Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
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
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total…
Reason Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total…
Reason Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II…
Reason Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II…
Reason CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
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