Ascend Laboratories, LLC — Class III: Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a ca
Ascend Laboratories, LLC has initiated a Class III recall for Dabigatran Etexilate Capsules, 75 mg (60-count blister packs) due to Out of Specification (OOS) results for Impurity II, Impurity III, and Total Impurities during 12-month stability testing.
This recall affects Ascend Laboratories, LLC, the manufacturer Alkem Laboratories Ltd., the distributor Major Pharmaceuticals, and quality/regulatory departments monitoring anticoagulant stability profiles.
A Class III designation indicates that the use of or exposure to the product is not likely to cause adverse health consequences. However, the OOS result at the 12-month stability mark suggests potential vulnerabilities in the formulation or packaging integrity that could impact the product's long-term shelf-life specifications. Regulatory teams should note that this involves a common anticoagulant, which may require monitoring for similar degradation patterns across other strengths or batches if the root cause is systemic.
QA teams should review stability data for dabigatran etexilate products to ensure impurity profiles remain within specification throughout shelf life. Procurement and pharmacy operations should identify and isolate the specific NDC 0904-7253-68 lots involved in this ongoing Class III recall.
Class III. Reason: 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. 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.. Firm: Ascend Laboratories, LLC (Bedminster NJ United States). Status: Ongoing.
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