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Artificial Tears, Polyvinyl Alcohol 1.4% Recalled by Optopics Laboratories

Date: 8/1/2000
Reason: Lack of assurance of sterility.
Distribution: AL, CA, FL, GA, MI, NC, NY, PA, OR, TX, UT and WV.

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Fairton, NJ, Aug 1 (SafetyAlerts) -- The Food and Drug Administration (FDA) today reported that Optopics Laboratories is recalling Artificial Tears, Polyvinyl Alcohol 1.4%. The report cites a lack of assurance of sterility.

PRODUCT
Artificial Tears, Polyvinyl Alcohol 1.4%, in 1-fluid ounce bottles, OTC ophthalmic solution, under the following labels: Optopics, Rite Aid, Eckerd, and Nex.

Recall #D-440-0.  Class II

CODE
Lot #8I101 EXP 9/01.

MANUFACTURER
Miza Pharmaceuticals, Inc., doing business as Optopics Laboratories, Fairton, New Jersey.

RECALLED BY
Manufacturer, by letter on April 14, 2000. Firm-initiated recall ongoing.  This is the first public notice issued by the FDA.

DISTRIBUTION
Oregon, Alabama, West Virginia, New York, California, Utah, Florida, Texas, North Carolina, Pennsylvania, Georgia, Michigan.

QUANTITY
19,755 bottles were distributed.

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


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