Dabigatran Etexilate Capsules Recalled Over Impurity Specification Failure
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.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA has classified this recall as Class III, which by definition indicates that use of or exposure to the product is not likely to cause adverse health consequences. No illnesses or injuries have been reported in connection with this recall.
Plain-English summary
Ascend Laboratories, LLC is recalling Dabigatran Etexilate Capsules, 75 mg, 30-count blister packs distributed nationwide in the U.S. The recall involves 936 cartons and is associated with lot number 25141586 with an expiration date of April 30, 2027.
The recall was initiated due to a failed impurity and degradation specification. An out-of-specification (OOS) result was observed in related substance test analysis with respect to Impurity II, Impurity III, and total impurities during 12-month stability testing.
The product was manufactured by Alkem Laboratories Ltd., Mumbai, India, and distributed by Major Pharmaceuticals, Indianapolis, IN. The product is a human prescription drug with NDC 0904-7253-04 and application number ANDA208040.
Consumers and healthcare providers should contact Ascend Laboratories, LLC for return instructions or further information. The FDA has classified this recall as Class III, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE)
- Brand
- DABIGATRAN ETEXILATE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Prescription Capsule
- Hazard
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 (3)
- Lot: 25141586
- Exp. April 30
- 2027.
UPCs (2)
- 0309047253043
- 0309047255108
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Ascend Laboratories, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same brand · DABIGATRAN ETEXILATE
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