D-0735-2026 Class III Ongoing
FDA drug recall D-0735-2026 was initiated by Ascend Laboratories, LLC on June 30, 2026 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-… The recall status is ongoing. Affected quantity: 1,753 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- July 29, 2026
- Initiation Date
- June 30, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,753 cartons
Product Description
Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.
Reason for Recall
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Distribution Pattern
USA Nationwide
Code Information
Lot: 25141707, Exp 4/30/2027.