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Terminated

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.

FDA Recall Z-0413-2011 · Posted 2010-10-26

Recalling FirmFerndale Laboratories, Inc.
Recall StatusTerminated
Product CodeKOX
Date Initiated2010-07-07
Date Terminated2011-03-02
Product Quantity55,000 bottles

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution: Throughout the US.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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