Class IIOngoing

Terlivaz (terlipressin for injection) recall

FDA recall D-0341-2024 · initiated Feb 6, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

Product: 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 company: Mallinckrodt Hospital Products Inc.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: USA nationwide
Initiated: Feb 6, 2024
FDA report date: Feb 28, 2024

This recall is linked to a product we cover: Terlivaz →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0341-2024 ↗

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