JUNE 2007
WEEK ENDING JUNE 2
PRODUCT
a)
HALOPERIDOL 0.5MG TABLET, 250 count bags (NDC #61392026325),
30 count bingo
card (NDC #61392026339) & 30 count boxes (NDC #61392026330),
Rx,
b) HALOPERIDOL 10MG TABLET, 30 count bingo card
(NDC
#61392027539), Rx,
c) HALOPERIDOL 1MG TABLET, 250
count bags (NDC #61392026625),
30 count bingo card (NDC #61392026639) &
30 count boxes (NDC #61392026630),
Rx,
d)
HALOPERIDOL 2MG TABLET, 250 count bags (NDC #61392026925), 30 count
bingo
card (NDC #61392026939) & 30 count boxex (NDC #61392026930), Rx,
e) HALOPERIDOL 5MG TABLET, 250 count bags
(NDC #61392027225), 30
count
bingo card (NDC #61392027239), 31 count bingo card (NDC #61392027231),
30 count boxes (NDC #61392027230), & 60 count boxes (NDC #61392027260),
Rx,
f) HYDRALAZINE 25MG TABLET, 250 count bags (NDC
#61392004325),
30 count bingo card (NDC #61392004339), 30 count boxes (NDC
#61392004330)
& 60 count boxes (NDC #61392004360), Rx,
g) HYDRALAZINE 50MG TABLET, 250 count bags
(NDC #61392063725)
& 30 count
boxes (NDC #61392063730), Rx,
h)
HYDROCHLOROTHIAZIDE 12.5MG CAPSULE, 250 count bags (NDC #61392057725)
&
30 count boxes (NDC #61392057730), Rx,
i)
HYDROCHLOROTHIAZIDE 25MG TABLET, 250 count bags (NDC #61392001125)
& 30
count boxes (NDC #61392001130), Rx,
j) HYDROCODONE/APAP
5/500MG TABLET (c), 15 count bingo card (NDC #61392071515),
30 count bingo
card (NDC #61392071539), 31 count bingo card (NDC #61392071531)
& 15
count bingo card (NDC #61392071505), Rx,
k) HYDROCODONE/APAP 7.5/500MG TABLET (c), 30 count bingo card
(NDC
#61392072939), Rx,
l) HYDROXYZINE 25MG
TABLET, 250 count bags (NDC #61392001325),
30 count bingo card (NDC
#61392001339) & 30 count boxes
(NDC #61392001330), Rx,
m) IBUPROFEN 200MG TABLET (BROWN), 30 count bingo card
(NDC #61392095139)
& 31 count bingo card (NDC #61392095131), OTC,
n) IBUPROFEN 400MG TABLET, 250 count bags
(NDC
#61392052725) &
60 count boxes (NDC #61392052760), Rx,
o) IBUPROFEN 600MG TABLET, 250 count bags
(NDC
#61392052925),
30 count bingo card (NDC #61392052939) & 30 count boxes
(NDC #61392052930), Rx,
p) IBUPROFEN 800MG TABLET,
30 count bingo card (NDC #61392052839),
Rx,
q)
IMIPRAMINE 10MG TABLET, 30 count bingo card (NDC #61392002539), Rx,
r) IMIPRAMINE 25MG TABLET, 30 count bingo card
(NDC
#61392002639), Rx,
s) IMIPRAMINE 50MG TABLET, 30
count bingo card (NDC #61392002739), Rx,
t)
INDOMETHACIN 25MG CAPSULE, 30 count bingo card (NDC #61392081539),
Rx,
u) ISONIAZID 300MG TABLET, 30 count bingo card
(NDC
#61392080339), Rx,
v) ISOSORBIDE DINITRATE 10MG
TABLET, 250 count bags (NDC #61392030525),
30 count bingo card (NDC
#61392030539), 31 count bingo card (NDC #61392030531),
30 count boxes (NDC
#61392030530) & 90 count boxes (NDC #61392030590), Rx,
w) ISOSORBIDE DINITRATE 20MG TABLET, 250 count bags
(NDC
#61392032125),
30 count bingo card (NDC #61392032139), 31 count bingo card (NDC #61392032131),
30 count boxes
(NDC #61392032130) & 90 count boxes (NDC #61392032190), Rx,
x) ISOSORBIDE DINITRATE 30MG
TABLET, 250 count bags (NDC #61392031825),
30 count bingo card (NDC
#61392031839) & 30 count box (NDC #61392031830),
Rx,
y) ISOSORBIDE DINITRATE 5MG TABLET, 30 count bingo card
(NDC
#61392031139) & 31 count bingo card (NDC #61392031131),
Rx,
z) ISOSORBIDE MONONITRATE 10MG TABLET, 30 count bingo card
(NDC #61392091239), Rx,
aa) ISOSORBIDE MONONITRATE
20MG TABLET, 250 count bags
(NDC #61392091325), 30 count bingo card (NDC
#61392091339),
30 count boxes (NDC #61392091330),
bb)
K-TAB 10mEqTABLET, 250 count bags (NDC #61392090025), 30 count
bingo card (NDC #61392090039), 60 count bingo card
(NDC #61392090065),
30 count boxes (NDC #61392090030) & 60 count boxes (NDC #61392090060),
Rx,
cc) LABETALOL 100MG TABLET, 250 count bags
(NDC #61392045925),
30 count bingo card (NDC #61392045939), & 30 count boxes
(NDC
#61392045930), Rx,
dd) LABETALOL 200MG TABLET, 30 count
bingo card (NDC #61392073339) &
31 count bingo card (NDC #61392073331),
Rx,
ee) LABETALOL 300MG TABLET, 30
count bingo card (NDC #61392077639),
Rx,
ff) LISINOPRIL 10MG TABLET, 250 count bags
(NDC
#61392069325), 30 count boxes (NDC #61392069330), &
60 count boxes (NDC
#61392069360), Rx,
gg) LISINOPRIL 2.5MG
TABLET, 250 count bags (NDC #61392069125),
30 count bingo card (NDC
#61392069139), 31 count bingo card
(NDC #61392069131), 30 count boxes (NDC
#61392069130) & 15
count bingo card (NDC #61392069105), Rx,
hh) LISINOPRIL 20MG TABLET, 250 count bags
(NDC #61392069425),
30 count bingo card (NDC #61392069439), 31 count bingo
card
(NDC #61392069431), 30 count boxes (NDC #61392069430),
60 count
boxes (NDC #61392069460), & 15 count bingo card
(NDC #61392069405), Rx,
ii) LISINOPRIL 30MG TABLET, 30 count
bingo card (NDC #61392069539),
Rx,
jj) LISINOPRIL 40MG TABLET, 250 count bags
(NDC
#61392069625),
30 count boxes (NDC #61392069630) & 60 count boxes (NDC
#61392069660),
Rx,
kk) LISINOPRIL/HCTZ 10/12.5MG TABLET, 30 count bingo card
(NDC #61392069739),
Rx,
ll) LISINOPRIL/HCTZ 20/12.5MG
TABLET, 250 count bags (NDC #61392069825),
30 count bingo card (NDC
#61392069839) & 30 count boxes (NDC #61392069830),
Rx,
mm) LOPERAMIDE 2MG CAPSULE, 250 count bags
(NDC
#61392033625)
& 30 count boxes (NDC #61392033630), Rx,
nn) LORATADINE 10MG TABLET, 250 count bags
(NDC
#61392056225)
& 30 count boxes (NDC #61392056230), OTC,
oo) LORAZEPAM 0.5MG TABLET (c), 30 count bingo card
(NDC
#61392045539),
31 count bingo card (NDC #61392045531) & 15 count bingo
card
(NDC #61392045505), Rx
pp)
LORAZEPAM 2MG TABLET (c), 30 count bingo card (NDC #61392045239), Rx,
qq) LOVASTATIN 10MG TABLET, 30 count bingo
card (NDC #61392079739), Rx,
rr)
LOVASTATIN 40MG TABLET, 30 count bingo card (NDC #61392073739), Rx,
ss) MECLIZINE 12.5MG TABLET, 250 count bags
(NDC #61392033825) & 30 count boxes
(NDC #61392033830), Rx,
tt) MECLIZINE 25MG TABLET, 250 count bags
(NDC #61392033925), 30
count boxes
(NDC #61392033930) & 60 count boxes (NDC #61392033960), Rx,
Recall # D-621-2007;
uu) METFORMIN 1000MG TABLET, 30 count bingo card (NDC
#61392068739), Rx,
vv) METFORMIN 500MG TABLET, 250
count bags (NDC #61392068525), 30 count
bingo card (NDC #61392068539), 30
count boxes (NDC #61392068530),
60 count boxes (NDC #61392068560) & 15
count bingo card (NDC #61392068505),
Rx,
ww)
METHAZOLAMIDE 50MG TABLET, 30 count bingo card (NDC #61392089039),
Rx,
xx) METHOCARBAMOL 500MG TABLET, 30 count bingo card
(NDC #61392046039), Rx,
yy) METHOCARBAMOL 750MG
TABLET, 250 count bags (NDC #61392077325),
30 count bingo card (NDC
#61392077339) & 30 count boxes (NDC #61392077330),
Rx,
zz) METHYLDOPA 250MG TABLET, 30 count bingo card
(NDC
#61392018439), Rx,
aaa) METOCLOPRAMIDE 10MG TABLET,
250 count bags (NDC #61392055825),
30 count bingo card (NDC #61392055839),
60 count bingo card (NDC #61392055865),
30 count boxes (NDC #61392055830),
60 count boxes (NDC #61392055860) &
90 count boxes (NDC #61392055890),
Rx,
bbb) METOCLOPRAMIDE 5MG TABLET, 250 count bags (NDC
#61392055725) &
30 count boxes (NDC #61392055730), Rx,
ccc) METOPROLOL TARTRATE 100MG TABLET, 250 count bags
(NDC
#61392028025),
30 count bingo card (NDC #61392028039), 31 count bingo card (NDC #61392028031),
30 count boxes
(NDC #61392028030), 60 count boxes (NDC
#61392028060), Rx,
ddd) METOPROLOL TARTRATE 25MG
TABLET, 250 count bag (NDC #61392028525),
30 count bingo card (NDC
#61392028539), 31 count bingo card (NDC #61392028531,
30 count boxes (NDC
#61392028530), 60 count boxes (NDC #61392028560), &
15 count bingo card
(NDC #61392028505), Rx,
eee) METOPROLOL TARTRATE 50MG
TABLET, 250 count bags (NDC #61392028625),
30 count bingo card (NDC
#61392028639), 31 count bingo card
(NDC #61392028631), 60 count bingo card (NDC #61392028665), 30 count boxes
(NDC #61392028630), 60 count boxes
(NDC
#61392028660), & 15 count bingo card
(NDC #61392028605), Rx,
fff) METRONIDAZOLE 250MG TABLET, 250 count bags
(NDC
#61392039725),
30 count bingo card (NDC #61392039739) & 30 count boxes (NDC #61392039730),
Rx,
ggg) METRONIDAZOLE 500MG
TABLET, 30 count bingo card (NDC #61392039939),
Rx,
hhh) MINOCYCLINE 100MG CAPSULE, 30 count bingo card
(NDC
#61392074139), Rx,
iii) MINOXIDIL 2.5MG TABLET, 30 count
bingo card (NDC #61392046139),
Rx,
jjj)
MULTIVITAMINS, THER W-MINERALS TABLET, 250 count bags
(NDC #61392035125)
& 30 count boxes (NDC #61392035130), OTC,
kkk)
MULTIVITAMINS, THERAPEUTIC TABLET, 250 count bags (NDC #61392035025)
&
30 count boxes (NDC #61392035030), OTC,
lll) NALTREXONE
50MG TABLET, 30 count bingo card (NDC #61392046639), Rx,
mmm) NAPROXEN 250MG TABLET, 30 count bingo card
(NDC
#61392028939), Rx,
nnn) NAPROXEN 375MG TABLET, 30
count bingo card (NDC #61392029239)
& 30 count boxes (NDC #61392029230),
ooo) NAPROXEN 500MG TABLET, 250 count bags
(NDC
#61392029525),
30 count bingo card (NDC #61392029539) & 30 count boxes
(NDC #61392029530), Rx,
ppp) NIFEDIAC ER 30MG
TABLET, 30 count bingo card (NDC #61392048439),
Rx,
qqq) NIFEDIAC ER 60MG TABLET, 30 count bingo card
(NDC
#61392048539), Rx,
rrr) NIFEDIAC ER 90MG TABLET, 30
count bingo card
(NDC #61392048639), Rx,
sss)
NIFEDIPINE 10MG CAPSULE, 30 count bingo card
(NDC #61392035639), Rx,
ttt) NITROFURANTOIN 100MG CAPSULE, 30 count bingo card
(NDC
#61392073439), Rx,
uuu) NORTRIPTYLINE 10MG CAPSULE, 30
count bingo card (NDC #61392036139)
& 31 count bingo card (NDC
#61392036131), Rx,
vvv) NORTRIPTYLINE 25MG CAPSULE, 30
count bingo card
(NDC #61392036439), Rx,
www)
NORTRIPTYLINE 50MG CAPSULE, 30 count bingo card
(NDC #61392036739), Rx,
xxx) NORTRIPTYLINE 75MG CAPSULE, 30 count bingo card
(NDC #61392037039), Rx,
yyy) OXYBUTYNIN 5MG TABLET,
250 count bags (NDC #61392013825),
30 count boxes (NDC #61392013830) &
60 count boxes (NDC #61392013860),
Rx,
zzz) OYSTER
SHELL 500MG TABLET, 250 count bags (NDC #61392000625),
30 count bingo card (NDC #61392000639), 30 count boxes
(NDC #61392000630)
& 60 count boxes (NDC #61392000660), OTC,
CODE
a) All
Lot Codes: U41008A25, U41008C25, U41321A25, 263k0506, 263L0519,
263M0510,
263A0618, 263A0627, 263C0615, 263D0630, 263E0625, 263F0616,
U41008B30,
U41321B30;
b) All Lot Codes: 275E0508, 37864, 275J0527, 39430, 39909,
275A0603, 275C0616,
42092, 275E0603, 275F0612
c) All Lot Codes:
U38605B25, U39754B25, U41330A25, U43225A25, U43614A25,
U43614C25, 266D0507,
266k0506, 266L0502, 266M0539, 40313, 266B0616,
266C0612, 266E0608, 266F0601,
U38605A30, U39754A30, U38605C30,
U41330B30, U43225B30, U43614B30;
d) All
Lot Codes: U41961A25, U41992A25, 269J0511, 269L0512, 269M0541,
269B0616,
269C0614, 269E0603, 269F0606, U38143A30, U41961B30, U41992B30;
e) All Lot
Codes: U37596B25, U37596D25, U39320A25, U43580A25, 272G0509,
272K0506,
272L0519, 272L0546, 272A0602, 272A0647, 41010, 272C0622, 272C0629,
272E0608,
272F0601, 42381, U37171C30, U37596A30, U37596C30, U38392A30,
U38891A30,
U38891B30, U39320B30, U38392B25, U41461A30, U37171A60, U37171B60,
U43580B60;
