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.
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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