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U.S. Department of Health and Human Services

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Enforcement Report for February 11, 2004

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.


February 11, 2004
04-06

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

______________________________
PRODUCT
a) Alfalfa Sprouts Harmony Farms brand packaged in 5 ounce
plastic clamshell containers. Net Wt. 5 oz. Product also
packaged in 1, 2, 3 and 5 pound clear plastic bags
labeled "ALFALFA SPROUTS" Grown & washed without
preservatives - fresh, crisp, live un-lettuce
alternative. Recall # F-097-4;
b) Gourmet Salad Sprouts Harmony Farms brand packaged in 5
oz. plastic clamshell containers. Recall # F-098-4;
c) Fresh Alfalfa & Oregon Onion Sprouts Harmony Farms brand
Packaaged in 5 oz. plastic clamshell containers. Recall
# F-099-4.
CODE
A309BESTBYNOV22 to A330BESTBYDEC17 Breakdown of code: "A" stands for Auburn, the three numbers after "A" are the Julian production date, the best by date is 21 days after the production date.
RECALLING FIRM/MANUFACTURER
Harmony Farms, Auburn, WA, by press release, letter and telephone on November 26, 2003. Firm initiated recall is complete.
REASON

Sprouts have been epidemiologically linked to illnesses of Salmonella serotype Chester.
VOLUME OF PRODUCT IN COMMERCE
18,951 pounds.
DISTRIBUTION
OR, WA, AK and ID.
 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
a) Plain Rum Ba-Ba sold in 2 sizes: Mini Plain Rum Ba-Ba,
Net Wt. 10 lbs. (4540 g).
Plain Large Rum Ba-Ba, Net Wt. 7 1/2 lbs. (3405 g).
Recall # F-102-4;
b) Cream Rum Ba-Ba sold in 2 sizes: Mini Cream Rum Ba-Ba,
Net Wt. 10 lbs. (4540 g),
Large Cream Rum Ba-Ba, Net Wt. 8 lbs. (3632 g).
Recall # F-103-4.
CODE
a) Mini Plain Rum Ba-Ba: Item # 13P, barcode # 70681 16013.
Large Plain Rum Ba-Ba: Item # 3P, barcode # 70681 16003;
b) Mini Cream Rum Ba-Ba: Item # 13C, barcode # 70681 30013.
Large Cream Rum Ba-Ba: Item # 3C, barcode # 70681 30003.
RECALLING FIRM/MANUFACTURER
Sapienza Pastry Inc., Elmont, NY, by telephone on January 20, 2004 and by letter on January 22, 2004. FDA initiated recall is ongoing.
REASON
Undeclared certified colors FD&C Yellow #5, FD&C Red #40, FD&C Red #3, and FD&C Blue #1.
VOLUME OF PRODUCT IN COMMERCE
174 cases.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Aloe vera lotion, in 2 oz. containers, packaged as part of
various hospital and amenity kits. All of the following Tri-
State kits are affected by this recall: Maternity kits
C1480, F410A, G610, M1851, M2100, S1053 and W270; Maternity
admission kit D421; Admission kits K272 and P800; VIP
Amenities kit F495; ORHS Amenities kit 0190; Wash basin kit
N210; Mercy PGH VIP kit VIP290; VIP kits VIP360 and VIP415;
and Baby Boom kit W370A. Recall # F-104-4.
CODE
All bottles. The product does not bear a lot number.
RECALLING FIRM/MANUFACTURER
Tri-State Hospital Supply Corp., Howell, MI, by letter dated December 17, 2003. Firm initiated recall is ongoing.
REASON
Lotion may be contaminated with the organism Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
Unavailable.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Preserved Ginger. The product is either repackaged in
smaller size retail containers or sold "as is" to other
repackers in the same bulk box as received. The
repackaged retail containers are in either three ounce
flexible plastic or four ounce rigid heart shaped
plastic containers. Recall # F-105-4;
b) Hawthorne/Haw Flakes. The product is repackaged in
smaller size retail containers. The repackaged retail
containers are in either three ounce flexible plastic or
four ounce rigid heart shaped plastic containers.
Recall # F-106-4;
c) Tamarind Candy. The product is repackaged in
smaller size retail containers or sold "as is" to other
repackers in the same bulk box as received. The
repackaged retail containers are in five ounce boxes.
Recall # F-107-4;
d) Preserved Sugar Kumquart/Mandarin. The product is either
repackaged in smaller size retail containers or sold "as
is" to other repackers in the same bulk box as received.
The repackaged retail containers are in four ounce
boxes. Recall # F-108-4;
e) Preserved Cream Prune. The product is either repackaged
in smaller size retail containers or sold "as is" to
other repackers in the same bulk box as received.
The repackaged retail containers are in four ounce
boxes. Recall # F-109-4;
f) Preserved Green Mango/Sweet and Sour Mango. The product
is either repackaged in smaller size retail containers
or sold "as is" to other repackers in the same bulk box
as received. The repackaged retail containers are in
four ounce boxes. Recall # F-110-4;
g) Dried/Preserved Raspberry. The product is either
repackaged in smaller size retail containers or sold "as
is" to other repackers in the same bulk box as received.
The repackaged retail containers are in four ounce
boxes. Recall # F-111-4;
h) Preserved Prune/Plum Candy. The product is either
repackaged in smaller size retail containers or sold "as
is" to other repackers in the same bulk box as received.
The repackaged retail containers are in four ounce
boxes. Recall # F-112-4;
i) Preserved Mandarin. The product is either repackaged in
smaller size retail containers or sold "as is" to other
repackers in the same bulk box as received. The
repackaged retail containers are in four ounce boxes.
Recall # F-113-4;
j) Dried Cranberry/Small Red Prune. The product is either
repackaged in smaller size retail containers or sold "as
is" to other repackers in the same bulk box as received.
The repackaged retail containers are in four ounce
boxes. Recall # F-114-4;
k) Preserved Plum. The product is either repackaged in
smaller size retail containers or sold "as is" to other
repackers in the same bulk box as received. The
repackaged retail containers are in three ounce boxes.
Recall # F-115-4;
l) Preserved Seedless Prune/Preserved Fruit Plum. The
product is either repackaged in smaller size retail
containers or sold "as is" to other repackers in the
same bulk box as received. The repackaged retail
containers are in 1.25 oz. packages. Recall # F-116-4;
m) Golden Plum/Maltose with Preserved Prune. The product is
either repackaged in smaller size retail containers or
sold "as is" to other repackers in the same bulk box as
received. The repackaged retail containers are in six
ounce packages. Recall # F-117-4;
CODE
a) Product code numbers: 3 oz. retail size: 104171A, 4 oz.
and Raw material bulk: 104172A;
b) Product code numbers: 3.5 oz. retail size unit
container: 0 51299 14199 8 Shipping case for 3.5 oz
retail units: 104199A, 2 oz. retail size unit container:
0 51299 14198 1 Shipping case for 2 oz. retail unit
container: 104198A, Raw material Bulk: 104421B;
c) Product code numbers: 5 oz. container: 0 51299 14349 7
Shipping case for 5 oz. units: 104349A, Raw Material
bulk: (None);
d) Product code numbers: 4 oz. container: 0 51299 14135 6,
Shipping case for 5 oz. retail size units: 104135A, Raw
Material bulk: (None);
e) Product code numbers: 4 oz. retail size unit container:
0 51299 14109 9, Shipping case for 5 oz. retail size
units: 104019, Raw Material bulk: 104410B;
f) 4 oz. retail size unit container: 0 51299 14509 5,
Shipping case for 4 oz. retail size units: 104509A, Raw
Material bulk: (None);
g) 2 oz. retail size unit container: 0 51299 14509 8,
Shipping case for 4 oz. retail size units: 104509A, Raw
Material bulk: 104407B;
h) 4 oz. retail size unit container: 0 51299 14520 0,
Shipping case for 4 oz. retail size units: 104047A, Raw
Material bulk: (None);
i) 3 oz. retail size unit container: 0 51229 104128 0,
Shipping case for 3 oz. retail size units: 104128, Raw
Material bulk: (None);
j) 2 oz. retail size unit container: 0 512900 14504 0,
Shipping case for 2 oz. retail size units: 104504A, Raw
Material bulk: 104414B;
k) 2 oz. retail size unit container: 0 51299 14049 6,
Shipping case for 2 oz. retail size units: 104049A, Raw
Material bulk: 104414B;
l) 2 oz. retail size unit container: 0 51299 14012 0,
Shipping case for 2 oz. retail size units: 104012, Raw
Material bulk: 104442B;
m) 2 oz. retail size unit container: 0 51299 11199 1,
Shipping case for 2 oz. retail size units: 101198, Raw
Material bulk: 1011198B.
RECALLING FIRM/MANUFACTURER
Roxy Trading Inc., Azusa, CA, by fax on July 29, 2003. FDA initiated recall is ongoing.
REASON
Products contain undeclared ingredients including unapproved colors and saccharin.
VOLUME OF PRODUCT IN COMMERCE
a) 54 cases of the 3oz, 121.52 cases of the 4 oz., and 47
cases of the 24 kgs;
b) 8.5 cases of 3.5 oz and 3.01 cases of the 2 oz;
c) 61.52 cases of 5 oz. boxes and 73.1 cases of bulk;
d) 39.78 cases of 4 oz. and 22 cases of the raw material;
e) 12 cases of 4 oz. boxes and 9 cases of the raw material;
f) 8.18 cases of 4 oz. boxes, 7.01 cases of 1.5 oz. pkg.
and 20 cases of the raw material.
g) 1 case of 2 oz. boxes, 6 cases of 4 oz. pkg, and 16
cases of the raw material;
h) 18 cases of 4 oz. pkg., and 4 cases of the raw material;
i) 22.02 cases 4 oz. pkg., 10.01 cases of 3 oz., and 38
cases of the raw material;
j) 9.21 cases of 2 oz. pkg., and 22 cases of the raw
material;
k) 3.81 cases of 3 oz. pkg., 9 cases of 4 oz. and 15.03
cases of the raw material;
l) 7.01 cases of 1.25 oz. pkg., and 14 cases of the raw
material;
m) 54 cases of 6 oz. pkgs., and 280 cases of the raw
material.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Lay's Salt & Vinegar Flavored Potato Chips, 11 1/2 oz. size.
Recall # F-100-4.
CODE
Lot code number 371128835; Pull Date of December 16.
RECALLING FIRM/MANUFACTURER
Frito Lay, Inc, Plano, TX, by e-mail on October 30, 2003. Firm initiated recall is complete.
REASON
The product actually contains Sour Cream & Onion Flavored Potato Chips.
VOLUME OF PRODUCT IN COMMERCE
769 cases (7,690 bags).
DISTRIBUTION
NC, SC, VA, TN, WV, KY and OH.

_______________________________
PRODUCT
Famous Fine French Confections brand Sweet Tooth Candies,
Assorted Chocolates, packaged in 1 lb, 1.5 lb, 3 lb, and 5
lb. boxes. Recall # F-101-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Famous Fine French Confections, Newport, KY, by telephone on September 30, 2003. Firm initiated recall is complete.
REASON
The product contains undeclared milk but cream is listed as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
Over 5,000 boxes.
DISTRIBUTION
KY.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Cerner HNA Classic Patient Management (U60)/Patient Linking (PHC) software, HNA Classic 306. Recall # B-0440-4.
CODE
HNA Classic 306, Revision 34 and Higher.
RECALLING FIRM/MANUFACTURER
Cerner Corporation, Kansas City, MO, by letter and by Internet Posting on August 28, 2003. Firm initiated recall is ongoing.
REASON
Blood bank software, which included a defect that could result in the failure to accurately display all alloantibodies when linking or combining medical records for the same patient, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0529-4.
CODE
Unit numbers: 15012-7080, 15386-3774, 15390-5187 Parts 1 and 2.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock Center, Lubbock, TX, by letter, dated September 26, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
REASON
TX.

_______________________________
PRODUCT
Source Plasma. Recall # B-0531-4.
CODE
Unit Number: 02LKYB1506.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Louisville, KY, by letter, dated December 11, 2002. Firm initiated recall is complete.
REASON
Source Plasma was not properly quarantined and was distributed after the receipt of information that disqualified the donor of the product.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
CA.

_______________________________
PRODUCT
COBASÓ AMPLICORÓ Analyer, BK Number 020018. Recall # B-0562-4.
CODE
Serial Number 733 & 1464.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corporation, Indianapolis, IN, by telephone on December 19, 2003, and by letter dated December 22, 2003.
Manufacturer: Roche Instrument Center, Switzerland. Firm initiated recall is complete.
REASON
Roche Diagnostics received reports of incorrect labeling on two Thermal Cycler Units for the COBAS? Amplicor? Analyzer. The identification stickers on the Thermal Cycler (TC) and Detection Position (DP) in some units may be reversed.
VOLUME OF PRODUCT IN COMMERCE
750.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Human Tissues. Recall # B-0579-4.
a) CryoGraft Femoral Popliteal Artery, Model No. R020;
b) CryoVein Femoral Vein, Model No. V060;
c) CryoVein Saphenous Vein, Model No. V010;
d) CryoGraft Tibialis Tendon, Model No. T080.
CODE
a) Serial No. 8281067;
b) Serial No. 8281053;
c) Serial No. 8032541;
d) Serial Nos. 8036675, 8036680, 8036668.
RECALLING FIRM/MANUFACTURER
CryLife, Inc., Kennesaw, GA, by letters beginning November 5, 2003. Firm initiated recall is complete.
REASON
Human tissues, collected from donors with positive cultures in associated tissues, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 tissues.
REASON
ID, KS, KY, NE, and PA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0580-4;
b) Red Blood Cells, Leukocytes Reduced. B-0582-4;
c) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-0584-4;
d) Platelets. Recall # B-0587-4;
e) Fresh Frozen Plasma. Recall # B-0589-4;
f) Plasma, Cryoprecipitate Reduced. Recall # B-0591-4;
g) Recovered Plasma. Recall # B-0592-4.
CODE
a) Units 0985261, 1033490;
b) Units 1003857, 1034887, 1051072, 1051086, 1051044;
c) Units 1009129, 1020451, 1035245;
d) Units 0985261, 1003490, 1038304;
e) Units 0985261, 1020451, 1033490, 1034887;
f) Unit 1009129;
g) Units 1003857, 1051072, 1051086.
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Minneapolis, MN, by recall notification beginning June 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose responses to multiple donor history questions were not recorded, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
MN and NY.

_______________________________
PRODUCT
Immune Globulin Intravenous (Human); Gammar-P I.V., 10 gm. Recall # B-0594-4.
CODE
Lot A631805.
RECALLING FIRM/MANUFACTURER
Aventis Behring L.L.C, Bradley, IL, by telephone on December 19, 2003, and by letter dated December 22, 2003. Firm initiated recall is complete.
REASON
Immune Globulin, with an increased rate of adverse event reports associated with allergic reactions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2,671 vials.
REASON
TN, NJ, NY, NH, AL, IL, and MO.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0596-4.
CODE
Unit number: 041FQ97343.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone March 28, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
AL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0597-4.
CODE
Unit number: 41GM57851.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone and by facsimile dated April 17, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
AL and Switzerland.

_______________________________
PRODUCT
Immune Globulin Intravenous (Human) 10%, Solvent/Detergent Treated; Gamimune N 10%. Recall # B-0616-4.
CODE
Lots 26N33W1, 26N34C1, 26N35V1, 26N36V1.
RECALLING FIRM/MANUFACTURER
Bayer Healthcare, LLC, Clayton, NC, by letter dated October 3, 2003. Firm initiated recall is ongoing.
REASON
Immune Globulin, with an increased rate of adverse event reports associated with allergic reactions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
4 lots, 10,372 units.
REASON
Nationwide.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0619-4.
CODE
Unit 06GV14741.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Los Angeles, CA, by telephone and by letter on August 28, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0620-4.
CODE
Units 54124936, 54120990, 54117105, 54112889, 54109452, 54104051, 54100794, 54097681, 54092013, 54088306.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Dallas, TX, by facsimile dated March 7, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who either tested positive or previously tested positive for hepatitis B by the polymerase chain reaction assay, was distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
REASON
IL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0621-4.
CODE
Units 18233-0407 - Parts 1& 2.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on October 17, 2003.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0622-4.
CODE
Unit 18233-1587.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone, and facsimile dated October 17, 2003.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0624-4.
CODE
Unit numbers 06GQ02729, 06LH61766, and 06FY38608.
RECALLING FIRM/MANUFACTURER
The American Red Cross Blood Services, Los Angeles, CA, by telephone on September 17, 2003. Firm initiated recall is complete.
REASON
Blood products, which were stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
REASON
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0625-4.
CODE
Unit number 03LL45980.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region, Atlanta, GA, by telephone and letter on May 9, 2003. 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.
REASON
GA.

_______________________________
PRODUCT
a) Platelets. Recall # B-0626-4;
b) Plasma. Recall # B-0627-4.
CODE
a) Unit numbers 28GG43041, 28GG50278, and 28GL22796;
b) Unit numbers 28LQ19214, 28LS21910, and 28KR25184.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region, Atlanta, GA, by letters on April 28, 2003, and October 16, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
REASON
GA, and SC.

_______________________________
PRODUCT
Source Plasma. Recall # B-0628-4.
CODE
Unit numbers 0460209607, 0460209165, 0460209073, 0460208956, 0460208886, 0460208740, 53909107, 39259646, 39253071, 39246707, 39243928, 39238542, 39235893, 39231246, 39222671, 39216540, 39213358, 39205629, 39201690, 39185310, 39170026, 39155337, 39146601, 39139726, 39128621, 39122902, 39094087, 39092755, 39090102, 39087515, 39085337, 39083272, 39081223, 39073808, 39069412, 39065490, 39051417, 39049599, 39046239, 39044426, 39041081, 39039538, 39036414, 39034823, and 39031990.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Dallas, TX, by facsimile on June 17, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was previously deferred due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
45 units.
REASON
CA, Germany, and Israel.

_______________________________
PRODUCT
Source Plasma. Recall # B-0629-4.
CODE
Unit numbers F-09816-018 and F-00410-018.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Fresno, CA, by facsimile on January 28, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
REASON
NC and Spain.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-0630-4.
CODE
Unit number: 6749724.
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Children's Memorial Hospital, Chicago, IL, by telephone on July 29, 2003. Firm initiated recall is complete.
REASON
Blood product, that was not properly quarantined after the donor requested not to use his blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-0631-4.
CODE
Unit numbers 46-DCLJDB-A, 46-DCLCHB-A, 46-DCKTQP-A,
46-DCKMBQ-A, 46-DCKLVD-A, 46-DCKLLK-A, and 46-DCKLGS-A.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Decatur, IL, by facsimile on July 18, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0632-4.
CODE
Unit number 6748914.
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Children's Memorial Hospital, Chicago, IL, by telephone on July 24, 2003. 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.
REASON
IL.

_______________________________
PRODUCT
Fresh Frozen Plasma. Unit # B-0633-4.
CODE
Unit number 6748386.
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Children's Memorial Hospital, Chicago, IL, by telephone on July 30, 2003. Firm initiated recall is complete.
REASON
Blood product, untested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
IL.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0634-4;
b) Platelets. Recall # B-0635-4;
c) Fresh Frozen Plasma. Recall # B-0636-4;
d) Recovered Plasma. Recall # B-0637-4.
CODE
a) and b) unit numbers 4430407 and 5830925;
c) Unit number 5830925;
d) Unit number 4430407.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone between October 26 and 28, 2003. Firm initiated recall is complete.
REASON
Blood product, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
REASON
IL and Scotland.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0638-4;
b) Platelets. Recall # B-0639-4;
c) Fresh Frozen Plasma. Recall # B-0640-4;
d) Recovered Plasma. Recall # B-0641-4.
CODE
a) Unit numbers 8586724 and 6318658;
b) and c) Unit number 6318658;
d) Unit number 8586724.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on October 21, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to medication with the drug Imuran, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
REASON
IL and Switzerland.

