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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.
August 15, 2007
07-33
___________________________________
PRODUCT
Lynae Shark Cartilage 750mg Capsules, Product Number FS1001, Lot Number FJ04101F, Expiration Date 12/2008, UPC Number 85714 00282 2, 100 capsules per bottle, Recall # Recall # F-465-7
CODE
Lot Number FJ04101F, Expiration Date 12/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boscogen Inc., Irvine, CA, by telephone on June 11, 2007, e-mails on June 12, 2007 and letters on June 13, 2007.
Manufacturer: NBTY Inc., Bohemia, NY. Firm initiated recall is complete.
REASON
Testing performed recently by the manufacturer, shows that the recalled capsules have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
487 bottles of 100 capsules each
DISTRIBUTION
CA, Canada, Romania, Switzerland, Thailand, The Netherlands and Vietnam
___________________________________
PRODUCT
H S Joy of Love Sexual Energizer 100% Pure Herbal Extract 500mg/Cap, 12 Caps/box, Recall # D-942-2007
CODE
''USEBY 09-05-09 LOT # I-05-06-2''
RECALLING FIRM/MANUFACTURER
Recalling Firm: Jen-On Herbal Science International Inc., City of Industry, CA, by telephone on April 12, 2007, press release on April 17, 2007 and by letter on April 18, 2007.
Manufacturer: Herbal Science International, Inc., Walnut, CA. Firm initiated recall is ongoing.
REASON
Unapproved New Drug. Product has been found to contain piperadino vardenafil, an analogue of Vardenafil, an FDA-approved drug used to treat Erectile Dysfunction (ED).
VOLUME OF PRODUCT IN COMMERCE
2,484 boxes
DISTRIBUTION
CA, CO, FL, NV, TX, WA, NJ, IL, MA
___________________________________
PRODUCT
a) Novolog Insulin Aspart Injection (rDNA origin), U-100, 100 units/mL human insulin, Rx;
distributed in the following containers: a) Novolog, 10 mL vials, NDC 0169-7501-11,
Walgreen item 680728 b) Novolog PenFill, 5 x 3 mL PenFill cartridges for use with NovoPen 3,
insulin delivery devices, NDC 0169-3303-12, Walgreen item 675572 c) Novolog Flexpen
Prefilled Syringe, 5 x 3 mL pre-filled insulin syringes, NDC 0169-6339-10, Walgreen item 680670
"NovoLog in unopened vials, cartridges and NovoLog Flex-Pen prefilled syringes should be stored
between 2° and 8°C (36° to 46°F). Do not freeze. Do not use NovoLog if it has been frozen or
exposed to temperatures that exceed 37°C (98.6°F)." Recall # D-851-2007;
b) Novolog Mix 70/30, 70% Insulin Aspart Protamine Suspension and 30% Insulin Aspart Injection,
(rDNA origin), U-100, 10 mL vial, 100 units/mL human insulin, Rx only, NDC 0169-3685-12,
Walgreen item 675106 "NovoLog Mix 70/30 should be stored between 2° and 8°C (36° to 46°F).
Do not freeze. Do not use NovoLog Mix 70/30 if it has been frozen." Recall # D-852-2007;
c) Novolin R Regular Human Insulin Injection (rDNA origin) U-100, 100 units/mL, OTC,
10 mL vials; NDC 0169-1833-11, Walgreen item 681247 Novolin R should be stored between 2°
and 8°C (36° to 46°F). Do not freeze, Recall # D-853-2007;
d) NPH Human Insulin (rDNA origin) Isophane Suspension, U-100, 100 units/mL, OTC,
distributed under the following labels and containers: a) Humulin N NPH Human Insulin
(rDNA origin) Isophane Suspension, HI-310, 10 mL vials, NDC 0002-8315-01,
Walgreen item 676096; c) Novolin N NPH Human Insulin Isophane Suspension
(rDNA origin), 10 mL vials, NDC 0169-1834-11, Walgreen item 681245; Insulin should be stored
in a cold place, preferably in a refrigerator, but not in the freezing compartment. Do not let it
freeze, Recall # D-854-2007;
e) 70% Human Insulin Isophane Suspension 30% Human Insulin Injection (rDNA origin), U-100,
100 units/mL human insulin, OTC, distributed under the following containers:
a) Humulin 70/30, HI-710, 10 mL vials, NDC 0002-8715-01, Walgreen item 678064
b) Humulin 70/30 Pen, 5 x 3 mL Disposable Pen Insulin Delivery Devices, HP-8770,
NDC 0002-8770-59, Walgreen item 680333
c) Novolin 70/30, 10 mL vials, NDC 0169-1837-11, Walgreen item 679253
d) Novolin 70/30 InnoLet Insulin Pen, 5 x 3 mL pre-filled disposable insulin dosers,
NDC 0139-2317-21, Walgreen item 652443
e) Novolin 70/30 PenFill, 5 x 3 mL cartridges for use with NovoPen 3 Insulin Delivery Device,
NDC 0169-3477-18, Walgreen item 681599 Insulin should be stored in a cold place, preferably
in a refrigerator, but not in the freezing compartment. Do not let it freeze.
Recall # D-855-2007;
f) Humalog Insulin Lispro Injection (rDNA origin), U-100, 100 units/mL human insulin, Rx,
distributed in the following containers:
a) Humalog, 10 mL vials, VL-7510, NDC 0002-7510-01, Walgreen item 673093
b) Humalog Pen, 5 x 3 mL Disposable Insulin Delivery Devices, HP-8725, NDC 0002-8725-59,
Walgreen item 680332 Humalog should be stored in a refrigerator between 2° and 8°C
(36° to 46°F), but not in the freezing compartment. Do not let it freeze. Do not use Humalog
if it has been frozen, Recall # D-856-2007;
g) Humalog Mix 75/25, 75% Insulin Lispro Protamine Suspension 25% Insulin Lispro Injection
(rDNA origin), U-100, 100 units/mL human insulin, Rx, distributed in the following containers:
a) Humalog Mix 75/25, 10 mL vial, VL-7511, NDC 0002-7511-01, Walgreen item 676801
b) Humalog Mix 75/25 Pen, 5 x 3 mL Disposable Insulin Delivery Devices, HP-8794,
NDC 0002-8794-59, Walgreen item 677240 Insulin should be stored in a cold place, preferably
in a refrigerator, but not in the freezing compartment. Do not let it freeze, Recall # D-857-2007;
h) Levemir Insulin Detemir Injection, (rDNA origin), U-100, 3 mL FlexPen Prefilled Syringe,
5 x 3 mL pre-filled insulin syringes, 100 units/mL insulin detemir, Rx only, NDC 0169-3439-10,
Walgreen item 592360 "Do not refrigerate. Do not freeze," Recall # D-858-2007;
i) Lovenox Injection, enoxaparin sodium 100 mg/mL, an Rx SVP; distributed in the following
containers: a) 40 mg/0.4 mL Prefilled Syringe, 10 syringes per box, NDC #0075-0620-40,
Walgreen item 686176
b) 60 mg/0.6 mL Graduated Prefilled Syringe, 10 syringes per box, NDC #0075-0621-60,
Walgreen item 686174 c) 80 mg/0.8 mL Graduated Prefilled Syringe, 10 syringes per box,
NDC #0075-0622-80, Walgreen item 686173 d) 100 mg/1 mL Graduated Prefilled Syringe,
10 syringes per box, NDC # 0075-0623-00, Walgreen item 686175 Store at 25°C (77°F);
excursions permitted to 15-30°C (59-86°F), Recall # D-859-2007;
j) Medroxyprogesterone Acetate Injection Suspension, 150mg/mL, an Rx svp hormone; distributed
as follows: a) in a 1 mL prefilled glass syringe, NDC #0703-6811-21, Walgreen item 600936
b) in a 1mL vial; NDC #59762-4537-01, Walgreens item 605717 Store at controlled room
temperature 20-25°C (68-77°F), Recall # D-860-2007;
k) Progesterone Injection, 50mg/mL, an Rx svp hormone in 10 mL vial; NDC #00591-3128-79,
Walgreen item 682894 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F),
Recall # D- 861-2007;
l) Androderm extended release transdermal patch, testosterone 5mg/24 hours; an Rx C-III hormone
gel; 30 patch pouches per box; NDC #52544-0470-30, Walgreen item 673155 Store patches
at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) in their sealed pouches until use.
