Shire PLC

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0625-2017Class IIKalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington,March 17, 2017
D-0432-2017Class IIIPentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured foDecember 2, 2016
D-0006-2017Class IIIVyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: SSeptember 2, 2016