RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I ___________________________________
PRODUCT
a) ETHEX Morphine Sulfate Extended-Release Tablets (Morphine sulfate), 60 mg, CII, packaged in 100-tablet bottles, RX, Recall # D-288-2008;
b) ETHEX Morphine Sulfate Extended-Release Tablets, (Morphine sulfate), 30 mg, CII, packaged in 100-tablet bottles, Recall # D-289-2008;
c) MS Extended-Release Tablets, 30mg, or Further Manufacturing, Processing or Repacking, Not For Sale in the United States (Export Only), RX Only; Recall # D-290-2008 CODE Lot #91762, Exp. 02/2010 (initially reported); 75091, Exp.7/2008; 75092, Exp. 7/2008; 77848, Exp. 7/2008; 77849, Exp. 10/2008; 77850, Exp. 10/2008; 77851, Exp. 10/2008; 82517, Exp. 11/2008; 82518, Exp. 11/2008; 83333, Exp. 10/2008; 83817, Exp. 11/2008; 83862, Exp. 10/2008; 84111, Exp. 10/2008; 84112, Exp. 11/2008; 84315, Exp. 11/2008; 84900, Exp. 12/2008; 85326, Exp. 11/2008; 85335, Exp. 11/2008; 85807, Exp. 11/2008; 86270, Exp. 11/2008; 86271, Exp. 12/2008; 86272, Exp. 4/2009; 86273, Exp. 4/2009; 86274, Exp. 6/2009; 86275, Exp. 6/2009; 86276, Exp. 8/2009; 87723, Exp. 8/2009; 87939, Exp. 9/2009; 88007, Exp. 10/2009; 89083, Exp. 12/2009; 89668, Exp. 10/2009; 89669, Exp. 9/2009; 89821, Exp. 12/2009; 90260, Exp. 1/2010; 90261, Exp. 1/2010; 90262, Exp. 1/2010; 90263, Exp. 1/2010; 90264, Exp. 1/2010; 90265, Exp. 1/2010; 90266, Exp. 1/2010; 90267, Exp. 1/2010; 90268, Exp. 2/2010; 90269, Exp. 2/2010; 90270, Exp. 2/2010; 90271, Exp. 2/2010; 90272, Exp. 2/2010; 91763, Exp. 1/2010; 91764, Exp. 1/2010; 91765, Exp. 2/2010;
b) Lots 75090, Exp. 6/2008; 77846, Exp. 9/2008; 77847, Exp. 11/2008; 80048, Exp. 7/2009; 83320, Exp. 7/2009; 89661, Exp. 11/2009; 89665, Exp. 7/2009; 90252, Exp. 11/2009; 90253, Exp. 1/2010; 90254, Exp. 1/2010; 90255, Exp. 1/2010; 90256, Exp. 1/2010; 90257, Exp. 1/2010; 90258, Exp. 4/2010; 93284, Exp. 4/2010;
c) Lot 84915, Repackage Contents By 12/13/2007 RECALLING FIRM/MANUFACTURER Recalling Firm: Ethex Corp., Bridgeton, MO, by letters dated May 19, 2008, by press release on June 9, 2008 and press release and letters dated June 13, 2008. 
Manufacturer: KV Pharmaceutical Co Westport, Saint Louis, MO. Firm initiated recall is ongoing.
REASON
Super-potent; over sized tablets
VOLUME OF PRODUCT IN COMMERCE
30-mg. - 181,496/100-ct. bottles and 734,392 bulk tablets; 60-mg. 282,603/100-ct. bottles DISTRIBUTION Canada ___________________________________
PRODUCT
a) Digitek (digoxin tablets, USP) 125 mcg (0.125 mg), an Rx oral cardiotonic ? 
a yellow, scored tablet imprinted with a "B" over "145"; single tablet unit dose blister packs, packaged as: UD100 tablets (10X10), NDC 51079-945-20; UD 300 tablets (10X30), NDC 51079-945-57; PC300 tablets (10X30), NDC 51079-945-56; and CP180 Patient Compliance Package (6X30), NDC 51079-945-66; Recall # D-291-2008;
b) Digitek (digoxin tablets, USP) 250 mcg (0.25 mg); an Rx oral cardiotonic ? 
