FDA Enforcement
Class II
Terminated
Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.
Recall: Z-0358-2014
·
Reported November 27, 2013
Enforcement
- Recall Number
- Z-0358-2014
- Event ID
- 66391
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Wexford Labs Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 27, 2013
- Initiation Date
- September 10, 2013
- Classification Date
- November 19, 2013
- Termination Date
- April 23, 2014
- Address
- 325 Leffingwell Ave, Kirkwood, MO, 63122-6409, United States
Description
Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.
Reason
Expired active ingredient was used in the manufacture of the product.
Code Info
Lot numbers 091721, exp. 10/13; 101521, exp. 11/13; 0109131, exp. 2/14; 0215131, exp. 3/14; 0320131, exp. 4/14; 0415132, exp. 5/14; 0516131, exp. 6/14; and 0624131, 7/14.
Distribution
Nationwide Distribution - USA including FL, SC, TX, MO, CA, OH, OK, MA, IN, and GA.
Quantity
7,020/1-qt. bottles (1755 gallons)