Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0715-2007

Contact lens solution. The product is distributed under the following trade names: Bausch & Lomb ReNu...

Bausch & Lomb Incorporated / initiated 2007-03-05 / Terminated

Bausch & Lomb Inc began a recall of Contact lens solution. The product is distributed under the following trade names: Bausch & Lomb ReNu Multi-Plus Multi-Purpose Solution, Equate Multi-Purpose... on . The reason FDA records is "A higher than expected amount of trace iron in some bottles of finished product that over time affects the product's stability and color". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0715-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Bausch & Lomb Incorporated
Product
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
Product code
LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
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.
FDA 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 in commerce
1.5 million units
Distribution
Worldwide, including USA, Argentina, Brazil, Canada, Chile, Costa Rica, Korea, Mexico, Taiwan and Venezuela.
Product codes and lots
Lot numbers appearing on the bottles distributed in the U.S.: GC6030, GC6037, GC6045, GC6061, GC6063, GC6072, GC6073 and GC6085. The lots all carry the expiration date ''2008-03'' on the bottle.   Lot numbers appearing on bottles distributed only outside of the U.S.: GC6038, GC6048 and GC6052.