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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
August 12, 1998

PRODUCT
Collyrium for Fresh Eyes, Eye Wash, (borate solution). NDC #: 00008-0769-01. Recall #D-217-8.

CODE

3950841 (EXP 7/98)
3950980 (EXP 8/98)
3951149 (EXP 9/98)
3951148 (EXP 10/98)
3951215 (EXP 10/98)
3951216 (EXP 10/98)
3960020 (EXP 12/98)
3960039 (EXP 1/99)
3960040 (EXP 2/99)
3960382 (EXP 4/99)
3961288 (EXP 9/99)
3961765 (EXP 9/99)
3961509 (EXP 10/99)
3961988 (EXP 11/99)
3961913 (EXP 12/99)
3970147 (EXP 2/00)
3970209 (EXP 2/00)
3970310 (EXP 4/00)
3971386 (EXP 4/00)
3971032 (EXP 4/00)
3971591 (EXP 5/00)
3971363 (EXP 7/00)
3971433 (EXP 8/00)
3971647 (EXP 9/00)
3971750 (EXP 10/00)
3971936 (EXP 11/00)
3981046 (EXP 12/00)
3981075 (EXP 1/01)
3981379 (EXP 1/01)
MANUFACTURER
Wyeth-Ayerst Laboratories, Rouses Point, New York 
(responsible firm).

RECALLED BY
Wyeth-Ayerst Laboratories, Richmond, Virginia, by letter dated July 15, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

1,923,379 bottles were distributed.

REASON
Contamination - Product contains trace amounts of benzophenone (varnish component of bottle label).

 

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.