Reported Apr 13, 2022 · Terminated
PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC…
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?
- PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc.
- Lot codes and dates
Lot #: a) 20VPHI03720VPHI03820VPHI039Exp 12/31/202221VPHI02121VPHI02221VPHI023Exp 6/30/202321VPHI04721VPHI048Exp 10/31/2023b) 21VPHI023Exp 6/30/2023
- Amount recalled
- a) 2,098 boxes; b) 700 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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