f) All Lot Codes: U41207B25, U42605A25, 043C0606, 043C0629,
043D0627,
043E0625, 043F0634, U41207C30, C42423A30, U42605C30, U41207A60,
C42423B60, U42605B60;
g) All Lot Codes: U39225R25, U40632A25, U40632C25,
U41211A25, U39225R30,
U40632B30, U40632D30, U41211B30;
h) All Lot Codes:
U36551A25, U38141B25, U41019C25, U41019D25, U42519A25,
U36551A30, U38141A30,
U39857A30, U40290A30, U40290B30, U41019A30,
U41019B30, U41019E30, U42519B30,
U42993A30;
i) All Lot Codes: U36432C25, U36432A25, U37883B25, U38912B25,
U39449A25,
U40281A25, U40591A25, U41173A25, U41943A25, U36432B30, U36432D30,
U37353A30, U37602A30, U37883A30, U37602B30, U38912A30, U39961A30,
U39915A30, U40281B30, U40281C30, U40591B30, U40591C30, U41172B30,
U41943B30, U41631A30, U42626A30;
j) All Lot Codes: 715C0515, 715D0524,
715F0524, 715G0512, 71550517, 715G0514,
715k0521, 715K0535, 715L0539,
715M0515, 715A0629, 715B0604, 715E0621,
715DO626, 715E0619, 715F0627,
715C0523, 37335, 37435, 715F0513, 715G0503,
715h0511, 715H0509, 715H0526,
715k0524, 715k0550, 715L0510, 715M0530,
715A0614, 715A0656, 715B0631,
715B0632, 715B0614, 715C0602, 715B0615,
715C0624, 715E0602, 715E0618,
715E0620, 715F0625, 715H0513, 715k0507,
715k0538, 715l0536, 715A0631,
715B0643, 36257, 36682, 37023, 37236, 37710,
38123, 38211, 38499, 38558,
40561, 715D0617, 715F0610, 715F0630, 715F0631,
715F0632;
k) All Lot
Codes: 729D0511, 729E0501, 729F0508, 729G0510, 729J0510,
729k0540, 729L0511,
729L0546, 729M0533, 729B0607, 729B0605,
729C0630, 729E0609, 729F0625,
729G0603;
l) All Lot Codes: U40386B25, U41206A25, 013k0516, 013L0515,
013L0530,
013M0519, 013A0621, 013A0627, 41319, U40386A30, U40716A30,
U41206B30;
m) All Lot Codes: 39112, 951a0621, 951B0625, 951D0607, 951E0609,
43205,
951FO626, 39113, 39952, 951EO632;
n) All Lot Codes: U36238B25,
U36238A60;
o) All Lot Codes: U42602A25, 529C0607, 42541, 42746, 529G0603,
U36188A30,
U36188B30, U42602B30;
p) All Lot Codes: 528F0513;
q) All
Lot Codes: 39908, 41269;
r) All Lot Codes: 39257, 40728, 40851, 42165;
s)
All Lot Codes: 39052, 027M0528, 43207
t) All Lot Codes: 39155, 41878,
41983;
u) All Lot Codes: 39283, 40789, 803F0601;
v) All Lot Codes:
U36433A25, U37594A25, U38486A25, U38728A25,
U39212B25, U39676C25, U41648A25,
305C0517, 305D0507, 305F0523,
305G0510, 37863, 305J0508, 305k0504, 305l0506,
305M0504, 305A0603,
305A0636, 305C0623, 305C0629, 305E0608, 305E0620,
305F0601, 305E0620,
305E0624, U36433D30, U36433E30, U36433F30, U37594B30,
U37594C30,
U38728B30, U38486C30, U39676B30, U39212C30, U39676D30, U41463A30,
U41648B30, U36433C90, U36433B90, U36433G90, U38486B90, U39212A90,
U39676A90, U41648C90;
w) All Lot Codes: U36243A25, U36243C25, U36243D25,
U36243E25, U36566D25,
U38412B25, U36243F25, U41464B25, U41465A25, 321D0507,
321H0533,
321k0504, 321L0506, 321M0504, 321A0603, 321A0658, 321C0623,
321C0629,
321E0608, 321F0601, 43276, 321G0608, 42640, U36566A30, U36566B30,
U36566C30, U38412A30, U39219A30, U38412C30, U41464A30, U41465B30,
U36243B90;
x) All Lot Codes: U41466A25, 36394, 38432, 39259, 318M0533,
318C0624,
318F0626, U41466B30;
y) All Lot Codes: 38177, 311k0510, 39033,
311L0529, 41545, 311F0601, 42459;
z) All Lot Codes: 41583;
aa) All Lot
Codes: U42100A25, 38989, 39959, 913B0613, 42097, 913F0626,
U42100B30;
bb) All Lot Codes: U36970B25, U36970C25, U38249A25, U38249D25, U37174E25,
U38249E25, U39182D25, U40671B25, U40872B25, U40957A25, C42149A25,
900D0503, 900E0501, 900F0520, 900F0523, 900G0501, 900J0502, 900K0504,
900k0545, 900L0505, 900M0521, 900A0623, 900A0631, 900A0649, 900C0625,
900E0628, 900F0626, 900F0640, 900G0510, 900A0643, U36970A30, U37174B30,
U37174D30, U38249C30, U38910A30, U38910B30, U39182B30, U40671A30,
U40957C30, C42149C30, U36970D60, U37174A60, U37174C60, U38249B60,
U39182A60, U39182C60, U40671C60, U40872A60, U40957B60, C42149B60;
cc) All
Lot Codes: U39381B25, U41527A25, U41628A25, 37982, 38834, 459A0612,
459A0637, 459A0655, 459D0602, 459F0601, U39381A30, U39381C30,
U41527B30,
U41628B30;
dd) All Lot Codes: 733G0505, 733J0516, 733L0515, 40132, 733A0614,
733B0608,
733C0623, 42241, 733E0602, 733F0601, 38838, 41885;
ee) All Lot
Codes: 37301, 37510, 37839, 38203, 39057, 776A0622, 776C0611,
776E0602,
776F0601;
ff) All Lot Codes: U38368A25, U38895C25, U38895D25, U40825A25,
U41126A25,
U41940A25, U42104A25, U43023A25, U43387D25, U38368C30, U38368B30,
U38895A30, U39962A30, U39962B30, U40175B30, U40292A30,
U40341A30,
U40675B30, U40825B30, U41126B30, U41940B30, U42104C30, U42283A30,
U42283B30, U42283C30, U43023B30, U42433B30, U43387B30, U43387E30,
U38895B60, U38895E60, U40175A60, U40675A60, U42104B60, U42433A60,
U43387A60, U43387C60;
gg) All Lot Codes: U37259B25, U38250B25, U38909B25,
U40126A25, U40360C25,
U41089A25, 691F0508, 691J0512, 691k0534, 691M0526,
691A0610, 691A0625,
691A0655, 691C0626, 691D0616, 42555, 691E0613, 691E0633,
691E0602, 42489,
U37259A30, U37259C30, U37674A30, U37674B30, U37674C30,
U38250A30,
U38250C30, U38909A30, U39480A30, U38909C30, U40126B30, U40315A30,
U40360A30, U40360B30, U42279A30, U42437A30, U43124A30, 42204, 42788,
43368
hh) All Lot Codes: U37254C25, U37675A25, U38985B25, U39479A25,
U38985C25,
U39338B25, U39519A25, U40359C25, U42990A25, 694G0516, 694J0503,
38836,
38837, 694K0518, 694L0519, 694M0527, 694B0641, 694D0607, 694D0615,
694D0624, 694D0627, 694E0625, 694F0635, 694E0617, 694F0606, 43335,
U37254B30, U38140A30, U37254D30, U37675C30, U38140B30, U38985A30,
U39338A30, U40172A30, U40359B30, U40359D30, U40666C30, U40666B30,
