Dabigatran Etexilate Drug Recalled Due to N-nitroso Impurity
Ascend Laboratories is recalling 13,560 bottles of Dabigatran Etexilate 75 mg capsules nationwide because testing detected N-nitroso-dabigatran impurity levels above acceptable limits. The issue stems from a manufacturing quality control deviation.
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 with no reported illnesses or injuries. The hazard is a manufacturing-related impurity (N-nitroso-dabigatran) at levels exceeding established acceptable daily intake limits in a prescription medication, representing a risk-of-harm situation without yet-reported adverse health events.
Plain-English summary
Ascend Laboratories, LLC is recalling 13,560 bottles of Dabigatran Etexilate Capsules, 75 mg nationwide in the United States. The affected lots are 22142462, 22142463, 22142464 (with expiration date 5/2024) and 22143000, 22143001, 22143002 (with expiration date 6/2024).
The recall results from a Current Good Manufacturing Practice (CGMP) deviation. Testing identified N-nitroso-dabigatran (NDAB) impurity levels in the affected lots that exceed the Acceptable Daily Intake Limit established for this substance.
Ascend Laboratories, LLC distributed the product (NDC 67877-474-60), which was manufactured by Alkem Laboratories Ltd. in India. The product was distributed nationwide.
Persons who have received the affected product should contact their healthcare provider or pharmacist for guidance regarding their medication therapy. The medication should not be discarded without consulting a healthcare professional about proper disposal methods.
The recalled product
- Product
- DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
- Brand
- DABIGATRAN ETEXILATE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug
- Hazard
- n-nitroso-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 (8)
- Lot #s: 22142462
- 22142463
- 22142464
- Exp 5/2024
- 22143000
- 22143001
- 22143002
- Exp 6/2024.
Distribution
Distributed nationwide across the United States.
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