ESTRADIOL

FDA Class II Recall: Teva's Estradiol Tablets Impacted by Cardinal Health's CGMP Storage Deviations

Cardinal Health initiated a Class II recall for Teva Pharmaceuticals' Estradiol Tablets (ANDA040197) due to critical CGMP deviations involving temperature excursions. This event, impacting nationwide USA distribution, underscores significant supply chain vulnerabilities for essential hormone therapies. Procurement directors must diversify Estradiol sourcing, while regulatory affairs heads must strengthen temperature control protocols to mitigate risks and ensure compliance, safeguarding patient access and business continuity.