U40666D30, U40666E30, C42128B30, C42395A30, U42990B30, U37254A60,
U37675B60, U40359A60, U40359E60, U40666A60, C42128C60, U40359X60,
C42395B60, 42205, 42866, 43788;
ii) All Lot Codes: 39825, 41057,
695C0622, 695D0602, 695E0603, 695F0601;
jj) All Lot Codes: U37348A25,
U37348C25, U37724C, U38851A25, U40340C25,
U40756C25, U41524B25, U42521A25,
U37348B30, U37348E30, U37724A30,
U37724D30, U37348F30, U38520A30, U38520B30,
U38851B30, U39448A30,
U39448B30, U39877B30, U40174A30, U40340A30, U40340D30,
U40340E30,
U40756B30, U41524C30, U42521B30, U43173A30, U37348D60, U37724B60,
U39877A60, U40340B60, U40756A60, U41524A60;
kk) All Lot Codes: 697k0539,
39536, 42096;
ll) All Lot Codes: U42184A25, 38173, 39325, 698C0612, 42240,
698E0620, U42184B30;
mm) All Lot Codes: U36173B25, U37559A25, U37559B25,
U38729A25, U40238B25,
U40607B25, U41510B25, U42998A25, U36173A30, U36173C30,
U36641A30,
U36641B30, U36173D30, U36930A30, U36930B30, U37265A30, U37265B30,
U38729B30, U37559C30, U39538A30, U39538B30, U40238A30, U39538C30,
U40238C30, U40238D30, U40607A30, U41510A30, U41633A30, U42667A30,
U42998B30;
nn) All Lot Codes: U37151A25, U37776B25, U38511B25, U39753A25,
U40173B25,
U41241A25, U42125B25, U42127A25, U37263A30, U37151B30, U37263B30,
U37776A30, U37776C30, U38011A30, U38511A30, U38894A30, U39753B30,
U38894B30, U40284A30, U40173A30, U40284B30, U38511C30, U42125A30,
U42127B30, U42780B30, U42780A30;
oo) All Lot Codes: 455H0504, 455J0509,
455J0535, 455K0530, 455K0549,
455L0504, 455K0547, 455L0523, 455M0510,
455M0511, 455L0519,
455A0625, 455B0601, 455A0655, 455B0624, 455B0635,
455C0625,
455C0604, 455D0608, 455E0608, 455F0633, 455F0634, 455F0637,
455H0508, 455A0632, 455a0637, 455C0622, 455D0603, 455E0611,
455E0606;
pp) All Lot Codes: 452H0525, 38814, 452k0516, 452l0523,
452A0637,
452M0530, 452C0608, 42288, 452E0622, 452F0612, 43188,
452F0635;
qq) All Lot Codes: 40226, 40693, 797C0605, 42566;
rr) All Lot
Codes: 37607, 38153, 38466, 38975, 737M0530, 40733, 40998,
737C0624,
737D0624, 737E0609;
ss) All Lot Codes: U40715A25, U41509B25, U40266A30,
U40715B30,
U40715C30, U41509A30;
tt) All Lot Codes: U37808A25, U38472B25,
U39879A25, U40750A25,
U41507A25, U41508C25, U42438B25, U37808, U38472A30,
U39879C30,
U40750C30, U41507C30, U41508B30, U42438C30, U43122B30,
U39879B60, U40750B60, U41507B60, U41508A60, U42438A60, U43122A60;
uu) All
Lot Codes: 687F0520, 687G0507, 687H0508, 687H0522, 38514, 687k0509,
687L0522, 687M0517, 687A0611, 687A0659, 687C0615, 687D0611, 687E0608,
687F0633, 687F0635, 43444;
vv) All Lot Codes: U37178A25, U38872A25,
U39379A25, U40004C25, U41017B25,
C42394B25, U43025A25, 685F0508, 685F0507,
685H0504, 685H0511,
685H0523, 38261, 685J0517, 685J0528, 685J0531, 685k0545,
685l0530,
685M0523, 685A0611, 685A0632, 685A0655, 685C0615, 685C0629,
685D0611,
685D0630, 685F0633, 685E0628, 685F0635, U37178C30, U37178D30,
U37879B30,
U37178E30, U37526B30, U37879C30, U38872B30, U38872D30, U38872E30,
U39379B30, U40004A30, U40004B30, U41017A30, U41017D30, C41623A30,
U43025C30, U43461A30, U37178B60, U37526A60, U37879A60, U38872C60,
U39379C60, U39379D60, U39802B60, U40004D60, U39802A60, U41017C60,
C41623B60, U42087A60, C42394C60, U42520A60, U43025B60, 42008, 43130;
ww)
All Lot Codes: 37962, 39511, 39874;
xx) All Lot Codes: 37126, 37500,
460H0535, 40424, 41501, 460C0625, 460F0616;
yy) All Lot Codes: U39849A25,
39235, 773M0519, 41877, 773E0601, U39849A30;
zz) All Lot Codes: 38999,
184M0540;
aaa) All Lot Codes: U37006B25, U37150B25, U37150D25, U38393A25,
U38780A25,
U39271B25, U39271E25, U40506B25, U40753B25, U42005B25, U42518A25,
C42393B25, 5580508, 558F0508, 558G0501, 558H0504, 558h0513, 558J0525,
558k0507, 558k0531, 558L0511, 558l0534, 558M0504, 558A0607, 558B0602,
558C0609, 558C0629, 558E0613, 588F0616, 558G0604, 558E0624, 558E0625,
558F0623, 558E0501, 558L0513, 558M0534, 558D0623, U36435A30, U37006E30,
U37150C30, U37150F30, U37728A30, U38393D30, U38562A30, U38393C30,
U39271A30, U38780B30, U39787A30, U40113B30, U40753A30, C41236A30,
U42005C30, U36435B60, U37006A60, U37006C60, U37728B60, U38393B60,
U39271D60, U40113A60, U39271F60, U39787C60, U40753C60, C41236B60,
U41242A60, U42005A60, C42393D60, U42518B60, C43002C60, U37006D90,
U37150A90, U37006F90, U37150E90, U39271C90, U39787B90, U40506A90,
U41242B90, C42393C90, U42518C90, C43002B90;
bbb) All Lot Codes:
U38320R25, U39673C25, U39673B25, U40457B25, U40631A25,
U40457C25, C41955B25,
C41955C25, U42350A25, C42614B25, C43266B25,
U38320R30, U39321A30, U39321B30,
U39321C30, U39321D30, U39673A30,
U40457A30, U40631B30, U41213A30, C41955A30,
C42614C30, C42703A30,
C42703C30, C43000A30, C42703B30, C43000B30, C43266A30,
U43224A30,
U43224B30, U43224C30;
ccc) All Lot Codes: U37913A25,
U37913D25, U38344A25, U38782A25, U39179B25,
U39690B25, U39690D25, U39690F25,
U41209B25, U41963B25, 38193, 280H0535,
280k0526, 280L0530, 280M0506,
280M0546, 280A0635, 280A0654, 280C0608,
280C0629, 42134, 280D0627, 42540,
280F0638, 37442, 38582, 280k0550,
42460, 42461, U37913B30, U37913C30,
U38344B30, U38508C30, U38782B30,
U39179A30, U39690A30, U39690E30, U41015A30,
U41209A30, U41963C30,
U42526A30, U37595A60, U38508A60, U38508B60, U38782C60,
U39179C60,
U39690C60, U41209C60, U41963A60, U43530A60;
ddd) All Lot
Codes: U36832B25, U36782B25, U37667A25, U36782E25, U38040B,
U38358A25,
U38727A25, U39069B25, U39446A25, U40003C25, U40767B25,
U40963A25, U41439B25,
C41735B25, U41962A25, U42630A25, C42897B25,
