Class 3 Device Recall Detachol Adhesive Remover

• Date Initiated by Firm: July 07, 2010
• Date Posted: October 26, 2010
• Recall Status: Terminated on March 02, 2011
• Recall Number: Z-0413-2011
• Recall Event ID: 56580
• Product Classification: Solvent, adhesive tape - Product Code KOX
• 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.
• Code Information: LOTS: 09216B, 09218A, 09219A, 09231A, 09232A, 10003A, and 10004A.
• Recalling Firm/ Manufacturer: Ferndale Laboratories, Inc.; 780 W 8 Mile Rd; Ferndale MI 48220
• For Additional Information Contact: 248-548-0900
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.