Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0358-2014Class II

Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm...

Wexford Labs Inc / initiated 2013-09-10 / Terminated / root cause: manufacturing process

Wexford Labs Inc began a recall of 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... on . FDA classified it as Class II and gives the reason as "Expired active ingredient was used in the manufacture of the product". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0358-2014
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Wexford Labs Inc
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.
Product code
LRJ Disinfectant, Medical Devices
Reason for recall
Expired active ingredient was used in the manufacture of the product.
Root cause tag
manufacturing process
FDA 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 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.
Product codes and lots
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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0358-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0358-2014Class IITerminatedVoluntary: Firm initiated