Shire PLC
Shire PLC appears in FDA public data with 3 recalls, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0625-2017, Class II) was initiated on March 17, 2017.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0625-2017 | Class II | Kalbitor (ecallantide), 10mg/mL, packaged in 3 vials per Carton, Rx Only, Dynax Corp., Burlington, | March 17, 2017 |
| D-0432-2017 | Class III | Pentasa (mesalamine) Controlled-Release Capsules, 250 mg, 240 count bottle, Rx only, Manufactured fo | December 2, 2016 |
| D-0006-2017 | Class III | Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: S | September 2, 2016 |