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The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
May 30, 2007
07-22
________________________________
PRODUCT
Jermuk Sodium Calcium Bicarbonate and Sulphate Mineral Water, 500ml bottle,
Recall # F-169-7
CODE
There are no lot numbers or production dates
RECALLING FIRM/MANUFACTURER
Recalling Firm: Importers Direct Wholesale Co., Los Angeles, CA,
by press statement on March 7, 2007, telephone on March 7, 2007, March 26,
2007 and by letter starting on March 9, 2007.
Manufacturer: Arpi Mineral Water Plant JSC, Vaik, Armenia. Firm
initiated recall is complete.
REASON
Sample analysis by FDA revealed excessive levels of arsenic.
VOLUME OF PRODUCT IN COMMERCE
10,000 cases (12 X 500ml bottles/case)
DISTRIBUTION
CA
___________________________________
PRODUCT
“Jermuk, Natural Mineral Water Sparkling”. The product is
additionally labeled as “Bottled by Jermuk Group CJSC” and “Sale
Agent Kradjian Importing Co. Inc.” 16.9 fl. oz. (500ml) Clear
Green Glass Bottles with metal twist off caps, Recall # F-170-7
CODE
All production codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kradjian Importing Co., Glendale, CA, by telephone, and
press statement on March 7, 2007, and by letters on March 7, 2007 and March
12, 2007.
Manufacturer: “Jermuk” CJSC, Jermuk, Armenia. Firm
initiated recall is complete.
REASON
Sample analysis by FDA revealed
excessive levels of Arsenic.
VOLUME OF PRODUCT IN COMMERCE
4,030 cases (12 X 16.9 fl. oz. bottles/case)
DISTRIBUTION
CA
___________________________________
PRODUCT
a) ''Jermuk Original Sparkiling Natural Mineral Water Fortified with Gas from
the Spring'' 0.5 Liter Green Glass Bottles (12 bottles/carton),
b) ''Jermuk Original Sparkiling Natural Mineral Water Fortified with Gas from
the Spring'' 1.0 liter plastic bottles, Recall # F-171-7
CODE
a) Manufacturer’s code of: PRD .26.10.06 EXP .26.10.07. (located on bottle)
b) Manufacturer’s code of: PRD .26.10.06 EXP .26.10.07. (located on bottle)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zetlian Bakery, Inc., Pico Rivera, CA, by telephone on
March 7, 2007, and by letter beginning on March 9, 2007.
Manufacturer: “Jermuk” CJSC, Jermuk, Armenia. Firm
initiated recall is ongoing.
REASON
Sample analysis by FDA revealed excessive levels of Arsenic.
VOLUME OF PRODUCT IN COMMERCE
24,954 X 0.5 liter glass bottles and 4,350 X 1 liter plastic bottles
DISTRIBUTION
CA
___________________________________
PRODUCT
Jermuk Natural Mineral Water Fortified with gas from the springs in 500ml bottles,
Recall # F-172-7
CODE
All production codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Andreas Andreasyan, N Hollywood, CA, by telephone on
March 16, 2007, letter beginning on March 21, 2007, and by press statement
on March 24, 2007.
Manufacturer: Sam Har LLC, Abovian, Armenia. Firm initiated recall
is complete.
REASON
Sample analysis by FDA revealed excessive levels of Arsenic.
VOLUME OF PRODUCT IN COMMERCE
7,450 cases (24 X 500ml bottles per case)
DISTRIBUTION
CA
___________________________________
PRODUCT
a) Health Valley Wheat Free, Dairy Free Chocolate Chip Oatmeal Cookies, 7.3
oz,
9 cookies per pack; UPC Code 0-35742-15255-7, Recall # F-265-7;
b) Health Valley Wheat Free, Dairy Free Oatmeal Raisin Cookies, 7.3 oz.,
9 cookies per pack; UPC Code 0- 35742-15256-4;, Recall #
F-266-7;
c) Health Valley Wheat Free, Dairy Free Peanut Crunch Oatmeal Cookies,
7.3 oz., 9 cookies per pack; UPC Code 0-35742-15257-1, Recall
# F-267-7
CODE
a) Lot: 21JUN07, 14SEP07;
b) Lot: 21JUN07, 28JUL07, 28OCT07;
c) Lot: 28JUL07, 02JUN07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hain Celestial, Irwindale, CA, by letters and telephone
beginning on March 16, 2007.
Manufacturer: Lovin Oven, LLC, Irwindale, CA. Firm initiated recall is
ongoing.
REASON
Cookies may contain undeclared wheat, barley, or rye.
VOLUME OF PRODUCT IN COMMERCE
3321 cases, 6 cartons per case
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Archer Farms imported Four Cheese risotto, product of Italy, net wt. 6 oz (170g).
The product is packaged in a paperboard box with UPC 0 85239 34790 4, Recall
# F-268-7
CODE
Best if Used By 16JUL2008AA (on bottom flap of box)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aulcorp Food Marketers, Inc, Vaughan, Ontario, Canada,
by telephone on April 4, 2007 and by e-mail on April 27, 2007.
Manufacturer: Firma Italia Spa, Milan, Italy. Firm initiated recall
is ongoing.
