Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a Ferndale Pharma Group company, Man
FDA device recall Z-0413-2011 · posted 2010-10-26 · Terminated
Recall details
- Recalling firm
- Ferndale Laboratories, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KOX
- Quantity affected
- 55,000 bottles
- Distribution
- Nationwide Distribution: Throughout the US.
- Date initiated
- 2010-07-07
- Date posted
- 2010-10-26
- Date terminated
- 2011-03-02
- Location
- Ferndale, MI
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