FDAHealthFebruary 12, 2025
Wuxi Medical lnstrument Factory Co., Ltd. — ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Med
⚠️ Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Is this relevant to me?
- Geography
- FL
- Source agency
- FDA
- Category
- Health
- Published
- February 12, 2025
FL
What's affected?
- Product
- ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufactured by Wuxi Medical Instrument Factory Co., Ltd., Made in China, Manufactured for: Rece International Corp., Miami Lakes, FL, 33014, USA, NDC: 70006-500-01.
- Lot code
- 200830
Additional details
Lot #s: 200830, Exp 08/29/2025; 210925, Exp 09/24/2026; 221225, Exp 12/24/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 37,500 Boxes.
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