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
Reported: February 28, 2024 Initiated: February 6, 2024 #D-0341-2024
Product Description
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.
Details
- Recalling Firm
- Mallinckrodt Hospital Products Inc.
- Units Affected
- 421 vials involved in this recall (2,448 vials distributed)
- Distribution
- USA nationwide
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mallinckrodt Hospital Products Inc.. Units affected: 421 vials involved in this recall (2,448 vials distributed).
Why was this product recalled? ▼
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 28, 2024. Severity: Moderate. Recall number: D-0341-2024.
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