Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mf
Summary
The FDA issued a Class II for Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/ by Mallinckrodt Hospital Products Inc.. Reason: cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified..
Details
Source
Drug Recall
External ID
D-0340-2024
Action Date
2024-02-28
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: 1564-103, Exp 9/30/2024
Quantity Affected: 8 vials involved in recall (16,479 vials distributed)
Reason for Recall
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Distribution
USA nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-06
Company
Bridgewater, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 41 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Mallinckrodt Hospital Products Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mallinckrodt Hospital Products Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mallinckrodt Hospital Products Inc. have FDA actions?
Mallinckrodt Hospital Products Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0340-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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