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SafetyAlerts
January 2, 2001

Collyrium Eye Wash Recalled by Bausch & Lomb

Rochester, NY (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Bausch & Lomb, Inc. is recalling certain lots of its Collyrium Eye Wash, (Boric Acid) because of phenol contamination (labeling component migration across the container wall).

This is the first public notice of this Class II recall issued by FDA.

PRODUCT
Collyrium Eye Wash, (Boric Acid) in 4-fluid ounce (118 mL) bottles, OTC aqueous ophthalmic solution indicated for cleansing the eye, under the Wyeth and Bausch & Lomb labels.

Recall #D-071-1.

CODE
Wyeth Laboratories, Inc. labeled product bearing lot numbers: 3981543 EXP 6/01; 3982156 EXP 6/01; 3982217 EXP 6/01;

Bausch & Lomb labeled product bearing lot numbers:
3982224 EXP 7/01; 3982225 EXP 8/01; 3982226 EXP 9/01; 3991526 EXP 1/02; 3991172 EXP 1/02; 3991269 EXP 4/02; 3990414 EXP 7/02.

MANUFACTURER
Wyeth-Ayerts Pharmaceuticals, Inc., Rouses Point, New York (contract manufacturer).

RECALLED BY
Bausch & Lomb, Inc., Rochester, New York, by letter dated December 13, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Volume of product in commerce:
Lot 3981543: 26,256 bottles
Lot 3982156: 79,032 bottles
Lot 3982217: 78,636 bottles
Lot 3982224: 78,684 bottles
Lot 3982225: 78,612 bottles
Lot 3982226: 78,888 bottles
Lot 3991526: 78,828 bottles
Lot 3991172: 77,484 bottles
Lot 3991269: 78,348 bottles
Lot 3990414: 49,656 bottles.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafetyAlerts subscribers January 2, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.