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Terminated

Counterfeit contact lenses labeled as: 'CooperVision Proclear compatibles (omafilcon A)'. Labeling on outer box reads in part: 'CooperVision proclear compatibles (omafilcon A) ***Norfolk, VA *** MADE IN USA ** Tinted soft contact lenses *** in a buffered 0.9% saline solution***''.

FDA Recall Z-0164-05 · Posted 2004-11-03

Recalling Firm1-800 Contacts Inc.
Recall StatusTerminated
Product CodeMVN
Date Initiated2004-10-13
Date Terminated2005-02-25
Product Quantity82,268

Reason for Recall

Identified lots of Proclear Compatible contact lenses are counterfeit and may not be sterile.

Firm Action

Identified lots of CooperVision Proclear Compatibles contact lenses are counterfeit and non-sterile.

Root Cause

Other

Distribution Pattern

Product distributed to customers nationwide and internationally. Product distributed in US and to Canada, England, New Zealand, New Foundland, British columbia,Guam, Egypt, Greece, Japan, Ireland and Autralia.

Official Source

View FDA Recall →

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

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