Vitae Enim Vitae Scientific recalls phenobarbital sodium injection (65mg/mL) due to potential sterility issues from manufacturing deviations. Products sold under specific NDC numbers and expiration dates are affected.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Vitae Enim Vitae Scientific has recalled phenobarbital sodium injection products because they may not be sterile. This is a serious risk as sterile medical injections can cause infections if contaminated.
Sterile medical injections must be free from bacteria and other contaminants. If the phenobarbital injection is not sterile, it could cause serious infections or other health complications when administered.
Patients prescribed phenobarbital injections by healthcare providers. Those using the recalled products are at risk of infection due to potential contamination.
Check for NDC numbers 42494-415-25 (25 vials per box) or 42494-415-03 (3 vials per box). Products with specific lot numbers and expiration dates listed in the recall notice are affected.
Immediately stop using any recalled phenobarbital sodium injection products as they may not be sterile and could cause infections.
Phenobarbital Sodium Injection, USP, 65mg/mL.
NDC 42494-415-25 (25 x 1 mL vials per box) and NDC 42494-415-03 (3 x 1 mL vials per box).
Check the NDC number on the product label and compare it to the list of affected NDCs provided in the recall notice.
We’ve drafted a message you can send Vitae Enim Vitae to request your refund or repair — edit it as you like.
Subject: Recall D-0743-2022 — Vitae Enim Vitae Vitae Enim Vitae Hello, I own a Vitae Enim Vitae that is covered by recall D-0743-2022 from Vitae Enim Vitae. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
