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U.S. Department of Health and Human Services

Class 2 Device Recall Ready To Use ThymoCide

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 Class 2 Recall
Ready To Use ThymoCide
see related information
Date Posted November 19, 2013
Recall Status1 Terminated on April 23, 2014
Recall Number Z-0358-2014
Recall Event ID 66391
Product Classification Disinfectant, Medical Devices - Product Code LRJ
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Wexford Labs Inc
325 Leffingwell Ave
Kirkwood, Missouri 63122-6409
For Additional Information Contact Mary Anne Auer
314-966-4134
Manufacturer Reason
for Recall
Expired active ingredient was used in the manufacture of the product.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 in Commerce 7,020/1-qt. bottles (1755 gallons)
Distribution Nationwide Distribution - USA including FL, SC, TX, MO, CA, OH, OK, MA, IN, and GA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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