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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

Product Description Custom Patient Prescriptions
Recall Number B-1150-13
Classification Class III
Code Info T12003022, T12003259, T12003260, T12003261, T12005541, T12003052, T12003212, T12007935, T12003055, T12007934, T12005543, T12003309, T12003290, T12005559, T12005560, T12005561, T12005824, T12005832, T12005833, T12005836, T12006132, T12006134, T12006136, T12006140, T12006142, T12006148, T12007600, T12007603, T12007604, T12007605, T12007610, T12005860, T12007138, T12007142, T12007146, T12002944, T12006685, T12002947, T12005534, T12005536, T12005539, T12007657, T12007926, T12007929, T12003220, T12007562, T12002866, T12003053, T12002871, T12002872, T12005850, T12006625, T12005585, T12005588, T12005590, T12005596, T12005597, T12005600, T12005615, T12005624, T12005867, T12005869, T12005870, T12005873, T12006167, T12006674, T12007645, T12007652, T12003262, T12002902, T12002904, T12003235, T12007955, T12006120, T12006125, T12006815, T12006816, T12006874, T12006877, T12006878, T12007030, T12007031, T12007039, T12007044, T12007159, T12007156, T12007157, T12003255, T12003258, T12007560, T12007990, T12007993, T12003251, T12003226, T12003242, T12005565, T12006113, T12006630, T12007957, T12003266, T12002846, T12002895, T12002908, T12006869, T12006991, T12006994, T12006996, T12007001, T12007003, T12007006, T12007076, T12007615, T12002900, T12002911, T12002913, T12002914, T12002915, T12005568, T12005572, T12005841, T12005842, T12005845, T12006626, T12006628, T12006634, T12007991, T12003240, T12003049, T12003050, T12006641, T12006644, T12006645, T12006665, T12006762, T12006883, T12006885, T12006888, T12006889, T12006892, T12006934, T12006935, T12006936, T12006938, T12006939, T12006948, T12007066, T12007631, T12007985, T12007989, T12003023, T12003214, T12006151, T12006624, T12006130, T12002853, T12003296, T12002924, T12002925, T12005854, T12005855, T12006154, T12006159, T12006160, T12006635, T12006647, T12006648, T12006649, T12006650, T12006652, T12006653, T12006654, T12007625, T12007919, T12007980, T12003005, T12003437, T12002949, T12003230, T12003268, T12007013, T12007015, T12007049, T12007127, T12007128, T12002989, T12003425, T12003426, T12003019, T12007126, T12002877, T12002882, T12002898, T12002961, T12002968, T12002969, T12002987, T12002988, T12002990, T12003000, T12003075, T12003216, T12003222, T12003227, T12003232, T12003233, T12003236, T12003237, T12003238, T12003241, T12003432, T12003435, T12006631, T12006742, T12006743, T12006744, T12006745, T12006746, T12006747, T12006806, T12006807, T12006810, T12006818, T12006820, T12006822, T12006823, T12006824, T12006825, T12006831, T12006833, T12006835, T12006839, T12006845, T12006849, T12006850, T12006851, T12006852, T12006887, T12006891, T12006952, T12006953, T12006954, T12006955, T12006957, T12006958, T12006959, T12006960, T12006961, T12006964, T12006965, T12006967, T12006968, T12006969, T12006970, T12006972, T12006974, T12006975, T12006976, T12006980, T12006984, T12006985, T12006986, T12006990, T12007022, T12007023, T12007027, T12007034, T12007035, T12007042, T12007043, T12007045, T12007048, T12007051, T12007054, T12007056, T12007062, T12007063, T12007068, T12007070, T12007071, T12007072, T12007073, T12007086, T12007089, T12007090, T12007091, T12007092, T12007102, T12007110, T12007112, T12007113, T12007116, T12007117, T12007153, T12007155, T12007565, T12007567, T12007575, T12007579, T12007580, T12007587, T12007616, T12007617, T12007944, T12007945, T12007949, T12007951, T12007952, T12007953, T12007956, T12007964, T12007983, T12007986, T12003029, T12002986, T12003442, T12005548, T12005554, T12005811, T12005817, T12005819, T12005839, T12006111, T12007096, T12007573, T12007584, T12005570, T12003010, T12003253, T12002948, T12003208, T12003246, T12003210, T12003265, T12003271, T12005835, T12003016, T12003009, T12003308, T12002972, T12006963, T12003273, T12003440, T12003035, T12003041, T12003044, T12003051, T12003282, T12003286, T12003301, T12006692, T12006768, T12006771, T12006772, T12006781, T12006784, T12006796, T12006799, T12006801, T12006804, T12006861, T12006898, T12006899, T12006913, T12006917, T12006920, T12006930, T12006933, T12007074, T12007081, T12007131, T12007595, T12007596, T12007598, T12007973, T12002955, T12003293, T12002958, T12002967, T12002973, T12002974, T12002978, T12002994, T12003013, T12003021, T12003026, T12003422, T12006757, T12006758, T12007101, T12003218, T12003223, T12002850, T12003213, T12003428, T12003247, T12003275, T12003277
Product Distributed Qty 62
Reason For Recall Allergenic Extracts, with confirmed OOS potency results at 15 month stability time point, were distributed.

Event Detail

Event Id 64097
Product Type Biologics
Status Terminated
Recalling Firm Jubilant HollisterStier, LLC
City Spokane
State WA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-14
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Multiple U.S. States; Philippines, Bermuda, India, Hong Kong, Japan, South Korea, Jamaica, Brazil