a white, scored tablet imprinted with a "B" over "146"; single tablet unit dose blister packs, packaged as: UD100 tablets (10x10), NDC 51079-946-20 and CP180 Patient Compliance Package, 180 tablets (6X30), NDC 51079-946-66; Recall # D-292-2008 CODE
a) Lot numbers: 7A666, exp. 7/08; 7F048, exp. 10/08; 7D352, exp. 12/08; 7P862, exp. 3/09; and 8C515, exp. 9/09; Lot number: 6S406, exp. 5/08; Lot numbers: 7J541, exp. 1/09; 7M709, exp. 3/09; 7P965, exp. 4/09; 8A266, exp. 7/09; and 8C514, exp. 9/09; Lot numbers: 7P964, exp. 4/09 and 8B371, exp. 8/09;
b) Lot numbers: 6S379, exp. 5/08; 7C971, exp. 9/08; 7J525, exp. 1/09; 7V200, exp. 6/09; Lot numbers: 7P963, exp. 4/09 and 8A332, exp. 7/09 RECALLING FIRM/MANUFACTURER UDL Laboratories, Inc., Rockford, IL, by letter on April 28, 2008. Firm initiated recall is ongoing.
REASON
Super-Potency; UDL repackaged lots of Digitek digoxin tablets that have been recalled by the manufacturer (Actavis) due to the tablets having a thickness approximately double that of their specification VOLUME OF PRODUCT IN COMMERCE
65,242 cartons of 100, 4,624 cartons of 300, 86,489 cartons of 180 DISTRIBUTION Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II ___________________________________
PRODUCT
a) Alcohol-Free Mouthwash, a yellow liquid in a 2 fl. oz. plastic bottle, 96 bottles per case, 4 fl. oz. (118 mL) plastic bottle, 24 bottles per case and 60 bottles per case, and in a 16 fl. oz. plastic bottle, 12 bottles per case; the mouthwash was distributed under the following labels, and in some cases may have been repackaged into hospital admission kits: 1) Hydrox Fresh Moment Alcohol Free Mouthwash, item #F0210 and I0210 (4 oz), and item D0212 (16 oz);
2) McKesson Medi-Pak Mouthwash, Reorder No. 23-I0210 (4 oz) and 23-D0212
(16 oz); 3) Cardinal Health Alcohol-Free Mouthwash, reorder AG-210 (4 oz) and AG-219 (2 oz), Recall # D-293-2008;
b) Alcohol-Free Mouthwash, a blue liquid in a 4 fl. oz. (118 mL) plastic bottle, 60 bottles per case, and in a 32 fl. oz. plastic bottle, 12 bottles per case; the mouthwash was distributed under the following labels, and in some cases may have been repackaged into hospital admission kits: 1) Hydrox Fresh Moment Alcohol Free Mouthwash, item #I0220 (4 oz) and D0224 (32 oz);
2) Careline Mouthwash Blue Alcohol Free, re-order 033-0040, UPC 6 90450 01029 4;
3) Freshscent Alcohol-Free Mouthwash, reorder #FMW2 (2 oz) and FMW4 (4 oz), UPC 0 85317 00231 2;
4) DawnMist Alcohol Free Mouth Rinse, reorder #MR02 (2 oz) and MR3350 (4 oz);
5) GS Select Mouthwash, and Evoke Alcohol Free Mouthwash, both labels are for 4 oz bottles with reorder #1958;
6) Bob Barker Alcohol-Free Mouthwash, 4 oz, part #AFM4;
7) Rensow Alcohol-Free Mouthwash, 4 oz., UPC 8 27912 06379 0, Re-Order #601-510;
8) Medline Alcohol Free SparkleFresh Mouthwash, Reorder MDS095029
(2 oz) and MDS095030 (4 oz); Recall # D-294-2008;
c) Mouthwash with 2.5% Alcohol, a yellow liquid in a 4 oz. (118 mL) plastic bottle, 60 bottles per case; the mouthwash was distributed under the following labels: 
