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.
What this means for you
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
- Hazard
- temperature-excursion
- drug-stability
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.
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