FDAFDA · Food and drugs·Recall number 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
Published February 28, 2024 · Recall initiated: February 6, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ACTHAR
- Manufacturer
- Mallinckrodt Hospital Products Inc.
- Distributor
- USA nationwide
- UPC
- 0363004871213
- Lot
- Lot #: 1564-103, Exp 9/30/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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