Vitae Enim Vitae Scientific, Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0741-2022Class IITETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, March 14, 2022
D-0742-2022Class IIPAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use ViMarch 14, 2022
D-0744-2022Class IIPHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-41March 14, 2022
D-0743-2022Class IIPHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-March 14, 2022