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Terminated

Contact lens solution. The product is distributed under the following trade names: Bausch & Lomb ReNu Multi-Plus Multi-Purpose Solution, Equate Multi-Purpose Solution and Target Brand Multi-Purpose Solution. The product is distributed in up to three sizes: 4 fl.oz., 12 fl. oz. and 16 fl. oz

FDA Recall Z-0715-2007 · Posted 2007-04-04

Recalling FirmBausch & Lomb Inc
Recall StatusTerminated
Product CodeLYL
Date Initiated2007-03-05
Date Terminated2008-01-09
Product Quantity1.5 million units

Reason for Recall

A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color.

Firm Action

The firm issued a press release on 03/05/2006. Consignees were notified on 03/06/2007 via a customized Recall Notification Package via overnight courier with tracking and delivery confirmation capability. Bausch & Lomb Sales Representatives will visit the home offices of the major wholesale and distributors concurrent with the mailing of the notification packages.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Argentina, Brazil, Canada, Chile, Costa Rica, Korea, Mexico, Taiwan and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020802RENUT MULTIPLUS MULLTI-PURPOSE SOLUTIONBausch & Lomb, Incorporated · 2002-05-31

Official Source

View FDA Recall →

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

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