Terlivaz recalled over manufacturing violations
- Recall date
- February 6, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Mallinckrodt Hospital Products Inc. recalls Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Pr…
- Recall number
- D-0341-2024
- FDA classification
- Class II
- Brand / firm
- Mallinckrodt Hospital Products Inc.
- Sold / distributed
- USA nationwide
Why it was recalled
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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