Vitae Enim Vitae Scientific recalls phenobarbital sodium injections (130 mg/mL) with potential sterility issues. Products manufactured for Cameron Pharmaceuticals may pose infection risks if used.
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 recalls phenobarbital sodium injections that may not be sterile, risking infections. This is a serious hazard for patients receiving these medications.
The injections were made without proper sterility assurance, which could lead to infections if used. This is a serious hazard for medical treatments where sterility is critical.
Patients prescribed phenobarbital injections by a healthcare provider. Those using the recalled products are at immediate risk of infection.
Check for vials labeled 'PHENOBARBITAL Sodium Injection, USP, 130 mg/mL' in boxes with 25 x 1 mL vials (NDC 42494-416-25) or 3 x 1 mL vials (NDC 42494-416-03). Lot numbers include 20VPSI011 through 22VPSI007.
Immediately discard any recalled phenobarbital injections as they may cause infections.
The product lacks assurance of sterility due to deviations from Current Good Manufacturing Practices.
Phenobarbital sodium injections (130 mg/mL) with NDC codes 42494-416-25 and 42494-416-03, manufactured for Cameron Pharmaceuticals.
Look for vials with lot numbers from 20VPSI011 to 22VPSI007, with expiration dates up to 12/31/2023.
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-0744-2022 — Vitae Enim Vitae Vitae Enim Vitae Hello, I own a Vitae Enim Vitae that is covered by recall D-0744-2022 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.
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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.
