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Recall Observatory FDA recall evidence

Drug product

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.

D-0247-2025

February 12, 2025

Class II

Product summary

Firm
Wuxi Medical lnstrument Factory Co., Ltd.
Event
Event 96210
Status
Ongoing
Classification
Class II
Quantity
37,500 Boxes
Official record key
drug-enforcement:D-0247-2025

Official wording

Reason: Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.

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

Distribution pattern: FL

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility