Terlivaz (terlipressin for injection) recall
FDA recall D-0341-2024 · initiated Feb 6, 2024
Mallinckrodt Hospital Products Inc. recalled Terlivaz (terlipressin for injection) in Feb 2024 — an FDA Class II recall (D-0341-2024) because cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 421 vials involved in this recall (2,448 vials distributed)
Details
- 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
- Recalling company
- Mallinckrodt Hospital Products Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide
- Initiated
- Feb 6, 2024
- FDA report date
- Feb 28, 2024
This recall is linked to a product we cover: Terlivaz →
Frequently asked
- Was Terlivaz (terlipressin for injection) recalled?
- Mallinckrodt Hospital Products Inc. recalled Terlivaz (terlipressin for injection) in Feb 2024 — an FDA Class II recall (D-0341-2024) because cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Terlivaz (terlipressin for injection) recalled?
- Per the FDA enforcement record, the reason for recall D-0341-2024 was: cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
- Is a recalled Terlivaz (terlipressin for injection) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Terlivaz (terlipressin for injection) are affected?
- Distributed: USA nationwide. The recall covers these lots — Lot #: 22TRP01-F2, Exp 6/30/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0341-2024.