|
Solvay Pharmaceuticals
Has Recalled Luvox
(For treatment of depressive
illness, SSRI class.)
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.
|