ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Sterile, 100 pieces per Box, 100 boxes per Carton, Sterile, Manufac…
Wuxi Medical lnstrument Factory Co., Ltd. · Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
- Status
- Ongoing
- City
- Wuxi
- State
- N/A
- Country
- China
- Classification
- Class II
- Product type
- Drugs
- Event ID
- 96210
- Recalling firm
- Wuxi Medical lnstrument Factory Co., Ltd.
- Address 1
- D, Zhangjing
- Address 2
- No. 43 Xixin Road; Xibeizhen Xishan
- Postal code
- N/A
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Letter
- Distribution pattern
- FL
- Recall number
- D-0247-2025
- Product quantity
- 37,500 Boxes
- Reason for recall
- Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
- Recall initiation date
- 20250212
- Center classification date
- 20250221
- Report date
- 20250305
- Code info
- Lot #s: 200830, Exp 08/29/2025; 210925, Exp 09/24/2026; 221225, Exp 12/24/2027.
- 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.