Reported Apr 13, 2022 · Terminated
TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only,…
Vitae Enim Vitae Scientific, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vitae Enim Vitae Scientific, Inc. · 3030 Bunker Hill St Ste 203 · San Diego, CA · 92109-5754
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: 21VTHI01721VTHI01821VTHI019Exp 5/31/2023
- Amount recalled
- 722 boxes
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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