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)