Multi-event February 2024 FDA Recall Terlivaz by Mallinckrodt Hospital Products Inc.
This Multi-event Class II drug recall was voluntarily initiated by Mallinckrodt Hospital Products Inc. on February 6, 2024 for the product Terlivaz. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0340-2024
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
02-06-2024
02-28-2024
8 vials involved in recall (16,479 vials distributed)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Mallinckrodt Hospital Products Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1
Batch or Lot Expiration Information
Lot# : 1564-103, Exp 9/30/2024
Affected Packages Involved in this Recall
Recall Number: D-0341-2024
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
02-06-2024
02-28-2024
421 vials involved in this recall (2,448 vials distributed)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Mallinckrodt Hospital Products Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 22TRP01-F2, Exp 6/30/2024
