Why it was recalled
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
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.
Lot numbers, UPCs & expiration codes
Lot #s: 200830, Exp 08/29/2025; 210925, Exp 09/24/2026; 221225, Exp 12/24/2027.
Where it was sold
FL
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0247-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 12, 2025
- FDA report date
- Mar 5, 2025
- Quantity
- 37,500 Boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wuxi Medical lnstrument Factory Co., Ltd.
Original FDA data
Every field from FDA enforcement report D-0247-2025, exactly as published.
Show all FDA fields
- City
- Wuxi
- Status
- Ongoing
- Country
- China
- Event ID
- 96210
- Address
- D, Zhangjing
- Address (line 2)
- No. 43 Xixin Road; Xibeizhen Xishan
- Code information
- Lot #s: 200830, Exp 08/29/2025; 210925, Exp 09/24/2026; 221225, Exp 12/24/2027.
- Report date
- Mar 5, 2025
- Product type
- Drugs
- Recall number
- D-0247-2025
- Classification
- Class II
- Recalling firm
- Wuxi Medical lnstrument Factory Co., Ltd.
- Product quantity
- 37,500 Boxes
- Reason for recall
- Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- FL
- Recall initiation date
- Feb 12, 2025
- Initial firm notification
- Letter
- Center classification date
- Feb 21, 2025