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Vitae Enim Vitae Scientific Recalls
4 recalls on record · April 13, 2022 to April 13, 2022 · Drugs
April 13, 2022DrugsFDA
Vitae Enim Vitae Scientific, Inc. recalls PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL
Hazard: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
April 13, 2022DrugsFDA
Vitae Enim Vitae Scientific, Inc. recalls PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL
Hazard: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
April 13, 2022DrugsFDA
Vitae Enim Vitae Scientific, Inc. recalls PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 725
Hazard: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
April 13, 2022DrugsFDA
Vitae Enim Vitae Scientific, Inc. recalls TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufacture
Hazard: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.