Status
Ongoing
Drug Enforcement D-0247-2025
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
Classification
Class II
Report Date
March 5, 2025
Termination Date
—
Product Information
- 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.
- Product quantity
- 37,500 Boxes
- Reason for recall
- Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- FL
Location & Firm
- Recalling firm
- Wuxi Medical lnstrument Factory Co., Ltd.
- Address
-
D, Zhangjing, No. 43 Xixin Road; Xibeizhen Xishan
China - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0247-2025
- Event ID
- 96210
- Recall initiation date
- February 12, 2025
- Center classification date
- February 21, 2025
- Code info
- Lot #s: 200830, Exp 08/29/2025; 210925, Exp 09/24/2026; 221225, Exp 12/24/2027.
- More code info
- —