Reported Apr 13, 2022 · Terminated
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…
Vitae Enim Vitae Scientific, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vitae Enim Vitae Scientific, Inc. · 3030 Bunker Hill St Ste 203 · San Diego, CA · 92109-5754
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: a) 20VPSI007Exp 3/31/202220VPSI015Exp 5/30/202220VPSI018Exp 6/1/202220VPSI032Exp 11/30/202221VPSI00221VPSI003Exp 1/31/202321VPSI006Exp 3/31/202321VPSI01221VPSI020Exp 5/31/202321VPSI035Exp 7/31/202321VPSI03721VPSI038Exp 8/31/202321VPSI04321VPSI044Exp 10/31/202321VPSI05021VPSI051Exp 11/30/202322VPSI004Exp 7/31/202422VPSI006Exp 8/31/2024b) 20VPSI008Exp 3/31/202220VPSI019Exp 6/30/202221VPSI050Exp 11/30/2023
- Amount recalled
- a) 21,501 boxes; b) 4,846 boxes
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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