36475, 285F0513, 285H0532,
285k0502, 285L0521, 285L0512, 285L0543, 285M0508,
39954, 285A0604, 285a0619,
285A0653, 285B0619, 285B0621, 285B0624, 285B0646,
285C0614, 285C0630,
285E0603, 285F0619, 285F0620, 36475, 285F0513, 37441,
285L0535, 39956,
285A0603, 285B0644, 285D0608, 285E0625, U36832A30,
U36782A30, U36832C30,
U36782D30, U37778A30, U38040A30, U38040C30,
U38358B30, U38358E30, U38358F30,
U38727B30, U39069A30, U39704B30,
U39704C30, U39446B30, U40003A30, U39704D30,
U40316A30, C41091A30,
C41735A30, C41906A30, U42003A30, U42630C30, C42897A30,
C42897D30,
C43434A30, C43443A30, U36782C60, U37667B60, U38040D60, U38358C60,
U38358D60, U38727C60, U39704A60, U40003B60, U40003D60, U40316B60,
U39704E60, U40767A60, U36782F60, C41091B60, U41462A60, U41439A60,
U41962B60, U41993A60, C41906B60, U42630B60, C42897C60, C43434B60,
41848,
285F0603, 285F0617;
eee) All Lot Codes: U38437A25, U38977A25, U39178A25,
U40170A25, U40808C25,
C42079B25, U43390A25, C43442B25, 286H0503, 286H0526,
286j0533, 286k0550,
286M0506, 286M0533, 286A0603, 286B0601, 286B0616,
286C0611, 286C0625,
286C0629, 286D0630, 286F0639, 286F0638, 286E0610,
286E0624, 286E0625,
286F0623, 286G0509, 286h0512, 286L0509, 286C0617,
286D0610, 286E0605,
U37777A30, U38437B30, U38509A30, U38509B30, U39178B30,
U38977D30,
U39694A30, U39694B30, U39694C30, U40808A30, U40808B30, c41190a30,
C43442A30, U43390C30, U37777B60, U38437C60, U38509C60, U38977B60,
U38977C60, U39694C60, U39939A60, U40170B60, U40599A60, U40808D60,
U41016A60, C41190B60, C42079C60, U42185A60, U42601A60,
U43168A60,
U43390B60, 41785, 286E0604, 286F0617;
fff) All Lot Codes:
U37810A25, U38144B25, U40288A25, U40686A25,
U41651A25, 36453, 36731, 37567,
37804, 38312, 41264, U37810B30,
U38144A30, U38144C30, U38144D30, U40288B30,
U40686B30, U41651B30;
ggg) All Lot Codes: 37613, 39034, 399A0614, 399D0611,
399E0614, 399F0635;
hhh) All Lot Codes: 39053, 39054, 741B0606,
41737;
iii) All Lot Codes: 39395, 39901, 461B0608, 461G0603;
jjj) All Lot
Codes: U36931A25, U37528B25, U38395C25, U39804A25, U40236A25,
U40436B25,
U40436C25, U40628B25, U40628C25, U41021A25, U41440A25,
U43047a25, C43469B25,
C42753B25, C43675B25, C43675E25, U36186A30,
U36931B30, U37528A30, U37845A30,
U38395A30, U38395B30, U38395E30,
U38395D30, U38893A30, U37528C30, U37528D30,
U39804B30, U37528E30,
U37528F30, U40236C30, U40236B30, U40436A30, U40436D30,
U40628A30,
U40628D30, U41021B30, U41440B30, U42002A30, U42671A30,
U43047B30,
C43469A30, C42753A30, C43675C30, C43675D30;
kkk) All Lot Codes:
U36448A25, U36448D25, U37144A25, U37144B25, U38483A25,
U40287A25, U40990A25,
U41274A25, U41994A25, C42793B25, U42666A25,
U36471B30, U36471A30, U36448C30,
U36448B30, U37144C30, U37593A30,
U37144D30, U38483B30, U38483C30, U37905A30,
U38986A30, U39986A30,
U40127A30, U40990B30, U41274B30, U41994B30, C42793A30,
C42793C30,
U42666B30, C43230A30, U42995A30, C43230B30;
lll) All Lot
Codes: 36162, 36990, 39035, 39396, 42093;
mmm) All Lot Codes: 39389,
289M0503, 40337, 289B0623, 289E0603,
289F0606;
nnn) All Lot Codes: 38815,
39037, 39955, 40302, 292B0621, 42692, 42695,
292F0623, U41372A30;
ooo)
All Lot Codes: U40207A25, U40955B25, U40955D25, 295k0505,
295M0509,
295A0637, 295B0629, U38037A30, U40207B30, U40955A30, U40955C30;
ppp) All Lot
Codes: 484M0519, 42985, 43033, 43806;
qqq) All Lot Codes: 485M0519, 42382,
43338;
rrr) All Lot Codes: 39840;
sss) All Lot Codes: 40479,
43194;
ttt) All Lot Codes: 37611, 37706, 40116, 40734, 42164, 42242;
uuu)
All Lot Codes: 361M0541, 361A0628, 41989, 41988, 42709, 42710, 42427;
vvv)
All Lot Codes: 364A0622, 364C0608, 364F0626;
www) All Lot Codes: 367L0533,
367B0610, 42745;
xxx) All Lot Codes: 37799, 38950, 41544;
yyy) All Lot
Codes: U37599B25, U38390B25, U41208A25, U37599C30,
U38390C30, U38390D30,
U39181A30, U39181B30, U40606A30,
U40453B30, U41208C30, U37599A60, U38390A60,
U40453A60, U41208B60;
zzz) All Lot Codes: U36507B25,
U36922B25, U37139B25, U39260A25,
U37139E25, U36922D25, U40314A25, U40314D25,
U40953A25,
U42672A25, 36457, 006E0508, 006F0513, 006G0507, 006H0509,
006j0504, 006J0516, 006K0517, 39009, 006L0532, 006M0517, 006A0624,
006A0627, 066B0615, 006D0602, 006E0603, 006F0633, 006E0602, 43204,
U36507A30, U36922A30, U36242B30, U36922C30, U37139C30, U38852A30,
U39260B30, U39022A30, U38147A30, U37882C30, U38852B30, U40000A30,
U39803B30, U40000B30, U40314B30, U40314E30, U40953C30, U43268B30,
U36242A60, U37139A60, U37139D60, U37882A60, U37882B60, U39803A60,
U40314C60, U40953B60, U41563A60, U41941A60, U41630A60, U42672B60,
U43268A60
RECALLING FIRM/MANUFACTURER Heartland
Repack Services, LLC, Toledo, OH,
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.
VOLUME OF PRODUCT IN COMMERCE 566,734,636
units
DISTRIBUTION Nationwide
PRODUCT Artificial
Tears Lubricant Eye Drops, ˝ fl. oz. (15mL),
CODE Lots: 047611, 067401, and 097651
RECALLING FIRM/MANUFACTURER Bausch & Lomb, Inc.,
Tampa, FL,
REASON The front panel of the carton incorrectly
states that the product is preservative free.
VOLUME OF PRODUCT IN
COMMERCE 10,092
units
DISTRIBUTION Nationwide
PRODUCT Oxybutynin
Chloride Tablets, 5mg, 100 tablet bottles, Rx only, NDC 0182-1289-89,
CODE
Lots: 4565031A, exp. 10/07; 4565034A,
exp. 12/07; 4565035A, exp. 12/07; 4566008AA, exp. 2/08; 4566016AA, exp. 3/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX
Pharmaceuticals, Miami, FL,
Manufacturer: Pliva
Inc., East Hanover, NJ.
REASON The product does not meet dissolution
specifications.