REASON
The product was found to be contaminated with salmonella based on FDA’s
sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
1811 cases (12- 6 oz. packages per case)
DISTRIBUTION
MN
___________________________________
PRODUCT
a) Tsar Nicoulai Hot Smoked Salmon in 4 oz/8 oz/1 lb/side fillet package,
vacuum packed, Recall # F-269-7;
b) Tsar Nicoulai Lemon Pepper Hot smoked Salmon, 4 oz package,
vacuum packed, Recall # F-270-7;
c) Tsar Nicoulai Lemon Pepper Cold Salmon, 4 oz. and side fillet
package, vacuum packed, Recall # F-271-7;
d) Tsar Nicoulai Salmon Gravlax Variety, 4 oz., 1 lb. and side fillet package,
vacuum packed, Recall # F-272-7;
e) Tsar Nicoulai Traditional (cold) Smoked Salmon, in 4 oz, 1 lb, and side
fillet packages, vacuum packed, Recall # F-273-7;
f) Tsar Nicoulai cold smoked sturgeon, in 4 oz and side fillet package,
vacuum packed, Recall # F-274-7;
g) Tsar Nicoulai sturgeon jerky, appr. 4 oz. per package, vacuum packed,
Recall # F-275-7;
h) Tsar Nicoulai sturgeon mousse in 1/2 pint pack, vacuum packed,
Recall # F-276-7;
i) Tsar Nicoulai Sturgeon Roulade, in 4 oz, 8 oz, 1 lb, and side fillet packages,
vacuum packed, Recall # F-277-7;
j) Tsar Nicoulai Sturgeon Sausage, in 4 oz packages, vacuum packed, Recall
# F-278-7
k) Tsar Nicoulai Triple Smoked (hot smoked) Sturgeon in 4 oz, 8 oz, 1 lb,
and side fillet packages, vacuum packed, Recall # F-279-7
CODE
All products in between production dates of Jan. 20 to September 20, 2005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tsar Nicoulai Caviar, LLC, San Francisco, CA, by
telephone on September 27, 2005.
Manufacturer Firm: Tsar Nicoulai Caviar, LLC, Wilton, CA. Firm
initiated recall is complete.
REASON
Product was manufactured under conditions whereby it was not adequately processed
to prevent outgrowth and toxin formation by pathogens..
VOLUME OF PRODUCT IN COMMERCE
2243.4 lbs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Mannatech Optimal Restoring Serum, 1.7 oz. (50mL), Product #20201; Recall #
F-282-7
CODE
Lot # 703182
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mannatech Incorporated, Coppell, TX, by letter on
May 2/3, 2007.
Manufacturer: DPT Lakewood, Inc, Lakewood, NJ. Firm initiated recall
is ongoing.
REASON
Initial shipment of product was found on stability testing to be contaminated
with Enterobacter gergoviae and Enterobacter cloacae.
VOLUME OF PRODUCT IN COMMERCE
7,076 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) San Benedetto 'the Verde' in Acqua Minerale Naturale The Vert/Gruner
Tee 1.5 L plastic bottles PET UPC 8 001620 004029, Recall
# F-280-7;
b) The San Benedetto Verde Green Tea 0.5 liter plastic bottles PET
UPC 8 001620 005422, Recall # F-281-7
CODE
a) A6219Y1344 07 11 2007;
b) A6220P0449 08 11 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Colavita USA Inc, Linden, NJ,
Manufacturer: Acqua Minerale S Benedetto, Veneto, Italy. Firm initiated
recall is ongoing.
REASON
Green Tea contains non-permitted colors.
VOLUME OF PRODUCT IN COMMERCE
389 cases of 6 x 1.5 liter bottles;873 cases of 12 x 0.5 liter bottles
DISTRIBUTION
NY, NJ, PA, CT, IL, and FL
___________________________________
PRODUCT
a) HALOPERIDOL 0.5MG TABLET, 250 count bags (NDC #61392026325),
30 count bingo card (NDC #61392026339) & 30 count boxes
(NDC #61392026330),
Rx, Recall # D-575-2007;
b) HALOPERIDOL 10MG TABLET, 30 count bingo card (NDC #61392027539), Rx,
Recall # D-576-2007;
c) HALOPERIDOL 1MG TABLET, 250 count bags (NDC #61392026625),
30 count bingo card (NDC #61392026639) & 30 count boxes
(NDC #61392026630),
Rx, Recall # D-577-2007;
d) HALOPERIDOL 2MG TABLET, 250 count bags (NDC #61392026925), 30 count
bingo card (NDC #61392026939) & 30 count boxex (NDC
#61392026930), Rx,
Recall # D-578-2007;
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,
Recall # D-580-2007;
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, Recall # D-581-2007;
g) HYDRALAZINE 50MG TABLET, 250 count bags (NDC #61392063725) & 30 count
boxes (NDC #61392063730), Rx, Recall # D-582-2007;
h) HYDROCHLOROTHIAZIDE 12.5MG CAPSULE, 250 count bags (NDC #61392057725)
& 30 count boxes (NDC #61392057730), Rx, Recall # D-583-2007;
i) HYDROCHLOROTHIAZIDE 25MG TABLET, 250 count bags (NDC #61392001125)
& 30 count boxes (NDC #61392001130), Rx, Recall # D-584-2007;
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,
Recall # D-585-2007;
k) HYDROCODONE/APAP 7.5/500MG TABLET (c), 30 count bingo card
(NDC #61392072939), Rx, Recall # D-586-2007;
l) HYDROXYZINE 25MG TABLET, 250 count bags (NDC #61392001325),
30 count bingo card (NDC #61392001339) & 30 count boxes
(NDC #61392001330), Rx, Recall # D-587-2007;
m) IBUPROFEN 200MG TABLET (BROWN), 30 count bingo card (NDC #61392095139)
& 31 count bingo card (NDC #61392095131), OTC, Recall
# D-588-2007;
n) IBUPROFEN 400MG TABLET, 250 count bags (NDC #61392052725) &
60 count boxes (NDC #61392052760), Rx, Recall # D-589-2007;
o) IBUPROFEN 600MG TABLET, 250 count bags (NDC #61392052925),
30 count bingo card (NDC #61392052939) & 30 count boxes
(NDC #61392052930), Rx, Recall # D-590-2007;
p) IBUPROFEN 800MG TABLET, 30 count bingo card (NDC #61392052839),
Rx, Recall # D-591-2007;
q) IMIPRAMINE 10MG TABLET, 30 count bingo card (NDC #61392002539), Rx,
Recall # D-592-2007;
r) IMIPRAMINE 25MG TABLET, 30 count bingo card (NDC #61392002639), Rx,
Recall # D-593-2007;
s) IMIPRAMINE 50MG TABLET, 30 count bingo card (NDC #61392002739), Rx,
Recall # D-594-2007;
t) INDOMETHACIN 25MG CAPSULE, 30 count bingo card (NDC #61392081539),
Rx, Recall # D-595-2007;
u) ISONIAZID 300MG TABLET, 30 count bingo card (NDC #61392080339), Rx,
Recall # D-596-2007;
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,
Recall # D-597-2007;
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,
Recall # D-598-2007;
x) ISOSORBIDE DINITRATE 30MG TABLET, 250 count bags (NDC #61392031825),
30 count bingo card (NDC #61392031839) & 30 count box
(NDC #61392031830),
Rx, Recall D-599-2007;
y) ISOSORBIDE DINITRATE 5MG TABLET, 30 count bingo card
(NDC #61392031139) & 31 count bingo card (NDC #61392031131),
Rx, Recall # D-600-2007;
z) ISOSORBIDE MONONITRATE 10MG TABLET, 30 count bingo card
(NDC #61392091239), Rx, Recall # D-601-2007;
aa) ISOSORBIDE MONONITRATE 20MG TABLET, 250 count bags
(NDC #61392091325), 30 count bingo card (NDC #61392091339),
30 count boxes (NDC #61392091330), Rx, D-602-2007;
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, Recall # D-603-2007;
cc) LABETALOL 100MG TABLET, 250 count bags (NDC #61392045925),
30 count bingo card (NDC #61392045939), & 30 count boxes
(NDC #61392045930), Rx, Recall # D-604-2007;
dd) LABETALOL 200MG TABLET, 30 count bingo card (NDC #61392073339) &
31 count bingo card (NDC #61392073331), Rx, Recall # D-605-2007;
ee) LABETALOL 300MG TABLET, 30 count bingo card (NDC #61392077639),
Rx, Recall # D-606-2007;
ff) LISINOPRIL 10MG TABLET, 250 count bags
(NDC #61392069325), 30 count boxes (NDC #61392069330), &
60 count boxes (NDC #61392069360), Rx, Recall # D-607-2007;
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, Recall # D-608-2007;
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, Recall # D-609-2007;
ii) LISINOPRIL 30MG TABLET, 30 count bingo card (NDC #61392069539),
Rx, Recall # D-610-2007;
jj) LISINOPRIL 40MG TABLET, 250 count bags (NDC #61392069625),
30 count boxes (NDC #61392069630) & 60 count boxes (NDC
#61392069660),
Rx, Recall # D-611-2007;
kk) LISINOPRIL/HCTZ 10/12.5MG TABLET, 30 count bingo card
(NDC #61392069739), Rx, Recall # D-612-2007;
ll) LISINOPRIL/HCTZ 20/12.5MG TABLET, 250 count bags (NDC #61392069825),
30 count bingo card (NDC #61392069839) & 30 count boxes
(NDC #61392069830),
Rx, Recall # D-613-2007;
mm) LOPERAMIDE 2MG CAPSULE, 250 count bags (NDC #61392033625)
& 30 count boxes (NDC #61392033630), Rx, Recall # D-614-2007;
nn) LORATADINE 10MG TABLET, 250 count bags (NDC #61392056225)
& 30 count boxes (NDC #61392056230), OTC, Recall # D-615-2007;
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, Recall # D-616-2007;
pp) LORAZEPAM 2MG TABLET (c), 30 count bingo card (NDC #61392045239), Rx,
Recall # D-617-2007;
qq) LOVASTATIN 10MG TABLET, 30 count bingo card (NDC #61392079739), Rx,
Recall # D-618-2007;
rr) LOVASTATIN 40MG TABLET, 30 count bingo card (NDC #61392073739), Rx,
Recall # D-619-2007;
ss) MECLIZINE 12.5MG TABLET, 250 count bags (NDC #61392033825) & 30 count
boxes
(NDC #61392033830), Rx, Recall # D-620-2007;
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,
Recall # D-622-2007;
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, Recall # D-623-2007;
ww) METHAZOLAMIDE 50MG TABLET, 30 count bingo card (NDC #61392089039),
Rx, Recall # D-624-2007;
xx) METHOCARBAMOL 500MG TABLET, 30 count bingo card
(NDC #61392046039), Rx, Recall # D-625-2007;
yy) METHOCARBAMOL 750MG TABLET, 250 count bags (NDC #61392077325),
30 count bingo card (NDC #61392077339) & 30 count boxes
