D-0247-2025 Class II Ongoing

Recalled by Wuxi Medical lnstrument Factory Co., Ltd. — Wuxi, N/A

Recall Details

Product Type
Drugs
Report Date
March 5, 2025
Initiation Date
February 12, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
37,500 Boxes

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.

Distribution Pattern

FL

Code Information

Lot #s: 200830, Exp 08/29/2025; 210925, Exp 09/24/2026; 221225, Exp 12/24/2027.