SafetyAlerts
April 2, 2003Hoffmann LaRoche Has Recalled Kytril Tablets
(SafetyAlerts)
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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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