US Drug Recall Register
Class II · Moderate risk Ongoing Initiated Feb 6, 2024 (3 years ago)

Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

What was recalled

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

Recalling firm
Mallinckrodt Hospital Products Inc.
NDC code
43825-200-01
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0341-2024

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.