FDA Recall D-0340-2024

Mallinckrodt Hospital Products Inc. · Bridgewater, NJ

Class II Ongoing 828 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot #: 1564-103, Exp 9/30/2024

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.

Recall record

Recall number: D-0340-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA nationwide
Recall initiated: 2024-02-06
Classified by FDA Center: 2024-02-21
FDA published: 2024-02-28
Recalling firm: Mallinckrodt Hospital Products Inc.
Firm location: Bridgewater, NJ

Drug identification

Brand name(s): ACTHAR
Generic name(s): REPOSITORY CORTICOTROPIN
Manufacturer(s): Mallinckrodt ARD LLC
NDC(s): 63004-8710, 63004-8712, 63004-8711
Route(s): INTRAMUSCULAR, SUBCUTANEOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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