Recall # D-862-2007;
m) Climara estradiol transdermal system, 0.075mg/24 hours, 5.7 mg of estradiol USP per patch,
4 patch pouches per box; NDC #50419-453-04, Walgreen item 674916 Do not store above
86°F (30°C). Do not store unpouched, Recall # D-863-2007;
n) Climara Pro (Estradiol/Levonorgestrel Transdermal System), 0.045 mg/day estradiol and
0.015 mg/day levonorgestrel - each patch contains 4.4 mg of estradiol and 1.39 mg of
levonorgestrel, 4 patch pouches per box; NDC 50419-491-04, Walgreen item 672455 Store at
20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F), Recall # D-864-2007;
o) Lidoderm (lidocaine 5%) Patch; Each adhesive patch contains 700 mg of lidocaine
(50 mg per gram adhesive) in an aqueous base; an Rx local anesthetic agent; box of 30
patches, packaged into individual child-resistant envelopes; NDC 63481-687-06,
Walgreen item 677264 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F),
Recall # D-865-2007;
p) Ortho Evra Transdermal System (norelgestromin and ethinyl estradiol, 0.15 mg - 0.02 mg/24 hours;
each patch contains 6.00 mg norelgestromin (NGMN) and 0.75 mg ethinyl estradiol (EE); an Rx
contraceptive; the patches were sold in folding cartons of 1 cycle each, with each cycle containing
3 patches, and 6 cartons per box; NDC # 0062-1920-15, Walgreens item 680711 Store at 25°C
(77°F); excursions permitted to 15-30°C (59-86°F). Store patches in their protective pouches.
Apply immediately upon removal from the protective pouch. Do not store in the refrigerator
or freezer, Recall # D-866-2007;
q) Vivelle Dot Estradiol Transdermal System, 0.05mg/24 hours; each patch contains 0.78 mg
estradiol; an Rx hormone; the patches were sold in calendar packs containing 8 patches, and 3
calendar packs per box; NDC #0078-0344-45, Walgreens item 684872 Store at controlled room
temperature 25°C (77°F), Recall # D-867-2007;
r) EpiPen Auto-Injector, each EpiPen auto-injector delivers a single dose of 0.3 mg epinephrine
from epinephrine injection, USP, 1:1000 (0.3 mL) in a sterile solution; an Rx svp; the EpiPens
were distributed in the following configurations: a) a single EpiPen auto-injector in an individual
carton, NDC 49502-500-01, Walgreen item 678922 b) EpiPen 2-Pak, a pack that contains two
EpiPen auto-injectors and one EpiPen trainer device, NDC 49502-500-02, Walgreen item 675592
Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F), Recall # D-868-2007;
s) Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection [rDNA origin]) (MS8031):
1 mg (1 unit)-(VL7529), with 1 mL of diluting solution and 1 Hyporet * HY7530 disposable
syringe); NDC 0002-8031-01, Walgreen item 676712 Before Reconstitution -- Vials of Glucagon,
as well as the Diluting Solution for Glucagon, may be stored at controlled room temperature 20°
to 25°C (68° to 77°F), Recall # D-869-2007;
t) ALPHAGAN® P (brimonidine tartrate) ophthalmic solution, brimonidine tartrate 0.15%
(1.5 mg/mL); an Rx sterile ophthalmic solution; 10 mL in 10 mL dropper bottle;
NDC 0023-9177-10, Walgreen item 672813 Store at 15°-25° C (59-77°F), Recall # D-870-2007;
u) ALREX® (loteprednol etabonate) ophthalmic suspension, Loteprednol Etabonate 2 mg (0.2%);
an Rx sterile, topical anti-inflammatory corticosteroid for ophthalmic use; packaged in a plastic
bottle with a controlled drop tip in the following sizes: a) 5 mL, AB35307, NDC 24208-353-05,
Walgreen item 673219
b) 10 mL, AB35309, NDC 24208-353-10, Walgreen item 673220 Store upright between
15°-25°C (59°-77°F). DO NOT FREEZE, Recall # D-869-2007; Recall # D-871-2007;
v) AZOPT® (brinzolamide) ophthalmic suspension 1%, an Rx sterile ophthalmic supplied in
15 mL plastic DROP-TAINER® dispensers with a controlled dispensing-tip; NDC 0065-0275-15,
Walgreen item 680158 Store at 4-30°C (39-86°F), Recall # D-872-2007;
w) Betimol® (timolol) ophthalmic solution 0.5%, each mL contains 5.12 mg of timolol hemihydrate
equivalent to 5.0 mg timolol; an Rx, sterile non-selective beta-adrenergic antagonist for ophthalmic
use; 10mL fill in 11 cc white, opaque, plastic, ophthalmic dispenser bottle with a controlled drop
tip; NDC 68669-525-10, Walgreen item 673885 Store between 15-30°C (59-86°F). Do not freeze.
Protect from light, Recall # D-873-2007;
x) Ciprofloxacin Hydrochloride Ophthalmic Solution 0.3%, packaged in a 5 mL dropper bottle,
each mL Ciprofloxacin HCl 3.5 mg equivalent to 3 mg base; an Rx, sterile fluoroquinolone
antibacterial; NDC 61314-0656-05, Walgreen item 670446 Store between 2-25°C (36-77°F).
Protect from light, Recall # D-874-2007;
y) Cosopt (dorzolamide hydrochloride-timolol maleate)ophthalmic solution, each mL of COSOPT
contains 20 mg dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5 mg timolol
(6.83 mg timolol maleate); an Rx, sterile combination of a topical carbonic anhydrase inhibitor
and a topical beta-adrenergic receptor blocking agent; 10 mL in an 18 mL capacity a white,
translucent, HDPE plastic ophthalmic dispenser bottle with a controlled drop tip and a white
polystyrene cap; NDC 0006-3628-36, Walgreen item 674907 Store COSOPT at 15-30°C
(59-86°F). Protect from light, Recall # D-875-2007;
z) Fluorometholone Ophthalmic Suspension, USP 0.1%, an Rx sterile, topical anti-inflammatory
agent for ophthalmic use; 10 mL dropper bottle; NDC 60758-0880-10, Walgreen item 599171
Store between 2° and 25°C (36°-77°F); protect from freezing. Shake well before using,
Recall # D-876-2007;
aa) Flurbiprofen Sodium Ophthalmic Solution 0.03%; flurbiprofen sodium 0.3 mg/mL; 2.5.mL
dropper bottle; NDC 24208-0314-25, Walgreen item 677573 Store at 15°25°C (5977°F),
Recall # D-877-2007;
