FDA Drug recall D-0340-2024
Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrod…
- FDA Drug
- Class II
- ongoing
- Published 2024-02-28
On 2024-02-28 the FDA classified a Class II recall of Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrod… by Mallinckrodt Hospital Products, citing cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0340-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-06 |
| Published | 2024-02-28 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mallinckrodt Hospital Products |
| Distribution | US |
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
Reason
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Identifiers
| ndc | 63004-8710-1 |
|---|---|
| ndc | 63004-8710-2 |
| ndc | 63004-8712-1 |
| ndc | 63004-8712-4 |
| ndc | 63004-8711-1 |
| ndc | 63004-8711-4 |
| code_info | Lot #: 1564-103, Exp 9/30/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0340-2024%22
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