FDA (Drugs) recall action 99330
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.
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
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.
Ascend Laboratories is recalling 1,753 cartons of dabigatran etexilate capsules (lot 25141707) due to out-of-specification results in impurity testing during 12-month stability studies.
Ascend Laboratories is recalling 2,717 cartons of Dabigatran Etexilate Capsules, 150 mg, because stability testing found impurities above specification.