FDA-Drug2024-02-28Class II
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
Mallinckrodt Hospital Products Inc.
Hazard
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Sold states
USA nationwide
Affected count
421 vials involved in this recall (2,448 vials distributed)
Manufactured in
440 Us Highway 22, Ste 302, Bridgewater, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0341-2024Don't want to check this manually?
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