Home / Recalls / Mallinckrodt Hospital Products Inc. / D-0341-2024

D-0341-2024 Class II Ongoing

Recalled by Mallinckrodt Hospital Products Inc. — Bridgewater, NJ

Recall Details

Product Type: Drugs
Report Date: February 28, 2024
Initiation Date: February 6, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 421 vials involved in this recall (2,448 vials distributed)

Product Description

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

Reason for Recall

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

Distribution Pattern

USA nationwide

Code Information

Lot #: 22TRP01-F2, Exp 6/30/2024