February 2025 FDA Recall Drug by Wuxi Medical Lnstrument Factory Co., Ltd.
D-0247-2025 - Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.

This Class II drug recall was voluntarily initiated by Wuxi Medical Lnstrument Factory Co., Ltd. on February 12, 2025 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility and cgmp deviations observed at the manufacturing site.. The product was distributed in FL and the recall is currently ongoing.

Recall Number: D-0247-2025

Reason for Recall
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Initiated
02-12-2025
Reported
03-05-2025
Quantity
37,500 Boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96210
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Wuxi Medical lnstrument Factory Co., Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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