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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0358-2014 | Class II | Terminated | Voluntary: Firm initiated |
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