REGULATORY INTELLIGENCE·Recall
FDA Class I Recall: Par Sterile Products' Treprostinil Injection Impacted by Particulate Matter
Par Sterile Products LLC has initiated a Class I recall for 466 vials of Treprostinil Injection (Lot#: 57014) due to particulate matter, impacting nationwide U.S. distribution. This high-severity event demands immediate attention from procurement and regulatory teams to assess supply chain integrity and patient safety risks associated with this critical cardiovascular drug. Decision-makers must evaluate current inventory and potential sourcing disruptions.
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