(NDC #61392077330),
Rx, Recall # D-626-2007;
zz) METHYLDOPA 250MG TABLET, 30 count bingo card (NDC #61392018439), Rx,
Recall # D-627-2007;
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, Recall # D-628-2007;
bbb) METOCLOPRAMIDE 5MG TABLET, 250 count bags (NDC #61392055725) &
30 count boxes (NDC #61392055730), Rx, Recall # D-629-2007;
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,
Recall # D-630-2007;
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, Recall # D-631-2007;
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, Recall # D-632-2007;
fff) METRONIDAZOLE 250MG TABLET, 250 count bags (NDC #61392039725),
30 count bingo card (NDC #61392039739) & 30 count boxes
(NDC #61392039730),
Rx, Recall # D-633-2007;
ggg) METRONIDAZOLE 500MG TABLET, 30 count bingo card (NDC #61392039939),
Rx, Recall # D-634-2007;
hhh) MINOCYCLINE 100MG CAPSULE, 30 count bingo card
(NDC #61392074139), Rx, Recall # D-635-2007;
iii) MINOXIDIL 2.5MG TABLET, 30 count bingo card (NDC #61392046139),
Rx, Recall # D-636-2007;
jjj) MULTIVITAMINS, THER W-MINERALS TABLET, 250 count bags
(NDC #61392035125) & 30 count boxes (NDC #61392035130),
OTC,
Recall # D-637-2007;
kkk) MULTIVITAMINS, THERAPEUTIC TABLET, 250 count bags (NDC #61392035025)
& 30 count boxes (NDC #61392035030), OTC, Recall # D-638-2007;
lll) NALTREXONE 50MG TABLET, 30 count bingo card (NDC #61392046639), Rx,
Recall # D-639-2007;
mmm) NAPROXEN 250MG TABLET, 30 count bingo card (NDC #61392028939), Rx,
Recall # D-640-2007;
nnn) NAPROXEN 375MG TABLET, 30 count bingo card (NDC #61392029239)
& 30 count boxes (NDC #61392029230), Rx, Recall # D-641-2007;
ooo) NAPROXEN 500MG TABLET, 250 count bags (NDC #61392029525),
30 count bingo card (NDC #61392029539) & 30 count boxes
(NDC #61392029530), Rx, Recall # D-642-2007;
ppp) NIFEDIAC ER 30MG TABLET, 30 count bingo card (NDC #61392048439),
Rx, Recall # D-643-2007;
qqq) NIFEDIAC ER 60MG TABLET, 30 count bingo card
(NDC #61392048539), Rx, Recall # D-644-2007;
rrr) NIFEDIAC ER 90MG TABLET, 30 count bingo card
(NDC #61392048639), Rx, Recall # D-645-2007;
sss) NIFEDIPINE 10MG CAPSULE, 30 count bingo card
(NDC #61392035639), Rx, Recall # D-646-2007;
ttt) NITROFURANTOIN 100MG CAPSULE, 30 count bingo card
(NDC #61392073439), Rx, Recall # D-647-2007;
uuu) NORTRIPTYLINE 10MG CAPSULE, 30 count bingo card (NDC #61392036139)
& 31 count bingo card (NDC #61392036131), Rx, Recall
# D-648-2007;
vvv) NORTRIPTYLINE 25MG CAPSULE, 30 count bingo card
(NDC #61392036439), Rx, Recall # D-649-2007;
www) NORTRIPTYLINE 50MG CAPSULE, 30 count bingo card
(NDC #61392036739), Rx, Recall # D-650-2007;
xxx) NORTRIPTYLINE 75MG CAPSULE, 30 count bingo card
(NDC #61392037039), Rx, Recall # D-651-2007;
yyy) OXYBUTYNIN 5MG TABLET, 250 count bags (NDC #61392013825),
30 count boxes (NDC #61392013830) & 60 count boxes (NDC
#61392013860),
Rx, Recall # D-652-2007;
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, Recall # D-653-2007;
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, by telephone between February 14,
2007 and February 20, 2007. Firm initiated recall is ongoing.
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, ½ fl. oz. (15mL), Recall # D-794-2007
CODE
Lots: 047611, 067401, and 097651
RECALLING FIRM/MANUFACTURER
Bausch & Lomb, Inc., Tampa, FL, by letter and fax on May 4, 2007. Firm
initiated recall is ongoing.
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,
Recall # D-799-2007
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, by letter on April 6,
2007.
Manufacturer: Pliva Inc., East Hanover, NJ. Firm initiated recall
is ongoing.
REASON
The product does not meet dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE
16,714 tablets
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
VITROS® Immunodiagnostic Products Troponin I Reagent Pack, REF/Catalog
No. 194 9882. A Troponin Immunoassay Method, IVD, Recall # Z-0820-2007
CODE
Lots 3151 and 3170
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-Clinical Diagnostics, Rochester, NY, by telephone,
fax, letter and e-mail on April 27, 2007 and by nationwide press release on
May 4, 2007.
Manufacturer: Ortho-Clinical Diagnostics, Cardiff, United Kingdom. Firm
initiated recall is ongoing.
REASON
Quality control and patient results can be lower than expected when the true
Troponin I value is less than or equal to 0.2 ng/mL which may result in the
device failing to detect myocardial injury.
VOLUME OF PRODUCT IN COMMERCE
Lot 3151: 1750 units; Lot 3170:
3316 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Endura No-React Dural Substitute 2 cm x 10 cm, Product code: ENR20210;
Recall # Z-0827-2007;
b) EnDura No-React Dural Substitute 4 cm X 10 cm, Product code: ENR20404,
Recall # Z-0828-2007;
c) EnDura No-React Dural Substitute 5 cm x 6 cm, Product code ENR20506,
Recall # Z-0829-2007;
d) Endura No-React Dural Substitute 6 cm x 10 cm, Product code: ENR20610,
Recall # Z-0830-2007;
e) EnDura No React Dural Substitute 10 cm x 12 cm; Product code: ENR21012,
Recall # Z-0831-2007;
f) EnDura No-React Dural Substitute 12 cm Diameter, Product code: ENR21212,
Recall # Z-0832-2007
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp, Plainsboro, NJ,
Manufacturer: Shelhigh, Inc, Union, NJ. Firm initiated recall is
ongoing.
REASON
Product is being recalled based on an FDA Public Health Notification and FDA
requested recall letter to Shelhigh citing sterility and other manufacturing
concerns.
VOLUME OF PRODUCT IN COMMERCE
12,736 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Abbott Precision Link Software (Version 2.1), (Version 2.2), (Version 2.3),
(Version 2.4), (Version 2.5), and (Version 2.6); Part Numbers: 99040-01, 99063-02.99514-01,97444-04,
97444-05,97445-05,97570-04, 98891-04,98929-05,98931-04, 98889-06, 98890-05,
98891-05, 98929-06,98931-05,99063-04, 99516-03, 80378-01,80379-01,80380-01,
80381-01, 80382-01,80383-01, 80392-01, 70519-01, 80392-02, Recall # Z-0709-2007
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Diabetes Care, Inc, Alameda, CA, by letter on
December 21, 2006.
Manufacturer: Lahlouh, Burlingame, CA. Recall initiated recall is ongoing.
REASON
If the time and date are not set correctly on both the user's meter and computer,
there is the potential for incorrect times and dates to be assigned to the
results in the Precision Link Software.
VOLUME OF PRODUCT IN COMMERCE
67,601 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number
08C89-01,
Recall # Z-0790-2007;
b) ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number
3M74-01,
Recall # Z-0791-2007;
c) ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20
(4 x 100 test kits),
07K60-25 (100 test kits) and 07K60-30 (4 x 500 test kits)
CODE
a) and b) All serial numbers;
c) Product Control/Lot # (For List #07K60-20): 42908JN00, 42964JN00 and 42905JN00;
(For List #07K60-25): 42909JN00, 42965JN00 and 42906JN00;
(For List #07K60-30): 42910JN00, 42966JN00, 42907JN00, and
42931JN00
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letters on March 28, 2007. Firm initiated
recall is ongoing.
REASON
If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating
folate-like by-products, the ARCHITECT Folate assay may experience calibration
failures and/or shifts in results.
VOLUME OF PRODUCT IN COMMERCE
3866 units
DISTRIBUTION
Internationally
___________________________________
PRODUCT
a) Polyester braided and coated nonabsorbable surgical suture with double needle,
size 2/0 (3.0 Metric), NSH 26 mm TAPER Needle. Product overwrap
label includes:
'2/0 (3.0 metric) CP523A Polybond Green Braided, Polyester
Coated Nonabsorbable
Sterile Suture Rx Only TAPER NSH 36' (90cm) 1/2 26mm. Product
box label
includes: '2/0 (3.0 metric) CP523A NSH 26 mm 1/2 TAPER POLYBOND
Green Polyester Braided Coated Nonabsorbable 36' (90cm),
Recall # Z-0807-2007;
b) Blue Polypropylene monofilament synthetic nonabsorbable
surgical suture with needle, size 3/0 (2.0 Metric), NFS-2,
19 mm Needle.
Box Label includes: '3/0 (2.0 metric) POLYPRO Blue Monofilament
Polypropylene
Nonabsorbable Suture 8665P Rx Only NFS-2 19 mm 3/8 CUTTING
18' (45 cm)
One Dozen Sterile. Side of box has an adhesive sticker label
which includes:
'Vet Use Only'. Packet Label includes: '3/0 (2.0 metric)
8665 NFS-2 19mm 3/8 TAPER
POLYPROPYLENE Blue Polypropylene Monofilament Synthetic
Nonabsorbable
Suture 18' (45 cm) STERILE EO. Product is also distributed
under two private labels,
Webster Veterinary and Butler. Webster Veterinary Box Label
includes:
'3/0 (2.0 metric) WEBPRO Blue Monofilament Polypropylene
Nonabsorbable
Suture Distributed by: WEBSTER VETERINARY One Dozen Sterile
07-836-4643(8665P) 26-B8665P-02 Vet Use Only CUTTING NFS-2
18' (45 cm)
3/8 19mm'.
Webster Veterinary Packet Label includes: '3/0 (2.0 metric)
WEBPRO
Blue Monofilament Polypropylene Nonabsorbable Sterile Suture
Vet Use Only
26-B8665P-02 NFS-2 18' (45 cm) CUTTING 3/8 19mm'.
Butler Box label includes: 'Butler 3/0 (2.0 metric) PROMEND
Blue Monofilament
Polypropelene 032002 Vet Use Only NFS-2 CUTTING 18' (45
cm) 3/8 19mm
01-B8665P-01 SUTUREVET'. Butler Packet Label includes: '3/0
(2.0 metric)
NFS-2 19mm 3/8 CUTTING 18' (45cm) 032002 PROMEND Blue Propylene
Monofilament Synthetic Nonabsorbable Suture STERILE EO,
Recall # Z-0808-2007;
c) Polydioxanone Violet monofilament synthetic absorbable suture with
needle, size 3/0 (2.0 Metric), NFS-2, 19 mm Needle.
