TETRACAINE 1% Tetracaine HCI Injection recalled over sterility concerns
- Recall date
- March 14, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- 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, Manufactur…
- Recall number
- D-0741-2022
- FDA classification
- Class II
- Brand / firm
- Vitae Enim Vitae Scientific, Inc.
- Sold / distributed
- Nationwide in the U.S.A
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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