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SafetyAlerts
January 30, 2002

Novartis Ophthalmics Has Recalled GenTeal Lubricant Eye Drops

Duluth, GA (SafetyAlerts) - The Food and Drug Administration (FDA) said that Novartis Ophthalmics, Inc. has recalled GenTeal Lubricant Eye Drops, 0.3% Hydroxypropyl methylcellulose 0.845 FL.OZ. (25mL) bottles.

PRODUCT
GenTeal Lubricant Eye Drops, 0.3% Hydroxypropyl methylcellulose 0.845 FL.OZ. (25mL) bottles, Recall # D-084-2.

CODE
Lot No. 96455.

RECALLING FIRM/MANUFACTURER
Novartis Ophthalmics, Inc. Duluth, GA, by letter dated Sept. 25, 2001. Firm initiated recall is ongoing.

REASON
Non-Sterile-contamination with penicillum sp.

VOLUME OF PRODUCT IN COMMERCE
22,272 units.

DISTRIBUTION
Nationwide
.

 
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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.