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.
- Company
- Ferndale Laboratories, Inc.
- Recall Initiated
- July 7, 2010
- Posted
- October 26, 2010
- Terminated
- March 2, 2011
- Recall Number
- Z-0413-2011
- Quantity
- 55,000 bottles
- Firm Location
- Ferndale, MI
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.
Distribution
Nationwide Distribution: Throughout the US.
Lot / Code Info
LOTS: 09216B, 09218A, 09219A, 09231A, 09232A, 10003A, and 10004A.
Root Cause
Other
Action Taken
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.