FDA-Drug2025-03-05Class 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.
Wuxi Medical lnstrument Factory Co., Ltd.
Hazard
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Sold states
FL
Affected count
37,500 Boxes
Manufactured in
D, Zhangjing, No. 43 Xixin Road; Xibeizhen Xishan, Wuxi, N/A, China
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0247-2025Don't want to check this manually?
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