bb) Gentamicin Sulfate Ophthalmic Solution 0.3%, 3 mg/mL gentamicin sulfate; an Rx, sterile
ophthalmic antibiotic; 5mL dropper bottle; NDC 24208-0580-60, Walgreen item 677824
Store between 15-25°C (59-77°F). Protect from light, Recall # Recall # D-878-2007;
cc) Levobunolol hydrochloride ophthalmic solution 0.5%, USP; an Rx sterile, noncardioselective
beta-adrenoceptor blocking agent for ophthalmic use; 5 mL dropper bottle; NDC 24208-0505-05,
Walgreen item 677245, Protect from light. Store at 15°-25°C (59°-77°F), Recall # D-879-2007;
dd) Lotemax (loteprednol etabonate) Ophthalmic Suspension 0.5%, each mL contains Loteprednol
Etabonate 5 mg; an Rx sterile, topical anti-inflammatory corticosteroid for ophthalmic use; 5 mL
plastic bottle with a controlled drop tip; NDC 24208-0299-05, Walgreen item 680164 Store
upright between 15°-25°C (59°- 77°F). DO NOT FREEZE, Recall # D-880-2007;
ee) LUMIGAN ® (bimatoprost) ophthalmic solution 0.03%, each mL contains bimatoprost 0.3 mg;
an Rx, sterile, synthetic prostamide analog with ocular hypotensive activity; packaged in
ophthalmic dispenser bottles and tips with turquoise polystyrene caps in the following sizes:
2.5 mL fill in 5 mL container - NDC 0023-9187-03, Walgreen item 676729; 5 mL fill in 10 mL
container - NDC 0023-9187-05; Walgreen item 676730 LUMIGAN ® should be stored in the
original container at 2° to 25°C (36° to 77°F), Recall # D-881-2007;
ff) Neomycin And Polymyxin B Sulfates And Dexamethasone Ophthalmic Suspension; 5 mL dropper
bottle, each mL contains Neomycin Sulfate equivalent to Neomycin 3.5 mg, Polymyxin B Sulfate
10,000 units, Dexamethasone 0.1%; NDC 61314-0630-06, Walgreen item 671628 Store at
8°- 27° C ( 46°- 80° F), Recall # D-882-2007;
gg) Ofloxacin Ophthalmic Solution 0.3%; ofloxacin 3 mg/mL, in 5 mL plastic dropper bottles;
an Rx, sterile fluorinated carboxyquinolone anti-infective for topical ophthalmic use;
NDC 24208-0434-05, Walgreen item 603423 Storage: Store at 15°-25°C (59°-77°F),
Recall # D-883-2007;
hh) Optivar Azelastine Hydrochloride Ophthalmic Solution, 0.05%; an Rx, sterile, relatively
selective H 1 -receptor antagonist for topical administration to the eyes; 6 mL solution in a
translucent 10 mL HDPE container with a LDPE dropper tip; NDC 0037-7025-60,
Walgreen item 680796 Store UPRIGHT between 2° and 25°C (36° and 77°F),
Recall # D-884-2007;
ii) PATANOL® (olopatadine hydrochloride) ophthalmic solution 0.1%; an Rx, sterile,
relatively selective H 1 - receptor antagonist and inhibitor of histamine release from the mast
cell for topical administration to the eyes; each mL contains 1.11 mg olopatadine hydrochloride
equivalent to 1 mg olopatadine, 5 mL in plastic DROP-TAINER® dispenser; NDC 0065-0271-05,
Walgreen item 681863 Store at 39°F-77°F (4°C-25°C), Recall # D-885-2007;
jj) Polmyxin B Sulfate And Trimethoprim Ophthalmic Solution, USP; polymyxin B sulfate 10,000
units/mL; trimethoprim sulfate equivalent to 1 mg/mL; an Rx, sterile antimicrobial solution for
topical ophthalmic use; 10 mL dropper bottle; NDC 61314-0628-10, Walgreen item 684677 Store
at 15°-25°C (59°-77°F) and protect from light, Recall # D-886-2007;
kk) Prednisolone Acetate Ophthalmic Suspension 1%; an Rx, sterile, topical anti-inflammatory agent
for ophthalmic use; packaged in 5 mL and 10 mL dropper bottles; 5 mL bottle:
NDC 61314-0637-05, Walgreen item 682441; 10 mL bottle: NDC 61314-0637-10, Walgreen
item 682442; Store at 15°C-30°C (59°F-86°F). Protect from freezing. Store in an upright position,
Recall # D-887-2007;
ll) RESTASIS® (cyclosporine) ophthalmic emulsion 0.05%; an Rx, sterile topical immunomodulator
with anti-inflammatory effects; Each single use vial contains 0.4 mL fill in a 0.9 mL LDPE vial/32
vials/polypropylene tray with an aluminum peelable lid; RESTASIS® 32 Vials 0.4 mL each –
NDC 0023-9163-32, Walgreen item 675052 Store RESTASIS® ophthalmic emulsion at 15°
to 25° C (59°-77° F), Recall # D-888-2007;
mm) Sulfacetamide Sodium Ophthalmic Solution USP 10%; sulfacetamide sodium 100 mg/mL;
an Rx, sterile, topical antibacterial agent for ophthalmic use; 15 mL dropper bottle;
NDC 24208-0670-04, Walgreen item 683917 Store at 8°-25°C (46°-77°F). Protect from light,
Recall # D-889-2007;
nn) Sulfacetamide Sodium and Prednisolone Sodium Phosphate Ophthalmic Solution; sulfacetamide
sodium 10%, prednisolone sodium phosphate 0.23% Eq; an Rx, sterile antibacterial and
corticosteroid combination, 10 mL dropper bottle; NDC 61314-0297-10, Walgreen item 671478
Store at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Do not freeze.
Store away from heat and light, Recall # D-890-2007;
oo) Timolol maleate ophthalmic gel forming solution 0.25%; each mL contains 2.5 mg of timolol
(3.4 mg of timolol maleate); an Rx, sterile non-selective beta-adrenergic receptor blocking agent;
5 mL dropper bottle; NDC 61314-0224-05, Walgreen item 685018 Store at 15-30°C (59-86°F).
Avoid Freezing. Protect from light, Recall # D-891-2007;
pp) Timolol maleate ophthalmic gel forming solution 0.5%; each mL contains 5 mg of timolol
(6.8 mg of timolol maleate); an Rx, sterile non-selective beta-adrenergic receptor blocking agent;
5 mL dropper bottle; NDC 61314-0225-05, Walgreen item 685020 Store at 15-30°C (59-86°F).
Avoid Freezing. Protect from light, Recall # D-892-2007;
qq) Timolol maleate ophthalmic solution 0.5%; each mL contains 5 mg of timolol (6.8 mg of timolol
maleate); an Rx, sterile non-selective beta-adrenergic receptor blocking agent; 5 mL dropper bottle;
gel forming solution: NDC 61314-0227-05, Walgreen item 685020 solution: NDC 61314-0227-05,
Walgreen item 684681 Store at room temperature, 15-30°C (59-86°F). Protect from freezing.
Protect from light, Recall # D-893-2007;
rr) Tobradex® (tobramycin and dexamethasone) ophthalmic suspension; each mL contains Tobramycin
0.3% (3 mg) and Dexamethasone 0.1% (1 mg); an Rx, sterile, multiple dose antibiotic and
steroid combination for topical ophthalmic use; supplied in 5 mL and 10 mL DROP-TAINER®
dispenser bottles. 5 mL: NDC 0065-0647-05, Walgreen item 685118 10 mL: NDC 0065-0647-10,
Walgreen item 685006 Store at 8° to 27°C (46° to 80°F), Recall # D-894-2007;
sis) Tobramycin Ophthalmic Solution USP 0.3%; each mL of contains tobramycin 3 mg;
an Rx sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of
external ophthalmic infections; 5 mL dropper bottle; NDC 24208-0290-05, Walgreen item 684922
Store at 8° - 27°C (46° - 80°F), Recall # D-895-2007;
tat) Travatan Ophthalmic Solution 0.004%, each mL contains 40 mug travoprost; an Rx, sterile
selective FP prostanoid receptor agonist; 2.5 mL solution in a 4 mL and a 5 mL solution in a 7.5 mL
natural polypropylene dispenser bottle with a natural polypropylene dropper tip; 2.5 mL fill:
NDC 0065-0266-25, Walgreen item 684662 5 mL fill: NDC 0065-0266-34, Walgreen
item 670775 Store at 2°-25°C (36°-77°F), Recall # D-896-2007;
uu) Vigamox (moxifloxacin HCl) ophthalmic solution 0.5%; Moxifloxacin 5 mg/mL; an Rx,
sterile 8-methoxy fluoroquinolone anti-infective for topical ophthalmic use; 3 mL in 6 mL
dropper bottle; NDC 0065-4013-03, Walgreen item 683058 Store at 2°C-25°C (36°F-77°F),
Recall # D-897-2007;
vv) Voltaren (diclofenac sodium) Ophthalmic Solution 0.1%; diclofenac sodium 1 mg/mL,
an Rx, sterile, topical, non-steroidal, anti-inflammatory product for ophthalmic use; 5.0 mL
fill is supplied in a 10.0 mL size low density polyethylene white bottle with a dropper tip;
Made in Canada, NDC 58768-100-05, Walgreen item 685666 Store at 15°C to 25°C (59° to 77°F),
Recall # D-898-2007;
ww) Zymar (gatifloxacin) ophthalmic solution) 0.3%; gatifloxacin 3 mg/mL; an Rx, sterile
8-methoxy fluoroquinolone anti-infective for topical ophthalmic use; 5 mL in 10 mL white,
low density polyethylene bottle with a controlled dropper tip; NDC 0023-9218-05, Walgreen
item 686171 Store at 15°-25°C (59°-77°F). Protect from freezing, Recall # D-899-2007;
xx) Bacitracin 0phthalmic Ointment USP, 500 units/gram; an Rx, sterile antibiotic used to treat
inflammation and infections of the eye; 3.5g (1/8 Oz) tube; NDC 0168-0026-38, Walgreen item
673187 Store at room temperature between 15°and 30°C (59°and 86°F). Protect from light,
Recall # D-900-2007;
yy) Ciloxan (ciprofloxacin hydrochloride) Ophthalmic Ointment 0.03%, each gram contains
Ciprofloxacin HCl 3.33 mg equivalent to 3 mg base; an Rx, sterile, multiple dose, antimicrobial
for topical ophthalmic use; 3.5 g aluminum tube; NDC 0065-0654-35, Walgreen item 674898
Store at 2° - 25°C (36° - 77°F), Recall # D-901-2007;
zz) Erythromycin Ophthalmic Ointment USP 0.5%, each gram contains Erythromycin USP 5 mg;
an Rx, sterile antibiotic used to treat inflammation and infections of the eye; 3.5g (1/8 Oz) tube;
dNDC 0168-0070-38, Walgreen item 677034 Store at controlled room temperature 15°-30°C
(59°-86°F). Avoid excessive heat. Protect from freezing, Recall # D-902-2007;
aaa) Antipyrine-Benzocaine Otic Solution; 1.4% benzocaine and 5.4% antipyrine with dehydrated
glycerin; an Rx, sterile otic analgesic and anesthetic; 15 mL dropper bottle; NDC 00603-7020-73,
Walgreen item 672853 Store at 59° to 86°F. Protect from light and heat, Recall # D-903-2007;
bbb) Oticaine (benzocaine) 20% Otic Drops; an Rx, sterile, otic local anesthetic; 15 mL dropper
bottle; NDC 00603-7238-73, Walgreen item 681584 Store at 59° to 86°F. Protect from light
and heat, Recall # D-904-2007;
ccc) Ciprodex (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension; each mL of
CIPRODEX® Otic contains ciprofloxacin hydrochloride (equivalent to 3 mg ciprofloxacin base)
and 1 mg dexamethasone; an Rx, sterile antibacterial/anti-inflammatory suspension for otic use;
7.5 mL fill in a dropper bottle; NDC 0065-8533-02, Walgreen item 673614 Store at controlled
room temperature, 15°C to 30°C (59°F to 86°F). Avoid freezing. Protect from light,
Recall # D-905-2007;
ddd) Cipro HC Otic Suspension; each mL contains ciprofloxacin hydrochloride (equivalent to
2 mg ciprofloxacin base) and 1 mg hydrocortisone; an Rx, sterile antibacterial/anti-inflammatory
suspension for otic use; 10 mL fill in a dropper bottle; NDC 0065-8531-10, Walgreen item 674909
Store at controlled room temperature, 15°C to 30°C (59°F to 86°F). Avoid freezing. Protect from
light, Recall # D-906-2007;
eee) Floxin (ofloxacin) Otic Solution 0.3%; ofloxacin 3 mg/mL; an Rx, sterile aqueous anti-infective
(anti-bacterial) solution for otic use; supplied in plastic dropper bottles containing 5 mL and
10 mL; 5 mL: NDC 63395-101-05, Walgreen item 677763 10 mL: NDC 63395-101-10,
Walgreen item 676975 Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
Protect from light, Recall # D-907-2007;
fff) Neomycin, Polymyxin B, Hydrocortisone Otic Suspension; each mL contains 5 mg neomycin
sulfate equivalent to 3.5 mg neomycin, 10,000 units polymixin B, 1% hydrocortisone; an
Rx, sterile antibiotic and steroid combination for otic use; 10 mL dropper bottle;
NDC 61314-0645-10, Walgreen item 671630 Store at controlled room temperature, 15°C to
30°C (59°F to 86°F). Avoid freezing, Recall # D-908-2007;
ggg) Acetaminophen Elixir; each 2.5 mL contains: Acetaminophen 80 mg; an OTC oral
analgesic-antipyretic; 4 fl. oz. bottle Silarx Walgreen item 683280 Store between 20-25°C
(68-77°F), Recall # D-909-2007;
hhh) Acetaminophen & Codeine Phosphate Oral Solution USP; Each 5 mL contains Acetaminophen
120 mg, Codeine Phosphate 12 mg; an Rx, Schedule C-V narcotic agonist-antagonist analgesic;
16 fl. oz. bottle; NDC 0121-0504-16, Walgreen item 672713 Keep tightly closed. Store at
controlled room temperature 15°-30°C (59°-86°F). Protect from light, Recall # D-910-2007;
iii) Belladonna Alkaloids with Phenobarbital Oral Elixir; an Rx oral antispasmodic, anticholinergic;
each 5 mL contains phenobarbital 16.2 mg, hyoscyamine sulfate 0.1037 mg, atropine
sulfate 0.0194 mg, scopolamine hydrobromide 0.0065 mg; 16 fl. oz. bottle; NDC 0603-1030-58,
Walgreen item 672847 Store at controlled room temperature 20° -25°C (68° -77°F),
Recall # D-911-2007;
jjj) Carafate (sucralfate) Suspension; 10 mL contains 1 g of sucralfate; an Rx oral medication;
14 fl oz bottles; NDC 58914-170-14, Walgreen item 674257 Store at controlled room temperature
20 -25°C (68 - 77°F), Recall # D-912-2007;
kkk) Ceron Oral Drops; each 1 mL contains Chlorpheniramine Maleate 1 mg, Phenylephrine
HCl 3.5 mg; an Rx oral liquid pediatric decongestant/antihistamine; 1 fl oz dropper bottle;
NDC 60258-416-30, Walgreen item 594430 Store at room temperature between 15 - 30 degrees
C (59 - 86 degrees F), Recall # D-913-2007;
lll) Cheratussin AC Syrup; each 5 mL contains codeine phosphate 10 mg, guaifenesin 100 mg;
an Rx Schedule C-V narcotic antitussive/expectorant; 16 fl. oz. bottle; NDC 0603-1075-58,
Walgreen item 674484 Store at controlled room temperature 15°-30°C (59°-86°F),
Recall # D-914-2007;
mmm) Cheratussin DAC Syrup; each 5 mL contains codeine phosphate 10 mg, guaifenesin 100 mg,
pseudoephedrine hydrochloride 30 mg.; an Rx Schedule C-V narcotic antitussive/expectorant/
decongestant; 16 fl. oz. bottle; NDC 0603-1078-58, Walgreen item 674485 Store at controlled
room temperature 15°-30°C (59°-86°F), Recall # D-915-2007;
nnn) Chlorhexidine Oral Rinse; chorhexidine gluconate 0.12%; an Rx dental solution; 473 mL bottle;
NDC #0093-0014-16, Walgreen item 674434 Store above freezing (32°F), Recall # D-916-2007;
ooo) Cyproheptadine Syrup; cyproheptadine hydrochloride 2 mg/5 mL, an Rx oral antihistamine
liquid; 16 fl oz bottle; NDC 00472-755-16, Walgreen item 675217 Store at controlled room
temperature 15 -30°C (59 - 86°F), Recall # D-917-2007;
ppp) Cytra-K Oral Solution; each 5 mL contains: Potassium Citrate Monohydrate 1100 mg,
Citric Acid Monohydrate 334 mg; an Rx oral systemic alkalinizer; 16 fl. oz. bottle;
NDC 60258-003-16, Walgreen item 675278 Store at room temperature, between 68 and 77
degrees F (20 and 25 degrees C), Recall # D-918-2007;
qqq) Fluoxetine Oral Solution; fluoxetine hydrochloride, 20 mg per 5 mL; an Rx psychotropic drug
for oral administration; 120 mL bottle; NDC 60432-162-04, Walgreen item 669491 Store at
Controlled Room Temperature, 15° to 30°C (59° to 86°F), Recall # D-919-2007;
rrr) Furosemide Oral Solution, furosemide 10mg/mL; an Rx oral diuretic; 60 mL bottle;
NDC 60432-613-60, Walgreen item 677647 Store at controlled room temperature 15°-30°C
(59°-86°F), Recall # D-920-2007;
sss) Griseofulvin Oral Suspension, griseofulvin 125 mg/5 mL;an Rx oral antibiotic derived from a
species of Penicillium; 120 mL bottle; NDC 10147-0810-04, Walgreen item 597032 Store at
controlled room temperature 15°-30°C (59°-86°F) in tight, light-resistant containers,
Recall # D-921-2007;
ttt) H-C Tussive Syrup; each 5 mL contains phenylephrine hydrochloride 5 mg, chlorpheniramine
maleate 2 mg, and hydrocodone bitartrate 2.5 mg; an Rx Schedule C-III narcotic antitussive
combination; 16 fl. oz. bottle; NDC 0603-1284-58, Walgreen item 679787 Store at controlled
room temperature 15°-30°C (59°-86°F); Recall # D-922-2007;
uuu) Ibuprofen Oral Suspension, ibuprofen 100mg/5mL; an OTC oral liquid nonsteroidal
anti-inflammatory; 16 fl. oz. bottle; NDC 0472-1270-16, Walgreen item 680154 Store at
20-25°C (68-77°F), Recall # D-923-2007;
vvv) Keppra Oral Solution; levetiracetam 100mg/mL; an Rx antiepileptic drug; 16 fl. oz. bottle;
NDC 50474-001-48, Walgreen item 580957 Store at 25°C (77°F); excursions permitted to
15-30°C (59-86°F), Recall # D-924-2007;
www) Lidocaine Hydrochloride Oral Topical Solution, USP 2% (Viscous), each mL contains:
lidocaine HCl 20 mg.; an Rx local anesthetic agent administered topically; 100 mL bottle;
NDC 50383-775-04, Walgreen item 684578 Store between 15 and 30°C. Protect from freezing,
Recall # D-925-2007;
xxx) Loratadine Syrup, Loratadine 5mg/5mL; an OTC oral antihistamine; 120 mL bottle;
NDC 51672-2073-8, Walgreen item 659679, Store between 20° to 25° C (68° to 77° F),
Recall # D-926-2007;
yyy) Nystatin Oral Suspension USP; nystatin, 100,000 units/mL ; an Rx oral antifungal antibiotic;
16 fl oz bottle; Qualitest Products, 130 Vintage NDC 0603-1481-58, Walgreen item 570689,
Store in a refrigerator, 2°-8°C (36°-46°F). Protect from light. Dispense in a tight, light-resistant
container, Recall # D-927-2007;
zzz) Phenobarbital Elixir; phenobarbital 20mg/5mL; an Rx barbiturate; 16 fl oz bottle;
Walgreen item 681762 Store this medicine at room temperature, in a tightly-closed container,
away from heat and light, Recall # D-928-2007;
aaaa) Phenyl Chlor-Tan Pediatric Suspension; phenylephrine tannate 5 mg, chlorpheniramine tannate
4.5 mg/5 mL; an Rx oral antihistamine/decongestant; 16 oz bottle; NDC 50383-842-16, Walgreen
item 681699, Store at room temperature away from sunlight and moisture, Recall # D-929-2007;
bbbb) Phenytoin Oral Suspension; phenytoin 125mg/5mL; an Rx oral anticonvulsant; 8 fl oz bottle;
NDC 00472-067-08, Walgreen item 682101 Store at controlled room temperature 20°-25°C
(68°-77°F). Protect from freezing and light, Recall # D-930-2007;
cccc) Poly-Vitamin Drops with Fluoride 0.25mg; Vitamin A/1500 IU, Vitamin D/400 IU, Vitamin
E/5 IU, Vitamin C/35mg, Thiamine/.5mg, Riboflavin/.6mg, Niacin/8mg, Vitamin B6/.4mg,
Vitamin B12/2mcg, Sodium Fluoride/.25mg/1mL; 50 mL dropper bottle; NDC 50383-642-50,
Walgreen item 679260 Store at room temperature between 59 and 86 degrees F (between 15 and
30 degrees C) away from heat and sunlight, Recall # D-931-2007;
dddd) Potassium Chloride Oral Solution 20%; 40 mEq/15 mL potassium and chloride; an Rx oral
electrolyte replacement; 16 fl oz bottle; NDC 00121-466-16, Walgreen item 649799,
Recall # D-932-2007;
eeee) Prednisolone Syrup, prednisolone 5mg/5ml; an Rx oral corticosteroid; 120ml bottle;
NDC 58177-912-03, Walgreen item 684606, Store at room temperature, away from heat and light,
Recall # D-933-2007;
ffff) Prednisolone Sodium Phosphate Oral Solution; prednisolone sodium phosphate 15mg/5mL;
an Rx oral corticosteroid; 8 fl oz bottle; NDC 60432-212-08, Walgreen item 662228 Store between
39 and 77 degrees F (4 and 25 degrees C), Recall # D-934-2007;
gggg) Promethazine Hydrochloride and Codeine Phosphate Syrup; promethazine hydrochloride
6.25 mg, codeine phosphate 10 mg/5 mL; an Rx schedule C-V narcotic antihistamine/cough
suppressant; 16 oz bottle; NDC 50383-804-16, Walgreen item 682586 Store at room temperature
between 68 and 77 degrees F (20 and 25 degrees C), in a tightly-closed container, away from
heat and light, Recall # D-935-2007;
hhhh) Q-Dryl AF Elixir, Diphenhydramine Hydrochloride Elixir, Alcohol Free; diphenhydramine
HCl 12.5 mg/5 mL; an OTC antihistamine; 480 mL bottle; NDC 00603-823-58, Walgreen item
566339, Recall # D-936-2007;
iiii) Q-Pap Drops, Acetaminophen Oral Drops, acetaminophen 80 mg/0.8 mL, an OTC pain reliever;
15mL bottle; NDC 00603-838-73, Walgreen item 683115 Store at room temperature between 59
and 86 degrees F (between 15 and 30 degrees C) away from moisture and sunlight. Do not freeze,
Recall # D-937-2007;
jjjj) Sulfatrim Suspension Pediatric, Grape; Sulfamethoxazole 200 mg and trimethoprim 40 mg/5 mL;
an Rx antibacterial; 16 fl oz bottle; NDC 0472-1285-16, Walgreen item 683923 Store at room
temperature, away from heat and light, Recall # D-938-2007;
kkkk) Tannate-12D S Suspension; phenylephrine tannate 5 mg , pyrilamine tannate 30 mg,
carbetapentane tannate 30 mg/5 mL; an Rx oral antitussive; 118 mL bottle; NDC 50383-841-04,
Walgreen item 655334 Store at room temperature between 68 and 77 degrees F (20 to 25 degrees
C) in a tightly-closed container, away from heat and light, Recall # D-939-2007;
llll) Tussionex Pennkinetic Oral Suspension, Extended Release; chlorpheniramine polistirex eq 8 mg
maleate/5mL, hydrocodone polistirex eq 10mg bitartrate/5mL; an Rx schedule C-III narcotic
antihistamine/cough suppressant; 473 mL bottle; NDC 53014-548-67, Walgreen item 680846.
