GUERBET LLC

FDA Regulatory Profile

GUERBET LLC appears in FDA public data with 2 recalls, 0 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0138-2020, Class III) was initiated on September 13, 2019.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0138-2020Class IIISodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power InjSeptember 13, 2019
D-0137-2020Class IIOptiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL UltSeptember 13, 2019