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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93945

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 06, 2024
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Mallinckrodt Hospital Products Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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

D-0340-2024
Recall number
D-0340-2024
Initiated
February 06, 2024
Classification
Class II
Status
Ongoing
Quantity
8 vials involved in recall (16,479 vials distributed)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Code information

Lot #: 1564-103, Exp 9/30/2024

Distribution pattern

USA nationwide

drug · product 2 of 2

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

D-0341-2024
Recall number
D-0341-2024
Initiated
February 06, 2024
Classification
Class II
Status
Ongoing
Quantity
421 vials involved in this recall (2,448 vials distributed)

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Code information

Lot #: 22TRP01-F2, Exp 6/30/2024

Distribution pattern

USA nationwide