Drug Enforcement D-0340-2024

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Status

Ongoing

Classification

Class II

Report Date

February 28, 2024

Termination Date

—

Product Information

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
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA nationwide

Location & Firm

Recalling firm
Mallinckrodt Hospital Products Inc.
Address
440 Us Highway 22, Ste 302

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0340-2024
Event ID
93945
Recall initiation date
February 6, 2024
Center classification date
February 21, 2024
Code info
Lot #: 1564-103, Exp 9/30/2024
More code info
—