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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.

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