Dabigatran Etexilate Capsules Recalled Over Impurity Test Failure
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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall, which by definition is not likely to cause adverse health consequences. No illnesses or injuries have been reported, and the issue involves an out-of-specification result in impurity testing rather than confirmed contamination or harm.
Plain-English summary
Ascend Laboratories, LLC is recalling 1,753 cartons of Dabigatran Etexilate Capsules, 110 mg, 60-count cartons (NDC 0904-7254-68), lot 25141707, with an expiration date of April 30, 2027. The product was distributed nationwide across the United States.
The recall was initiated due to an out-of-specification (OOS) result observed during related substance test analysis. Specifically, the OOS result involved Impurity II, Impurity III, and Total Impurity testing conducted as part of a 12-month long-term stability study.
The affected product is a prescription anticoagulant medication. No illnesses or injuries have been reported in connection with this recall.
Consumers or healthcare providers in possession of the recalled lot should not use the product. Ascend Laboratories is a division of Major Pharmaceuticals, which is handling the recall. Healthcare providers should contact their pharmacy or distributor to arrange for return or replacement of the affected medication.
The recalled product
- Product
- DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
- Brand
- DABIGATRAN ETEXILATE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Prescription Capsule
- Hazard
- impurity-test-failure
- out-of-specification
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 (2)
- Lot: 25141707
- Exp 4/30/2027.
UPCs (2)
- 0309047253043
- 0309047255108
Distribution
Distributed nationwide across the United States.
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