Drug recall D-0738-2026
Product
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, NDC 0904-7253-68.
Reason for recall
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Lots and codes
Lot: 25141585, Exp. April 30, 2027.
Recall details
- Recalling firm
- Ascend Laboratories, LLC, Bedminster, NJ
- Quantity
- 924 cartons x 12 x 6 x 10 (in blister pack)
- Distribution
- USA Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 16, 2026
Related products
- Dabigatran Etexilate – drug information
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- NDC 0904-7255 Dabigatran Etexilate · Dabigatran Etexilate Mesylate 150 mg/1 · Major Pharmaceuticals