REGULATORY INTELLIGENCE·Recall
FDA Issues Class I Recall for InvaGen's Vigabatrin Oral Solution Due to Critical Packaging Defect
InvaGen Pharmaceuticals initiated a Class I recall for 1,240 boxes of Vigabatrin for Oral Solution, USP 500 mg, due to defective packaging causing powder leakage. This event, impacting nationwide US distribution, necessitates immediate action from procurement and regulatory teams to ensure patient safety and maintain supply chain integrity for this critical anti-epileptic agent.
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