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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
February 24, 1999

PRODUCT
Loperamide 2 mg. Tablets in 6, 12, 18 and 24 count blister cards under the following labels: Family Pharmacy, Arbor, Market Basket, medic, Family Independent, Grand Union, Goldline, Brook's, Freds, Fedco, Duane Reade, Hills, Happy Harry's, Quality Choice, Pathmark, MS, Kerr, Rite Aid, Shopko, Select, K & B, Smart Choice, Ames, FDC, REX, RMC, First Choice, and Kinney's. Recall #D-115-9.

CODE
7027851, 7027852, 7027853, 7027854, 7027855, 7027585,
7027856, 7027859, 7027857, 7027858, 7027860, 7027861, 7027862, 7027863, 7027864, 7027865, 7027866, 7027867, 7027868, 7027869, 7030557, 7038535, 7038536, 7038538, 7038540, 7038542, 7038543, 7038544, 7038545, 7038546, 7038547, 7038548, 7038549, 7038550, 7038552, 7038553, 7038555, 7038554, 7038556, 7038558, 7038713, 7038714, 7038829, 7038831, 7038832, 7038833, 7038834, 7038835,
7038836, 7038838, 7038839, 7038888, 7040076, 7040077, 7040078, 7040079, 7040236, 7049303, 7049304, 7049305, 7049306, 7049332, 7049526, 7049527, 7049528, 7049529, 7049530, 7049531, 7049533, 7049695, 7050616, 7050619, 7050620, 7050621, 7050623, 7050633, 7050656, 7050658, 7050689, 7050690, 7050691, 7050897, 7050898, 7050905, 7050907, 7050922, 7050923, 7050924, 7050925, 7050974,
7050975, 7050976, 7050978, 7050979, 7050985, 7050988, 7050989, 7050990, 7050991, 7051074, 7051075, 7051215, 7051216, 7051228, 7051229, 7051231, 7051233, 7051234, 7061230, 7061636, 7061650, 7061654, 7061656, 7061658, 7061659, 7061660, 7061661, 7061662, 7061663, 7061806, 7062151, 7062152, 7062153, 7062154, 7062168, 7062169, 7062170, 7062171, 7062172, 7062173, 7062174, 7062177,
7062178, 7062256, 7062284, 7062285, 7062286, 7062287, 7062288, 7062429, 7062430, 7072699, 7072700, 7072701, 7072702, 7072703, 7072704, 7072705, 7072838, 7072851, 7073014, 7073015, 7073083, 7083481, 7085481, 7094727, 7094728, 7094730, 7094731, 7094732, 7094733, 7094734, 7094735, 7094736, 7094742, 7094743, 7094745, 7094747, 7094748, 7095603, 7095604, 7095605, 7095606, 7095608,
7095609, 7095610, 7095611, 7095612, 7095613, 7106304, 7106310, 7106311, 7106312, 7117236, 7117237, 7117238, 7117275, 7117276, 7117278, 7117277, 7117279, 7117280, 7117281, 7117282, 7117283, 7117284, 7128256, 7128257, 7128258, 7128259, 7128260, 7128266, 7128267, 7128268, 7128270, 8010192, 8010255, 8010256, 8010257, 8010258, 8010259, 8010260, 8010261, 8017991, 8019759, 8019760,
8019768, 8019769, 8019771, 8019774, 8019775, 8019776, 8019790, 8019792, 8019793, 8019866, 8019867, 8019868, 8019869, 8019870, 8019871, 8019872, 8019873, 8019874, 8019875, 8019877, 8019902, 8020601, 8021073, 8030808, 8031515, 8031516, 8031517, 8031531, 8031532, 8031533, 8031534, 8031535, 8031536, 8031537, 8031538, 8031539, 8031540, 8031541, 8031542, 8031582, 8031583, 8031585,
8031587, 8031589, 8031590, 8031591, 8031691, 8031778, 8031779, 8031780, 8031781, 8031782, 8031784, 8031785, 8031786, 8031801, 8031802, 8031803, 8031804, 8031805, 8031806, 8031807, 8031808, 8031809, 8031810, 8031811, 8031812, 8031818, 8031819, 8031971, 8032072, 8032137, 8032138, 8032141, 8032143, 8032145, 8032146, 8032148, 8032149, 8032150, 8032173, 8042375, 8042384, 8042476,
8042703, 8053438, 8053943, 8053944, 8053945, 8053946, 8053947, 8053949, 8053950, 8053952, 8053953, 8053954, 8053963, 8054025, 8054026, 8054200, 8054201, 8054202, 8054203, 8054204, 8054205, 8054206, 8054207, 8054208, 8054209, 8054288, 8054289, 8054290, 8054291, 8054292, 8054293, 8054294, 8054295, 8054296, 8054297, 8054299, 8054341, 8064785, 8064843, 8064844, 8064845, 8064846,
8064847, 8064848, 8064849, 8064850, 8064851, 8064852, 8064853, 8064854, 8064855, 8064856, 8064857, 8064858, 8064859, 8064860, 8065138, 8075505, 8076072, 8076073, 8076074, 8076076, 8076077, 8076078, 8076079, 8076097, 8076099, 8076100, 8076101, 8076102, 8076105, 8076106, 8076149, 8076150, 8076151, 8076152, 8086579, 8086480, 8086577, 8086578, 8086580, 8086581, 8086582, 8086583,
8086584, 8086585, 8086586, 8086587, 8086588, 8086589, 8086590, 8086591, 8086592, 8086594, 8086714, 8086715, 8086716, 8086717, 8097483, 8097484, 8097485, 8097486, 8097487, 8097488, 8097489, 8097490, 8097492, 8097493, 8097494, 8097495, 8098122, 8108729, 8108730, 8108731, 8108732, 8110232, 8110233, 8119448, 8119449, 8119450, 8119451, 8119452, 8119453, 8119454, 8119455, 8119456,
8119457, 8119458, 8119459, 8119460, 8119461, 8119462, 8119463, 8119464, 8119465, 8119466, 8119467, 8119468, 8119469, 8119470, 8119830, 8119831, 8119836, 8119978.  EXP dates are throughout
1999 and 2000.

MANUFACTURER
Novapharm Ltd., Scarborough, Ontario, Canada.

RECALLED BY
Granutec, Inc., Wilson, North Carolina, by letter on December 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY

188,000,000 tablets were distributed.

REASON
Product exceeds impurity level.

 

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.