Vitae Enim Vitae Scientific, Inc.: Drug Recall

Recall #D-0741-2022 · 03/14/2022

Class II: Risk

Recall Details

Recall Number
D-0741-2022
Classification
Class II
Product Type
Drug
Recalling Firm
Vitae Enim Vitae Scientific, Inc.
Status
Terminated
Date Initiated
03/14/2022
Location
San Diego, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
722 boxes

Reason for Recall

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 Description

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.

Distribution Pattern

Nationwide in the U.S.A

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.