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Ascend Laboratories, LLC: Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by:

DrugsSource: FDA (drug) · Date: 2026-07-29

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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, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.
Reason / hazard
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.
Classification
Class III
Status
Ongoing
Distribution / sold at
USA Nationwide
Recall initiated
2026-06-30
Code info
Lot: 25141584, Exp 4/30/2027.
Product quantity
2,717 cartons
Voluntary mandated
Voluntary: Firm initiated
City
Bedminster
State
NJ
Country
United States
Event id
99330
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