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
Recalled April 13, 2022 · FDA recall D-0741-2022 · Vitae Enim Vitae Scientific
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. · FDA Class II
Units
722 boxes
Sold at
Nationwide in the U.S.A
Description
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Product
TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10.
Manufacturer(s)
Vitae Enim Vitae Scientific, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →