MAY 2007
WEEK ENDING MAY 5
PRODUCT Dramamine Less
Drowsy Formula (Meclizine hydrochloride), 25 mg Tablets, packaged in 8 count
vials and double count value pack, Single pack NDC 0501-6201-08, Double pack NDC
0501-6201-16,
CODE Lot numbers 81948 exp
12/31/09, and 84515 exp 12/31/09. Lot number 87295 exp 8/31/10 (value
pack)
RECALLING FIRM/MANUFACTURER McNeil Consumers Healthcare,
Division of McNeil-PPC, Inc, Fort Washington, PA,
REASON Labeling; immediate
container label incorrectly states dosing at 1-2 tablets every 4 to 6 hours not
to exceed 8 tablets in 24 hours. Label should state dosing at 1-2 tablets daily
or as directed by a doctor.
VOLUME OF PRODUCT IN COMMERCE 549,798
vials
DISTRIBUTION Nationwide
WEEK ENDING MAY 12
PRODUCT Grifulvin
V® (griseofulvin) microsize oral suspension, 125 mg/5mL, 4 fl oz glass bottles,
Rx only, NDC 0062-0206-04,
CODE Lots:
5CA136, Exp. 03/31/2007; 5CA138, Exp. 03/31/2007; 5CA139, Exp. 03/31/2007;
5CA143, Exp. 03/31/2007; 5CA144, Exp. 03/31/2007; 5CA145, Exp. 03/31/2007;
CA146, Exp. 03/31/2007; 5CA147, Exp. 03/31/2007; 5CA148, Exp. 03/31/2007;
5CA149, Exp. 03/31/2007; 5CA150, Exp. 03/31/2007; 5CA 151, Exp. 03/31/2007;
5CA164, Exp. 03/31/2007; 5CA165, Exp. 04/30/2007; 6CA616, Exp. 03/31/2008;
6DA636, Exp. 04/30/2008; 6DA637, Exp. 04/30/2008; 6DA638, Exp. 04/30/2008;
6DA640, Exp. 04/30/2008; 6DA646, Exp. 04/30/2008; 6DA647, Exp. 04/30/2008;
6DA648, Exp. 04/30/2008; 6DA649, Exp. 04/30/2008; 6DA657, Exp. 04/30/2008;
6EA670, Exp. 05/31/2008; 6GA731, Exp. 07/31/2008; 6HA846, Exp. 07/31/2008;
6HA851, Exp. 08/31/2008; 6HA868, Exp. 07/31/2008; 6HA873, Exp. 09/30/2008;
6HA874, Exp. 08/31/2008; 6JA936, Exp. 09/30/2008; 6JA937, Exp. 09/30/2008;
6KA987, Exp. 09/30/2008; 6KA988, Exp. 09/30/2008; 6KA989, Exp. 09/30/2008;
6MA193, Exp. 11/30/2008
RECALLING FIRM/MANUFACTURER Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ,
REASON
Product
may contain glass fragments.
VOLUME OF PRODUCT IN
COMMERCE 1,010,480/4-fl. oz.
bottles
DISTRIBUTION Nationwide
WEEK ENDING MAY 19
PRODUCT Ultra-TechneKow®
DTE Technetium Tc 99m Generator (UTK-DTE™), radiopharmaceutical, Rx only,
catalogue numbers N883 through N895,
CODE Lot 7030, exp. 3/9/07
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Mallinckrodt Inc,
Hazelwood, MO,
Manufacturer: Mallinckrodt Inc, Maryland Heights, MO.
REASON
Sterility test
failure
VOLUME OF PRODUCT IN COMMERCE 166 generators
DISTRIBUTION Nationwide, Canada, Panama, Dominican
Republic, Mexico and Colombia
PRODUCT Ultra-TechneKow®
DTE Technetium Tc 99m Generator (UTK-DTE™), radiopharmaceutical, Rx only,
catalogue numbers N884 through N895,
CODE Lots: 7032, exp. 3/12/07; 7801, exp.
3/12/07; 7033, exp. 3/14/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mallinckrodt Inc, Hazelwood, MO,
Manufacturer: Mallinckrodt Inc,
Maryland Heights, MO.
REASON Lack of sterility assurance
VOLUME OF PRODUCT IN COMMERCE 365
generators
DISTRIBUTION Nationwide, Canada, Panama,
Dominican Republic, Mexico and
Colombia
PRODUCT
1)
CARBAMAZEPINE 200MG TABLET, 250 count bags (NDC #61392003825), 30 count bingo
card (NDC #61392003839), 60 count bingo card (NDC #61392003865), 30 count box (NDC #61392003830), 60 count box
(NDC #61392003860) & 90 count box (NDC
#61392003890), Rx,
2) CARBAMAZEPINE
CHEW 100MG TABLET, 250 count bags (NDC #61392002925), 30 count bingo card (NDC
#61392002939) & 30 count boxes (NDC #61392002930), Rx,
3) CARBIDOPA LEVODOPA 10/100MG TABLET, 250 count bags (NDC #61392017725), 30 count boxes (NDC #61392017730) & 60 count boxes (NDC #61392017760), Rx,
4) CARBIDOPA LEVODOPA 25/100MG TABLET, 250 count bags (NDC #61392018025), 30 count bingo card (NDC #61392018039), 31 count bingo card (NDC #61392018031), 60 count bingo card (NDC #61392018065), 90 count bingo card (NDC #61392018095), 30 count boxes (NDC #61392018030), 60 count boxes (NDC #61392018060) & 90 count boxes (NDC #61392018090), Rx,
5) CARBIDOPA LEVODOPA 25/250MG TABLET, 250 count bags (NDC #61392018325), 30 count bingo card (NDC #61392018339), & 30 count boxes (NDC #61392018330), Rx,
6) CARBIDOPA LEVODOPA ER 50/200MG TABLET, 250 count bags (NDC #61392064725) & 30 count boxes (NDC #61392064730), Rx,
7) CARISOPRODOL 350MG TABLET (c), 30 count bingo card (NDC #61392094939), Rx,
8) CHLORDIAZAPOXIDE 25MG CAPSULE (c), 30 count bingo card (NDC #61392053439), Rx,
9) CHLORPROMAZINE 10MG TABLET, 30 count bingo card (NDC #61392088039), Rx,
10) CHLORPROMAZINE 200MG TABLET, 30 count bingo card (NDC #61392088239), Rx,
11) CHLORPROMAZINE 25MG TABLET, 30 count bingo card
(NDC #61392004039), Rx,
12) CHLORPROMAZINE 50MG TABLET, 30 count bingo card
(NDC #61392088139), Rx,
13) CIMETIDINE 400MG TABLET, 30 count bingo card
(NDC #61392020039), Rx,
14) CLINDAMYCIN 300MG CAPSULE, 30 count bingo card
(NDC #61392077439), Rx,
15) CLOMIPRAMINE 50MG
CAPSULE, 30 count bingo card (NDC #61392088539), Rx,
16) CLONAZEPAM 0.5MG TABLET (c), 15 count bingo card
(NDC #61392082515), 30
count bingo card (NDC #61392082539), 31 count bingo card (NDC #61392082531)
& 15 count bingo card (NDC #61392082505), Rx,
17) CLONAZEPAM 1MG TABLET (c), 30 count bingo card
(NDC
#61392082639), 31 count bingo card (NDC #61392082631) & 15 count bingo card
(NDC #61392082605), Rx,
18) CLONAZEPAM 2MG TABLET
(c), 30 count bingo card (NDC #61392082839) & 31 count bingo card (NDC
#61392082831), RX,
19) CLONIDINE HCL 0.1MG TABLET,
250 count bags (NDC #61392051325), 30 count bingo card (NDC #61392051339), 31
count bingo card (NDC #61392051331), 30 count boxes (NDC #61392051330) 60 count
boxes (NDC #61392051360), 90 count boxes (NDC #61392051390); & 15 count
bingo card (NDC #61392051305), Rx,
20) CLONIDINE HCL 0.2MG TABLET, 250 count bags
(NDC
#61392051625), 30 count bingo card (NDC #61392051639), 31 count bingo card (NDC
#61392051631), 30 count boxes (NDC #61392051630) & 60 count boxes (NDC
#61392051660), Rx,
21) CLONIDINE HCL 0.3MG
TABLET, 250 count bags (NDC #61392051925), 30 count bingo card (NDC
#61392051939) & 30 count boxes (NDC #61392051930), Rx,
22) COLCHICINE 0.6MG TABLET, 250 count bags
(NDC
#61392017425), 30 count bingo card (NDC #61392017439), & 30 count boxes (NDC
#61392017430), Rx,
23) CYCLOBENZAPRINE 10MG TABLET,
250 count bags (NDC #61392009825) & 30 count boxes (NDC #61392009830), Rx,
24) CYPROHEPTADINE 4MG TABLET, 250 count bags
(NDC
#61392020925) & 30 count boxes (NDC #61392020930), Rx,
25) DIAZEPAM 10MG TABLET (c), 30 count bingo card
(NDC
#61392053539), Rx,
26) DIAZEPAM 2MG TABLET (c), 30 count bingo card
(NDC #61392072639), Rx,
27) DIAZEPAM 5MG TABLET (c), 30 count bingo card
(NDC #61392083139), 31 count bingo card (NDC #61392083131) & 15 count bingo
card (NDC #61392083105), Rx,
28) DICYCLOMINE 10MG
CAPSULE, 250 count bags (NDC #61392018225), 30 count bingo card (NDC
#61392018239) & 30 count boxes (NDC #61392018230), Rx,
29) DICYCLOMINE 20MG TABLET, 250 count bags (NDC #61392004125), 30 count
bingo card (NDC #61392004139) & 30 count boxes (NDC #61392004130), Rx,
30) DIGITEK 0.125MG TABLET, 250 count bags
(NDC
#61392099825), 30 count bingo card (NDC #61392099839), 31 count bingo card (NDC
#61392099831), 30 count boxes (NDC #61392099830) & 15 count bingo card (NDC
#61392099805), Rx,
31) DIGITEK 0.25MG TABLET, 250
count bags (NDC #61392083925), 30 count bingo card (NDC #61392083939), 31 count
bingo card (NDC #61392083931), 30 count boxes (NDC #61392083930) & 15 count
bingo card (NDC #61392083905), Rx,
32) DILTIAZEM
120MG TABLET, 250 count bags (NDC #61392014525), 30 count bingo card (NDC
#61392014539), & 30 count boxes (NDC #61392014530), Rx,
33) DILTIAZEM 30MG TABLET, 250 count bags
(NDC #61392005325),
30 count bingo card (NDC #61392005339), 30 count boxes (NDC #61392005330) &
60 count boxes (NDC #61392005360), Rx,
34) DILTIAZEM
60MG TABLET, 250 count bags (NDC #61392072025) & 30 count boxes (NDC
#61392072030), Rx,
35) DILTIAZEM 90MG TABLET, 30
count bingo card (NDC #61392014639) & 30 count boxes (NDC #61392014630), Rx,
36) DILTIAZEM ER 120MG CAPSULE, 250
count bags (NDC #61392096125), 30 count bingo card (NDC #61392096139) & 30
count boxes (NDC #61392096130), Rx,
37) DILTIAZEM ER 180MG CAPSULE, 250 count bags (NDC #61392096225), 30 count bingo card (NDC #61392096239) & 30 count boxes (NDC #61392096230), Rx,
38) DILTIAZEM ER 240MG CAPSULE, 250 count bags
(NDC #61392096325), 30 count
bingo card (NDC #61392096339) & 30 count boxes (NDC #61392096330), Rx,
39) DILTIAZEM ER 300MG CAPSULE, 250 count bags
(NDC
#61392096425), 30 count bingo card (NDC #61392096439) & 30 count boxes (NDC
#61392096430), Rx,
40) DIPHENHYDRAMINE 25MG CAPSULE,
250 count bags (NDC #61392022025) & 30 count boxes (NDC #61392022030), Rx,
41) DIPHENOXY
W/ATROP 2.5/.025MG TABLET (c),
30 count bingo card (NDC #61392086539), Rx,
42)
DIPYRIDAMOLE 25MG TABLET, 30 count bingo card (NDC #61392054939), Rx,
43) DIPYRIDAMOLE 50MG TABLET, 30 count bingo card
(NDC
#61392055239), Rx,
44) DIPYRIDAMOLE 75MG TABLET, 30
count bingo card (NDC #61392014239), Rx,
45)DOCUSATE
CALCIUM 240MG CAPSULE, 250 count bags (NDC #61392021325) & 30 count boxes (NDC #61392021330), OTC,
46) DOCUSATE SODIUM 100MG
CAPSULE, 250 count bags (NDC #61392001925), 30 count boxes (NDC #61392001930)
& 60 count boxes (NDC #61392001960), OTC,
47)
DOXAZOSIN 1MG TABLET, 30 count bingo card (NDC #61392065439) & 30 count
boxes (NDC #61392065430), Rx,
48) DOXAZOSIN 2MG
TABLET, 250 count bags (NDC #61392065625), 30 count bingo card (NDC
#61392065639) & 30 count boxes (NDC #61392065630), Rx,
49) DOXAZOSIN 4MG TABLET, 30 count bingo card
(NDC
#61392065539), Rx,
50) DOXAZOSIN 8MG TABLET, 30
count bingo card (NDC #61392065739) & 30 count box (NDC 61392065730), Rx,
51) DOXEPIN 50MG CAPSULE, 30 count bingo card
(NDC #61392012239), Rx,
52) DOXEPIN HCL 10MG CAPSULE, 30 count bingo card
(NDC
#61392012039), Rx,
53) DOXEPIN HCL 25MG CAPSULE, 30
count bingo card (NDC #61392012139), Rx,
54)
ENALAPRIL 10MG TABLET, 250 count bags (NDC #61392065125) & 30 count boxes (NDC #61392065130), Rx,
55) ENALAPRIL 2.5MG TABLET,
250 count bags (NDC #61392064925), Rx,
56) ENALAPRIL 20MG TABLET, 30 count bingo card (NDC #61392065239), Rx,
57) ENALAPRIL 5MG TABLET, 250 count bags (NDC #61392065025) & 30 count boxes (NDC #61392065030), Rx,
58) FAMOTIDINE 20MG TABLET, 250 count bags (NDC #61392066325), 30 count bingo card (NDC #61392066339), 30 count box (NDC #61392066330), & 60 count box (NDC #61392066360), Rx,
59) FAMOTIDINE 40MG TABLET, 30 count bingo card (NDC #61392066439), Rx,
60) FLUDROCORTISONE 0.1MG TABLET, 250 count bags (NDC #61392058325), 30 count bingo card (NDC #61392058339) & 30 count boxes (NDC #61392058330), Rx,
61) FLUOXETINE 10MG TABLET, 250 count bags (NDC #61392056125) & 30 count boxes (NDC #61392056130), Rx,
62) FLUOXETINE 20MG CAPSULE, 250 count bags
(NDC #61392066925) & 30 count
boxes (NDC #61392066930), Rx,
63) FLUOXETINE 40MG
CAPSULE, 30 count bingo card (NDC #61392074039), Rx,
64) FLUPHENAZINE 10MG TABLET, 30 count bingo
(NDC
#61392015039), Rx,
65) FLUPHENAZINE 1MG TABLET, 30 count bingo card (NDC #61392005739), Rx,
66) FLUPHENAZINE 2.5MG TABLET, 30 count bingo card
(NDC #61392005839), Rx,
67) FLUPHENAZINE 5MG TABLET, 30 count bingo card
(NDC #61392015139), Rx,
68) FOLIC ACID 1MG TABLET,
250 count bag (NDC #61392024425), 30 count boxes (NDC #61392024430), & 60
count boxes (NDC #61392024460), Rx,
69) FUROSEMIDE 20MG TABLET, 250 count bags (NDC #61392025625), 30 count bingo card (NDC #61392025639), 31 count bingo card (NDC #61392025631), 30 count boxes (NDC #61392025630), 60 count boxes (NDC #61392025660), 90 count boxes (NDC #61392025690) & 15 count bingo card (NDC #61392025605), Rx,
70) FUROSEMIDE 40MG TABLET, 250 count bags
(NDC #61392025325), 30 count bingo
card (NDC #61392025339), 60 count bingo card (NDC #61392025365), 30 count boxes
(NDC #61392025330), 60 count boxes (NDC #61392025360) & 15 count bingo card
(NDC #61392025305), Rx,
71) FUROSEMIDE 80MG TABLET,
250 count bags (NDC #61392025425), 30 count bingo card (NDC #61392025439), 30
count boxes (NDC #61392025430), 60 count boxes (NDC #61392025460) & 15 count
bingo card (NDC #61392025405), Rx,
72) GABAPENTIN
100MG CAPSULE, 250 count bags (NDC #61392076025) & 30 count boxes (NDC
#61392076030), Rx,
73) GABAPENTIN 100MG TABLET, 60 count boxes (NDC #61392075360), Rx,
74) GABAPENTIN 300MG CAPSULE, 250 count bags
(NDC #61392076125) & 30
count boxes (NDC #61392076130), Rx,
75) GABAPENTIN
300MG TABLET, 30 count boxes (NDC #61392074830), Rx,
76) GABAPENTIN 400MG CAPSULE, 250 count bags
(NDC
#61392076225) & 30 count boxes (NDC #61392076230), Rx,
77) GEMFIBROZIL 600MG TABLET, 30 count bingo card
(NDC
#61392009339) & 31 count bingo card (NDC #61392009331), Rx,
78) GLIPIZIDE 10MG TABLET, 250 count bags
(NDC #61392006425),
30 count bingo card (NDC #61392006439), 30 count boxes (NDC #61392006430), &
60 count boxes (NDC #61392006460), Rx,
79) GLIPIZIDE
5MG TABLET, 250 count bags (NDC #61392006325), 30 count bingo card (NDC
#61392006339) & 30 count boxes (NDC #61392006330), Rx,
80) GLYBURIDE 2.5MG TABLET, 250 count bags
(NDC
#61392070925), 30 count bingo card (NDC #61392070939) & 30 count boxes (NDC
#61392070930), Rx,
81) GLYBURIDE 5MG TABLET, 250
count bags (NDC #61392083425), 30 count bingo card (NDC #61392083439), 31 count
bingo card (NDC #61392083431), 30 count boxes (NDC #61392083430) & 60 count
boxes (NDC #61392083460),
CODE
1)
All Lot Codes: U37155B25, U37881B25, U37881C25, U38723B25, U37881E25, U38200B25,
U39689A25, U39689B25, U38723H25, U41283A25, U41283G25, C41416B25, U42048A25,
U42064A25, U42668A25, 37030, 37169, 038G0505, 038h0512, 038J0522, 038L0507,
038A0646, 038A0657, 038B0628, 038B0637, 038B0642, 038D0620, 038E0603, 038G0510,
038A0644, 038E0615, U37155C30, U37352A30, U37352B30, U37529A30, U38723C30,
U38723E30, U39742A30, U39742B30, U39689C30, U38723K30, U41283D30, C41416A30,
U42048D30, U42064D30, U37155A60, U37529B60, U37881A60, U38200A60, U38723F60,
U38723G60, U41283C60, U41283E60, U42048C60, U42064C60, U42668B60, U37881D90,
U38723A90, U38723D90, U38723J90, U41283B90, U41283F90, U42048B90,
U42064B90;
2) All Lot Codes: U37270B25, U38367B25, U38873B25, U39518B25,
U40001A25, U42673A25, 029H0525, 029H0529, 38532, 029k0520, 029L0521, 029M0514,
029A0621, 029A0659, 029C0622, 029C0630, 029D0616, 029D0627, 029F0625, 029F0626,
U37270A30, U38367A30, U38367C30, U38873A30, U39518A30, U39784A30, U39784B30,
U39635B30, U40001B30, U39635A30, U42673B30, U42968A30;
3) All Lot Codes:
U37598C25, U38915B25, U39605B25, U40169A25, U40830B25, U41589A25, U37598A30,
U38198A30, U37598D30, U38198B30, U38915A30, U39605B30, U40169B30, U40169D30,
U40830A30, U40830D30, U41589C30, U37598B60, U38915C60, U40169C60, U40830C60,
U41589B60;
4) All Lot Codes: U36923C25, U37513B25, U38146A25, U38722C25,
U38413B25, U39220A25, U39786B25, U41006A25, U42065B25, C42674B25, C42632C25,
180D0520, 180G0501, 180H0504, 180H0526, 180J0530, 180L0506, 180L0525, 180M0513,
180M0546, 180A0649, 180C0618, 180D0618, 180D0619, 180E0614, 180E0616, 180F0621,
180F0635, 180F0637, 42844, 180F0622, 180h0513, 180A0643, 180C0621, 180E0615,
180G0509, 180j0516, 180L0524, 180C0620, U36836A30, U36923B30, U37513C30,
U37846A30, U38146A30, U38722A30, U38146B30, U38471B30, U39220B30, U38722D30,
U39220D30, U39495A30, U39786C30, U40438A30, C41451A30, U42608A30, C42632A30,
C42986A30, C43203A30, C43308A30, U36836B60, U36836C60, U37846B60, U38471A30,
U38722B60, U39786B60, U38471C60, U40438B60, U41006B60, U41371B60, C41451B60,
U42089A60, U42065A60, U42608B60, C42674C60, U43313B60, C43308B60, U36836D90,
U36923A90, U36923D90, U37513A90, U37268A90, U38413A90, U39220C90, U41006C90,
U41371A90, C42632B90, C42986B90, C43203B90, U43313A90;
5) All Lot Codes:
U39801A25, U39376A25, U39376B25, U40390B25, U41571A25, U42440A25, 183F0525,
183G0510, 183H0508, 183J0505, 183k0524, 183L0522, 183M0517, 183M0540, 183A0603,
183B0619, 183B0629, 183C0603, 183C0624, 183D0602, 183D0619, 183E0610, 183F0635,
183G0601, U37906A30, U37906B30, U37906C30, U38946A30, U39376A30, U39801B30,
U40390A30, U39801C30, U40390C30, U40766A30, U40766B30, U41571B30,
U42440B30;
6) All Lot Codes: U39499B25, U39499A30, U41697R30, U41702R30;
7) All Lot Codes: 949H0508, 949k0523, 949B0625, 41804,
949E0602;
8) All Lot Codes: 37993;
9) All Lot
Codes: 38397, 39902;
10) All Lot Codes: 36612, 37228, 882M0540;
11) All Lot Codes: 37214, 040J0525, 040M0511, 41262;
12) All Lot Codes: 881A0615, 881B0607;
13) All Lot Codes: 40667, 43340;
14) All Lot Codes: 39907, 41263, 43336;
15) All Lot Codes: 36673, 37210, 39399, 885M0529;
16) All Lot Codes:
825G0512, 825H0517, 825k0515, 825m0515, 825F0629, 825E0612, 825C0523, 825D0521,
37334, 825F0528, 37421, 825G0505, 825H0504, 825H0513, 825k0531, 825k0548,
825L0542, 825K0517, 825a0610, 825M0533, 825B0608, 825B0612, 825B0630, 825D0605,
825D0624, 825E0609, 825F0635, 825F0637, 825G0608, 38839, 39433, 825F0633, 42023,
825D0606;
17) All Lot Codes: 826D0591, 826F0520, 826G0507, 826H0513, 826J0508,
826L0532, 826A0608, 826M0521, 826B0601, 826B0621, 826D0625, 826D0624, 826E0609,
826F0635, 39899, 826B0605, 42024, 43805;
18) All Lot Codes: 37305, 38460,
39159, 38461, 39158, 40080, 40081, 40082, 40707, 41151, 41986, 828E0610, 37680,
41080;
19) All Lot Codes: U36524A25, U36524C25, U37527C25, U39413B25, U39847A25, U39847C25, U40279B25, U40456B25, U40754B25, U40754D25, U41429A25, U42439A25, 513E0508, 513G0503, 513h0512, 513J0531, 513k0509, 513L0515, 513M0530, 513A0607, 513A0619, 513B0601, 513D0601, 513E0609, 513F0612, 513F0635, 513G0604, 513D0620, 513E0610, U37349A30, U37349B30, U37527B30, U37943B30, U39413A30, U39847B30, U39847D30, U40279C30, U40456A30, U40754C30, U41169B30, U41429C30, U42999A30, C43454A30, U36524B60, U36524E60, U37527A60, U38947A60, U40279A60, U40456C60, U40754A60, U41169A60, U41429B60, U42439B60, U42999B60, C43454B60, U36524D90, U37349C90, U37943a90, U38947B90, 513D0613, 513F0611, 513G0607;
20) All Lot Codes: U37176A25, U38657A25, U38657D25, U39691A25, U39691D25,
U40718A25, U41430C25, U43220A25, U43584A25, 516G0510, 516H0512, 516J0530,
516K0517, 516L0520, 516M0506, 516M0525, 516A0611, 516A0653, 516B0607, 516C0605,
516C0626, 516DO602, 516E0601, 516F0612, 516G0608, 516E0602, U37176B30,
U37176C30, U37672B30, U38657B30, U39264A30, U39264C30, U40343A30, U38657E30,
U41430A30, U41430D30, U42663B30, U43220B30, U43584B30, U43584C30, U37672A60,
U38657C, U39264B60, U39691B60, U39691C60, U40718B60, U41430B60,
U42663A60;
21) All Lot Codes: U38324A25, U39692B25, U40748B25, U41436A25,
U42664A25, 37230, 519J0531, 519L0507, 519A0602, 519A0611, 519B0606, 519C0623,
519F0616, U38324B30, U38324C30, U39692A30, U40748A30, U41436B30, U42664B30;
22) All Lot Codes: U38566A25, U40594A25, U40594C25, U41398A25, U42516A25, 174k0539, 174L0502, 174M0510, 174A0605, 174C0601, 174F0634, U38566B30, U38566C30, U38566D30, U40594B30, U40594D30, U41398B30, U42516B30;
23) All Lot Codes: U39261A25, U40401B25, U43227A25, U43227B25, U43533B25, U39261B30, U39261C30, U40401A30, U40401C30, U40869A30, U40869B30, C42392A30, C42392B30, U43227C30, U43533A30, U43533C30;
24) All Lot Codes: U37553A25, U37912A25, U38602B25, U37553A30, U37912B30, U38602A30, U38602C30, U40240A30, U40240B30, U41902A30;
25) All Lot Codes: 535H0531, 39055, 40420, 535B0643, 42094, 535F0626;
26) All Lot Codes: 41639, 42696;
27) All Lot Codes: 831k0507,
831K0538, 831M0533, 831A0621, 831B0610, 831B0646, 831C0624, 831D0611, 831F0606,
831F0604, 831G0606, 38114, 38816, 40732, 42178;
28) All Lot Codes:
U41166B25, U41591A25, 38151, 182H0518, 182J0514, 182M0533, 40312, 182C0605,
182C0623, 182E0609, 182E0630, U41166A30, U41591B30;
29) All Lot Codes: U38680B25, U38680D25, 38294, 40115, 40384, 041B0607, 41775, U38680A30, U38680C30, U41437A30;
30) All Lot Codes: U40873A25, C40989B25, U41329A25, C42068B25, C42834B25, 998F0512, 998H0508, 998J0501, 998k0506, 998L0516, 998M0507, 998A0617, 998B0629, 998B0634, 998C0612, 998D0620, 998E0617, 998E0622, 998E0625, 998F0616, 998F0641, 998D0619, U38783A30, U39339A30, U39601A30, U38783B30, U39601B30, U40265A30, U39601C30, C40989A30, U41329B30, C42068A30, C42068C30, C42834A30, C43283A30, C42771A30, 998D0606;
31) All Lot Codes: U37783C25, U38732B25, U40339A25, U41699A25, C42375A25, 839G0509, 839M0541, 839A0621, 839B0616, 839B0638, 839C0612, 42120, 839F0613, 839F0614, 839F0641, 42085, , U37783A30, U37783B30, U38732A30, U38732C30, U39378A30, U40339B30, U41450A30, U41699B30, C42375A30, C42376B30, 839D0606;
32) All Lot Codes: U41458B25, 37975, 145L0541, 145B0607, 41741, U41458A30;
33) All Lot Codes: U37601B25, U37601C25, U38724A25, U38724C25, U40713C25, U41588A25, 053D0505, 053G0519, 053H0523, 053k0524, 053L0511, 39641, 053M0540, 053A0608, 053B0620, 053B0636, U38724B30, U40713A30, U41588C30, U43120A30, U37601A60, U37601D60, U40713B60, U40713D60, U41588B60, U43120B60;
34) All Lot Codes: U39477A25, U39477C25, U40687A25, U413322B25, U41726A25, U42103A25, U39315A30, U39477B30, U39477D30, U40687B30, U41322A30, U41322C30, U41726B30, U42103B30;
35) All Lot Codes: 37974, 38833, 39780, 146A0645, 41703, 42352,
U41326A30;
36) All Lot Codes: U37951A25, U37951B25,
U40398A25, U41624A25, U42742A25, U43269A25, 38627, 961K0524, 961L0518, 961M0525,
961A0641, 961B0606, 961C0622, 961D0616, 961E0614, 961F0616, U37951C30,
U39731A30, U40398B30, U40688A30, U41624A30, U42742B30, U43269B30;
37) All Lot Codes: U40691A25, U41595B25, U42741A25, U43170A25, 962H0518, 962J0512, 962L0512, 962M0525, 962A0639, 962B0606, U39606A30, U40440A30, U40691B30, U41590A30, U41595A30, U42741B30, U43170B30;
38) All Lot Codes: U38615A25, U41373A25, U42740A25, U43221A25, 963j0524, 963L0515, 963M0514, 963B0606, U38615B30, U39175A30, U39858B30, U39858A30, U41570A30, U41373B30, U42740B30, U43221B30;
39) All Lot Codes: U43311A25, 40079, 40730, 41500, 964E0614, U42510A30, U42101A30;
40) All Lot Codes: U37145A25, U36526C25, U38776A25, U39937B25, U39937C25, U40208C25, C41881B25, U41459A25, U36526A30, U36526B30, U37145B30, U37564A30, U37564B30, U38481A30, U38776B30, U39267A30, U39937A30, U39937D30, U40208A30, U40208B30, C41881A30, U41459B30;
41) All Lot Codes: 865D0511, 865-H0523, 38817, 865K0507, 39397, 39398,
865M0533, 865A0615, 865C0605, 865B0607, 865C0629, 865E0609, 865F0616;
42)
All Lot Codes: 39994, 41987, 43196;
43) All Lot Codes: 552L0546,
42355;
44) All Lot Codes: 37852, 38264, 142A0624;
45) All Lot Codes: U36338B25, U36472B25, U38567B25, U38567D25, U41945A25,
U36338A30, U36338D30, U36338C30, U36472A30, U37597A30, U38567A30, U37597B30,
U38567C30, U38567E30, U41376A30, U40674A30, U41945B30;
46) All Lot Codes:
U38411A25, U39048C25, U39048E25, U40131A25, U40441B25, C40596B25, U41022B25,
U41022C25, C42009B25, C42253B25, C42704D25, C43076A25, U38474A30, U39048A30,
U39048B30, U39048D30, C39859A30, U40131B30, C40251A30, C40596A30, C41622A30,
C42704A30, C43076A30, C43076B30, C43790A30, U38474B60, U38474C60, U38870A60,
U38411B60, U38474D60, C39859B60, C40251B60, U40441A60, U40542A60, U41022A60,
U41022D60, C41622B60, U41569A60, C42009C60, C42253C60, C42704C60, C42704B60,
C43076C60;
47) All Lot Codes: 40421, 654D0601, U41237A30;
48) All
Lot Codes: U39342A25, 38265, 38337, 39510, 39958, 40304, 40817, 656C0605,
656E0623, 656F0635, U39342B30, U39342C30, U39342D30, U41249A30;
49) All Lot Codes: 39081, 39993, 40422, 41000, 655C0623, 42691, 655E0628;
50) All Lot Codes: 40572, 41094, R40575R30;
51) All Lot Codes: 40084,
40191, 41773;
52) All Lot Codes: 39791, 42091;
53) All Lot Codes:
39030, 39256, 39925, 43810;
54) All Lot Codes: U40342C25, U41289A25,
U40342B30, U40342A30, U40342D30, U40342E30, U41289B30;
55) All Lot Codes:
U41626A25;
56) All Lot Codes: 652J0511, 39014, 39394, 652l0533, 652M0541,
652D0624, 652E0610, 652F0601;
57) All Lot Codes: U40809A25, U41523A25,
U40242A30, U40809B30, U41523B30;
58) All Lot Codes: U38360A25, U38848A25,
U39932B25, U41442A25, 663H0525, 663j0505, 663L0525, 663m0539, 663A0650,
663B0641, 41638, 663C0624, U38360B30, U38781A30, U38848C30, U39071A30,
U39412B30, U39932A30, U39932D30, U40289A30, U40289B30, U40356A30, U41168A30,
U41442C30, U42107A30, U43026B30, U38360C60, U38848B60, U39412A60, U39932C60,
U40356B60, U41442B60, U43026A60;
59) All Lot Codes: 40385, 40846, 42095, 664F0612, 43339, 43811;
60)
All Lot Codes: U40400A25, U41427A25, 583k0530, 583A0626, 40816, 583C0623,
U40400B30, U40400C30, U41427B30;
61) All Lot Codes: U41995A25, U41995C25,
U41995B30;
62) All Lot Codes: U38984A25, U41562A25, U42969A25, U38984B30,
U39416A30, U41562B30, U41990A30, U42969B30;
63) All Lot Codes: 39015,
740M0513, 740B0624, 740D0624, 740E0616;
.
64) All Lot Codes: 37865, 39258,
150mo542, 42287, 43208;
65) All Lot Codes: 37312, 37968, 39900, 41559, 43206;
66) All Lot Codes: 37312, 37968, 39900, 41559, 43206;
67) All Lot Codes: 38152, 151H0518, 151k0504, 151C0629, 151F0601;
68) All Lot Codes: U38777B25, U39218B25, U39675D25, U39218G25, U40755A25, U41521B25, U42050A25, C42896B25, C43237B25, C42495D25, U43459A25, U38777A30, U39218B25, U38777C30, U39675A30, U39675B30, U39218C30, U39218D30, U39218F30, U39675E30, U40595B30, U40755B30, U41521C30, U41521D30, C41908A30, C42495A30, C42495B30, C42495C30, C42896A30, C43237A30, U39675C60, U39218E60, U40595A60, U41521A60, C41908B60, C42495E60, C42896C60;
69) All Lot Codes: U36929F25, U37430B25, U37430C25, U37514B25, U37266A25,
U38438B25, U39313A25, C39968B25, U40344A25, C42263D25, C42651B25, C43075C25,
C43384C25, 256D0503, 256F0520, 256G0501, 256H0503, 256J0504, 256k0538, 256L0514,
256L0529, 256M0542, 256M0547, 256A0619, 256A0649, 256A0658, 256C0609, 256D0601,
256E0608, 256E0614, 256E0631, 256F0640, 256E0602, 256E0632, U36553A30,
U36553D30, U36929A30, U36553E30, U36929D30, U37430A30, U37514A30, U37430D30,
U38361B30, U38441B, U38441A, U38438A30, U39313B30, U39313C30, U38438D30,
U38441E30, U39313E30, C39968A30, U38438F30, U38441F30, U40344C30, C40710,
C41511A30, C42263A30, C42650A30, C43075A30, C43384A30, C42650C30, U36553C60,
U36929C60, U36929E60, U37514C60, U38361A60, U38438C60, U38441D60, U38438E60,
U40344B60, U40344E60, U38441G60, C40710B60, C41511B60, C42263C60, C42651C60,
C42650B60, C43075D60, C43384D60, U36553B90, U36929B90, U38441C90, U39313D90,
U40344D90, C41511C90, C42263B90, C43075B30, C42651B90, C43384B90,
256D0622;
70) All Lot Codes: U38530A25, U38530E25, U38896A25, U39047A25,
U40002A25, U40239A25, U40239B25, C40442C25, U40670A25, U41276B25, U42049B25,
C42613B25, C42751B25, C42832B25, C42833B25, 253J0506, 253K0508, 253L0521,
253L0543, 253M0549, 253A0618, 253A0635, 253A0654, 253B0622, 253B0630, 253B0638,
253B0642, 253F0640, 253F0641, 253A0642, 253C0617, 253E0605, U38530C30,
U38530D30, U39047B30, U38896C30, U39374A30, U39374B30, U39374D30, U39911A30,
