MALLINCKRODT PHARMACEUTICALS

FDA Regulatory Profile

MALLINCKRODT PHARMACEUTICALS appears in FDA public data with 2 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-1295-2019, Class II) was initiated on May 13, 2019.

Summary

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

Recent Recalls

NumberClassProductDate
D-1295-2019Class IIAmitiza (lubiprostone) capsules, 24 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma AMay 13, 2019
D-1294-2019Class IIAmitiza (lubiprostone) capsules, 8 mcg, 60-count bottle, Rx only, Manufactured by: Sucampo Pharma AmMay 13, 2019