Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Terlivaz (terlipressin for injection) Recalled by Mallinckrodt Hospital Products Inc. Due to cGMP deviations: Temperature excursion due to shipping delay...

Date: February 6, 2024
Company: Mallinckrodt Hospital Products Inc.
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Mallinckrodt Hospital Products Inc. directly.

Affected Products

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

Quantity: 421 vials involved in this recall (2,448 vials distributed)

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mallinckrodt Hospital Products Inc.

Mallinckrodt Hospital Products Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report