Store at room temperature in a tightly-closed container, away from heat and light,
Recall # D-940-2007;
mmmm) Zyrtec Syrup; cetirizine hydrochloride 1mg/1mL; an Rx antihistamine; 120 mL;
NDC 0069-5530-47, Walgreen item 686281 Store at 20-25°C (68-77°F); excursions permitted
to 15-30°C (59-86°F) [see USP Controlled Room Temperature]; or Store refrigerated, 2-8°C
(36-46°F), Recall # D-941-2007
CODE
Shipment numbers 874497, 874503, 874542, 875023, 875114, 877282, 875296, all shipped on 2/16/07
RECALLING FIRM/MANUFACTURER
Walgreen Co., Deerfield, IL, by telephone on February 21-23, 2007 or letter dated February 23, 2007. Firm initiated recall is ongoing.
REASON
Product was subjected to below freezing temperatures.
VOLUME OF PRODUCT IN COMMERCE
7,996 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Diltiazem Hydrochloride Extended-Release Capsules 240mg, 90 count bottles, Rx Only, Recall # D-950-2007
CODE
P050217 Exp Sept 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biovail Pharmaceuticals, Mississauga, Canada, by letters on June 27, 2007.
Manufacturer: Biovail Laboratories International SRL, Dorado, PR. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Specifications.
VOLUME OF PRODUCT IN COMMERCE
15,555 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL Transducer CW-USLRBP CyberWand USL Renal/Bladder Probe Set CW-USLTT CyberWand USL Transducer Sterilization Tray, Recall # Z-1073-2007
CODE
Product distributed prior to May 7, 2007.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gyrus ACMI Corp., Southborough, MA, by visit and letter dated May 23, 2007.
Manufacturer: Cybersonics, Inc., Erie, PA. Firm initiated recall is ongoing.
REASON
Sterilization Instructions not adequate for sterilizing.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. P/N 280000, Recall # Z-1127-2007
CODE
Serial numbers prior to 07060782
RECALLING FIRM/MANUFACTURER
Instrumentation Laboratory, Co., Lexington, MA, by letter, on June 19, 2007. Firm initiated recall is ongoing.
REASON
ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube.
VOLUME OF PRODUCT IN COMMERCE
94 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Philips Medical HeartStartXL Defibrillator/Monitor Model: M4735A, Recall # Z-1128-2007
CODE
Serial Numbers: US00453441 through US00453910
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter dated June 11, 2007. Firm initiated recall is ongoing.
REASON
The ECG signal may become unusable to assess patient condition and need for therapy.
VOLUME OF PRODUCT IN COMMERCE
312 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets, Recall # Z-1129-2007
CODE
Lot # D628223, D627616, D620544, D630503; 340-4127- Lot# D620104; 340-4119- Lot# D623716
RECALLING FIRM/MANUFACTURER
Curlin Medical Llc, Huntington Beach, CA, by letter on February 9, 2007 and March 15, 2007. Firm initiated recall is complete.
REASON
The Administration Sets may leak at the reservoir bag.
VOLUME OF PRODUCT IN COMMERCE
25,280 sets
DISTRIBUTION
PA
__________________________________
PRODUCT
Possis AngioJet XVG Thrombectomy Sets, Model/Order # 105042-001, Sterilized with Ethylene Oxide, (These sets are used with the new AngioJet Ultra Console), Recall # Z-1131-2007
CODE
71851, 71852, 71997, 72086, 72539, 73170, 73171, 73646, 73758
RECALLING FIRM/MANUFACTURER
Possis Medical, Inc., Minneapolis, MN, by letter dated June 19, 2007. Firm initiated recall is ongoing.
REASON
Mislabeling. Possis AngioJet XVG Catheter Thrombectomy Sets display incorrect information on the outer packaging box and also on the inner sterile tray. The labeling incorrectly states that the unit is indicated for use in coronary vessels. These units should be indicated for use only for peripheral arteries.
VOLUME OF PRODUCT IN COMMERCE
188 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Embrace Enteral Pump, Recall # Z-1141-2007
CODE
List # 55335 and 55336
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ross Products Division Abbott Laboratories, Columbus, OH, by letter dated June 25, 2007 and July 26, 2007.
Manufacturer: Abbott Laboratories, Inc., Columbus, OH. Firm initiated recall is ongoing.
REASON
Continued use of the pump may cause the door pivot point on the back of the pump to crack or break. This will cause the pump to shut down and stop the initiation of enteral feeding.
VOLUME OF PRODUCT IN COMMERCE
10,377 pumps
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
The Companion ClearStar Pump System, for enteral feeding, Recall # Z-1142-2007
CODE
List #55238 & 55239
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ross Products Division Abbott Laboratories, Columbus, OH, by letter dated June 25, 2007 and July 26, 2007.
Manufacturer: Frantz Medical Development Ltd, Mentor, OH. Firm initiated recall is ongoing.
REASON
The transducer adapter bracket on the pump could crack or break and potentially result in an under delivery of the enteral product.
VOLUME OF PRODUCT IN COMMERCE
27,300 units
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
a) Kimberly-Clark Microcuff Endotracheal Tube, Pediatric Oral/Nasal Magill, sizes 3.0mm, 3.5mm,
4.0mm, and 4.5mm, Rx Only, Sterile, Product code 35111-07, 35112-07, 35113-07 and
35114-07, Recall # Z-1143-2007;
b) Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm,
4.0mm and 4.5mm, Rx Only, Sterile, Product code 35161-07, 35162-07, 35163-07 and 35164-07,
Recall # Z-1144-2007
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kimberly-Clark Corp., Roswell, GA, by letter on/about June 4, 2007 and fax on June 5, 2007.
Manufacturer: Unomedical, Kedahkedah, Malaysia. Firm initiated recall is ongoing.
REASON
The tubes may kink during use which may impede or prevent ventilation.
VOLUME OF PRODUCT IN COMMERCE
4,376 cases (43,760 units)
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
Isoloc software Version 6.5, Part Number NT-NW-425-520. Software for image guided radiation therapy, Recall # Z-1145-2007
CODE
Isoloc 6.5 and Isoloc 4.5
RECALLING FIRM/MANUFACTURER
Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on January 6, 2006. Firm initiated recall is complete.
REASON
Isoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to "Anatomic Landmark" setting.
VOLUME OF PRODUCT IN COMMERCE
132 units
DISTRIBUTION
Nationwide, Korea, Spain, and UK
__________________________________
PRODUCT
ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment, Recall # Z-1146-2007
CODE
6.5 version
RECALLING FIRM/MANUFACTURER
Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on April 7, 2006. Firm initiated recall is ongoing.
REASON
This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update gantry angles; wrong shifts for two of three axes of treatment table movement.
VOLUME OF PRODUCT IN COMMERCE
141 units
DISTRIBUTION
Nationwide, Korea, Spain, and UK
__________________________________
PRODUCT
ISOLOC 4.2 Software Part Number NT-NW-425-520. Radiation treatment software, Recall # Z-1147-2007
CODE
Version 4.2
RECALLING FIRM/MANUFACTURER
Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on May 31, 2005. Firm initiated recall is ongoing.
REASON
When the ISOLOC (Version 4.2) profile distance unit is set to "centimeter" and the user clicked the "back" button in the digitizer window, the marker and target coordinates in the localization window erroneously display values ten times greater than the correct values.
VOLUME OF PRODUCT IN COMMERCE
85 units
DISTRIBUTION
Nationwide, Korea, Spain, and UK
__________________________________
PRODUCT
VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right), Recall # Z-1149-2007
CODE
Serial numbers: 34333, 35808, 37033, 37035, 37087, 38464, 38703, 38704, 38805, 40518, 40528, 071189, 0711102, 0711191, 0713127, 0713131, 0713148, 0713462, 0713563, 0713992, 0716616, 0718748, 0719938, 0719939, 0719940, 0719941, 0719942, 0719957, 0719958, 0719959, 0719960, 0719989, 0719992, 0719994, 0719996, 0720596, 0722098, 0722117, 0722119, 0722120, 0722121, 0722122, 0722123, 0722124, 0722125, 0722138, 0722139, 0722143, 0722144, 0722145, 0723618, 0723619, 0723621, 0723623, 0723624, 0723728, 0723729, 0723730, 0723732, 0724103, 0724106, 0724110, 0724807, 0724809, 0724810, 0724811, 0724812, 0724813, 0724814, 0724815, 0724816, 0726588, 0726593, 0726594, 0726595, 0726597, 0726601, 0726602, 0726603, 0726608, 0726611, 0726612, 0726613, 0726614, 0726615, 0726617, 0726632, 0726633, 0726634, 0726635, 0726636, 0726637, 0726765, 0726766, 0726767, 0726777, 0726779
RECALLING FIRM/MANUFACTURER
Applied Composite Technology, Gunnison, UT, by telephone on June 20 and 21, 2007. Firm initiated recall is ongoing.
