Class II Recall

Vitae Enim Vitae Scientific, Inc.

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.
Reason
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Classification
Class II
Status
Terminated
Lot
Lot #: 21VTHI017, 21VTHI018, 21VTHI019, Exp 5/31/2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.