January 2, 2001Collyrium Eye Wash Recalled by
Bausch & Lomb
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.
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.
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
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.
Wyeth-Ayerts Pharmaceuticals, Inc., Rouses Point, New York (contract manufacturer).
Bausch & Lomb, Inc., Rochester, New York, by letter dated December 13, 2000.
Firm-initiated recall ongoing.
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.
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