Vitae Enim Vitae Scientific, Inc. 2022-04-13 Health serious FDA
Health · FDA · Recall #FDA-D-0743-2022
PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC… Recall
Issued April 13, 2022 · Vitae Enim Vitae Scientific, Inc.
In April 2022, Vitae Enim Vitae Scientific, Inc. recalled the PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC…, 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 PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC… 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-0743-2022
- 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.