Vitae Enim Vitae Scientific recalls
FDA enforcement reports naming Vitae Enim Vitae Scientific, Inc. as the recalling firm.
- Recall reports
- 4
- Class I (serious)
- 0
- Most recent report
- Apr 13, 2022
- Apr 13, 2022TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vi…Drug · Vitae Enim Vitae Scientific, Inc.Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.Class II
- Apr 13, 2022PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL…Drug · Vitae Enim Vitae Scientific, Inc.Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.Class II
- Apr 13, 2022PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (N…Drug · Vitae Enim Vitae Scientific, Inc.Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.Class II
- Apr 13, 2022PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box…Drug · Vitae Enim Vitae Scientific, Inc.Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.Class II