REASON
Prosthetic foot device may loosen or separate during use; due to structural inconsistency that may cause a pyramid failure.
VOLUME OF PRODUCT IN COMMERCE
97 units
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
Biomet Straight Magnum Inserter Handle, a preparatory instrument used for Acetabular component insertion; REF # or Catalog Number: S313141. (systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38), Recall # Z-1151-2007
CODE
Lots: 824920, 559080, 509420, 493210, 221060, 167220 and 129030
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter on June 13, 2007. Firm initiated recall is ongoing.
REASON
The instrument was manufactured incorrectly and use could result in the instrument binding to the Acetabular component and cause implant to not release following impaction.
VOLUME OF PRODUCT IN COMMERCE
94 units
DISTRIBUTION
Nationwide, Australia, Finland
__________________________________
PRODUCT
ISOLOC Software Versions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy treatment software, Recall # Z-1152-2007
CODE
Versions 6.0 & 4.2
RECALLING FIRM/MANUFACTURER
Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on April 28, 2005. Firm initiated recall is ongoing.
REASON
When ISOLOC version 6.0 and 4.2 distance unit is set to centimeter, the localization coordinates were rounded to the nearest millimeter which could affect positioning by 0.5 mm.
VOLUME OF PRODUCT IN COMMERCE
84 units
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
ISOLOC Software Version 6.0, Localization software for determining treatment machine position (to position patients) for high accuracy radiotherapy, Part Number NT-NW-425-520, Recall # Z-1153-2007
CODE
Version 6.0
RECALLING FIRM/MANUFACTURER
Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on April 11, 2005. Firm initiated recall is ongoing.
REASON
When ISOLOC version 6.0 was used in the centimeter mode, the display in the couch moves window had a rounding error relative to the Portal Image Marker window of up to 0.5 mm.
VOLUME OF PRODUCT IN COMMERCE
84 units
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
ISOLOC Software Version 6.0, Part Number NT-NW-425-520, Recall # Z-1154-2007
CODE
Version 6.0
RECALLING FIRM/MANUFACTURER
Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on December 30, 2004. Firm initiated recall is ongoing.
REASON
When ISOLOC version 6.0 software was used in the Anatomic Landmark mode, the couch moves display in the Couch Translator window was incorrect.
VOLUME OF PRODUCT IN COMMERCE
79 units
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
ISOLOC Software Version 4.2, Part Number NT-NW-425-520. Image guided radiation treatment software, Recall Z-1155-2007
CODE
Version 4.2
RECALLING FIRM/MANUFACTURER
Northwest Medical Physics Equipment, Inc., Everett, WA, by e-mail on November 30, 2004. Firm initiated recall is ongoing.
REASON
When ISOLOC Version 4.2 unit is set to centimeter and the user clicks the Reenter button in the digitizer window, the coordinates of the markers and target in the anatomic imaging system erroneously displays values ten times greater than the correct values.
VOLUME OF PRODUCT IN COMMERCE
83 units
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
a) Precision Bipolar Device ClearGlide EVH Small (endoscopic vessel harvesting system)
The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra
Retractor and a Vessel Dissector. Datascope Cardiac Assist Sterile R, Part number KTV 15,
Recall # Z-1156-2007;
b) The ClearGlide EVH small with Scissors. The kit includes three Precision Bipolar Devices,
an Optical Vessel Dissector, a Small Ultra Retractor, a Vessel Dissector, and the ENDOPATH
5mm curved scissors. Datascope Cardiac Assist Sterile, Part Number KTV 17, Recall # Z-1157-2007;
c) Precision Bipolar Device 6 pack Consists of a six-pack of the Precision Bipolar Device,
Part number PBD01, Recall # Z-1158-2007
CODE
a) Lot numbers: 12499, Exp. 4/21/09; 12500, Exp. 4/22/09; 12501, Exp. 4/27/09;
12504, Exp. 5/04/09 and 12505, Exp. 5/13/09;
b) Lot numbers: 12492, Exp. 4/30/09; 12502, Exp. 4/27/09; 12512, Exp. 5/6/09;
c) Lot number 12517, Exp. 5/13/09; 12512m
RECALLING FIRM/MANUFACTURER
Recalling Firm: Datascope Corp., Fairfield, NJ, by letter the week of May 7, 2007.
Manufacturer: Accellent, Inc., Laconia, NH. Firm initiated recall is ongoing.
REASON
Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device.
VOLUME OF PRODUCT IN COMMERCE
1,671 units
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Recall # Z-1161-2007
CODE
Lots distributed in US: C64701, C64702, C64703, C64704, C64705, C64706, C64801, C64802, C64803, C64804, C70101, C70102, C70103, C70104, C70105, C70201, C70202, C70203, C70204, C70205, C70206, C70207, C70208, C70209, C70210, C70211, C70212, C70213, C70214, C70215, C70216, C70217, C70218, C70219, C70220, C70221, C70222, C70223, C70224, C70225, C70226, C70227, C70228, C70229, C70230, C70231, C70232, C70233, C70301. Lots distributed OUS: C51301, C52501, C52502, C52703, C61401, C61402, C61403, C61501, C61502, C61503, C61601, C61602, C61603, C61604, C61605, C61701, C61702, C61801, C61802, C61803, C61804, C61805, C61901, C61902, C62001, C62002, C62003, C62004, C63701, C63901, C64001, C64002, C64101, C64102, C64501, C65101, C65102
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick MA, by letter on May 1, 2007.
Manufacturer Firm: Boston Scientific, Cupertino, CA. Firm initiated recall is ongoing.
REASON
Boston Scientific NexStent Carotid Stent device failed to deploy when the outer catheter (proximal outer and distal sheath) did not pull back and expose the self-expanding stent.
VOLUME OF PRODUCT IN COMMERCE
2,487 units
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413, Recall # Z-1162-2007
CODE
Lot: U1621121
RECALLING FIRM/MANUFACTURER
Cook Urological, Inc. Spencer, IN, by letter dated June 12, 2007. Firm initiated recall is ongoing.
REASON
Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.
VOLUME OF PRODUCT IN COMMERCE
100 units
DISTRIBUTION
Nationwide and Canada
__________________________________
PRODUCT
a) Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391022,
(5-Pack Carton Label), Angiographic Catheters. Boston Scientific Impulse Flextrusion
Shaft 5F FR4 16391-02 H74916391021, (Single Pack Carton/Pouch Label), Angiographic
Catheters, Recall# Z-1159-2007;
b) Boston Scientific Impulse Flextrusion Shaft 5F FL4 16391-22 H74916391222,
(5-Pack Carton Label), Angiographic Catheters. Boston Scientific Impulse Flextrusion
Shaft 5F FL4 16391-22 H74916391221, (Single Pack Carton/Pouch Label), Angiographic
Catheters, Recall # Z-1160-2007
CODE
a) Lot: 688254;
b) Lot: 688277
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Natick, MA, by telephone, memo and letter dated June 4, 2007.
Manufacturer: Availmed S.A. de CV, Tijuana, Mexico. Firm initiated recall is ongoing.
REASON
Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton.
VOLUME OF PRODUCT IN COMMERCE
468 devices
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
STA Liatest Free Protein S For in vitro diagnostic use. 2-8 degrees C, 1 - 6 x 5 ml Buffer 2 - 6 x 6 ml Latex, Catalog number: 0516, Recall # Z-1072-2007
CODE
Lot Numbers: 061312, Exp 5/31/07; 061991, Exp 8/31/07; 062633, Exp 10/31/07; 063281, Exp 12/31/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diagnostica Stago, Inc., Parsippany, NJ, by letter on May 8, 2007.
