FDA (Drugs) recall action 99421
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
The agency’s own wording, quoted from the enforcement report.
Ascend Laboratories, LLC is recalling Dabigatran Etexilate Capsules (75 mg) because testing showed impurities exceeded established limits during stability testing.
Ascend Laboratories is recalling dabigatran etexilate capsules due to an out-of-specification result in related substance testing involving Impurity II, Impurity III, and total impurities observed during 12-month stability testing.
Ascend Laboratories, LLC is recalling Dabigatran Etexilate Capsules (150 mg) because testing showed impurities exceeded established limits during stability testing.