Why it was recalled
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
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
Lot numbers, UPCs & expiration codes
Lot #: 1564-103, Exp 9/30/2024
Where it was sold
USA nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0340-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 6, 2024
- FDA report date
- Feb 28, 2024
- Quantity
- 8 vials involved in recall (16,479 vials distributed)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mallinckrodt Hospital Products Inc.
Original FDA data
Every field from FDA enforcement report D-0340-2024, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 93945
- Address
- 440 Us Highway 22
- Address (line 2)
- Ste 302
- Code information
- Lot #: 1564-103, Exp 9/30/2024
- Postal code
- 08807-2477
- Report date
- Feb 28, 2024
- Product type
- Drugs
- Recall number
- D-0340-2024
- Classification
- Class II
- Recalling firm
- Mallinckrodt Hospital Products Inc.
- Product quantity
- 8 vials involved in recall (16,479 vials distributed)
- Reason for recall
- cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA nationwide
- Recall initiation date
- Feb 6, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 21, 2024