Date Initiated by Firm |
March 20, 2003 |
Date Posted |
September 23, 2003 |
Recall Status1 |
Terminated 3 on September 22, 2003 |
Recall Number |
Z-1253-03 |
Recall Event ID |
27074 |
Product Classification |
Enzyme Immunoassay, Cocaine And Cocaine Metabolites - Product Code DIO
|
Product |
DrugCheck 8 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP
Product Code 60800 |
Code Information |
All |
Recalling Firm/ Manufacturer |
Drug Free Enterprises Inc 5302 Derry Ave., Ste A Agoura Hills CA 91301
|
Manufacturer Reason for Recall |
Label lacks professional use legend and name and address of the manufacturer.
|
FDA Determined Cause 2 |
Other |
Action |
The firm sent a letter to customers requesting that they overlabel their stock on 3/20/2003. This recall is complete. |
Quantity in Commerce |
Undetermined. |
Distribution |
Nationwide |
Total Product Life Cycle |
TPLC Device Report
|
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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.
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