ViaMed Alcohol Prep Pads recall
FDA recall D-0247-2025 · initiated Feb 12, 2025
Wuxi Medical lnstrument Factory Co., Ltd. recalled ViaMed Alcohol Prep Pads in Feb 2025 — an FDA Class II recall (D-0247-2025) because Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 37,500 Boxes
Details
- 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.
- Recalling company
- Wuxi Medical lnstrument Factory Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- FL
- Initiated
- Feb 12, 2025
- FDA report date
- Mar 5, 2025
Frequently asked
- Was ViaMed Alcohol Prep Pads recalled?
- Wuxi Medical lnstrument Factory Co., Ltd. recalled ViaMed Alcohol Prep Pads in Feb 2025 — an FDA Class II recall (D-0247-2025) because Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was ViaMed Alcohol Prep Pads recalled?
- Per the FDA enforcement record, the reason for recall D-0247-2025 was: Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
- Is a recalled ViaMed Alcohol Prep Pads dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of ViaMed Alcohol Prep Pads are affected?
- Distributed: FL. The recall covers these lots — Lot #s: 200830, Exp 08/29/2025; 210925, Exp 09/24/2026; 221225, Exp 12/24/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0247-2025.