Product is sealed inside an inner foil pouch with an outside
tyvek pouch.
The outer tyvek pouch has the defective seal.
Product is boxed (12 to a box) and shrink wrapped. Product
is labeled STERILE.
Box Label includes: '3/0 (2.0 metric) MONO-DOX Violet Monofilament
Polydioxanone Suture USP M398A CP-B-M398A-04 Rx Only NFS-2
19 mm
3/8 CUTTING Manufactured by: CP Medical Portland, OR USA
30' (75 cm)
One Dozen Sterile Synthetic Absorbable Suture '. Packet
Label includes:
'3/0 (2.0 metric) 398 NFS-2 19mm 3/8 CUTTING 30' (75cm)
POLYDIOXANONE
Violet (PDO) Monofilament Synthetic Absorbable Suture STERILE
EO.
Product is also distributed under three private labels,
Webster Veterinary Box Label
includes: '3/0 (2.0 metric) WEBMAX Violet Monofilament Polydioxanone
Suture
Distributed by: WEBSTER VETERINARY 07-836-4288(M398A) 26-BM398A-01
Vet Use Only CUTTING NFS-2 30' (75 cm) 3/8 19mm'. Webster
Veterinary Packet
Label includes: '3/0 (2.0 metric) 07-836-4288(M398A) WEBMAX
Violet Monofilament
Polydioxanone Absorbable Sterile Suture 30' (75cm) Vet Use
Only, CUTTING
NFS-2 3/8 19mm 26-SM398A-01'. Butler Box label includes:
'Butler 3/0 (2.0 metric)
MONOSORB Violet Monofilament Polydioxanone Suture 029254
Vet Use Only
NFS-2 CUTTING 30' (75 cm) 3/8 19mm 01-BM398A-02 SUTUREVET'.
Butler
Packet Label includes: '3/0 (2.0 metric) NFS-2 19mm 3/8
CUTTING 30' (75cm)
029254 MONOSORB Violet Monofilament Prolydioxanone Synthetic
Absorbable
Suture STERILE EO Distributed Exclusively by: Butler Animal
Health Supply'.
Phoenix Pharmaceutical Box label includes: '3/0 (2.0 metric)
0398 Poly-Dox Sutures
VIOLET MONOFILAMENT (Polydioxanone) Suture Sterile Synthetic
Absorbable
Suture 30' (75cm) Vet Use Only Cutting PFS-2 3/8 19mm. Phoenix
Pharmaceutical
Packet label includes: '3/0 (2.0 metric) 0398 Poly-Dox Sutures
VIOLET
MONOFILAMENT (Polydioxanone) Suture 30' (75cm) Sterile,
Synthetic Absorbable
Suture Veterinary Use Only Cutting PFS-2 3/8 19mm, Recall
# Z-0809-2007
CODE
a) Lot numbers: I0625120 expiration 2011-08, and I0627120-01 expiration 2011-08;
b) CP Medical Product label is coded 8665P. Lot number J0629930-1 expiration
2011-09.
Private distributed label for Webster Veterinary is coded
07-836-4643(8665P).
Lot number J0629930-1 expiration 2011-09. Private distributed
label for Butler is
coded 032002. Lot number J0629930-1 expiration 2011-09;
c) CP Medical Product label is coded M398A. Lot number 070122-03 expiration
2010-12.
Private distributed label for Webster Veterinary is coded
07-836-4288(M398A).
Lot number 070122-03 expiration 2010-12. Private distributed
label for Butler is
coded 029254. Lot number 070122-03 expiration 2010-12. Private
distributed label
for Phoenix Pharmaceutical is coded 0398. Lot number 070122-03
expiration 2010-12
RECALLING FIRM/MANUFACTURER
C P Medical, Portland, OR, by telephone on April 3, 2007, by follow-up
letter dated April 9, 2007, April 17 and April 18, 2007. Firm initiated recall
is ongoing.
REASON
Potential for sterility of product to be compromised. Suture package seals
incomplete or missing.
VOLUME OF PRODUCT IN COMMERCE
Polyester - 1,452 suture packets two lots; Polypropylene - 1,332 suture packets;
Polydioxanone - 13,596 suture packets
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic
analyzer Diagnostica Stago France; Item Number: 56602, Recall # Z-0812-2007
CODE
All units with the last 4 digits of the serial number under 3450. Serial numbers
5050012 6060290 6070319 6070346 6090389 6090416 6090417 6090418 6100419 7010600
7010601 7010602 7010603 7010604 7010605 7010606 7010607 7010608 7010609 7010611
7010612 7020648 7020649 7020650 7020651 7020652 7020653 7020654 7020655 7020656
7020683 7020684 7020685 7020686 7020687 7030745 7030746 7030747 7030748 7030749
7030751 7030752 7040808 7040809 7040810 7040811 7040812 7040813 7040814 7040815
7040816 7040817 7050834 7050835 7050836 7050837 7050838 7050871 7050872 7050873
7050874 7050875 7050876 7050877 7050878 7050879 7060931 7060932 7060933 7060935
7060936 7060937 7060938 7060939 7060940 7091037 7091038 7091039 7091040 7091041
7091060 7091079 7091080 7091081 7121199 7121200 7121201 7121202 7121203 8011222
8011223 8011224 8011225 8011226 8011228 8011229 8011230 8011231 8021232 8021233
8021234 8021235 8021236 8021237 8021238 8021239 8021240 8021241 8021242 8021243
8021244 8021245 8021246 8021247 8021248 8021249 8021250 8021251 8031259 8031260
8031261 8031262 8031263 8031264 8031265 8031269 8031286 8031287 8031288 8031289
8031290 8041304 8041305 8041306 8041307 8041308 8041309 8041310 8041312 8041313
8041314 8041315 8041316 8041317 8041318 8061357 8061358 8071387 8071388 8071389
8071390 8071391 8071392 8071393 8071394 9011495 9011496 9011497 9011498 9011499
9011500 9011501 9021521 9021524 9021525 9021526 9021528 9021529 9021530 9021531
9021532 9021537 9021538 9021539 9021540 9031557 9031558 9031559 9041594 9041595
9041596 9041597 9041598 9041599 9051600 9051601 9051602 9051603 9051604 9061645
9061646 9061647 9061648 9061659 9061660 9061661 9061662 9061663 9071689 9071690
9071691 9071693 9071694 9071695 9071696 9071700 9081714 9081715 9081729 9081730
9081731 9081736 9081737 9091739 9091741 9091768 9091769 9091770 9091774 9091775
9091776 9091777 9091778 9091779 9091783 9091784 9091785 9091786 9091787 9101842
9101843 9101844 9101845 9101846 9101847 9101848 9101856 9111858 9111861 9111862
9111863 9111864 9111865 9111866 9111867 9111868 9111874 9111876 9111877 9111878
9111879 9111880 9111881 9111882 9111906 9111907 9111908 9111909 9111910 9111913
9111914 9111916 9111917 9111918 9111919 9111920 9121937 9121939 9121940 9121942
9121943 9121945 9121948 9121949 9121950 9121951 11971 11972 11973 11974 11975
11976 11977 11991 11992 11993 11994 11995 11996 11997 11998 21999 22000 22003
22008 22009 22010 22014 22015 22016 22017 22018 22019 22023 32036 32037 32038
32039 32040 32041 32042 32061 32062 32063 32064 32065 32071 32073 32074 32083
42109 42110 42111 42112 52141 52142 72239 72240 72241 82250 82251 82254 82255
82256 82257 82258 82259 82266 82267 82268 92269 92277 92278 92280 92281 92283
92288 92289 92290 92291 92293 92294 102299 102301 102302 102303 102304 102328
102331 102333 102334 102335 102336 102338 102339 102340 102342 102344 102345
102346 112350 112351 112352 112353 112354 112355 112356 112357 112368 112371
112372 112379 112380 112381 112382 112383 112384 112385 112386 112387 112388
122423 122424 122425 122427 122428 122429 122430 122431 122432 122433 1012434
1012435 1012456 1012457 1012458 1012460 1012461 1012462 1012463 1012465 1012474
1012475 1012476 1022502 1022513 1022514 1022515 1022516 1022517 1022518 1022520
1022521 1032523 1032524 1032527 1032528 1042578 1042579 1042580 1042581 1042582
1042583 1042584 1042585 1042586 1042587 1042588 1042589 1042590 1042591 1052634
1052635 1052636 1052637 1052638 1052639 1052640 1052641 1052642 1052643 1052645
1052647 1062676 10626771062678 1062683 1062684 1062685 1062686 1062687 1062688
1062689 1062690 1062691 1062692 1062693 1062694 1062696 1062697 1062699 1062700
1062702 1062703 1062704 1062705 1062706 1072751 1072752 1072753 1072754 1072755
1072757 1072758 1072759 1072766 1072767 1072768 1072769 1072770 1092815 1092816
1092817 1092818 1092819 1092820 1092821 1092822 1092823 1092824 1092825 1092826
1092827 1092828 1092830 1092831 1092832 1092833 1092834 1092836 1092848 1092849
1092850 1092851 1092852 1092853 1092854 1092855 1092856 1092857 1092858 1092861
1092862 1102869 1102871 1102873 1102874 1102875 1102876 1102877 1102895 1102911
1112927 1112949 1112950 1112951 1112952 1112953 1112954 1112955 1112956 1112957
1112958 1112959 1112960 1112961 1112962 1123008 1123009 1123011 1123013 1123014
1123015 1123016 2013050 2013051 2013052 2023108 2023109 2023110 2023111 2023112
2023113 2023114 2023115 2023116 2023117 2023118 2023121 2023122 2023123 2023124
2023125 2023126 2023127 2023128 2023129 2023130 2023131 2023132 2023133 2023134
2023151 2023152 2023153 2023188 2023189 2023190 2023191 2023192 2033193 2033194
2033195 2033196 2033197 2033198 2033199 2033200 2033201 2033202 2033203 2043224
2043225 2043226 2043227 2043228 2043229 2043230 2043231 2043232 2043233 2043234
2043237 2043238 2043239 2043240 2043241 2043242 2043243 2043244 2043245 2043251
2043252 2043253 2043254 2043255 2043256 2043257 2043258 2043259 2043260 2043266
2043268 2043269 2043271 2043272 2043288 2043289 2043291 2043292 2043293 2043295
2043296 2043297 2053299 2053300 2053301 2053302 2053303 2053304 2053305 2053346
2053348 2053349 2053350 2053351 2053352 2053353 2053354 2053355 2053356 2053357
2053358 2053359 2053360 2053361 2053362 2063364 2063365 2063366 2063367 2063368
2073397 2073398 2073399 2073400 2073401 2073402 2073404 2073405 2073406 2073418
2073419 2073420 2073421 2073422 2073423 2073424 2073425 2073446 2073447 2073448
2073449
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diagnostica Stago, Inc, Parsippany, NJ, by visit beginning
on January 18, 2007.
