FDAClass IIApril 13, 2022

TETRACAINE 1% Tetracaine HCI Injection recall: Sterility Concern

TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals…

Why was TETRACAINE 1% Tetracaine HCI Injection recalled?

Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 21VTHI017, 21VTHI018, 21VTHI019, Exp 5/31/2023

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…
Recalling firm
Vitae Enim Vitae Scientific, Inc.
Quantity
722 boxes
Distribution
Nationwide in the U.S.A
Recall date
April 13, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls