# FDA recall D-0340-2024

> **Mallinckrodt Hospital Products Inc.** · Class II · drug recall initiated 2024-02-06.

## 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 for recall

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

## Distribution

USA nationwide

## Key facts

- **Recall number:** D-0340-2024
- **Recalling firm:** Mallinckrodt Hospital Products Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-02-06
- **Report date:** 2024-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bridgewater, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0340-2024

## Citation

> AI Analytics. FDA recall D-0340-2024. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-0340-2024. Source: US FDA. Licensed CC0.

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