Drug 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
D-0341-2024
Product summary
- Event
- Event 93945
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 421 vials involved in this recall (2,448 vials distributed)
- Official record key
drug-enforcement:D-0341-2024
Official wording
Reason: cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Code information: Lot #: 22TRP01-F2, Exp 6/30/2024
Distribution pattern: USA nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations