FDARecalled Feb 28, 2024 · #D-0340-2024
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
Hazard
Class II — temporary health risk
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cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified. Classification: Class II Distribution: USA nationwide
Product details
- 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
- Type
- Drugs
- Manufacturer
- Mallinckrodt Hospital Products Inc.
- Model numbers
- 1564-103
- UPCs
- —