1) Hydrox Fresh Moment Mouthwash and Gargle, item #I5200;
2) McKesson Medi-Pak Mouthwash, Reorder No. 23-I5200;
3) Medline SparkleFresh Mouthwash, REF MDS095040; Recall # D-295-2008 CODE
a) 1) All lots; 2) Lots 22862, 22864, 22979, 22995, 23053, 23056, 23267, 23272, 23418, 23481, 23488, 23558, 23581, 23754, 23763, 23829, 23837, 23916, 23918, 24047, 24096, 24194, 24212, 26265, 24279, 24268, 24350, 24476, 24566, 24637, 24702, 24715, 24847, 24875, 24921, 24950, 24989, 25075, 25103, 25233, 25286, 25339, 25548, 25552, 25554, 25616, 25642, 25793, 25936, 25966, 26005, 26045, 26048, 26049, 26174, 26214, 26223, 26240, 26488, 26507, 26511, 26512; Lots 22995, 23481, 24397, 24566, 24702, 25642, 26045, 26335, 26547;
3) Lots 22818, 22864, 22876, 22877, 22925, 22926, 22936, 22981, 22996, 23006, 23013, 23014, 23046, 23104, 23110, 23114, 23164, 23176, 23184, 23215, 23219, 23236, 23304, 23307, 23313, 23351, 23353, 23358, 23359, 23394, 23424, 23425, 23443, 23444, 23500, 23523, 23535, 23546, 23552, 23584, 23700, 23706, 23754, 23941, 23965, 23996, 24035, 24046, 24047, 24124, 24128, 24178, 24181, 24194, 24260, 24261, 24268, 24325, 24326, 24365, 24386, 24389, 24460, 24465, 24466, 24537, 24540, 24590, 24599, 24660, 24661, 24698, 24701, 24713, 24734, 24751, 24753, 24756, 24779, 24781, 24798, 24817, 24828, 24888, 24903, 24954, 24969, 25001, 25008, 25012, 25044, 25084, 25086, 25090, 25096, 25101, 25149, 25193, 25198, 25199, 25204, 25253, 25299, 25300, 25301, 25305, 25335, 25363, 25406, 25409, 25416, 25478, 25479, 25481, 25515, 25522, 25554, 25578, 25581, 25594, 25627, 25666, 25681, 25686, 25688, 25729, 25732, 25738, 25789, 25791, 25797, 25836, 25840, 25875, 25877, 25899, 25910, 25949, 25966, 25967, 25968, 25997, 26004, 26005, 26021, 26025, 26037, 26039, 26041, 26097, 26099, 26102, 26115, 26121, 26144, 26194, 26219, 26220, 26228, 26230, 26233, 26254, 26272, 26282, 26324, 26326, 26330, 26380, 26383, 26431, 26488, 26495, 26497, 26534, 26547, 26556; reorder AG-219 - lots 22818, 22936, 23176, 23394, 23500, 23700, 23965, 24072, 24602, 24954, 25090, 25301, 25457, 25666, 25797, 26160, 26324;
b) 1) All lots;
2) Lots 22871, 22873, 22985, 23068, 23145, 23158, 23246, 23315, 23342, 23380, 23453, 23530, 23780, 23824, 24150, 24230, 24299, 24302, 24369, 24378, 24398, 24435, 24648, 24742, 24803, 24882, 24885, 24918, 25140, 25356, 25372, 25455, 25465, 25773, 26148, 26150;
3) Lots 23621, 23846, 23973, 24790, 25713, 25939, 26451; Lots 23621, 23843, 24006, 24069, 24070, 24340, 24544, 24634, 24639, 24800, 24811, 25021, 25027, 25177, 25186, 25463, 25465, 25472, 25571, 25739, 25868, 25976, 25977, 26111, 26119, 26265, 26359, 26361, 26407,
