Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PHENOBARBITAL Sodium Injection Recalled by Vitae Enim Vitae Scientific, Inc. Due to Lack of Assurance of Sterility: deviations from Current...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Vitae Enim Vitae Scientific, Inc. directly.
Affected Products
PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (NDC 42494-415-03), Rx only, Manufactured for Cameron Pharmaceuticals, LLC.
Quantity: a) 21,501 boxes; b) 4,846 boxes
Why Was This Recalled?
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Vitae Enim Vitae Scientific, Inc.
Vitae Enim Vitae Scientific, Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report