Recall Z-0715-2007 ยท LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Bausch & Lomb Inc
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
| Date | Apr 4, 2007 (initiated Mar 5, 2007) |
| Status | Terminated |
| Reason | A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color. |
| Root cause | Other |
| 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. |
| Quantity | 1.5 million units |
| Distribution | Worldwide, including USA, Argentina, Brazil, Canada, Chile, Costa Rica, Korea, Mexico, Taiwan and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020802 | RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION Bausch & Lomb, Incorporated, May 31, 2002 |