Mallinckrodt Hospital Products Inc.: Drug Recall

Recall #D-0341-2024 · 02/06/2024

Class II: Risk

Recall Details

Recall Number: D-0341-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Mallinckrodt Hospital Products Inc.
Status: Ongoing
Date Initiated: 02/06/2024
Location: Bridgewater, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 421 vials involved in this recall (2,448 vials distributed)

Reason for Recall

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

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

Distribution Pattern

USA nationwide

Other Recalls by Mallinckrodt Hospital Products Inc.

Class II: Risk 02/06/2024

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

View all recalls by Mallinckrodt Hospital Products Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.