ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per B...
FDA Recall #D-0247-2025 — Class II — February 12, 2025
Product Description
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.
Reason for Recall
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Recalling Firm
Wuxi Medical lnstrument Factory Co., Ltd. — Wuxi, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
37,500 Boxes
Distribution
FL
Code Information
Lot #s: 200830, Exp 08/29/2025; 210925, Exp 09/24/2026; 221225, Exp 12/24/2027.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated