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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.
December 21, 2005
05-51
______________________________
PRODUCT
Yoruk Brand Yellow Raisins in 1 lb. plastic bags. Recall # F-036-6
CODE
N/A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethnic International Holding, Inc., Cranbury, NJ, by press
release on October 6, 2005, and by letters on October 11, 2005.
Manufacturer: Kadouri International Food Inc., Brooklyn, NY. Firm initiated
recall is complete.
REASON
A sample collected by the New York State Agriculture and Markets revealed
undeclared sulfites at the level of 752 ppm. in 1 lb packages of Yoruk Brand
raisins.
VOLUME OF PRODUCT IN COMMERCE
81/1 lb packages
DISTRIBUTION
NY, VA, and MD
______________________________
PRODUCT
Peanut butter cookies, individually wrapped in clear cello, and placed in
box with 5 other cookies. Sold in a “tower” of products called Gourmet Tower
of Treats. The “towers” consist of various size boxes filled with various
confectionary products, stacked one on top of another (largest box on bottom,
up to the smallest box on top) and tied together with a ribbon Tower contains
extra fancy gift pears, mini mint chocolates, white chocolate cookie bars
(eggs listed are listed as an ingredient), German chocolate cookie bars (eggs
are listed as an ingredient) and peanut butter cookie bars. Product is sold
via firm’s catalog. “Tower” and list of ingredients are placed in shipping
box. Recall # F-037-6
CODE
Codes are printed on the nutritional sheets contained with each tower: 2435PH,
2465PH, 2345PH, 2295PH, 2635PH
RECALLING FIRM/MANUFACTURER
Harry & David, Medford, OR, by telephone on September 22, 2005, press
release on September 23, 2005, and by letters on September 24, 2005. Firm
initiated recall is complete.
REASON
Peanut Butter Cookie Bars contain undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
542 gift towers
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Rima Qualita Brand Meatless Spaghetti Sauce, 6 lb. 10 oz cans, Recall # F-040-6
CODE
5242X1SGSA and 5246Y1SGSA
RECALLING FIRM/MANUFACTURER
Hirzel Canning Co., Northwood, OH, by telephone beginning on October 20,
2005. Firm initiated recall is ongoing.
REASON
The product contained milk, which was not listed as an ingredient on the
label.
VOLUME OF PRODUCT IN COMMERCE
634 cases, each case contains 6 cans
DISTRIBUTION
IA, IL, PA, and KY
______________________________
PRODUCT
Florentine Cake, 4 oz, UPC 8 08330 0081 9, Recall # F-034-6
CODE
No codes
RECALLING FIRM/MANUFACTURER
Fernando’s Bakery Inc., Linden, NJ, by telephone beginning on September 13,
2005. Firm initiated recall is complete.
REASON
A sample of the product analyzed by the New York State Department of Agriculture
and Markets revealed the presence of color additive, FD&C Yellow No.
5 which was not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
12 cakes
DISTRIBUTION
NY
______________________________
PRODUCT
Children’s Motrin Grape Suspension 4 oz. Ibuprofen 100 mg/5 ml suspension,
Pain Reliever/Fever Reducer, NDC # 50580-603-04, Recall # D-047-6
CODE
Lot number JAM129 exp. 1/07
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McN, Fort Washington,
PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Product intended for destruction due to microbial contamination was possibly
diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown
_______________________________
PRODUCT
Children’s Motrin Berry Suspension 4 oz. Ibuprofen 100 mg/5 ml, OTC Pain
Reliever/Fever Reducer, NDC # 50580-601-04, Recall # D-049-6
CODE
Lot number JFM179 exp 6/07
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort
Washington, PA, by letter dated September 19, 2005. Firm initiated recall
is ongoing.
REASON
Presence of foreign matter: Product intended for destruction due to a lint
free cloth found on an in-line screen was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown
_______________________________
PRODUCT
Infant Tylenol Concentrated Drops Cherry Flavor 1 oz. Acetaminophen 80 mg/0.8
ml, OTC, NDC # 50580-186-30, Recall # D-050-6
CODE
Lot number HLM187 exp 10/05
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort
Washington, PA, by letter dated September 19, 2005. Firm initiated recall
is complete.
REASON
Presence of particulate matter: Product intended for destruction due to the
potential of metal shavings in the product was possibly diverted to retail
stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown
_______________________________
PRODUCT
Methotrexate Active Pharmaceutical Ingredient, Bulk Powder, 10kg, 10.5kg
and 20kg drums, Rx only - For manufacturing, processing, or repacking, NDC
12780-0491-0, CAS-59-05-2, Recall # D-064-6
CODE
Batch No. 1098057; 1097859; 1101822; 1098687
RECALLING FIRM/MANUFACTURER
Recalling Firm: SST Corporation, Clifton, NJ, by e-mail.
