REGULATORY INTELLIGENCE·Recall
Azurity Pharmaceuticals Recalls Eprontia (Topiramate) Oral Solution Over Impurity C Exceedance
Azurity Pharmaceuticals initiated a Class III recall of 2,220 bottles of Eprontia (topiramate) oral solution nationwide due to out-of-specification levels of Impurity C (4,5-desisopropylidene topiramate) found during stability testing. This voluntary action, terminated on April 24, 2024, underscores the critical importance of robust quality control and stability programs for pharmaceutical manufacturers.
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