Prescription Drug Dabigatran Etexilate Recalled for Excess Nitrosamine Impurity
Ascend Laboratories is recalling 12,804 bottles of Dabigatran Etexilate 150mg capsules nationwide due to detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake limit caused by manufacturing process deviations.
- Product
- DABIGATRAN ETEXILATE — DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
- Category
- Drug
- Distribution
- Distributed nationwide