ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carto
Summary
The FDA issued a Class II for ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, by Wuxi Medical lnstrument Factory Co., Ltd.. Reason: Lack of assurance of sterility and cGMP deviations observed at the manufacturing site..
Details
Source
Drug Recall
External ID
D-0247-2025
Action Date
2025-03-05
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot #s: 200830, Exp 08/29/2025; 210925, Exp 09/24/2026; 221225, Exp 12/24/2027.
Quantity Affected: 37,500 Boxes
Reason for Recall
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Distribution
FL
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-12
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Wuxi Medical lnstrument Factory Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wuxi Medical lnstrument Factory Co., Ltd. have FDA actions?
This is the only FDA action we have on record for Wuxi Medical lnstrument Factory Co., Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0247-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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