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SafetyAlerts
April 2, 2003

Hoffmann LaRoche Has Recalled Kytril Tablets

(SafetyAlerts) - The Food and Drug Administration (FDA) has released the following information.


PRODUCT
Kytril Tablets (granisetron HC1), 1mg, 2 tablet unit of use package and 20 tablet single unit package, Rx only. Recall # D-195-3.

CODE
Blister of 20 tablets: Lot numbers 029055 Exp. 4/2003;
029056 Exp. 4/2003; 036198 Exp. 3/2005; 036199 exp. 3/2005;
036200 Exp. 3/2005; 039142 Exp. 7/2005;
Blister of 2 tablets: Lot number 028107 Exp. 4/2003.

RECALLING FIRM/MANUFACTURER
Hoffmann LaRoche, Inc., Nutley, NJ, by letters on February 28, 2003. Firm initiated recall is ongoing.

REASON
Mispackaged; blistercard incorrectly contains two tablets rather than one tablet.

VOLUME OF PRODUCT IN COMMERCE
64,073 packages.

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.