Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01

Recall Insight

This FDA Drug action (record #D-0341-2024) was formally reported on February 28, 2024, with the manufacturer initiating the action on February 6, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Mallinckrodt Hospital Products Inc. is listed as the recalling firm, operating out of Bridgewater, NJ. Federal records indicate 421 vials involved in this recall (2,448 vials distributed) units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified. Distribution data in the federal record shows the product reached: USA nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 5 were also issued by FDA Drug. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.