REGULATORY INTELLIGENCE·Recall
Mallinckrodt's Terlivaz (Terlipressin) Faces Class II FDA Recall Over Shipping Temperature Excursion
Mallinckrodt Hospital Products Inc. has initiated a Class II FDA recall for 421 vials of Terlivaz (terlipressin for injection) distributed nationwide. This action, D-0341-2024, stems from cGMP deviations, specifically a temperature excursion during shipping from the manufacturer to the distributor. Procurement and regulatory teams must assess immediate supply chain impacts for this critical vasopressin receptor agonist.
90-Day Activity