NRAC Issue #1633 ADDENDUM June 5, 2007 NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C. --------------------------------------------------------------------------- PRODUCT a) ACETAMINOPHEN 325 mg tablet, 250 count bags (NDC #61392000525); 30 count bingo card (NDC #61392000539); 60 count bingo card (NDC #61392000565); and 30 count boxes (NDC #61392000530), OTC RECALL NUMBER # D-735-2007 PRODUCT b) ACETAMINOPHEN 500 mg caplet, 250 count bags (NDC #61392094825) & 30 count boxes (NDC #61392094830), OTC RECALL NUMBER # D-736-2007 PRODUCT c) ACETAMINOPHEN 500 mg gelcap, 30 count bingo card (NDC #61392064439), OTC RECALL NUMBER # D-737-2007 PRODUCT d) ACETAMINOPHEN 500 mg tablet, 250 count bags (NDC #61392003025), 30 count bingo card (NDC #61392003039), 30 count boxes (NDC #61392003030) & 60 count boxes (NDC #61392003060), OTC RECALL NUMBER # D-738-2007 PRODUCT e) ACETAMINOPHEN/COD#3 300/30 mg tablet (c), 30 count bingo card (NDC #61392071439) & 31 count bingo card (NDC #61392071431), Rx RECALL NUMBER # D-739-2007 PRODUCT f) ACETAMINOPHEN/COD#4 300/60 mg tablet (c), 30 count bingo card (NDC #61392002839), Rx RECALL NUMBER # D-740-2007 PRODUCT g) ACETAZOLAMIDE 250 mg tablet, 30 count bingo card (NDC #61392017639), Rx RECALL NUMBER # D-741-2007 PRODUCT h) ALBUTEROL SULFATE 2 mg tablet, 30 count bingo card (NDC #61392056739) Rx RECALL NUMBER # D-742-2007 PRODUCT i) ALBUTEROL SULFATE 4 mg tablet, 30 count bingo card (NDC #61392057039), Rx RECALL NUMBER # D-743-2007 PRODUCT j) ALLOPURINOL 100 mg tablet, 250 count bags (NDC #61392010325), 30 count bingo card (NDC #61392010339), 30 count boxes (NDC #61392010330), & 60 count boxes (NDC #61392010360), Rx RECALL NUMBER # D-744-2007 PRODUCT k) ALLOPURINOL 300 mg tablet, 250 count bags (NDC #61392010425) & 30 count boxes (NDC #61392010430), Rx RECALL NUMBER # D-745-2007 PRODUCT l) ALPRAZOLAM 0.25 mg tablet (c), 30 count bing card (NDC #61392003439), 31 count bingo card (NDC #61392003431) & 15 count bingo card (NDC #61392003439), Rx RECALL NUMBER # D-746-2007 PRODUCT m) ALPRAZOLAM 0.5 mg tablet (c), 30 count bingo card (NDC #61392003539, 31 count bingo card (NDC #61392003531) & 15 count bingo card (NDC #61392003505), Rx RECALL NUMBER # D-747-2007 PRODUCT n) ALPRAZOLAM 1 mg tablet (c), 30 count bingo card (NDC #61392003639), Rx RECALL NUMBER # D-748-2007 PRODUCT o) AMANTADINE 100 mg capsule, 250 count bags (NDC #61392004225), 30 count bingo card (NDC #61392004239) & 30 count boxes (NDC #61392004230), Rx RECALL NUMBER # D-749-2007 PRODUCT p) AMIODARONE 200 mg tablet, 250 count bags (NDC #61392093525), 30 count boxes (NDC #61392093530) & 60 count boxes (NDC #61392093560), Rx RECALL NUMBER # D-750-2007 PRODUCT q) AMITRIPTYLINE 100 mg tablet, 30 count bingo card (NDC #61392015339), Rx RECALL NUMBER # D-751-2007 