# FDA recall D-0341-2024

> **Mallinckrodt Hospital Products Inc.** · Class II · drug recall initiated 2024-02-06.

## 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

## Reason for recall

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

## Distribution

USA nationwide

## Key facts

- **Recall number:** D-0341-2024
- **Recalling firm:** Mallinckrodt Hospital Products Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-02-06
- **Report date:** 2024-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bridgewater, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0341-2024

## Citation

> AI Analytics. FDA recall D-0341-2024. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-0341-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*