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Terminated

DrugCheck 5, in-vitro diagnostic test for drugs of abuse: AMP, COC, THC, OPI, MET.

FDA Recall Z-0239-04 · Posted 2003-12-18

Recall StatusTerminated
Product CodeDIO
Date Initiated2003-03-20
Date Terminated2003-12-17
Product Quantity2800 units

Reason for Recall

Lacks professional use labeling and firm name and address.

Firm Action

Firm sent letters and stickers to customers in April 2003 asking them to overlabel existing stocks and to tell the firm how many were overlabeled. Recall is complete.

Root Cause

Other

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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