VOLUME OF PRODUCT IN COMMERCE 16,714
tablets
DISTRIBUTION Nationwide
WEEK ENDING JUNE 9
PRODUCT
a)
ACETAMINOPHEN 325MG 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,
b) ACETAMINOPHEN 500MG CAPLET, 250
count bags (NDC #61392094825) & 30 count boxes (NDC
#61392094830), OTC,
c) ACETAMINOPHEN 500MG GELCAP, 30
count bingo card (NDC #61392064439), OTC,
d) ACETAMINOPHEN 500MG TABLET, 250 count bags
(NDC #61392003025), 30 count bingo card (NDC #61392003039), 30 count boxes (NDC #61392003030) & 60 count boxes
(NDC
#61392003060), OTC,
e) ACETAMINOPHEN/COD#3 300/30MG
TABLET (c), 30 count bingo card (NDC #61392071439) &
31 count bingo card (NDC #61392071431), Rx,
f) ACETAMINOPHEN/COD#4 300/60MG TABLET (c), 30 count bingo card
(NDC #61392002839), Rx,
g)
ACETAZOLAMIDE 250MG TABLET, 30 count bingo card (NDC #61392017639), Rx,
h) ALBUTEROL SULFATE 2MG
TABLET, 30 count bingo card (NDC #61392056739) Rx,
i) ALBUTEROL SULFATE 4MG TABLET, 30 count bingo card
(NDC
#61392057039), Rx,
j) ALLOPURINOL 100MG
TABLET, 250 count bags (NDC #61392010325), 30 count bingo
card (NDC #61392010339), 30 count boxes (NDC #61392010330), & 60 count boxes
(NDC #61392010360), Rx,
k) ALLOPURINOL 300MG TABLET, 250 count bags (NDC #61392010425)
& 30 count boxes (NDC #61392010430), Rx,
l) ALPRAZOLAM 0.25MG TABLET (c), 30 count bingo card
(NDC
#61392003439), 31 count bingo card (NDC #61392003431)
& 15 count bingo card (NDC #61392003439), Rx,
m) ALPRAZOLAM 0.5MG TABLET (c), 30 count bingo card
(NDC
#61392003539, 31 count bingo card (NDC #61392003531)
& 15 count bingo card (NDC #61392003505), Rx,
n) ALPRAZOLAM 1MG TABLET (c), 30 count bingo card
(NDC
#61392003639), Rx,
o) AMANTADINE
100MG CAPSULE, 250 count bags (NDC #61392004225), 30
count bingo card (NDC #61392004239) & 30 count boxes (NDC #61392004230), Rx,;
p) AMIODARONE 200MG TABLET,
250 count bags (NDC #61392093525), 30 count boxes (NDC
#61392093530) & 60 count boxes (NDC #61392093560),
Rx,
q) AMITRIPTYLINE 100MG TABLET, 30 count bingo card (NDC #61392015339), Rx,
r)
AMITRIPTYLINE 25MG TABLET, 30 count boxes (NDC #61392014030) Rx,
s) AMITRIPTYLINE 50MG TABLET,
30 count bingo card (NDC #61392014139), Rx,
t) ASPIRIN 325MG TABLET, 250 count bags
(NDC #61392003325), 30
count bingo card (NDC #61392003339), & 30 count boxes (NDC #61392003330), OTC,
u)
ASPIRIN BUFFERED 325MG TABLET, 250 count bags (NDC #61392003125), 30 count bingo card
(NDC #61392003139), & 30 count
boxes (NDC #61392003130), OTC,
v)
ASPIRIN CHEW 81MG TABLET, 250 count bags (NDC #61392003225), 30 count bingo card
(NDC #61392003239), 31 count bingo
card (NDC #61392003231), & 30 count boxes (NDC
#61392003230), OTC,
w) ASPIRIN EC 325MG TABLET, 250
count bags (NDC #61392089925), & 30 count boxes (NDC
#61392089930),
x) ASPIRIN EC 81MG TABLET, 250 count bags (NDC #61392009625), OTC,
y)
ATENOLOL 100MG TABLET, 250 count bags (NDC #61392054625) & 30 count boxes
(NDC #61392054630), Rx,;
z) ATENOLOL 25MG 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,
aa) ATENOLOL 50MG TABLET, 150
count bags (NDC #61392054325), 30 count boxes (NDC
#61392054330) & 60 count boxes (NDC #61392054360), Rx, ;
bb) AZATHIOPRINE 50MG TABLET, 30
count bingo card (NDC #61392080439), Rx,
cc) BACLOFEN 10MG TABLET, 250 count bags
(NDC #61392070625),
30 count bingo card (NDC #61392070639) & 30 count
boxes (NDC #61392070630), Rx,
dd)
BACLOFEN 20MG TABLET, 30 count bingo card (NDC #61392070739), Rx,
ee) BENZONATATE 100MG
CAPSULE, 250 count bags (NDC #61392057225) & 30 count
boxes (NDC #61392057230), Rx,
ff) BENZTROPINE 0.5MG
TABLET, 250 count bags (NDC #61392016725) & 30 count
boxes (NDC #61392016730), Rx,
gg) BENZTROPINE 1MG
TABLET, 250 count bags (NDC #61392017025), 30 count bingo
card (NDC #61392017039), 31 count bingo card (NDC
#61392017031) & 30 count boxes (NDC #61392017030),
Rx,
hh) BENZTROPINE 2MG TABLET, 250 count bags (NDC
#61392016425) & 30 count boxes (NDC #61392016430),
Rx,
ii) BISACODYL 5MG TABLET, 250 count bags (NDC
#61392017325) & 30 count boxes (NDC #61392017330),
OTC,
jj) BUMETANIDE 0.5MG TABLET, 250 count bags (NDC
#61392004825), 30 count bingo card (NDC #61392004839),
& 30 count boxes (NDC #61392004830) Rx,
kk) BUMETANIDE 1MG TABLET, 250 count bags
(NDC #61392004925)
& 30 count boxes (NDC #61392004930), Rx,
ll) BUMETANIDE 2MG TABLET, 250 count bags
(NDC #61392005025), 30
count bingo card (NDC #61392005039), 30 count boxes (NDC #61392005030), Rx,
mm)
BUPROPION 100MG TABLET, 250 count bags (NDC #61392099725),
30 count bingo card (NDC #61392099739), 30 count
boxes (NDC #61392099730), Rx,
nn) BUPROPION 75MG TABLET, 250 count bags
(NDC #61392099625), 30 count bingo card (NDC #61392099639), 30 count
boxes (NDC #61392099630), Rx,
oo) BUSPIRONE 10MG TABLET, 30 count bingo card
(NDC #61392066139), 30 count boxes (NDC #61392066130), & 60 count
boxes (NDC #61392066160), Rx,
pp) BUSPIRONE 5MG TABLET, 30 count boxes
(NDC #61392066030) & 60 count boxes (NDC #61392066060), Rx,
qq) BUSPIRONE 7.5MG TABLET, 250 count bags
(NDC #61392066225), 30 count bingo card (NDC #61392066239), 30 count boxes (NDC #61392066230) & 60 count boxes
(NDC
#61392066260),
rr) CAPTOPRIL 12.5MG TABLET, 250 count
bags (NDC #61392060425) & 30 count boxes (NDC
#61392060430), Rx,
ss) CAPTOPRIL 25MG TABLET, 250 count
bags (NDC #61392060525), 30 count bingo card (NDC
#61392060539) & 30 count boxes (NDC #61392060530), Rx,
tt) CAPTOPRIL 50MG TABLET, 30
count bingo card (NDC #61392014739), Rx,
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
RECALLING
FIRM/MANUFACTURER Heartland Repack Services LLC, Toledo, OH,
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.
VOLUME OF PRODUCT IN COMMERCE 566,734,636
units
DISTRIBUTION Nationwide
PRODUCT Midazolam
HCl Injection, 5mg/5mL (1 mg/mL), 5mL Vials, Rx only, For IM or IV Use Only,
CODE
06P0671A; 06P0641A; 06P0711A;
06P0721A; 06P0731A. All have exp. of October, 2008
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Baxter, New Providence, NJ,
Manufacturer: MOVA Pharma Corp.,
Caguas,
PR.
REASON Lack
of Assurance of Sterility; leaking closure and white crusted powder near neck of
the vial.
VOLUME OF PRODUCT IN COMMERCE 321,300
vials
DISTRIBUTION Nationwide
PRODUCT AMPicillin
and Sulbactam for Injection, USP, 3g/ 20mL Vial and 15g/100mL Pharmacy Bulk
Package, Sterile, For Intravenous Use Only, -NDC 10019-630-02, NDC 10019-638-03,
CODE
Lots: 3g -- P0424, exp. May
2007; P0436, exp. July 2007. Lot 15g -- P1338, exp March 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Baxter, New Providence, RI,
Manufacturer:
G. C. Hanford Manufacturing Co., Syracuse, NY.
REASON
Presence of Particulate
Matter
VOLUME OF PRODUCT IN COMMERCE 47,314
vials
DISTRIBUTION Nationwide
PRODUCT Sicor
Terbutaline Sulfate Injection, USP, 1mg/mL volume in 2 mL vial, Rx only, NDC
0703-1271-04,
CODE Lot 06J104, exp.
