Drug recall D-0341-2024

Class II Ongoing reported Feb 28, 2024

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

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
Mallinckrodt Hospital Products Inc., Bridgewater, NJ
Quantity
421 vials involved in this recall (2,448 vials distributed)
Distribution
USA nationwide
Type
Voluntary: Firm initiated
Recall initiated
February 6, 2024

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