fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 170831, EXP 8/31/2019; 180704, EXP 7/04/2020
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- CAO Group, Inc.
- Reason for Recall:
- cGMP violations noted during the firm's most recent inspection.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105
Product Codes/Lot Numbers:
Lot # 170831, EXP 8/31/2019; 180704, EXP 7/04/2020
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0290-2019
Related Recalls
cGMP violations noted during the firm's most recent inspection.
cGMP violations noted during the firm's most recent inspection.
cGMP violations noted during the firm's most recent inspection.