7/31/08
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Teva Pharmaceuticals USA, North Wales, PA,
Manufacturer: Teva
Sicor, Irvine, CA. F
REASON Product failed specification for
pH
VOLUME OF PRODUCT IN COMMERCE 126,475
vials
DISTRIBUTION Nationwide
WEEK ENDING JUNE 16
PRODUCT
a) Thyro-Tab
(levothyroxine sodium tablets), 0.025 mg, 150,000-tablet bulk
drums intended for repackaging, Rx only,
b) Levothroid
(levothyroxine sodium tablets, USP), 25 mcg, 100-
and
1,000-tablet bottles, RX only, NDC 0456-1320-01
(100-ct.) and
NDC 0456-1320-00 (1,000-ct.),
c)
Thyro-Tab (levothyroxine sodium tablets), 0.050 mg,
150,000-tablet
bulk drums intended for repackaging, RX
only;
d) Levothroid (levothyroxine sodium tablets, USP), 50 mcg, 100- and
1,000-tablet bottles, NDC
0456-1321-01 (100-ct) and NDC 0456-1321-00 (1,000-ct), RX
only,
e) Thyro-Tab (levothyroxine sodium tablets), 0.137
mg, 150,000-tablet bulk
drums intended for repackaging,
RX only,
f) Levothroid (levothyroxine sodium tablets, USP), 137 mcg, 100- and
1,000-tablet bottles, NDC
0456-1331-01 (100-ct) and NDC 0456-1331-00 (1,000-ct), RX
only,
CODE
a) Lots: HA02306, Exp.
2/07; HA04806, Exp. 3/07; HA11406, Exp. 5/07;
HA14306,
Exp. 6/07; HA17706, Exp. 7/07;
b) Lots: 020652, 020653 Exp. 2/07; 040601,
040623 Exp. 3/07;
060602, 060603 Exp. 5/07; 060641,
060642, Exp. 6/07;
070627, 070628, Exp. 7/07;
c) Lot
HB02306, Exp. 2/07;
d) Lots: 020655, 020654, Exp. 2/07;
e) Lot:
HC24205, Exp. 3/07;
f) Lots: 110545, 110544, Exp. 3/07
RECALLING
FIRM/MANUFACTURER Lloyd Inc., of Iowa, Shenandoah, IA,
REASON
Product may not maintain potency
throughout shelf life.
VOLUME OF PRODUCT IN
COMMERCE 12,877,900 tablets
DISTRIBUTION Nationwide
PRODUCT Catalina
Medical Oxygen Aluminum Cylinders fitted with Young-Do CGA 870 post valves
(single 0-ring design). Catalina purchased and installed these valves between
February 1999 and March 2003,
CODE The valves can be identified by the Young-Do logo and a lot number beginning
with the numbers 99, 00, 01, or 02 (for year of manufacture). The Catalina
cylinders are marked either M4002 . . . CATALINA or CLIFFDIV, each followed by a
serial number. A warning label with the Catalina logo is attached to the
side of the cylinder.
RECALLING
FIRM/MANUFACTURER Catalina Cylinders, Garden Grove, CA,
REASON Defective container; oxygen leaking at the valve
or cylinder/valve interface.
VOLUME OF PRODUCT IN
COMMERCE 770,000
cylinders
DISTRIBUTION Nationwide and
Canada
PRODUCT
a)
Miracle II, by Tedco, Miracle Neutralizer, Nature's Miracle for the Total Body,
Sopi' H20, Biodegradable, 22 oz (638 mL), 1 gal, 5 gal,
15 gal, and 55 gal,
b) Miracle
II, by Tedco, Neutralizer, Nature's Miracle for the Total Body,
Sopi' H20, Biodegradable, 2X, 22 oz (638 mL) and 1 gal.,
c) Miracle II, by
Tedco, Neutralizer, Nature's Miracle
for the Total Body, Sopi' H20, Biodegradable, 3X, 22 oz
(638 mL) and 1 gal.,
d) Miracle II, by Tedco,
Neutralizer Gel, Nature's Miracle for the Total Body, Sopi' H20, Biodegradable, 8 oz (232mL), 22 oz, 1 gal, 5 gal, and 15 gal,
e) Miracle II, by Tedco,
Neutralizer Gel, Nature's Miracle for the Total Body, Sopi' H20, Biodegradable, 7X, 8 oz (232mL), 22 oz, and 1 gal,
CODE Recall includes all product without a
code number distributed between January 3 and April 7, 2006
RECALLING FIRM/MANUFACTURER Tedco, Inc., West Monroe,
LA,
REASON This is an extension of a recall
initiated in January 2006 due to microbial contamination. Because these products
have no code number, but have similar labeling, they cannot be distinguished
from product having microbial contamination.
VOLUME OF PRODUCT IN
COMMERCE 68,711
units
DISTRIBUTION Nationwide, Australia, Germany, and
England
PRODUCT
a) Thyro-Tab
(levothyroxine sodium tablets), 0.050mg, 150,000-tablet bulk
drums intended for repackaging, Rx only,
b) Levothroid
(levothyroxine sodium tablets, USP), 50 mcg, 100-
and 1,000-tablet bottles, RX, NDC 0456-1321-01 (100
tablets) and 0456-1321-00 (1,000 tablets),
CODE
a) Lots: HA05206, HB05206, HC05206,
HA08606, HB11406, HC11406, HB14306, HC14306, HD14306,
HA17806, HB17806, HC17806, HB20206, HC20206, HB23606;
b) Lots: 040602, 040603, 040624, Exp. 3/07; 050606, 050608, Exp. 4/07;
060607, 060613, Exp. 5/07; 060643, 060644, 060658,
060660, 070610, Exp. 6/07; 070629, 070631, 070632,
070641, 070642, Exp. 7/07; 080648, 080655, 080660,
080661, Exp. 8/07; 090641, 090642, Exp. 9/07
RECALLING
FIRM/MANUFACTURER Lloyd Inc of Iowa, Shenandoah, IA,
REASON
Product may not maintain potency
throughout labeled shelf life.
VOLUME OF PRODUCT IN
COMMERCE 27,838,500 tablets
(repackaged)
DISTRIBUTION Nationwide
PRODUCT Doxycyline
Hyclate 20mg tablets. 100 count bottles. NDC 00172-4626-60, RX only,
CODE
Lot Numbers: 156268A and 156269A
RECALLING FIRM/MANUFACTURER IVAX Pharmaceuticals,
Miami, FL,
REASON Failed USP dissolution requirements
VOLUME OF PRODUCT IN COMMERCE 10,729 (100 tablet
bottles)
DISTRIBUTION Nationwide
Confidence, Inc. Issues a Recall of all lots of Long Weekend
Confidence, Inc. of Port Washington, NY, that it is recalling the Company's supplement product sold under the name Long Weekend. The Company has been informed by the Food and Drug Administration (FDA) that lab analysis of Long Weekend samples found that the product contains undeclared tadalafil, an FDA approved drug used as treatment for male Erectile Dysfunction (ED). The FDA has not approved Long Weekend as a drug; therefore the safety and effectiveness of this product is unknown.
Consumers should discontinue use of Long Weekend and consult their health care professional about approved treatments for erectile dysfunction (ED). FDA encourages men who experience ED to seek guidance from a health care professional.
The product was sold through mail orders and retailers located nationwide, in Puerto Rico, Canada, the United Kingdom, Russia, and China.