PRODUCT r) AMITRIPTYLINE 25 mg tablet, 30 count boxes (NDC #61392014030) Rx RECALL NUMBER # D-752-2007 PRODUCT s) AMITRIPTYLINE 50 mg tablet, 30 count bingo card (NDC #61392014139), Rx RECALL NUMBER # D-753-2007 PRODUCT t) ASPIRIN 325 mg tablet, 250 count bags (NDC #61392003325), 30 count bingo card (NDC #61392003339), & 30 count boxes (NDC #61392003330), OTC RECALL NUMBER # D-754-2007 PRODUCT u) ASPIRIN BUFFERED 325 mg tablet, 250 count bags (NDC #61392003125), 30 count bingo card (NDC #61392003139), & 30 count boxes (NDC #61392003130), OTC RECALL NUMBER # D-755-2007 PRODUCT v) ASPIRIN CHEW 81 mg tablet, 250 count bags (NDC #61392003225), 30 count bingo card (NDC #61392003239), 31 count bingo card (NDC #61392003231), & 30 count boxes (NDC #61392003230), OTC RECALL NUMBER # D-756-2007 PRODUCT w) ASPIRIN EC 325 mg tablet, 250 count bags (NDC #61392089925), & 30 count boxes (NDC #61392089930) RECALL NUMBER # D-757-2007 PRODUCT x) ASPIRIN EC 81 mg tablet, 250 count bags (NDC #61392009625), OTC RECALL NUMBER # D-758-2007 PRODUCT y) ATENOLOL 100 mg tablet, 250 count bags (NDC #61392054625) & 30 count boxes (NDC #61392054630), Rx RECALL NUMBER # D-759-2007 PRODUCT z) ATENOLOL 25 mg tablet, 250 count bags (NDC #61392054225), 30 count bingo card (NDC #61392054239), 31 count bingo card (NDC #61392054231), 30 count boxes (NDC #61392054230), 60 count boxes (NDC #61392054260) and 15 count bingo card (NDC #61392054205), Rx RECALL NUMBER # D-760-2007 PRODUCT aa) ATENOLOL 50 mg tablet, 150 count bags (NDC #61392054325), 30 count boxes (NDC #61392054330) & 60 count boxes (NDC #61392054360), Rx RECALL NUMBER # D-761-2007 PRODUCT bb) AZATHIOPRINE 50 mg tablet, 30 count bingo card (NDC #61392080439), Rx RECALL NUMBER # D-762-2007 PRODUCT cc) BACLOFEN 10 mg tablet, 250 count bags (NDC #61392070625), 30 count bingo card (NDC #61392070639) & 30 count boxes (NDC #61392070630), Rx RECALL NUMBER # D-763-2007 PRODUCT dd) BACLOFEN 20 mg tablet, 30 count bingo card (NDC #61392070739), Rx RECALL NUMBER # D-764-2007 PRODUCT ee) BENZONATATE 100 mg capsule, 250 count bags (NDC #61392057225) & 30 count boxes (NDC #61392057230), Rx RECALL NUMBER # D-765-2007 PRODUCT ff) BENZTROPINE 0.5 mg tablet, 250 count bags (NDC #61392016725) & 30 count boxes (NDC #61392016730), Rx RECALL NUMBER # D-766-2007 PRODUCT gg) BENZTROPINE 1 mg tablet, 250 count bags (NDC #61392017025), 30 count bingo card (NDC #61392017039), 31 count bingo card (NDC #61392017031) & 30 count boxes (NDC #61392017030), Rx RECALL NUMBER # D-767-2007 PRODUCT hh) BENZTROPINE 2 mg tablet, 250 count bags (NDC #61392016425) & 30 count boxes (NDC #61392016430), Rx RECALL NUMBER # D-768-2007 PRODUCT ii) BISACODYL 5 mg tablet, 250 count bags (NDC #61392017325) & 30 count boxes (NDC #61392017330), OTC RECALL NUMBER # D-769-2007 