U39911B30, U39374F30, C40442, U40670C30, U40670D30, C41287A30, U42049C30,
C42347A30, C42613D30, C42613A30, C42751A30, C42833A30, C43265A30, C43418A30,
C43470A30, C43418B30, U38530B60, U38896B60, U39374C60, U39374E60, U40439A60,
C40442B60, U40439B60, U40670B60, C41287B60, U41276A60, U41276C60, U42049A60,
C42347B60, C42613C60, C42751C60, C42832C60, C43265B60, C43470B60, 253D0606,
253F0636, 253F0642;
71) All Lot Codes: U36928A25, U37525B25, U37525C25, U38778C25, U39726B25, U40714A25, U41370A25, C41754B25, U42441A25, 254E0501, 254F0508, 254G0505, 254H0511, 254J0517, 254k0527, 254k0540, 254L0514, 254M0522, 254A0619, 254A0656, 254B0626, 254C0616, 254D0601, 254D0630, 254F0612, 254E0628, 254F0623, U37267A30, U37267B30, U37525A30, U37525D30, U38513A30, U38778A30, U38513C30, U38778B30, U39726A30, U39880B30, U39880C30, U39726D30, U38778D30, U40714B30, U41370C30, C41754A30, U36928B60, U38513B60, U39726C60, U39880A, U40714C60, U41370B60, C41754C60, U42441B60, 42075;
72) All Lot Codes: U37812R25, U38288R25, U38619R25, U39146R25, U40831A25, U41282A25, U42739A25, U43191A25, U37812R30, U38288R30, U38619R30, U39146R30, U39497A30, U39876A30, U40831B30, U41170A30, U41282B30, U41282C30, U42739B30, U43191B30, U43385A30, U43385B30, U43385C30;
73) All Lot Codes: U42442C60, U43190A60;
74) All Lot Codes: U37952R25, U38321R25, U38618R25, U39147R25, U41171B25, U41281C25, U42086A25, U42627A25, U37952R30,U38321R30, U38618R30, U39147R30, U39964A30, U39964B30, U40387A30, U41171B30, U41281A30, U41281B30, U42086B30, U42627B30, U43174A30, U43174B30, U43386A30, U43386B30;
75) All Lot Codes: U42779B30;
76) All Lot Codes: U39148R25, U40399B25, U41567A25, U39148R30, U39539A30, U40399A30, U41567B30, U41404A30, U42610A30;
77) All Lot Codes: 093j0532, 093L0501, 093A0626, 093B0619, 093C0623, 093C0629, 093E0601, 42711, 093G0606, 093F0608, 42353;
78) All Lot Codes: U38290B25, U38290C25, U38290D25, U40204A25, U40828A25, U41244B25, 37224, 064H0529, 064J0513, 064j0529, 064k0544, 064L0512, 064L0540, 064M0549, 064A0626, 064A0652,064B0616, U38290A30, U38617A30, U38617B30, U38617C30, U39266B30, U39266C30, U40204B30, U40828B30, U41244C30, U41244D30, U42606A30, C43745A30, U39266A60, U40204C60, U41244A60, U42606B60;
79) All Lot Codes: U36825R25, U37248A25, U38014C25, U38682A25, U38682B25, U39265A25, U39671A25, U39987C25, U40130A25, U39987B25, U40130B25, U40130D25, U40827A25, U41090B25, C42579B25, 36872, 37223, 063H0518, 063J0512, 063j0529, 063L0511, 063M0543, 063A0610, 063B0601, U36825R30, U37248A30, U38014A30, U38014B30, U38682C30, U39265B30, U39671B30, U39987A30, U40130C30, U40827B30, U41090A30, U41090C30, C42579C30;
80) All Lot Codes: U38369A25, U39340A25, U39340B25, U40826B25, U42735B25,
709k0505, 709L0519, 709M0503, 709M0535, 709A0618, 709A0654, 41001, 709C0615,
709D0627, 709F0616, 709F0635, U38369B30, U38847A30, U38847B30, U39729A30,
U39340C30, U39729B30, U40826A30, U39340D30, U42735A30;
81) All Lot
Codes: U38325C25, U38958A25, U38958C25, U39380A25, U41448B25, 834H0535,
834J0534, 834L0521, 834M0503, 834M0509, 834M0524, 834A0628, 834C0623, 834E0601,
834E0622, 834F0616, 834E0623, 834F0623, U38325A30, U38958B30, U39730B30,
U39730C30, U40389A30, U41448C30, U42434B30, U38325B60, U39730A60, U39380B60,
U40389B60, U41448A60, U42434A60, U43223A60
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 Prasco
Fexofenadine Hydrochloride Tablets, 60 mg, 100-count bottles, 48 bottles per
case, Rx Only, NDC 66993-107-02,
CODE 1100743, Exp. 1/31/09; 1100744, Exp.
1/31/09; and 1102674, Exp. 3/19/09
RECALLING
FIRM/MANUFACTURER Sanofi - Aventis US LLC, Kansas City, MO,
REASON
Labeling Error; some of the labels are
missing certain portions of text (strength, tablet count, and/or NDC
number).
VOLUME OF PRODUCT IN COMMERCE 78,887/100-tablet
bottles
DISTRIBUTION OH
Spectrum Laboratory Products, Inc. Recalls Caffeine Citrated, Powder, Purified
Spectrum Laboratory Products, Inc, (Spectrum), Gardena, California, is recalling Caffeine Citrated, Powder, Purified, after receiving a complaint about potential sub potency. Caffeine Citrated is a cerebral and respiratory stimulant used primarily to treat idiopathic apnea of prematurity. Blood levels of caffeine in patients were determined to be significantly lower than would be expected. The use of sub-potent compounded preparations made may lead to sub-therapeutic caffeine blood levels and an unacceptable risk of respiratory depression.
