Vitae Enim Vitae Scientific, Inc. FDA Recalls

4 recalls on file across drugs, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, ManufactureClass IIMar 14, 2022Lack of Assurance of Sterility: deviations from Current Good	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into que	Class IIDrugs	Mar 14, 2022
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 Class IIMar 14, 2022Lack of Assurance of Sterility: deviations from Current Good	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into que	Class IIDrugs	Mar 14, 2022
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 1mLClass IIMar 14, 2022Lack of Assurance of Sterility: deviations from Current Good	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into que	Class IIDrugs	Mar 14, 2022
PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 725Class IIMar 14, 2022Lack of Assurance of Sterility: deviations from Current Good	Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into que	Class IIDrugs	Mar 14, 2022