Z-0413-2011

Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a Ferndale Pharma Group...

Name: Z-0413-2011 Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a Ferndale Pharma Group...
Creator: Ferndale Laboratories, Inc.
Published: 2010-07-07
License: https://open.fda.gov/license/

Ferndale Laboratories, Inc. / initiated 2010-07-07 / Terminated

FDA source

Ferndale Laboratories, Inc. began a recall of Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a Ferndale Pharma Group company, Manufactured by Ferndale Laboratories... on 2010-07-07. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0413-2011
Status: Terminated
Initiated: 2010-07-07
Posted: 2010-10-26
Terminated: 2011-03-02
Recalling firm: Ferndale Laboratories, Inc.
Product: 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.
Product code: KOX Solvent, Adhesive Tape
Reason for recall: 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.
FDA 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 in commerce: 55,000 bottles
Distribution: Nationwide Distribution: Throughout the US.
Product codes and lots: LOTS: 09216B, 09218A, 09219A, 09231A, 09232A, 10003A, and 10004A.

Product code KOX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)