Recalls / Class II
Class IID-0340-2024
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
- Brand name
- Acthar
- Generic name
- Repository Corticotropin
- Active ingredient
- Corticotropin
- Route
- Intramuscular, Subcutaneous
- NDCs
- 63004-8710, 63004-8712, 63004-8711
- FDA application
- NDA008372
- Affected lot / code info
- Lot #: 1564-103, Exp 9/30/2024
Why it was recalled
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Recalling firm
- Firm
- Mallinckrodt Hospital Products Inc.
- Manufacturer
- Mallinckrodt ARD LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 440 Us Highway 22, Ste 302, Bridgewater, New Jersey 08807-2477
Distribution
- Quantity
- 8 vials involved in recall (16,479 vials distributed)
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2024-02-06
- FDA classified
- 2024-02-21
- Posted by FDA
- 2024-02-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0340-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.