Jubilant Draximage Inc

FDA Regulatory Profile

Jubilant Draximage Inc 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-1189-2022, Class II) was initiated on June 16, 2022.

Summary

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

Recent Recalls

NumberClassProductDate
D-1189-2022Class IIDraximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 June 16, 2022
D-1062-2020Class IIDRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION), 20 mg vial, Rx onMarch 19, 2020
D-0812-2016Class IIISODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc.March 11, 2016