4) Lots 23391, 23404, 23501, 23514, 23973, 24108, 24312, 24534, 24606, 24851, 24952, 25038, 25135, 25463, 25572, 25713, 25802, 25939, 26083, 26298, 26396, Lots 22826, 22831, 22832, 23077, 23084, 23202, 23203, 23213, 23228, 23234, 23278, 23286, 23360, 23361, 23373, 23379, 23404, 23407, 23416, 23459, 23461, 23473, 23489, 23559, 23567, 23568, 23669, 23672, 23682, 23801, 23802, 23803, 23861, 23863, 23866, 23961, 23974, 23975, 23999, 24000, 24042, 24044, 24070, 24099, 24113, 24121, 24123, 24333, 24337, 24492, 24495, 24510, 24513, 24515, 24518, 24528, 24577, 24578, 24614, 24616, 24666, 24669, 24859, 24863, 24926, 24938, 24978, 24979, 24983, 24990, 24991, 25027, 25031, 25038, 25042, 25055, 25064, 25067, 25119, 25122, 25134, 25135, 25144, 25167, 25171, 25177, 25315, 25320, 25323, 25372, 25386, 25419, 25421, 25423, 25434, 25444, 25446, 25448, 25453, 25455, 25585, 25588, 25699, 25706, 25707, 25709, 25713, 25816, 25818, 25909, 25916, 25929, 25931, 25939, 25946, 25959, 25971, 25977, 25978, 25982, 25986, 25991, 26073, 26077, 26083, 26111, 26164, 26167, 26183, 26185, 26196, 26239, 26241, 26244, 26248, 26287, 26290, 26291, 26295, 26298, 26352, 26359, 26372, 26377, 26379, 26395, 26422, 26424, 26426, 26451, 26454, 26457, 26480, 26500;
5) Lots 23029, 23041, 23227, 23286, 23287, 23514, 23516, 23880, 23980, 24094, 24164, 24310, 24470, 24546, 24646, 24763, 24872, 24998, 25200, 25328, 25388, 25483, 25575, 25655, 25658, 25739, 25742, 25868, 25931, 25982, 25986, 26008, 26149, 26267, 26396, 26433;
6) Lots 24544, 26189, 26342, 26287, 24837, 24909, 25100, 25142, 25689, 26073, 26189, 26287, 26342;
7) Lots 25589, 25655, 25658, 25914;
8) Lots 23074, 23296, 23391, 23576, 23689, 23846, 23973, 24108, 24312, 24416, 24534, 24606, 24790, 24973, 25231, 25572, 25713, 26442, 26443, 26451, 26461, 26465, 26467, 26500, 26502, 26529, 26544; lots 22821, 22838, 22845, 22846, 22857, 22873, 22968, 22969, 22978, 22982, 23018, 23061, 23062, 23084, 23107, 23108, 23140, 23158, 23167, 23244, 23248, 23249, 23294, 23329, 23334, 23338, 23427, 23433, 23434, 23437, 23462, 23497, 23506, 23517, 23524, 23609, 23682, 23723, 23733, 23736, 23737, 23747, 23771, 23782, 23802, 23820, 23866, 23881, 23882, 23927, 23930, 23944, 23952, 23959, 24000, 24006, 24021, 24025, 24027, 24052, 24078, 24123, 24142, 24151, 24166, 24204, 24206, 24242, 24244, 24258, 24270, 24279, 24309, 24310, 24335, 24381, 24382, 24398, 24422, 24426, 24439, 24478, 24489, 24573, 24575, 24613, 24623, 24643, 24663, 24675, 24676, 24683, 24693, 24708, 24709, 24767, 24770, 24772, 24897, 24941, 25032, 25165, 25218, 25266, 25268, 25352, 25375, 25388, 25392, 25405, 25487, 25512, 25569, 25571, 25589, 25601, 25629, 25721, 25727, 24416, 26442, 26443, 26451, 26461, 26465, 26467, 26500, 26502, 26529, 26544;
c) 1) All lots; 2) Lots 22962, 23771, 23927, 24381, 24870, 25121, 25468, 25661, 26138, 26365; 3) - 22855, 22962, 24870, 25121, 25468 RECALLING FIRM/MANUFACTURER Hydrox Chemical Co., Elgin, IL, by press release, e-mail and letter on May 23, 2008. Firm initiated recall is ongoing.
REASON
CGMP Deviations. The mouthwash was manufactured under conditions where by it may be contaminated with the bacteria Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
60,000,000 bottles estimated
DISTRIBUTION
Nationwide

Source: FDA


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