D-0247-2025 Class II Ongoing
FDA drug recall D-0247-2025 was initiated by Wuxi Medical Lnstrument Factory Co., Ltd. on Feb 12, 2025 and is designated Class II. Reason for recall: Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. The recall status is ongoing. Affected quantity: 37,500 Boxes.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 5, 2025
- Initiation Date
- Feb 12, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37,500 Boxes
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.
Reason for recall
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Distribution pattern
FL
Code information
Lot #s: 200830, Exp 08/29/2025; 210925, Exp 09/24/2026; 221225, Exp 12/24/2027.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0247-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026