PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: March 5, 2025 Initiated: February 12, 2025 #D-0247-2025

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.

Details

Units Affected
37,500 Boxes
Distribution
FL
Location
Wuxi, N/A

Frequently Asked Questions

What product was recalled?
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.. Recalled by Wuxi Medical lnstrument Factory Co., Ltd.. Units affected: 37,500 Boxes.
Why was this product recalled?
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 5, 2025. Severity: Moderate. Recall number: D-0247-2025.