Prescription drug Dabigatran Etexilate recalled for elevated nitrosamine impurity
Ascend Laboratories is recalling Dabigatran Etexilate 150mg capsules due to elevated N-nitroso-Dabigatran impurity from a manufacturing deviation. Affected lots were distributed nationwide; consult your physician before making changes to your medication.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall due to manufacturing deviation resulting in N-nitroso-Dabigatran impurity above the FDA's recommended interim limit. No illnesses or injuries are documented in the source material.
Plain-English summary
Ascend Laboratories is recalling Dabigatran Etexilate 150mg capsules manufactured by Alkem Laboratories Ltd. in India and distributed nationwide. The recall affects 10,444 bottles with lot numbers 24142192, 24142193, 24142194 (expiring April 30, 2026) and lot 24142463 (expiring May 31, 2026).
The recall was issued due to a Current Good Manufacturing Practice (CGMP) deviation resulting in elevated levels of N-nitroso-Dabigatran impurity. The detected impurity levels exceeded the FDA's recommended interim limit.
Dabigatran Etexilate is a prescription medication. Patients taking medication from affected lots should not stop their medication without consulting their physician. Individuals who have received affected lot numbers should check with their pharmacy or healthcare provider about their specific situation.
The recalled product
- Product
- DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
- Brand
- DABIGATRAN ETEXILATE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug
- Hazard
- nitrosamine-impurity
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #: 24142192
- 24142193
- 24142194
- Exp. Date April 30
- 2026
- 24142463
- Exp. Date May 31
Distribution
Distributed nationwide across the United States.
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