Manufacturer: Orion Corporation Fermion, Espoo, Finland. Firm initiated recall
is ongoing.
REASON
Methotrexate API contaminated with Ethylene Glycol during manufacture.
VOLUME OF PRODUCT IN COMMERCE
140.5 kg
DISTRIBUTION
IL, OH, VA, and PR
_______________________________
PRODUCT
Darvon Compound (propoxphene hydrochloride, aspirin and caffeine capsules),
USP * 65 mg * NDC 66591-612-41 * 100 Pulvules * Rx only, Recall # D-065-6
CODE
Lot 03246A, 03247A and 03248A, 04190A, 04210A, 05015A, 05029A, 05057A, 05057B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Xanodyne Pharmaceuticals, Inc., Florence, KY, by letter starting
December 8, 2005.
Manufacturer: Aaipharma, Wilmington, NC. Firm initiated recall is ongoing.
REASON
Dissolution Failure: aspirin and propoxyphene hydrochloride (18 month stability)
VOLUME OF PRODUCT IN COMMERCE
85,252 bottles/100 count bottles
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0376-6
CODE
Unit number: 157377118
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Lubbock Center, Lubbock, Texas, by facsimile on April
21, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor who had lived in an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0398-6
CODE
Unit number: 6598068
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on March 4,
2005. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
_______________________________
PRODUCT
Source Plasma, Recall # B-0400-6
CODE
Unit numbers: 7030313694, 7030313277, 7030222921, 7030216042
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., San Antonio, TX, by facsimile on May 12, 2004. Firm
initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new
variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC and the UK
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0402-6;
b) Fresh Frozen Plasma, Recall # B-0403-6
CODE
a) and b) Unit number: H15741
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, Inc., South Bend, IN, by letter and personal
visit on September 30, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication
Prednisone, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0404-6;
b) Platelets, Recall # B-0405-6;
c) Fresh Frozen Plasma, Recall # B-0406-6
CODE
a), b), and c) Unit number: W95080
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, Mi, by facsimile on August
18, 2005 and August 19, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom an arm scrub was not performed,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA and MI
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0409-6
CODE
Unit number: 9587070
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on
September 6, 2005. Firm initiated recall is complete.
REASON
Blood product, which tested positive for West Nile Virus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
_______________________________
PRODUCT
Source Plasma, Recall # B-0401-6
CODE
Unit numbers: 7030277638, 7030276824, 7030275835, 7030274997
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., San Antonio, TX, by facsimile on February 3, 2004. Firm
initiated recall is complete.
REASON
Blood products, which tested negative for viral markers, but were collected
from a donor who was subsequently determined to have a previous positive
viral marker test, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0407-6;
b) Fresh Frozen Plasma, Recall # B-0408-6
CODE
a) and b) Unit number: T56207
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI, by facsimile on October
3, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
_______________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0410-6
CODE
Unit numbers: 22FC26575, 22FC26756, 22FC28157, 22FJ97098, 22FJ97241, 22FN72258,
22FN72512, 22FN72674, 22FN72677, 22FN72680, 22FX16296, 22GQ08029, 22GQ08180,
22GQ08259, 22GQ08294, 22KC75010, 22KF56588, 22KL20526, 22KL21170, 22KN60801,
22KT73012, 22KV78758, 22KV78760, 22KW65338, 22KW65403, 22KW65825, 22KZ75074,
22LC21894, 22LJ90944, 22LW80588
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone
on July 26, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during
shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
PA
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0414-6
CODE
Unit numbers: 0641314, 0702615
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on December
27, 1999. Firm initiated recall is complete.
REASON
Blood products, for which there was no documentation of weld acceptability
for the sterile docking of the filter, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO
_______________________________
PRODUCT
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R;
Recall # Z-0275-06
CODE
All Serial numbers beginning with 20000
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Renal Division, McGaw Park,
IL, by letters dated September 28, 2005.
Manufacturer: Baxter Healthcare Corporation, Largo. FL. Firm initiated recall
is ongoing.
REASON
Inadequate instructions for routing single tubing lines through the double-tubing
clips on the front of the instrument to eliminate the risk of kinks in the
tubing, which have been associated with a death and a serious injury.
VOLUME OF PRODUCT IN COMMERCE
2,838 units
DISTRIBUTION
Nationwide, Mexico and Asia
_______________________________
PRODUCT
a) Guidant INSIGNIA I Entra family of pacemakers includes
the following: SSI (model numbers 0484 and 0485); DDD
(models 0985, 0986); SR (models 1195, 1198); and DR
(models1294, 1295, 1296). Intermedics NEXUS Entra family
of pacemakers includes the following: SSI (model 1326);
DDD (model 1426); SR (model 1398) and DR (model 1494).
