Class II
Ongoing
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
This recall is currently active, issued February 28, 2024. It was issued by Mallinckrodt Hospital Products Inc..
- Recall Initiated
- February 6, 2024
- Posted
- February 28, 2024
- Recall Number
- D-0340-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 8 vials involved in recall (16,479 vials distributed)
- Firm Location
- Bridgewater, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
Distribution
USA nationwide
Lot / Code Info
Lot #: 1564-103, Exp 9/30/2024
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