Manufacturer: Diagnostica Stago, Franconville, France. Firm initiated recall is ongoing.
REASON
Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.
VOLUME OF PRODUCT IN COMMERCE
365 units
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together with the following aspirators: Straight Aspirator - 1000370-NAV, 7 French Aspirator - 100936, Keane - Moses Extended Straight Aspirator - 1000748, 15 degree aspirator - 1003895, Fried 45 Degree Aspirator - 1000541, Kuhn 90 degree Aspirator - 1000543-NAV, Recall # Z-1130-2007
CODE
No manufacturing or serial numbers.
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on May 18, 2007. Firm initiated recall is ongoing.
REASON
Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity.
VOLUME OF PRODUCT IN COMMERCE
65,624 units (Domestic); 2,361 units (Internationally)
DISTRIBUTION
Nationwide and Internationally
__________________________________
PRODUCT
a) Femoral Speed Block Size 2, Part/Catalog #800-01-365; positioning device included as part
of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; Recall # Z-1135-2007;
b) Femoral Speed Block Size 4 Part/Catalog #800-01-366; positioning device included as part
of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; Recall # Z-1136-2007;
c) Femoral Speed Block Size 6, Part/Catalog #800-01-367; positioning device included as part
of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; Recall # Z-1137-2007;
d) Femoral Speed Block Size 8, Part/Catalog #800-01-368; positioning device included as part
of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; Recall # Z-1138-2007;
e) Femoral Speed Block Size 10, Part/Catalog #800-01-369; positioning device included as part
of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; Recall # Z-1139-2007;
f) Femoral Speed Block Size 12, Part/Catalog #800-01-370; positioning device included as part
of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; Recall # Z-1140-2007
CODE
a) MIKA-05-001, MIKA-05-002, MIKA-05-003, MIKA-05-004, MIKA-05-005, MIKA-05-006,
MIKA-05-007, MIKA-05-008, MIKA-05-009, MIKA-05-010, MIKA-05-016, MIKA-05-018,
MIKA-05-019, MIKA-05-020, MIKA-05-021, MIKA-05-022, MIKA-05-023, MIKA-05-024,
MIKA-05-025, MIKA-05-026, MIKA-05-027, MIKA-05-028, MIKA-05-029, and MIKA-05-030;
b) MIKA-05-001, MIKA-05-002, MIKA-05-003, MIKA-05-004, MIKA-05-005, MIKA-05-006,
MIKA-05-007, MIKA-05-008, MIKA-05-009, MIKA-05-010, MIKA-05-016, MIKA-05-018,
MIKA-05-019, MIKA-05-020, MIKA-05-021, MIKA-05-022, MIKA-05-023, MIKA-05-024,
MIKA-05-025, MIKA-05-026, MIKA-05-027, MIKA-05-028, MIKA-05-029, and MIKA-05-030;
c) MIKA-05-001, MIKA-05-002, MIKA-05-003, MIKA-05-004, MIKA-05-005, MIKA-05-006,
MIKA-05-007, MIKA-05-008, MIKA-05-009, MIKA-05-010, MIKA-05-016, MIKA-05-018,
MIKA-05-019, MIKA-05-020, MIKA-05-021, MIKA-05-022, MIKA-05-023, MIKA-05-024,
MIKA-05-025, MIKA-05-026, MIKA-05-027, MIKA-05-028, MIKA-05-029, and MIKA-05-030;
d) MIKA-05-001, MIKA-05-002, MIKA-05-003, MIKA-05-004, MIKA-05-005, MIKA-05-006,
MIKA-05-007, MIKA-05-008, MIKA-05-009, MIKA-05-010, MIKA-05-016, MIKA-05-018,
MIKA-05-019, MIKA-05-020, MIKA-05-021, MIKA-05-022, MIKA-05-023, MIKA-05-024,
MIKA-05-025, MIKA-05-026, MIKA-05-027, MIKA-05-028, MIKA-05-029, and MIKA-05-030;
e) MIKA-05-001, MIKA-05-002, MIKA-05-003, MIKA-05-004, MIKA-05-005, MIKA-05-006,
MIKA-05-007, MIKA-05-008, MIKA-05-009, MIKA-05-010, MIKA-05-016, MIKA-05-018,
MIKA-05-019, MIKA-05-020, MIKA-05-021, MIKA-05-022, MIKA-05-023, MIKA-05-024,
MIKA-05-025, MIKA-05-026, MIKA-05-027, MIKA-05-028, MIKA-05-029, and MIKA-05-030;
f) MIKA-05-001, MIKA-05-002, MIKA-05-003, MIKA-05-004, MIKA-05-005, MIKA-05-006,
MIKA-05-007, MIKA-05-008, MIKA-05-009, MIKA-05-010, MIKA-05-016, MIKA-05-018,
MIKA-05-019, MIKA-05-020, MIKA-05-021, MIKA-05-022, MIKA-05-023, MIKA-05-024,
MIKA-05-025, MIKA-05-026, MIKA-05-027, MIKA-05-028, MIKA-05-029, and MIKA-05-030
RECALLING FIRM/MANUFACTURER
Recalling Firm: Encore Medical, Lp, Austin, TX, by letter on August 25, 2006.
Manufacturer: Terray Corp., Arnptiot Ontario, Canada. Firm initiated recall is complete.
REASON
Complaints received that device used to prepare femur to receive femoral implant would split during surgery.
VOLUME OF PRODUCT IN COMMERCE
144 Speedblocks
DISTRIBUTION
Nationwide and Japan
___________________________________
PRODUCT
a) Bioplex Copper 10%, a feed premix, packaged in 25kg bags, Recall # V-056-2007;
b) Bioplex ZMC 842 + Co, a feed premix packaged in 25kg bags, Recall # V-057-2007;
c) Bioplex Quadra, a feed premix packaged in 25kg bags, Recall # V-058-2007;
d) Purina Ratite Bioplex, a feed premix packaged in 25kg bags, Recall # V-059-2007;
e) Bioplex mix Woody's, a feed premix packaged in 25kg bags, Recall # V-060-2007;
f) Stocker 4, a feed premix packaged in 25kg bags, Recall # V-061-2007;
g) TCN Equi-Mix, a feed premix packaged in 25kg bags, Recall # V-062-2007;
h) Hi-5, a feed premix packaged in 25kg bags, Recall # V-063-2007 ;
i) GHC Yeast Mineral Blend, a feed premix packaged in 25kg bags, Recall # V-064-2007;
j) PCLS Organic, a feed premix packaged in 25kg bags, Recall # V-065-2007;
k) Tri-Star Bio-Sacc, a feed premix packaged in 25kg bags, Recall # V-066-2007;
l) Bioplex/Selplex, a feed premix packaged in 25kg bags, Recall # V-067-2007;
m) Rangen Custom Blend, a feed premix packaged in 25kg bags, Recall # V-068-2007
CODE
a) 264995, 264996, 264997, 265270, 265431, 266526, 266750, 266751, 267315, 265779 1-4;
b) 266478 78-80;
c) 266105 1-6;
d) 266961, 265591;
e) 266752;
f) 266979;
g) 265779 1-4, 266039 1-4, 266485 1-4, 266912 1-4;
h) 265640, 265641;
i) 265198;
j) 265889, 266249, 266250, 266251, 265890 1-5, 266101 1-3, 266646 1-4, 266989 1-4;
k) 266156, 266157;
l) 265949, 266967 1-3;
m) 267250, 267251 1-3
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alltech, Inc., Nicholasville, KY, by telephone and e-mail.
Manufacturer: Alltech, Inc., Alexandria, Canada. Firm initiated recall is ongoing.
REASON
Bioplex Copper 10%, a feed premix, and premixes containing Bioplex Copper, were made using copper sulfate pentahydrate that was contaminated with dioxin like PCBs.
VOLUME OF PRODUCT IN COMMERCE
147,785 kg
DISTRIBUTION
Nationwide and Internationally
END OF ENFORCEMENT REPORT FOR AUGUST 15, 2007
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