REGULATORY INTELLIGENCE·Recall
FDA Terminates Class II Recall for Calvin Scott & Company's Diethylpropion Due to Repackaging cGMP Failures
Calvin Scott & Company, Inc. faced a Class II FDA recall for Diethylpropion 25 mg tablets, terminated April 22, 2024. The recall stemmed from critical cGMP deviations, specifically repackaging into pouches without supporting stability studies. This event underscores the imperative for robust quality agreements and rigorous oversight of third-party repackaging operations to mitigate supply chain and regulatory risks for procurement and regulatory affairs teams.
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