PRODUCT jj) BUMETANIDE 0.5 mg tablet, 250 count bags (NDC #61392004825), 30 count bingo card (NDC #61392004839), & 30 count boxes (NDC #61392004830) Rx RECALL NUMBER # D-770-2007 PRODUCT kk) BUMETANIDE 1 mg tablet, 250 count bags (NDC #61392004925) & 30 count boxes (NDC #61392004930), Rx RECALL NUMBER # D-771-2007 PRODUCT ll) BUMETANIDE 2 mg tablet, 250 count bags (NDC #61392005025), 30 count bingo card (NDC #61392005039), 30 count boxes (NDC #61392005030), Rx RECALL NUMBER # D-772-2007 PRODUCT mm) BUPROPION 100 mg tablet, 250 count bags (NDC #61392099725), 30 count bingo card (NDC #61392099739), 30 count boxes (NDC #61392099730), Rx RECALL NUMBER # D-773-2007 PRODUCT nn) BUPROPION 75 mg tablet, 250 count bags (NDC #61392099625), 30 count bingo card (NDC #61392099639), 30 count boxes (NDC #61392099630), Rx RECALL NUMBER # D-774-2007 PRODUCT oo) BUSPIRONE 10 mg tablet, 30 count bingo card (NDC #61392066139), 30 count boxes (NDC #61392066130), & 60 count boxes (NDC #61392066160), Rx RECALL NUMBER # D-775-2007 PRODUCT pp) BUSPIRONE 5 mg tablet, 30 count boxes (NDC #61392066030) & 60 count boxes (NDC #61392066060), Rx RECALL NUMBER # D-776-2007 PRODUCT qq) BUSPIRONE 7.5 mg tablet, 250 count bags (NDC #61392066225), 30 count bingo card (NDC #61392066239), 30 count boxes (NDC #61392066230) & 60 count boxes (NDC #61392066260) RECALL NUMBER # D-777-2007 PRODUCT rr) CAPTOPRIL 12.5 mg tablet, 250 count bags (NDC #61392060425) & 30 count boxes (NDC #61392060430), Rx RECALL NUMBER # D-778-2007 PRODUCT ss) CAPTOPRIL 25 mg tablet, 250 count bags (NDC #61392060525), 30 count bingo card (NDC #61392060539) & 30 count boxes (NDC #61392060530), Rx RECALL NUMBER # D-779-2007 PRODUCT tt) CAPTOPRIL 50 mg tablet, 30 count bingo card (NDC #61392014739), Rx RECALL NUMBER # D-780-2007 CODE a) All Lot Codes: U36506A25, U36506B25, U37138C25, U37493B25, U37493D25, U37273A25, U38528B25, U37850C25, U39336A25, C39967B25, U40129D25, C43327R25, 005E0501, 005G0519, 005J0508, 005J0523, 005k0513, 005L0522, 005M0544, 005A0608, 005A0658, 005F0508, 0005h0513, 005K0536, 005A0643, U36274D30, U36274F30, U37138A30, U36506C30, U37138B30, U37138D30, 37493C30, U36916A30, U37850A30, U37138E30, U37850B30, U38528A30, U39046A30, U39336B30, U39670A30, U38774C30, C39967A30, U40129A30, U40129E30, C43327A30, C43695A30, C43327R30, U36274A60, U36274B60, U36274C60, U36274E60, U37493A60, U38528C60, U38774A60, U38774B60, U40129B60, U39999A60, U40129C60, C43695B60, C43327R60; b) All Lot Codes: C43727B25, U36270C30; c) Code Information : All Lot Codes: 39906, 644B0633, 42356; d) All Lot Codes: U36511B25, U37533B25, U37847C25, U39882B25, 030E0501, 37028, 030F0520, 030G0507, 030h0513, 030J0508, 030k0510, 030k0545, 030L0532, 030M0527, 030A0609, U36241A30, U36511C30, U36915A30, U37141B30, U37533D30, U37533C30, U37847A30, 