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Ascend Laboratories, LLC: Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratori

DrugsSource: FDA (drug) · Date: 2026-08-05

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Ascend Laboratories, LLC
Product
Dabigatran Etexilate Capsules, 150 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 0904-7255-68.
Reason / hazard
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
Classification
Class III
Status
Ongoing
Distribution / sold at
USA Nationwide
Recall initiated
2026-07-16
Code info
Lot: 25141583, Exp. April 30, 2027.
Product quantity
3,600 cartons x 6 x 10 (in blister pack)
Voluntary mandated
Voluntary: Firm initiated
City
Bedminster
State
NJ
Country
United States
Event id
99421
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