REGULATORY INTELLIGENCE·Recall
Mylan Pharmaceuticals' Sotalol HCL Recall: Metal Particulate Contamination Impacts US Supply
Mylan Pharmaceuticals initiated a Class II recall for Sotalol HCL Tablets (80 mg) due to metal particulate contamination from its Morgantown, WV facility. This event, impacting 300 bottles nationwide, underscores critical quality control vulnerabilities. Procurement and supply chain leaders must reassess supplier qualification and risk mitigation strategies for essential cardiovascular drugs.
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