38196A30, U37847B30, U37847E30, U39377A30, U38850B30, U39882A30, U39882D30, U40205A30, U36511A60, U37141A60, U36241B60, U37533A60, U36915B60, U38196B60, U37847D60, U38850A60, U39882C60; e) All Lot Codes: 714D0512, 714G0505, 714G0507, 714H0509, 38157, 38155, 714J0517, 714J0518, 714J0514, 38463, 714k0507, 38800, 714L0522, 714A0638, 714B0632, 714C0629, 714E0608, 714F0616, 37434, 38998, 714M0527; f) All Lot Codes: 40993, 41391, 42025; g) All Lot Codes: 36733, 176F0504, 176H0533, 176L0536, 176E0623; h) All Lot Codes: 36398, 36999, 567h0509; i) All Lot Codes: 36608, 38156, 570A0624; j) All Lot Codes: U36142B25, U36142F25, U36142D25, U36142G25, U37172B25, U38561A25, U38561B25, U38725B25, U39746B25, U39746D25, U41327A25, 103D0505, 103E0501, 103F0520, 103G0510, 103h0513, 103J0523, 103K0538, 103l0518, 103L0541, 103M0511, 103A0614, 103A0636, U36142C30, U36142E30, U36834A30, U36142H30, U37172A30, U36834B30, U37172C30, U37172D30, U38725A30, U39746A30, U38725C30, U39746C30, U38561C30, U40717A30, U41327B30, U42625A30, U43312A30, C43579A30, U36142A60; k) All Lot Codes: U38726A25, U38726B30, U38726C30, U41627A30, U43388A30, U43388B30; l) All Lot Codes: 034G0503, 034H0511, 034j0509, 034J0525, 034j0531, 034k0528, 034k0548, 034L0538, 034M0525, 034A0639, 034B0605, 034C0605, 034D0607, 034E0622, 034F0633, 034k0527, 034L0536, 034E0623, 034D0621; m) All Lot Codes: 035G0507, 035h0511, 035j0531, 035K0548, 035M0530, 035M0546, 035B0646, 035C0605, 035D0608, 035E0608, 035F0633, 40083, 40518, 41905, 035F0603; n) All Lot Codes: 036k0546, 036L0511, 036M0544, 036A0639, 636B0621, 41056, 036C0605, 036E0608; o) All Lot Codes: U37170C25, U37170B25, U39881D25, U41176B25, 042F0504, 042k0524, 042L0518, 042M0525, 042A0638, 042A0653, 042B0626, 42693, 42694, 042F0612, U36643A30, U36643B30, U37170A30, U38531A30, U38531B30, U39881A30, U39881C30, U39881B30, U39881E30, U41176A30, U41176C30; p) Code Information : All Lot Codes: U37161B25, U37161D25, U39023A25, U39740E25, U41251A25, U47323A25, U37161A30, U37161C30, U37161E30, U39023B30, U39740A30, U39740B30, U39740D30, U41251C30, U47323C30, U39740C60, U41251B60, U47323B60; q) All Lot Codes: 36386, 37973, 39051, 153M0544; r) All Lot Codes: U41377A30; s) All Lot Codes: 36994, 141h0509, 141k0538, 40736, 141C0616, 141F0612; t) All Lot Codes: U37142A25, U37142B25, U37886C25, U37886B25, U38961B25, U39317A25, U39916C25, U39916D25, U40206B25, U40824B25, C41132B25, C41883B25, U41650A25, 36459, 033H0509, 033h0513, 033K0519, 033k0545, 39434, 39435, 033M0530, 033M0547, 033A0656, 033B0631, 41738, 033E0602, 033F0601, 033G0606, 033F0606, U36565A30, U36565B30, U36919A30, U37142C30, U37142D30, U37886A30, U37886D30, U38961A30, U38961C30, U39317B30, U39916A30, U38961D30, U39916B30, U40206A30, U39916E30, U40206C30, U40824A30, U40824C30, C41132A30, C41883A30; u) All