FastStat Topical Hemostat Introductory Kit recall: CGMP Deviations
FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk Drive West…
Why was FastStat Topical Hemostat Introductory Kit 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 #: 170626, EXP 6/26/2019; 171214, EXP 1214/2019.
- Product
- FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk Drive West…
- Recalling firm
- CAO Group, Inc.
- Quantity
- 602 cartons
- Distribution
- Nationwide in the US
- Recall date
- December 19, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)