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 & CAPAReason 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
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. 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.