Terlivaz Injection, Powder, Lyophilized, For Solution
FDA Recall NDC 43825-200
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Terlivaz (NDC 43825-200). A significant event, classified as Class II, was initiated on Feb 06, 2024 by Mallinckrodt Hospital Products Inc.. The reported reason for this action was: "cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Feb 06, 2024
Feb 28, 2024
421 vials involved in this recall (2,448 vials distributed)
Recall Profile & Regulatory Data
Event ID
93945
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Mallinckrodt Hospital Products Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide
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
Batch or Lot Expiration Information
Lot# : 22TRP01-F2, Exp 6/30/2024
Affected Packages Involved in this Recall
43825-200-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
