Recall Z-0413-2011 ยท KOX Solvent, Adhesive Tape
Ferndale Laboratories, Inc.
Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a Ferndale Pharma Group company, Manufactured by Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A.
| Date | Oct 26, 2010 (initiated Jul 7, 2010) |
| Status | Terminated |
| Reason | There is a defect on the neck surface of the bottles, causing bottles to leak. Bottle defect may potentially cause contamination of solvent stored in bottles. |
| Root cause | Other |
| Action | Ferndale Pharma Group issued an Urgent Medical Device Recall letter dated July 7, 2010 to customers identifying the affected product. Customers were instructed to identify and quarantine all affected product and return it to Ferndale Laboratories for a credit. Customers are requested to complete and return an enclosed response form. Customers can contact Ferndale at 800-621-6003. |
| Quantity | 55,000 bottles |
| Distribution | Nationwide Distribution: Throughout the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.