Recalls / Class II
Class IID-0341-2024
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
- Brand name
- Terlivaz
- Generic name
- Terlipressin
- Active ingredient
- Terlipressin
- Route
- Intravenous
- NDC
- 43825-200
- FDA application
- NDA022231
- Affected lot / code info
- Lot #: 22TRP01-F2, Exp 6/30/2024
Why it was recalled
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Recalling firm
- Firm
- Mallinckrodt Hospital Products Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 440 Us Highway 22, Ste 302, Bridgewater, New Jersey 08807-2477
Distribution
- Quantity
- 421 vials involved in this recall (2,448 vials distributed)
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2024-02-06
- FDA classified
- 2024-02-21
- Posted by FDA
- 2024-02-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0341-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.