Terlivaz recall: CGMP Deviations
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
Why was Terlivaz recalled?
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 22TRP01-F2, Exp 6/30/2024
- 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
- Recalling firm
- Mallinckrodt Hospital Products Inc.
- Quantity
- 421 vials involved in this recall (2,448 vials distributed)
- Distribution
- USA nationwide
- Recall date
- February 28, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)