Lot Codes: U40954B25, 36387, 39788, 42493, U40954A30, U40954C30; v) All Lot Codes: U38529B25, U39936A25, U39936C25, U39936D25, U40391C25, U40669B25, C41025B25, U41649A25, U41649B25, C42377B25, C42652B25, C43074B25, U43267A25, 032K0508, 032k0542, 032M0520, 032A0616, 032A0654, 032B0627, 032B0645, 032E0608, 032F0626, 032G0601, 032F0609, U38529A30, U39375A30, U39603B30, U39375B30, U39603A30, U39936B30, U39936E30, U40345A30, U40391A30, U40391B30, U40669A30, U40541A30, U40669C30, C41025A30, C42377A30, C42652A30, C43074A30; w) All Lot Codes: U36332A25, U36332C25, U37257B25, U37562A25, U38479A25, U39024B25, U40452C25, C41133B25, U41997A25, U41594A25, U36332B30, U36635A30, U36635B30, U37257A30, U37257C30, U38479B30, U36332D30, U37562B30, U39024B30, U39024C30, U39478A30, U36332E30, U39960A30, U39960B30, U39024D30, U40452A30, U40452B30, U40452D30, U40665A30, U40452E30, C41133A30, U4199730, U41594B30; x) All Lot Codes: U41275A25, U41275B25; y) All Lot Codes: U41445A25, U41445B30; z) All Lot Codes: U37948A25, U38512C25, U39805C25, U40283C25, U40283B25, U41378A25, U42994A25, 542H0504, 542J0517, 542K0516, 542L0515, 542M0516, 542A0605, 542A0654, 542A0655, 524C0615, 542D0602, 542E0608, 542E0609, 542E0620, 542E0628, 542F0612, 542D0619, 542E0603, 542E0625, U37948B30, U38512A30, U38963A30, U39343B30, U39805A30, U39805C30, U40283A30, U40630B30, U41005A30, U41378C30, U42230A30, U42781A30, U42994B30, U38512B60, U39343A60, U40630A60, U41005B60, U41378B60, 542D0606; aa) All Lot Codes: U36567D25, U36979A25, U36979C25, U37949A25, U37264C25, U37673B30, U38568B25, U39852A25, U39852D25, U39852E25, U39934B25, U39852J25, U41964C25, U42665A25, U36567A30, U36567C30, U37264A30, U36979D30, U37673A30, U37949B30, U38568A30, U38730A30, U38730B30, U38568C30, U39852B30, U39934A25, U39852F30, U39852G30, U39852H30, U39852K30, U41964B30, U42665B30, U36567B60, U36979B60, U37264B60, U39852C60, U41964A60; bb) All Lot Codes: 40299, 40812, 41385, 42542; cc) All Lot Codes: U38343B25, U39452A25, U40676B25, U40956A25, U41636A25, 706J0522, 706k0539, 706L0512, 706L0530, 706A0605, 705A0621, 706A0641, 706D0607, 706F0609, 706FO620, 706E0620, U37811A30, U38343A30, U38343C30, U39452B30, U40676A30, U40956B30, U41636B30; dd) All Lot Codes: 707J0522, 707K0539, 707L0530, 707L0544, 707A0657, 707B0618, 707D0602, 707D0615, 707D0627, 707F0622; ee) All Lot Codes: U38359C25, U40402C25, U41020A25, U38359A30, U38359B30, U38359D30, U40402A30, U40402B30, U40402D30, U41020B30, U41020C30, U41240A30; ff) All Lot Codes: U36885A25, U37531B25, U38323B25, U39785A25, U39785D25, U39785C25, U40592B25, U41214A25, U36885A30, U37531A30, U37531C30, U37531D30, U38323A30, U39262A30, U39262B30, U39785E30, U39785B30, U40346A30, U40592A30, U40592C30, U41214B30; gg) All Lot Codes: