Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1256-03

DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/MTD Product Code 60925

Drug Free Enterprises / initiated 2003-03-20 / Terminated / root cause: labeling and UDI

Drug Free Enterprises Inc began a recall of DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/MTD Product Code 60925 on . The reason FDA records is "Label lacks professional use legend and name and address of the manufacturer". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1256-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Drug Free Enterprises
Product
DrugCheck 9 Test Cup AMP/COC/OPI/THC/MET/BZD/BAR/PCP/MTD Product Code 60925
Product code
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Reason for recall
Label lacks professional use legend and name and address of the manufacturer.
Root cause tag
labeling and UDI
FDA root cause
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
Product codes and lots
All