FDA DrugNot Yet Classified
FDA Recall: Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack, Rx only, Manufactured by: Alkem
Description
Failed impurity/degradation specification:12M Long-term Stability conditions (25 ¿2 ¿C/60 ¿5%RH), an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities
Hazard
Failed impurity/degradation specification:12M Long-term Stability conditions (25 ¿2 ¿C/60 ¿5%RH), an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities
Remedy
936 cartons x 12 x 3 x 10 (in blister pack)
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