FDA Drug recall D-0247-2025
ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufac…
- FDA Drug
- Class II
- ongoing
- Published 2025-03-05
On 2025-03-05 the FDA classified a Class II recall of ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufac… by Wuxi Medical Lnstrument Factory, citing lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0247-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-12 |
| Published | 2025-03-05 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Wuxi Medical Lnstrument Factory |
| Distribution | FL |
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.
Reason
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Identifiers
| code_info | Lot #s: 200830, Exp 08/29/2025; 210925, Exp 09/24/2026; 221225, Exp 12/24/2027. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0247-2025%22
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