REGULATORY INTELLIGENCE·Recall
FDA Class I Recall: Taro Pharmaceuticals' Phenytoin Oral Suspension Faces Critical Resuspension Failure
Taro Pharmaceuticals U.S.A., Inc. initiated a Class I recall for Phenytoin Oral Suspension USP due to critical resuspension problems, impacting 29,172 bottles nationwide. This event, now terminated, underscores significant quality control risks for procurement and regulatory teams, necessitating rigorous supplier due diligence and robust supply chain resilience strategies for anti-epileptic agents.
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