FDA Recalls TERLIVAZ Terlipressin Due to Temperature Excursion During Shipping
Mallinckrodt recalls TERLIVAZ (terlipressin) injection due to temperature excursion during shipping. A cGMP deviation may compromise drug stability.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves a risk-of-harm product (an injectable medication for serious medical conditions) with potential for patient harm that has not yet been reported. Temperature excursion during shipping can compromise pharmaceutical stability and drug efficacy.
Plain-English summary
Mallinckrodt Hospital Products Inc. is recalling TERLIVAZ (terlipressin for injection), 0.85 mg/vial, due to a cGMP deviation caused by temperature excursion during shipping from the manufacturer to the distributor. Lot #22TRP01-F2 (expiration 6/30/2024), involving 421 vials, was distributed nationwide.
Temperature excursions during shipping can affect the stability of injectable medications. Terlipressin is used to treat serious conditions including hepatorenal syndrome and variceal bleeding, where efficacy is critical to patient outcomes.
Healthcare providers who received this lot should contact Mallinckrodt Hospital Products Inc. for guidance on recalled product and appropriate steps to take.
The recalled product
- Product
- TERLIVAZ (TERLIPRESSIN)
- Brand
- TERLIVAZ
- Manufacturer
- Mallinckrodt Hospital Products Inc.
- Category
- Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 22TRP01-F2
- Exp 6/30/2024
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Mallinckrodt Hospital Products Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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