← FDA ENFORCEMENT
D-0341-2024Class II

Mallinckrodt Hospital Products Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Mallinckrodt Hospital Products Inc.
Product type
Drug
Status
Ongoing
Report date
2024-02-28
Distribution
USA nationwide
Firm state
NJ
Product quantity
421 vials involved in this recall (2,448 vials distributed)
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →