REGULATORY INTELLIGENCE·Product Recall
FDA Class III Recall: Par Pharmaceutical's Prednisone Labeling Error Impacts Nationwide Supply
Par Pharmaceutical Inc. initiated a nationwide Class III recall of 13,008 bottles of Prednisone Tablets, USP 5 mg, due to an incorrect expiration date. This voluntary action, terminated in April 2021, highlights critical labeling quality control gaps. Procurement and regulatory teams must scrutinize supplier quality systems, especially for high-volume generic corticosteroids like Prednisone, to mitigate supply chain disruption and compliance risks.
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