva Holding AS is recalling Temozolomide Capsules due to manufacturing deviations that allowed possible cross-contamination with beta-lactam products.
Deva Holding AS is recalling Temozolomide capsules due to manufacturing deviations that allowed possible cross-contamination with beta-lactam products.