FDA-Drug2022-04-13Class II
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.
Vitae Enim Vitae Scientific, Inc.
Hazard
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Sold states
Nationwide in the U.S.A
Affected count
722 boxes
Manufactured in
3030 Bunker Hill St Ste 203, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0741-2022Don't want to check this manually?
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