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Terminated

Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1) Illusion style, Chestnut Brown, Violet and others and 2) 2 Tone style: like Misty Blue among others)Eye contact lens Product Usage - Eye contact lens

FDA Recall Z-0950-2015 · Posted 2015-01-12

Recalling FirmIntertrade Imports Inc.
Recall StatusTerminated
Product CodeLPM
Date Initiated2014-09-10
Date Terminated2019-10-07
Product Quantity750 units

Reason for Recall

A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses. I Color Color Complete brand color contact lenses are unapproved medical devices.

Firm Action

The firm verbally contacted each distributor on September 10, 2014 to notify them about the recall and actions that needs to be taken.

Root Cause

Material/Component Contamination

Distribution Pattern

Worlldwide Distribution - USA including Texas, California, Florida, and St. Lucia, Barbados and St. Marten.

Official Source

View FDA Recall →

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

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