The INSIGNIA I Entra pacemakers are multiprogrammable
pacemakers from Guidant. The NEXUS I Entra pacemakers
are multiprogrammable pacemakers from Intermedics.
The family consists of both dual-chamber and single-
chamber models, offering adaptive-rate therapy and
providing various levels of therapeutic and diagnostic
functionality. The INSIGNIA and NEXUS I Entra adaptive-
rate models have an accelerometer, which is a motion
sensor that responds to patient activity. Sterilized
with gaseous ethylene oxide. Recall # Z-0191-06;
b) Guidant INSIGNIA I Ultra family of pacemakers includes
the following: SR (models1190); and DR (models1290,
1291). Intermedics NEXUS I Ultra family of pacemakers
includes the following: SR (model 1390) and DR (model
1490, 1491). The INSIGNIA I Ultra pacemakers are
multiprogrammable pacemakers from Guidant.
The NEXUS I Ultra pacemakers are multiprogrammable
pacemakers from Intermedics. The family consists of both
dual-chamber and single-chamber models, offering
adaptive-rate therapy and providing various
levels of therapeutic and diagnostic functionality.
These pacemakers include ventricular Automatic Capture
which automatically measures the ventricular pacing
threshold and adjusts the pacing output to 0.5 V above
the measured threshold.
Two sensors are available: these adapt the pacing rate
to the patient’s changing metabolic demand. Minute
ventilation responds to changes in respiration, and
the accelerometer responds to patient activity
(motion).
INSIGNIA and NEXUS I Ultra models can use either the
accelerometer or minute ventilation sensor,
or a blend of both accelerometer and minute ventilation.
Sterilized with gaseous ethylene oxide.
Recall # Z-0192-06;
c) Guidant INSIGNIA I Plus family of pacemakers includes
the following: SR (model 1194); and DR (models1297,
1298). Intermedics NEXUS I Plus family of pacemakers
includes the following: SR (model 1394) and DR (model
1467, 1468). The INSIGNIA I Plus pacemakers are
multiprogrammable pacemakers from Guidant.
The NEXUS I Plus pacemakers are multiprogrammable
pacemakers from Intermedics. The family consists of
both dual-chamber and single-chamber models,
offering adaptive-rate therapy and providing various
levels of therapeutic and diagnostic functionality.
Two sensors are available: these adapt the pacing rate
to the patient's changing metabolic demand. Minute
ventilation responds to changes in respiration, and
the accelerometer responds to patient activity (motion).
INSIGNIA and NEXUS I Plus models can use either the
accelerometer or minute ventilation sensor, or a blend
of both accelerometer and minute ventilation. Sterilized
with gaseous ethylene oxide. Recall # Z-0193-06;
d) Guidant INSIGNIA I AVT family of pacemakers includes the
following: SSI (model 482), VDD (model 882), DDD (model
982), SR (model 1192 and DR (model 1292).
Intermedics NEXUS I AVT family of pacemakers includes
the following: SR (model 1392).
The INSIGNIA I AVT pacemakers are multiprogrammable
pacemakers from Guidant.
The NEXUS I AVT pacemakers are multiprogrammable
pacemakers from Intermedics. The family consists of both
dual-chamber and single-chamber models, offering
adaptive-rate therapy and providing various levels of
therapeutic and diagnostic functionality.
These pacemakers include ventricular Automatic
Capture which automatically measures the ventricular
pacing threshold and adjusts the pacing output to
0.5 V above the measured threshold. The INSIGNIA and
NEXUS I Plus adaptive-rate models have an accelerometer,
which is a motion sensor that responds to patient
activity. Sterilized with gaseous ethylene oxide.
Recall # Z-0194-05
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, Saint Paul, MN, by press release and
letters dated September 22, 2005, and by Advisory update in December 2005.
Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is
ongoing.
REASON
Another failure mode, which occurs at a low rate, has been identified with
the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors
which may be observed include; intermittent or permanent loss of pacing output
without warning, intermittent or permanent loss of telemetry and appearance
of a reset warning message upon interrogation.
VOLUME OF PRODUCT IN COMMERCE
341,000
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
a) Liko UNO 100 Patient Lift, Recall # Z-0276-06;
b) Liko UNO 102 Patient Lift, Recall # Z-0277-06;
c) SABINA I and SABINA II Patient Lift, Recall # Z-0278-06
CODE
a) S/N Range: 7090602-7093161;
b) Serial Numbers: 33590-42291;
c) Serial Numbers: 401205-414442
RECALLING FIRM/MANUFACTURER
Recalling Firm: Liko, Inc, Franklin, MA, by letter on/about December 1, 2005.
Manufacturer: Liko AB, Lulea, Sweden. Firm initiated recall is ongoing.
REASON
Incorrect length leg pin bolts may cause patient lift failures.
VOLUME OF PRODUCT IN COMMERCE
3,141 units
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers:
250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620, Recall #
Z-0279-06
CODE
Lots 05258F through 05299FG2
RECALLING FIRM/MANUFACTURER
Styker Endoscopy, San Jose, CA, by letters on November 18, 2005. Firm initiated
recall is ongoing.
REASON
Devices sterility may be compromised as evidenced by a crack in the package.
VOLUME OF PRODUCT IN COMMERCE
12,766 boxes, 6 units per box
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
a) 16 G /5F Dual Lumen L-Cath catheter only. Recall # Z-0282-06;
b) 16 G / 5F Dual Lumen L-Cath Basic Kit with Insyte Autoguard,
Recall # Z-0283-06;
c) 16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte
Autoguard, Recall # Z-0284-06;
d) 16 G / 5F Dual Lumen L-Cath Basic Kit with Introsyte,
Recall # Z-0285-06;
e) 16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte,
Recall # Z-0286-06;
f) 16 G / 5F Dual Lumen L-Cath Basic Kit with U-Wing,
Recall # Z-0287-06;
g) 16 G / 5F Dual Lumen L-Cath complete kit with U-Wing,
Recall # Z-0288-06
CODE
a) REF 384468. All lots manufactured since 1999 to
3/7/2005;
b) REF 384584;
c) REF 384590;
d) REF 384426;
e) REF 384427;
f) REF 384424;
g) REF 384425
RECALLING FIRM/MANUFACTURER
Becton Dickinson Infusion Therapy, Sandy, UT, by telephone and letter on
March 25, 2005.
REASON
Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
VOLUME OF PRODUCT IN COMMERCE
33,265 units
DISTRIBUTION
Nationwide, Australia, Canada, and Japan
_______________________________
PRODUCT
Toshiba Excelart VANTAGE Model MRT-1503, Magnetic Resonance Imaging Systems,
Regulation Number 21 CPR § 892.1000, Regulatory Class II, Product Code 90-LNH
and was cleared with K032490, Recall # Z-0281-06
CODE
Serial Numbers: A4622037, A4612031, A4622017, A4532013, A4582010, A5532048,
A4592013, A4532012, A5532022, A4602028, A3592003, A4522007, A5512041, A4612015,
A4572020, A4602029, A4622039, A4612030, A4542015, A4602014, A4602026, A4622036,
A5522045, A5532047, A4612033, A5512040, A4612032, A4562003, A4572004, A4592012,
A4562018, A4622035, A4522009, A4602025, A3582001, A5512043, A45320 11, A4602024,
A5512018, A4572006, A4572023, A5512019, A5532049, A3592002, A4602027, A4552002,
A4512006, A4552017, A5522046, A4572005, A4562019, A4572021, A4522008, A4612034,
A4582009, A3612004, A4622016, A4532010, A3622001, A5512044, A4552016, A4572007,
A4592011, A4572008, & A5512042
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Sys Inc, Tustin, CA, by letter on letter
on October 12, 2005.
Manufacturer: Toshiba Medical Systems Company, Tochigi-Ken, Japan. Firm initiated
recall is ongoing.
REASON
There is a hardware problem of water leakage in the cooling system inside
the ASGC, requiring the replacement of the gradient coil.
VOLUME OF PRODUCT IN COMMERCE
65 units
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Bio-Rad brand "TOX/See Drug Screen Test"; Catalog numbers: 1945182EX,
1945216, 194-5223, Recall # Z-0289-06
CODE
9450311-1, 9450319, 9450545, 9450547, 9450311, 9451356, 94532016CE
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bio-Rad Laboratories, Inc, Hercules, CA, by telephone, fax
and e-mail on June 4, 2004.
Manufacturer: Applied Biotech Inc., San Diego, CA. Firm initiated recall
is complete.
REASON
The device was producing false negative results for cocaine tests.
VOLUME OF PRODUCT IN COMMERCE
384 units
DISTRIBUTION
Nationwide, Canada, France, UK, Germany and Italy
_______________________________
PRODUCT
Tradition Game Bird Starter for Pheasant, Quail, Chukar, packaged in 50 lb.
bags, Recall # V-017-6
CODE
Lot 62081105
RECALLING FIRM/MANUFACTURER
Hubbard Feeds, Inc., Hopkinsville, KY, by telephone on September 27, 2005.
Firm initiated recall is ongoing.
REASON
Product has the potential to be contaminated with Salmonella, an organism
which can cause serious and sometimes fatal infections in young children,
frail or elderly people, and others with weakened immune systems.
VOLUME OF PRODUCT IN COMMERCE
23/50 lb. bags
DISTRIBUTION
KY
END OF ENFORCEMENT REPORT FOR DECEMBER 21, 2005
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