_______________________________
PRODUCT
Capture-R_ Ready Screen (Pooled Cells); 960 tests
Solid Phase System for the Detection of Unexpected IgG
Antibodies to Red Cells. Recall # B-0642-4.
CODE
Lot 03514; Expiration date - February 16, 2001.
RECALLING FIRM/MANUFACTURER
Immucor, Inc., Norcross, GA, by facsimile and e-mail on February 2, 2001. Firm initiated recall is complete.
REASON
Test kits, possibly packaged with incorrect test wells (microplates), were distributed.
VOLUME OF PRODUCT IN COMMERCE
198 kits.
REASON
CA, DE, IA, MN, NJ, TN, Belgium, Germany, and Spain.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0650-4;
b) Platelets, Leukocytes Reduced. Recall # B-0651-4;
c) Recovered Plasma. Recall # B-0652-4.
CODE
a) and c) Units 27GY57892, 27GY53190;
b) Unit 27GY57892.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by letter dated July 14, 2003. 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
5 units.
REASON
PA, WV, and MD.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0659-4;
b) Platelets, Leukocytes Reduced. Recall # B-0660-4.
CODE
a) and b) Unit number 33GF51493.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone on October 30, 2003, and by letter on October 31, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
REASON
CT.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0581-4;
b) Red Blood Cells, Leukocytes Reduced. B-0583-4;
c) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-0585-4;
d) Red Blood Cells, Leukocytes Reduced, Washed, Irradiated.
Recall # B-0586-4;
e) Platelets. Recall # B-0588-4;
f) Fresh Frozen Plasma. Recall # B-0590-4;
g) Recovered Plasma. Recall # B-0593-4.
CODE
a) Units 1048388, 1048454;
b) Units 1020237, 1051044;
c) Units 1018424, 1051106;
d) Unit 1035415;
e) Unit 1048454;
f) Unit 1020237;
g) Unit 1051044.
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Minneapolis, MN, by recall notification beginning June 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose responses to multiple donor history questions were not recorded, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
MN and NY.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0598-4.
CODE
Unit number: 41GM57851.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone and by facsimile dated April 17, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
AL and Switzerland.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0599-4.
CODE
Unit 33GE71683.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Connecticut Region, Farmington, CT, by facsimile dated September 22, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
CA.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0617-4.
CODE
Units 100401058 and 100403495.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on October 16, 2003. Firm initiated recall is complete.
REASON
Blood products, which were stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
REASON
AZ.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0618-4.
CODE
Unit 100403369.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on September 20, 2003. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
REASON
AZ.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0623-4.
CODE
Unit 18233-1587.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Cheyenne, WY, by telephone, and facsimile dated October 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0643-4;
b) Fresh Frozen Plasma. Recall # B-0644-4;
c) Cryoprecipitated AHF. Recall # B-0645-4;
d) Plasma, Cryoprecipitate Reduced. Recall # B-0646-4.
CODE
a) Unit 12FR71395, 12FP69526;
b) Unit 12FR71395;
c) and d) Unit 12FP69526.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, North Carolina, by letter dated February 19, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of H.E.L.L.P. Syndrome, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 Units.
REASON
NC, and GA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0661-4;
b) Platelets, Leukocytes Reduced. Recall # B-0662-4;
c) Fresh Frozen Plasma. Recall # B-0663-4.
CODE
a), b) and c) Unit number 33GY58675.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone on November 7 and 10, 2003, and by letter on November 12, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
REASON
CT and VA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0664-4;
b) Recovered Plasma. Recall # B-0665-4.
CODE
a) and b) Unit number 33GS38497.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone and letter on November 19, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
REASON
CT and CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0666-4;
b) Platelets, Leukocytes Reduced. Recall # B-0667-4;
c) Fresh Frozen Plasma. Recall # B-0668-4.
CODE
a) b)and c) Unit number 33GE62577.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone on November 7 and 10, 2003, and by letter on November 13, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
REASON
CT and VA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0669-4;
b) Fresh Frozen Plasma. Recall # B-0670-4.
CODE
a) and b) Unit number 33GR50536.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone on November 7 and 10, 2003, and by letter on November 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
REASON
CT.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0671-4;
b) Recovered Plasma. Recall # B-0672-4.
CODE
a) and b) Unit number 33GJ51767.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone and by letter on December 2, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
REASON
CT and CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0673-4;
b) Recovered Plasma. Recall # B-0674-4.
CODE
a) and b) Unit number 33GT37607.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by telephone and by letter on December 2, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
REASON
CT and CA.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
50 mL sterile plastic centrifuge tubes. Recall # Z-0512-04.
CODE
Codes 3250, 3250P, 3252, 3252P and the lot numbers: 69766 through 87512 which were manufactured from 02/03/03 - 09/22/2003 Also: 3250-DES1, 3250P-DES1, 3252-DES1, 3252P-DES1, 3250P-MIS1, 3252P-MIS1, 3250P-USA1, 3252P-USA1.
RECALLING FIRM/MANUFACTURER
Stockwell Scientific, Inc., Scottsdale, AZ, by letter on December 30, 2003. FDA initiated recall is ongoing.
REASON
Tubes are brittle and break during centrifuging specimens.
VOLUME OF PRODUCT IN COMMERCE
3,762 cases (500 tube each).
REASON
Nationwide and Canada.

_______________________________
PRODUCT
Product is packaged in a box and is labeled: Syphilis TREP-CHEX No. 720-100-10, 960 test, For in Vitro Diagnostic Use. Recall # Z-0513-04.
CODE
Lot Number 71303, expiration date June 2004.
RECALLING FIRM/MANUFACTURER
Diamedix Corporation, Miami, FL, by letter on December 9, 2003. Firm initiated recall is ongoing.
REASON
The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results.
VOLUME OF PRODUCT IN COMMERCE
8.
REASON
AZ, CA and TX.
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
a) TDx/TDxFLx C-Reactive Protein (CRP) Reagents, list 9550-
60; Recall # Z-0507-04;
b) TDx/TDxFLx REA Ethanol, list 9545-60; Recall # Z-0508-
04;
c) TDx/TDxFLx Salicylate, list 9533-60; Recall # Z-0509-04;
d) TDx/TDxFLx Methadone, list 9676-60; Recall # Z-0510-04;
e) Adx Methadone, list 9676-55; Recall # Z-0511-04
CODE
a) All lots with insert version 66-9771/R3. The corrected
insert is version 34-2897/R4;
b) All lots with insert version 69-5787/R4. The corrected
insert is version 34-2778/R5;
c) All lots with insert version 69-6373/R4, 69-6003/R3 or
66-6296/R2. The corrected insert is version 34-3033/R5;
d) All lots with insert version 69-5996/R3. The corrected
insert is version 34-2361/R4;
e) All lots with insert version 69-5997/R4. The corrected
insert is version 69-6506/R5.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter dated 12/5/03.
REASON
The reagent package inserts for the products contain incorrect information in the Specific Performance Characteristics section. Accuracy by Correlation table.
VOLUME OF PRODUCT IN COMMERCE
8,139 kits.
REASON
Nationwide and Internationally.

