Terlivaz — Class II drug recall D-0341-2024
Ongoing recall by Mallinckrodt Hospital Products Inc., reported 2024-02-28, distributed nationwide. cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distri
| Recall number | D-0341-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mallinckrodt Hospital Products Inc., Bridgewater, NJ, United States |
| Recall initiated | 2024-02-06 |
| Classified | 2024-02-21 |
| Reported by FDA | 2024-02-28 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, temperature control |
| NDC | 43825-0200, 43825-0200-01 |
| Lot numbers | 22TRP01-F2 |
| Expiration dates | 2024-06-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0341-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.