Recall Z-0358-2014 ยท LRJ Disinfectant, Medical Devices
Wexford Labs Inc
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.
| Date | Nov 19, 2013 (initiated Sep 10, 2013) |
| Status | Terminated |
| Reason | Expired active ingredient was used in the manufacture of the product. |
| Root cause | Nonconforming Material/Component |
| Action | Wexford Labs, Inc. sent undated letters by e-mail to affected customers beginning September 10, 2013, and follow-up phone calls were initiated requesting return of the affected product. E-mail letters dated September 26, 2013, were issued requesting return of product and asking the customers to notify their downstream customers. Customers with questions were instructed to call 800-506-1146. For questions regarding this recall call 314-966-4134, |
| Quantity | 7,020/1-qt. bottles (1755 gallons) |
| Distribution | Nationwide Distribution - USA including FL, SC, TX, MO, CA, OH, OK, MA, IN, and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.