The recalled Long Weekend is sold in 3-capsule boxes. The capsules are sealed in a foil blister-pack, and the blister-pack is stamped with the LOT # and EXP date. The product is sold under the American Best Nutrition label and bears UPC 809515-0542.
Consumers should return any unused Long Weekend, for a refund of the full purchase price or price for the unused portion, to the Company's address in Port Washington, NY, or contact Jim Chao at 516-767-1870 or email jim@confidenceusa.com to receive further instructions for returning the product or with any questions.
WEEK ENDING JUNE 23
PRODUCT Armour
Thyroid (thyroid tablets, USP), 3 grain (180 mg), each tablet contains
levothyroxine (T4) 144 mcg and liothyronine (T3) 27 mcg, 100-tablet bottles, Rx
only, NDC 0456-0462-01,
CODE Lots:
010711, exp. 6/08; 030714, exp. 7/08; 030723, exp. 8/08
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Forest Pharmaceuticals
Inc., Earth City, MO
Manufacturer:
Forest Pharmaceuticals Inc., Cincinnati, OH.
REASON
Printing error on bottle label
incorrectly states 144 mcg Levothyroxine (T4) per tablet. Label should state 114
mcg Levothyroxine (T4) per tablet.
VOLUME OF PRODUCT IN
COMMERCE 10,781/100-tablet bottles
DISTRIBUTION Nationwide and
Belgium
PRODUCT
a)
Cooldent-Coolmint Ice Toothpaste & Toothpaste/Brush Combo, 6.4 oz tubes,
labeled ingredients include Sodium Monofluorophosphate
0.5% and Diglycol. UPC barcodes: 8-40929-03901-5 &
8-40929-03903-9, R
b) Cooldent-Spearmint Toothpaste &
Toothpaste/Brush Combo, 6.4 oz tubes, labeled ingredients
include Sodium Monofluorophosphate 0.5% and Diglycol. UPC
barcodes: 8-40929-03904-6 & 8-40929-03906-0,
c) Cooldent-Fluoride Toothpaste & Toothpaste/Brush Combo, 6.4 oz tubes, labeled ingredients include Sodium Monofluorophosphate 0.5% and
Diglycol.
UPC barcodes: 8-40929-03907-7 &
8-40929-03908-4,
CODE
a) Item
Numbers: S3901(toothpaste with toothbrush) & S3903 (toothpaste only);
b)
Item Numbers: S3904 (toothhpaste only) & S3906 (toothpaste with
toothbrush);
c) Item Numbers: S3907 (toothpaste only) & S3908 (toothpaste
with toothbrush)
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Selective Imports Corp., Vernon, CA,
Manufacturer: Goldcredit
International Enterprises, Wuxi, Jiangsu, China (Mainland).
REASON
Toothpaste from China contains
the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN
COMMERCE 399,120 tubes
DISTRIBUTION AZ, CA,
FL, GA, IL, UT, & TX
WEEK ENDING JUNE 30
PRODUCT RHINO
V MAX (also labeled as RHINO V.MAX), Energy Enhancer Dietary Supplement, 5 and
15 capsules blister pack cartons,
CODE N/A
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Cosmos Trading, Los Angeles,
CA,
Manufacturer: MegaCare, Inc., Las Vegas, NV.
REASON
Unapproved New Drug;
Product found to contain Aminotadalafil an analogue of tadalafil, a drug product
to treat erectile dysfunction.
VOLUME OF PRODUCT IN
COMMERCE 4,976 retail units
DISTRIBUTION CA,
and NV
PRODUCT Oxycodone
Hydrochloride Extended-Release Tablets, 10 mg, packaged in 100-tablet bottles,
Rx only, NDC 60951-702-70,
CODE Lot
400586NV
RECALLING FIRM/MANUFACTURER
Recalling Firm: Endo
Pharmaceutical, Inc., Westbury, NY,
Manufacturer: Novartis Consumer Health Inc., Lincoln, NE.
REASON
Mislabeled; a bottle
labeled to contain Oxycodone Hydrochloride Extended-Release Tablets actually
contains Opana ER (oxymorphone hydrochloride).
VOLUME OF PRODUCT IN
COMMERCE 25,222/100-tablet
bottles
DISTRIBUTION Nationwide
PRODUCT Fleet®
Liquid Glycerin Suppositories, Glycerin USP, 5.6 g in each 5.5 mL average
delivered dose from applicator, packed 4 applicators 7.5 mL each/box, 12
boxes/case, UPC 301320185829
CODE
0625135 0625431 0616527 0615934 0614437
0612534 0611538 0610009 0608710 0607323 0605410 0603917 0602430 0601402 0600534
0534911 0533503 0532732 0532244 0531404 0528503 0527204 0527201 0526625 0525516
0524131 0522903 0521616 0518815 0517001 0516732 0514030 0512937 0510816 0506923
0505417 0503924 0501901 0501113 0500605 0500328 0436505 0435504 0435212 0434904
0431321 0431320 0429903 0427429 0427114 0424002 0421714 0421604 0420301 0417624
0417501 0417301 0431817 0410529 0409902 0408525 0407812 0406120
0404924
RECALLING FIRM/MANUFACTURER C. B. Fleet Company,
Inc., Lynchburg, VA
REASON Subpotent; glycerin
VOLUME
OF PRODUCT IN COMMERCE 140,405
cases
DISTRIBUTION Nationwide, PR and
Taiwan
PRODUCT Aldara
Cream, 5%, Cream (Imiquimod), Net Wt. 0.25 g per packet (12 single use packets
per box), NDC 0089-0610-12, NDA 20-723,
CODE Lot No: HK137A
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Graceway Pharmaceuticals
LLC,
Bristol, TN,
Manufacturer: 3M Health Care, Ltd., Loughborough, UK.
REASON Container Leakage; product packaging not properly
sealed resulting in leaking.
VOLUME OF PRODUCT IN
COMMERCE 17,831 unit cartons
DISTRIBUTION NJ,
NY, OH, IL, LA, and
CA
PRODUCT Ibuprofen
Tablets, USP, 200 mg (White Caplets), bulk, NET WEIGHT: 17.00 Kg, NDC
53746-138-00, OTC, IMPORTANT: This is a bulk shipment intended for further
processing only,
CODE Bulk Lot No.
B04906 (exp. July 2007)
RECALLING
FIRM/MANUFACTURER Interpharm, Inc., Hauppauge, NY,
REASON
Failed USP requirement for
impurity.
VOLUME OF PRODUCT IN COMMERCE 51,829
tablets
DISTRIBUTION FL
PRODUCT
a)
PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets)
0.45 mg/1.5 mg, Rx only, NDC 0046-0937-09. One carton
contains
3 EZ-DIAL® Dispensers of 28 tablets each: 1 EZ-DIAL® Dispenser
(NDC 0046-0937-08) contains 28 gold
PREMPRO Tablets containing
0.45 mg of the conjugated
estrogens found in Premarin® and 1.5 mg of
medroxyprogesterone acetate,
b) PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets)
0.3 mg/1.5
mg, Rx only, NDC 0046-0938-09. One carton contains
3 EZ-DIAL® Dispensers of 28 tablets each: 1
EZ-DIAL® Dispenser
(NDC 0046-0938-08) contains 28 cream PREMPRO Tablets
containing
0.3 mg of the conjugated estrogens found in
Premarin® and 1.5 mg of
medroxyprogesterone acetate,
CODE
a) Lot B38457 (EXP 7/07);
b)
Lots B40785 (EXP 5/07) and B40786 (EXP 5/07)
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals,
Philadelphia, PA,
Manufacturer: Wyeth
Pharmaceuticals, Inc., Rouses Point, NY.
REASON Failed USP Dissolution Test
Requirement.
VOLUME OF PRODUCT IN COMMERCE
PREMPRO
0.45mg/1.5mg: 24,081 cartons of 3 dispensers;
PREMPRO 0.3mg/1.5mg: 49,779
cartons of 3 dispensers
DISTRIBUTION Nationwide