Caffeine Citrated, Powder, Purified, is identified as Catalog Number CA110. Recalled lots include the following: TS0225, UK0821 and VI1203.
Pharmacies that have used the above lots of Caffeine Citrated, Powder, Purified, should stop using it and contact Spectrum to make arrangements to return it. Caffeine Citrated, Powder, Purified, was distributed to pharmacies, hospitals, two universities, laboratories, and pharmacy distributors. It can be identified by catalog number CA110 and the name “Caffeine Citrated, Powder, Purified” on the label.
Consumers with questions may contact Stephen Newton at 1-800-791-3210, Ext. 349
Pharmacies are urged to examine their supplies for any of the recalled Caffeine Citrated, Powder, Purified, and immediately discontinue its use. Patients and consumers who suspect that they have received medications in any dosage form made from the three lot numbers of Caffeine Citrated, Powder, Purified, that are being recalled, should contact their pharmacy or physician.
WEEK ENDING MAY 26
PRODUCT LEVIROL
Sexual Performance Formula Dietary Supplement, a proprietary blend of: Epimedium
(Epimedium sagittatum leaf), 2 Capsules per pack,
CODE
Lot # 0606332 expires 06/09 & Lot #
0605143 expires 05/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Levirol, LLC, Tempe, AZ,
Manufacturer:
Bactolac Pharmaceutical,
Inc, Hauppauge, NY.
REASON Unapproved New Drug; product found to contain the
undeclared ingredient Aminotadalafil, an analogue of Tadalafil, the active
pharmaceutical ingredient found in an FDA approved drug used for erectile
dysfunction.
VOLUME OF PRODUCT IN COMMERCE 22,658
capsules (11,329 x2 capsule
packages)
DISTRIBUTION Nationwide and Canada
PRODUCT LIVIRO3
Natural Energy Enhancer Nutritional Supplement, 450mg Capsules, packaged in
boxes of 10 capsules and bottles of 20 capsules,
CODE The firm indicated the distributed 5
lots(#1-5) Lot#1 Exp. Date 03/2006, Lot#2 Exp. Date 11/2008, Lot#3 Exp. Date
0/2009, Lot#4 Exp. Date 07/2009 & Lot#5 Exp. Date 07/2009 NOTE: THIS IS WHAT
WAS FOUND ON SAMPLE COLLECTED- Underneath the aluminum try that contains all 10
capsules of LIVIRO3 (found inside box), there are lot codes and expiration dated
imprinted on it. The lot code for the FDA sample is LOT 0730 EXP 07/30/2009.
There might be other lot codes since it appears that the lot code correspond
with the expiration date. Note: Other codes pending
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Ebek, Inc, Los
Angeles, CA,
Manufacturer: West Coast Laboratories Inc, Gardena, CA.
REASON
Unapproved New
Drug; product to contain the undeclared ingredient Tadalafil, the active
pharmaceutical ingredient in an FDA approved drug used to treat erectile
dysfunction
VOLUME OF PRODUCT IN COMMERCE 278,260
capsules
DISTRIBUTION Nationwide
PRODUCT
a)
Children's Mucinex Expectorant (Guaifenesin, USP, 100mg/5mL), Grape Flavor
Liquid, 4 fl oz. (118mL) bottle, NDC 63824-173-64,
b) Children's
Mucinex Cough (Guaifenesin, USP 100mg/5mL and Dextromethorphan HBr 5mg/5mL), Cherry Flavor Liquid, 4 fl oz. (118mL),
Expectorant and Cough Suppresent, NDC 63824-174-64, CODE
a) Lot #605010,
605011, 605012, 606001, 606002, 606003, 606004, 606005,
606006, 606007, 606008, 606009, 606010, 606011, 606012,
606014, 606015, 606016, 606017, 606018, 606019, 606020,
608004, 608005, 608006, 608007, 608008, 608009, 608010,
608031, 608032, 609001, 609002, 609003, 609004, 609005,
609006, 609023, 609024, 609025, 609026, 609027, 609028,
609029, 609030, 609031, 609032, 609033, 609034, 609035,
610023, 610024, 610025, 610026, 610027, 610028, 610029,
610030, 610032;
b) Lot #605007, 605008, 605009, 605021, 605022, 605023,
605024, 605025, 605026, 605027, 605028, 605029, 607001,
607002, 607003, 607004, 607005, 607006, 607007, 607008,
607009, 607010, 607011, 608011, 608012, 608013, 608014,
608015, 608016, 608017, 608018, 608019, 608020, 608021,
608022, 608028, 609007, 609008, 609009, 609010, 609011,
609012, 609013, 609014, 609015, 609016, 609017, 609018,
609019, 609020, 609021, 609022, 610003, 610004, 610005, 610006, 610007, 610008, 610009, 610010, 610011, 610012, 610013,
610014, 610015, 610016, 610017, 610018, 610019
RECALLING FIRM/MANUFACTURER
Recalling Firm: Adams
Respiratory Therapeutics, Inc, Fort Worth, TX,
Manufacturer: QPharma,
LLC, Lawrenceville, NJ.
REASON Misbranded;
calibrated dosage dispensing cup may be confusing to consumers as measurements
are shown in units of teaspoon and tablespoon while dosages are all listed in
teaspoons
VOLUME OF PRODUCT IN COMMERCE 2,102,856
bottles
DISTRIBUTION Nationwide and PR
AMO Announces Recall of Complete® Moistureplus™ Multipurpose Solution
Advanced Medical Optics is recalling its Complete® MoisturePlusTM contact lens solutions because patients who had developed Acanthamoeba keratitis (AK) since January 2005. A total of 39 of these patients were soft contact lens wearers, 21 of whom reported using Complete® MoisturePlusTM products.
Consumers who believe they are in possession of the recalled product should discontinue use immediately and call 1-888-899-9183. The company is currently contacting retailers, customers and distributors regarding return and replacement instructions. Reply cards and mailing slips are being provided for return of product. Retailers may also call 1-888-899-9183 for more information.
Please report any adverse reactions experienced with the use of this product and/or quality problems to AMO by calling 1-calling 1-800-347-5005.