_______________________________
PRODUCT
a) Neonatal Total Galactose Test Kit, contents for 960
assays, Item #NG-1000. Recall # Z-514-04;
b) Neonatal Total Galactose Test Kit, contents for 4800
assays, Item #NG-4000. Recall # Z-515-04.
CODE
a) Lots #177835, Exp 1/7/04; #178068, Exp 2/7/04;
#195324, Exp 2/18/04; #204423, Exp 4/8/04; #207440,
Exp 4/29/04; #213466, Exp 5/24/04;
b) Lots #178052, Exp 2/7/04; #182567, Exp 1/7/04;
#195339, Exp 2/18/04; #207487, Exp 4/29/04.
RECALLING FIRM/MANUFACTURER
Perkin Elmer Life and Analytical Sciences, Inc., Norton, OH, by letter on January 9, 2004. FDA initiated recall is ongoing.
REASON
The device is not stable throughout its labeled expiration date.
VOLUME OF PRODUCT IN COMMERCE
511 kits.
REASON
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

_______________________________
PRODUCT
Animal feed component, bulk processed waste by-product (dryer waste, wet waste, and vacuum waste) containing ruminant material. The label is the bill of lading that accompanies the trailer with waste material. Recall # V-010-4.
CODE
No Code.
RECALLING FIRM/MANUFACTURER
Iams Co., Lewisburg, OH, by telephone and visit on January 21, 2004. FDA initiated recall is complete.
REASON
The product is an ingredient for animal feed that contains ruminant material and lacks the required BSE cautionary statement.
VOLUME OF PRODUCT IN COMMERCE
1,227,824 KG.
REASON
OH and IN.

_______________________________
PRODUCT
a) Custom Blend Encore Complete Equine Supplement, packaged
in 50-lb. bags. Recall # V-011-4;
b) Unlabeled 5-lb. white plastic jars of Interfarma
CartiFlex, 4 jars per case. Recall # V-012-4.
CODE
a) Lot #121931;
b) Lot #121832.
RECALLING FIRM/MANUFACTURER
Ameri-Pac, Inc., Saint Joseph, MO, by telephone on January 21, 2004 and January 28, 2004. FDA initiated recall is ongoing.
REASON
Product lacks the BSE warning statement "Do Not Feed to Cattle or Other Ruminants".
VOLUME OF PRODUCT IN COMMERCE
a) 6/50-lb. bags;
b) 25/4/5-lb. bags.
REASON
MN, and FL.

_______________________________
PRODUCT
Entire Rabbit Ration packaged in 50 lb. bags. Recall # V-018-4.
CODE
Lot number: F14933896.
RECALLING FIRM/MANUFACTURER
Ranchway Feeds, Incorporated, Fort Collins, CO, by fax on July 25, 2003 and letter on August 5,2003. Firm initiated recall is complete.
REASON
Rabbit feed contains high levels of Vitamin D, when formulation calls for none.
VOLUME OF PRODUCT IN COMMERCE
8,000 pounds.
REASON
CO, WY, and NM.

