Why it was recalled
cGMP violations noted during the firm's most recent inspection.
Product 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
Lot numbers, UPCs & expiration codes
Lot # 170831, EXP 8/31/2019; 180704, EXP 7/04/2020
Where it was sold
Nationwide in the US
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-0290-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 16, 2018
- FDA report date
- Dec 19, 2018
- Quantity
- 115 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CAO Group, Inc.
Original FDA data
Every field from FDA enforcement report D-0290-2019, exactly as published.
Show all FDA fields
- City
- West Jordan
- State
- UT
- Status
- Terminated
- Country
- United States
- Event ID
- 81556
- Address
- 4628 W Skyhawk Dr
- Code information
- Lot # 170831, EXP 8/31/2019; 180704, EXP 7/04/2020
- Postal code
- 84084-4501
- Report date
- Dec 19, 2018
- Product type
- Drugs
- Recall number
- D-0290-2019
- Classification
- Class II
- Recalling firm
- CAO Group, Inc.
- Product quantity
- 115 kits
- Termination date
- Feb 27, 2020
- Reason for recall
- cGMP violations noted during the firm's most recent inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Nov 16, 2018
- Initial firm notification
- Letter
- Center classification date
- Dec 11, 2018