Class II
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.
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.