Mallinckrodt Hospital Products Inc.

FDA Regulatory Profile

Mallinckrodt Hospital Products Inc. appears in FDA public data with 2 recalls, 0 510(k) clearances, 7 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0340-2024, Class II) was initiated on February 6, 2024.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
7
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0340-2024Class IIActhar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-doFebruary 6, 2024
D-0341-2024Class IITerlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: MalliFebruary 6, 2024