Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences

SafetyAlerts
July 31, 2002

Solvay Pharmaceuticals Has Recalled Luvox

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

PRODUCT
a) Luvox (Fluvoxamine Maleate) Tablets (scored), 25 mg,
100 count bottles and unit dose packages of 100, Rx
Only. Recall # D-354-2;
b) Luvox (Fluvoxamine Maleate) Tablets (scored), 50 mg,
100 count bottles and unit dose packages of 100, Rx
Only. Recall # D-355-2;
c) Luvox (Fluvoxamine Maleate) Tablets (scored), 100 mg,
100 count bottles and unit dose packages of 100, Rx
Only. Recall # D-356-2.

CODE
a)LUVOX 25mg - Lots 90645, 90646, 91001, 91338, 91375,
91721, 92032, 92038;
b) LUVOX 50mg - Lots 90576, 90610, 90611, 90612, 90613, 90614,
90615, 90644, 90731, 90733, 90734, 90735, 90736, 90737, 90841,
90842, 90843, 90844, 90845, 90846, 90996, 90997, 90998, 90999,
91000, 91229, 91230, 91232, 91233, 91234, 91235, 91236, 91237,
91320, 91321, 91322, 91323, 91376, 91377, 91378, 91379, 91380,
91543, 91544, 91617, 91618, 91619, 91620, 91621, 91646, 91653,
92094, 92165;
c) LUVOX 100mg - Lots 90410, 90411, 90414, 90415, 90454, 90455, 90456, 90457, 90555, 90556,
90557, 90558, 90559, 90560, 90561, 90562, 90563, 90564, 90699, 90700, 90701, 90702, 90703, 90704,
90705, 90713, 90714, 90715, 90716, 90717, 90718, 90719, 90720, 90721, 90722, 90831, 90832, 90833,
90834, 90835, 90836, 90837, 90838, 90849, 90850, 90851, 90852, 90853, 90854, 90855, 90856, 90857,
90858, 90865, 90866, 90867, 90868, 90869, 90870, 90931, 90932, 90933, 90934, 90935, 90936, 91003,
91004, 91005, 91006, 91007, 91008, 91009, 91010, 91011, 91112, 91113, 91114, 91115, 91116, 91117,
91118, 91119, 91120, 91238, 91240, 91241, 91242, 91243, 91244, 91245, 91246, 91247, 91289, 91290,
91291, 91292, 91294, 91295, 91296, 91297, 91315, 91316, 91317, 91324, 91325, 91326, 91327, 91328,
91329, 91330, 91331, 91364, 91365, 91366, 91367, 91368, 91369, 91370, 91371, 91372, 91373, 91374,
91384, 91385, 91386, 91387, 91388, 91389, 91390, 91391, 91392, 91393, 91394, 91395, 91396, 91397,
91398, 91399, 91535, 91536, 91537, 91538, 91539, 91540, 91541, 91542, 91610, 91611, 91645, 91647,
91648, 91649, 91650, 91651, 91652, 91658, 92091, 92092, 92093, 92113, 92114, 92115, 92116, 92117,
92118, 92119, 92120, 92121, 92163.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Solvay Pharmaceuticals, Inc., Marietta, GA, by letter on May 29, 2002.
Manufacturer: Solvay Pharmaceuticals, Inc., Baudette, MN.Firm initiated recall is ongoing.

REASON
Inaccuracies in data submitted to the New Drug Application by Solvay (stability).

VOLUME OF PRODUCT IN COMMERCE
1,503,114 units.

DISTRIBUTION
Nationwide
.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

Sign-up for SafetyAlerts by Email -
The free internet newsletter that could
some day literally save your life - or
the life of someone you know.

 

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.