Vitae Enim Vitae Scientific, Inc. 2022-04-13 Health serious FDA
Health · FDA · Recall #FDA-D-0741-2022
TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use… Recall
Issued April 13, 2022 · Vitae Enim Vitae Scientific, Inc.
In April 2022, Vitae Enim Vitae Scientific, Inc. recalled the TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Vitae Enim Vitae Scientific, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Vitae Enim Vitae Scientific, Inc.
- Category
- Health
- Recall date
- April 13, 2022
- Units affected
- Not reported
- Sold at
- Nationwide in the U.S.A
- Recall number
- FDA-D-0741-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Vitae Enim Vitae Scientific, Inc. has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.