D-0293-2019 Class II Terminated
FDA drug recall D-0293-2019 was initiated by CAO Group, Inc. on November 16, 2018 and is designated Class II. Reason for recall: cGMP violations noted during the firm's most recent inspection. The recall status is terminated (terminated February 27, 2020). Affected quantity: 602 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- December 19, 2018
- Initiation Date
- November 16, 2018
- Termination Date
- February 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 602 cartons
Product Description
FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. NDC 1406001003
Reason for Recall
cGMP violations noted during the firm's most recent inspection.
Distribution Pattern
Nationwide in the US
Code Information
Lot #: 170626, EXP 6/26/2019; 171214, EXP 1214/2019.