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
Reported: February 28, 2024 Initiated: February 6, 2024 #D-0340-2024
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
Reason for Recall
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Details
- Recalling Firm
- Mallinckrodt Hospital Products Inc.
- Units Affected
- 8 vials involved in recall (16,479 vials distributed)
- Distribution
- USA nationwide
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mallinckrodt Hospital Products Inc.. Units affected: 8 vials involved in recall (16,479 vials distributed).
Why was this product recalled? ▼
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 28, 2024. Severity: Moderate. Recall number: D-0340-2024.
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