fas.TRACT Coagulative Hemostatic Gel recall: CGMP Deviations
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
Why was fas.TRACT Coagulative Hemostatic Gel recalled?
cGMP violations noted during the firm's most recent inspection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 170831, EXP 8/31/2019; 180704, EXP 7/04/2020
- Product
- 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
- Recalling firm
- CAO Group, Inc.
- Quantity
- 115 kits
- Distribution
- Nationwide in the US
- Recall date
- December 19, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)