Wed Mar 05 2025
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
---|---|---|---|
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. | Rece International Corp | FL | 37,500 Boxes |