Manufacturer: Diagnostica Stago, Franconville, France. Firm initiated
recall is ongoing.
REASON
Result of complaints of field failures of the silicon bridge rectifier, resulting
in smoke billowing out of the unit and burnt circuit boards, wires and connectors.
VOLUME OF PRODUCT IN COMMERCE
693 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
BD 5mlSyringe Luer-Lok Tip Bulk Sterile Convenience Pak Latex Free, Recall #
Z-0813-2007
CODE
Lot number: 7002604 Ref 309703
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ,
by letters on April 2, 2007 and May 3, 2007.
Manufacturer: Becton Dickinson Medical Systems, Canaan, CT. Firm
initiated recall is ongoing.
REASON
Small cracks in plastic trays of one lot of BD 5mL Syringe Luer Lok Tp, Bulk
Sterile Convenience Packs that may adversely affect tray integrity and steriity.
VOLUME OF PRODUCT IN COMMERCE
1500 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Definium AMX 700 Digital mobile x-ray system, Recall # Z-0821-2007
CODE
973971AMXD1, 973971AMXD2, 402449CDP1, 402449CDP2, 601426DAMX1, and 972566D700A
RECALLING FIRM/MANUFACTURER
GE Medical Systems LLC, Waukesha, WI, by visit beginning December 21, 2006. Firm
initiated recall is ongoing.
REASON
When using the Tech Switch on exposures, 750ms, 100 kVp and 100 mAs the exposure
terminates prematurely.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) BinaxNOW Influenza A&B 10 Test KIT Part Number: 416-110 contains NP Swabs
with '8995' labeled on the swab wrapper, Recall # Z-0822-2007;
b) BinaxNOW Influenza A&B 22 Test Kit Part Number: 416-022, contains NP Swabs
with '8995' labeled on the swab wrapper, Recall # Z-0823-2007;
c) BinaxNOW RSV 10 Test Kit Part Number : 430-100, contains NP Swabs
with '8995' labeled on the swab wrapper, Recall # Z-0824-2007;
d) BinaxNOW Nasopharyngeal (NP) Accessory Pak, Part Number 400-065,
contain NP Swabs with '8995' labeled on the swab wrapper,
Recall # Z-0825-2007;
e) BinaxNOW A&B Kit 10 Test Kit (Japan) Part No. 416-110J contains
NP Swabs with '8995' labeled on the swab wrapper, Recall #
Z-0826-2007
CODE
a) Kit Lot Numbers: 023378, 023411, 023433, 023616, 024021, 024384,
024479, 024480, 024622 NP Swabs Lot Number: 8995;
b) Kit Lot Numbers:024020, 024175, 024360, 024361, 024385, 024596,
024597, 024703, 024705, 024704, 024714, 024715, 024718, 024726,
025087
NP Swabs Lot Number: 8995;
c) Kit Lot Numbers: 023437, 024056, 024057, 024436, 024516, 024518, 024694,
024695, 024882, 025090, 025089 NP Swabs Lot Number: 8995;
d) Kit lot Numbers: 023357, 023566, 024629, 024631;
e) Lot number: 24162
RECALLING FIRM/MANUFACTURER
Recalling Firm: Inverness Medical Professional Diagnostics, Scarborough,
ME, by letter on March 28, 2007.
Manufacturer: Puritan Medical Products Co., LLC, Guilford, ME. Firm
initiated recall is ongoing.
REASON
Tip of the foam swab could detach from the shaft causing injury to the patient.
VOLUME OF PRODUCT IN COMMERCE
13,934 kits, 185,150 Swabs
DISTRIBUTION
Nationwide and Japan
___________________________________
PRODUCT
BD AutoShield Pen Needle, Recall # Z-0838-2007
CODE
Re-order Number: 329300
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson and Company, Franklin Lakes, NJ, by telephone
and letter on April 23, 2007.
Manufacturer: Becton Dickinson Vascular Access S.A. de C.V., Nogales, Sonora
Vexico. Firm initiated recall is ongoing.
REASON
Complaints were received regarding needle stick injuries while administering
insulin to patients. Label will be revised to provide clear direction on product
usage.
VOLUME OF PRODUCT IN COMMERCE
496,200 units
DISTRIBUTION
NJ, MO, TX, OH, NM, IL, ND, FL, KS, VA, LA, and GA
___________________________________
PRODUCT
Medtronic Buffer Solution pH 1.07 500ml REF 9012D1071, Recall # Z-0817-2007
CODE
Lot #2610596
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neurological, Minneapolis, MN, on April
2007 by letter.
Manufacturer: Medtronic A/S, Skovlunde, Denmark. Firm initiated
recall is ongoing.
REASON
Medtronic pH 1.07 buffer solution lot #2610596 was mislabeled. The pink pH
1.07 buffer solution (catalog number 9012D1091) was placed in the pH 7.01 buffer
solution bottle (catalog number 9012D1071).
VOLUME OF PRODUCT IN COMMERCE
238 units
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR MAY 30, 2007
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