On February 6, 2024, Mallinckrodt Hospital Products Inc. initiated a Class II recall of Terlivaz, the injectable form of terlipressin. The recall covers the 0.85mg per vial, single-dose vial product, distributed under NDC 43825-200-01.
The stated reason for the recall is a current good manufacturing practice (cGMP) deviation. Specifically, a temperature excursion occurred due to a shipping delay between the manufacturer and the distributor. According to the event record, the affected distributor has been notified.
The recall is classified as Class II. The status of the action is listed as ongoing as of the reported date. No additional details about the scope of affected lots or further distribution were included in this record.
This recall pertains to a manufacturing and distribution issue rather than a change in the approved use of terlipressin. The event data does not include any statement regarding harm, adverse events, or safety findings tied to this recall.
For background on terlipressin, its approved status, and general context, readers can consult the compound overview.