Drug recall D-0736-2026
Product
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.
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.
Lots and codes
Lot: 25141584, Exp 4/30/2027.
Recall details
- Recalling firm
- Ascend Laboratories, LLC, Bedminster, NJ
- Quantity
- 2,717 cartons
- Distribution
- USA Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 30, 2026
Related products
- Dabigatran Etexilate – drug information
- NDC 0904-7254 Dabigatran Etexilate · Dabigatran Etexilate Mesylate 110 mg/1 · Major Pharmaceuticals
- NDC 0904-7253 Dabigatran Etexilate · Dabigatran Etexilate Mesylate 75 mg/1 · Major Pharmaceuticals
- NDC 0904-7255 Dabigatran Etexilate · Dabigatran Etexilate Mesylate 150 mg/1 · Major Pharmaceuticals