U36887A25, U37907A25, U38391B25, U38391C25, U38916A25, U39180A25, U39856A25, U39856C25, U39856D25, U41425A25, U42607B25, U43121A25, U43531A25, 36589, 36868, 170F0513, 170G0519, 170H0513, 170J0504, 170k0510, 170l0505, 170M0522, 170A0614, 170A0627, 170B0636, 170D0627, 170E0633, 42084, 170D0630, U36887A30, U37565A30, U37565B30, U37907B, U37907C30, U38391A30, U37565C30, U38391D30, U38916B30, U39180B30, U39856A30, U39856E30, U40711A30, U41425B30, U41944A30, U42607A30, U43121B30, U43531B30; hh) All Lot Codes: U36891A25, U37351B25, U41243A25, U42515A25, U36891A30, U37351A30, U37351C30, U41243B30, U42515B30; ii) All Lot Codes: U36324C25, U37530B25, U38565C25, U39481A25, U39912D25, U41125A25, U41813B25, U42997A25, U43458A25, U36324A30, U36528B30, U36728A30, U37530A30, U37530D30, U37911A30, U38565B30, U38908A30, U38565D30, U37530F30, U38908B30, U39481A30, U39912A30, U39912C30, U39912E30, U40593A30, U41813C30, U42997C30, U43458B30, U43458C30, U36324B60, U36528A60, U36324D60, U37530C60, U37530E60, U38565A60, U39912B60, U41125B60, U41813A60, U42997B60; jj) All Lot Codes: U39604A25, U39604B25, U39604D25, U39604E25, U39604F25, 048A0646, 048E0601, U39604C30; kk) All Lot Codes: U39914B25, U39914C25, U39914A30, U39914D30, U41088A30; ll) All Lot Codes: U40829B25, U41245B25, 39429, 050L0533, 050B0603, 050B0645, 41774, 050E0601, U40829A30, U41245A30, U41245C30; mm) All Lot Codes: U41449B25, 997M0511, 997A0621, 997B0622, 997C0629, 997E0601, U41449A30; nn) All Lot Codes: U37494A25, U41247A25, 37487, 38171, 39401, 996M0528, 996B0639, 996D0608, 42748, 42749, U37494A30, U41247B30; oo) All Lot Codes: 661E0508, 661F0507, 37440, 661G0509, 661H0508, 38192, 661h0533, 661K0518, 661k0544, 661k0550, 661M0530, 661A0650, U38473A30, U38473C30, U39520A30, U39520B30, U39933B30, U39933C30, U40357A30, U40357C30, U39933D30, U38473B, U39933A25, U40357B60, U41250A60; pp) All Lot Codes: U37945B30, U37945C30, U38480A30, U40397B30, U40633B30, U40633A30, U41441B60, U42106B30, U37945A60, U40397A60, U41441A60, U42106A60; qq) All Lot Codes: U40634A25, U40634E25, U41652A25, 38835, 662M0502, 662MO529, 40968, 662C0626, 662E0603, U39183B30, U40634B30, U40634D30, U40634F30, U41652C30, U39183A60, U40634C60, U41652B60; rr) All Lot Codes: U41426A25, U41426B30; ss) All Lot Codes: U41290A25, U42105B25, 605G0516, 605k0536, 605L5018, 605M0539, 605A0616, 605B0622, 43034, U41290B30, U42105A30; tt) All Lot Codes: 147F0508, 147K0538, 147A0610, 147G0604 MANUFACTURED & RECALLED BY Heartland Repack Services LLC, Toledo, OH QUANTITY 566,734,636 units DISTRIBUTION Nationwide REASON Misbranding. There is the possibility of multiple product packaging mix-ups. An OTC drug, Rx drug ,or nutritional supplement other than what is indicated on the product labeling, may be inside the packaging. ---------------------------------------------------------------------------