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SafetyAlerts
Aug 1, 2000

Artificial Tears, Polyvinyl Alcohol 1.4% Recalled by Optopics Laboratories

Fairton, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Optopics Laboratories is conducting a recall of Artificial Tears, Polyvinyl Alcohol 1.4% because there is 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 concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafeMail subscribers August 1, 2000.

 
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.