REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: CareFusion 213 LLC's BD PurPrep Antiseptic Faces Sterility Assurance Deficiencies
CareFusion 213 LLC has initiated a Class II recall for specific lots of its BD PurPrep Povidone-iodine and Isopropyl Alcohol Sterile Solution due to a lack of sterility assurance. This voluntary action, impacting nationwide distribution, poses significant supply chain and patient safety risks for healthcare providers relying on this critical antiseptic. Procurement and regulatory teams must assess immediate inventory and sourcing strategies.
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