_______________________________
PRODUCT
a) "Whole Corn "Maiz Entero" in 50 lbs bags (205042).
Animal Feed manufactured using Corn (whole, chopped,
pellets, mashed and/or crumble: (All labels are in
Spanish since product is for local distribution).
Recall # V-021-4;
b) Chopped Corn "Maiz Partido" in 50 lbs bags (205142).
Animal feed manufactured using Corn (whole, chopped,
pellets, mashed, and/or crumble: (All labels are Spanish
since product is for local distribution).
Recall # V-022-4;
c) 16% Calf Ration feed for calf, pellets in 50 lbs. bags
(217222) Animal Feed manufactured using Corn (whole,
chopped, pellets, mashed and/or crumble: (All labels are
in Spanish since product is for local distribution).
Recall # V-023-4;
d) 18% Dairy Milk Producer, feed for dairy cattle, mashed
product in 50 lbs bags (231712) Animal feed manufactured
using corn. All labels are in Spanish since product is
for local distribution. Recall # V-024-4.
CODE
a) 6476, 6477, 6491, 6492, 6511, 6526, 6563, 6564, 6573,
6574, 6575, 6603, 6604, 6610, 6625, 6630, 6631, 6652,
6657, 6660, 6661, 6678, 6710, 6711, 6726, 6727, 6741,
6742, 6768, 6776, 6777, 6793, 6805, 6818, 6826, 6827,
6849, 6850, 6884, 6885, 6927, 6928, 6952, 6953, 6975,
7003, 7010, 7011, 7040, 7041, 7070, 7071, 7082, 7083,
7120, 7121, 7137, 7140, 7150, 7155, 7156, 7162, 7205,
7222, 7223, 7231, 7249, 7250, 7259, 7265, 7270, 7271,
7308, 7309, 7390, 7391, 7424, 7439, 7440, 7441, 7469,
7500, 7516, 7524, 7538, 7539, 7561, 7578, 75797593,
7594, 7602, 7606, 7616, 7617, 7621, 7622, 7702;
There is no expiration date.
b) 6478, 6493, 6512, 6520, 6537, 6565, 6576, 6577, 6605,
6611, 6632, 6653, 6662, 6679, 6708, 6709, 6728, 6739,
6740, 6778, 6794, 6806, 6828, 6851, 6875, 6886, 6910,
6926, 6954, 6976, 6990, 7004, 7012, 7042, 7064, 7072,
7073, 7118, 7119, 7138, 7157, 7190, 7214, 7232, 7251,
7252, 7272, 7289, 7310, 7381, 7392, 7393, 7409, 7410,
7421, 7437, 7438, 7470, 7492, 7501, 7517, 7536, 7540,
7557, 7580, 7589, 7601, 7623, 7669, 7670, 7703;
There is no expiration date.
c) 6800, 6967, 7569. There is no expiration date.
d) Uncoded.
RECALLING FIRM/MANUFACTURER
Federacion de Asociaciones Pecuarias de P.R. Inc., Mayaguez, PR, by visits, on June 17, 2003. FDA initiated recall is ongoing.
REASON
Laboratory analysis revealed the presence of FENITROTHION.
VOLUME OF PRODUCT IN COMMERCE
192,306 lbs.
REASON
PR.
 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS III

_______________________________
PRODUCT
Xylazine hydrochloride, 100 mg/ml, packaged in 50-ml. vials, NADA #139-236, RX. The product is packaged under the following private labels: (1) AnaSed Injectable. The responsible firm on the label is listed as Manufactured for LLoyd Laboratories, Shenandoah, Iowa, and manufactured by Akorn Inc., Decatur, IL; (2) Cervizine Injectable. The responsible firm is listed on the label as Manufactured for Wildlife Pharmaceuticals Inc, Fort Collins, CO; (3) Butler Xylazine-100 Injectable, The responsible firm is listed on the label as Manufactured for The Butler Company, Columbus Ohio, and Manufactured by Taylor Pharmaceuticals, Decatur, IL; (4) nv AnaSed. The responsible firm is listed on the label as Manufactured by Vet-A-Mix, Shanendoah, Iowa, and Manufactured for Novopharm Limited, Toronto, Canada.
Recall # V-013-4.
CODE
KA34401, KB09802, KB09802A, and KB09802B.
RECALLING FIRM/MANUFACTURER
Lloyd Inc., Shenandoah, IA, by letters on April 14, 2003 and April 23, 2003. FDA initiated recall is ongoing.
REASON
Product may not have been manufactured under aseptic conditions.
VOLUME OF PRODUCT IN COMMERCE
32,449 bottles.
REASON
Nationwide, Canada and UAE.

_______________________________
PRODUCT
NEXABAND S/C Tropical Adhesive (2-octyl cyanoacrylate), each package containing one 1.5ml bottle, with disposable pipettes and package insert. Recall # V-014-4.
CODE
Lot 83-002-3G01, Product Code: 5297, Lot Number 111144.
RECALLING FIRM/MANUFACTURER
Closure Medical, Raleigh, NC, by letter on April 14, 2003. Firm initiated recall is ongoing.
REASON
Insert Mix-up. NEXABAND Liquid package inserts were discovered in NEXABAND S/C product containers.
VOLUME OF PRODUCT IN COMMERCE
5,506 units.
REASON
Nationwide.

_______________________________
PRODUCT
a) IVERHART Plus (ivermectin/pyrante), contains 6 Flavored
Chewables. Recommended for dogs up to 25 lbs body
weight. Recall # V-015-4;
b) IVERHART Plus (ivermectin/pyrante), contains 6 Flavored
Chewables. Recommended for dogs 26 to 50 lbs body
weight. Recall # V-016-4;
c) IVERHART Plus (ivermectin/pyrante), contains 6 Flavored
Chewables. Recommended for dogs 51 to 100 lbs body
weight. Recall # V-017-4.
CODE
a) IVERHART Plus lot number 03046 (small) tablets, 0170DS,
display containing 10 boxes, each with a blister card
holding 6 doses and 0180TS, towers containing 20 blister
cards, each holding 6 doses;
b) IVERHART Plus lot number 03047 (medium) tablets, 0170DM,
display containing 10 boxes, each with a blister card
holding 6 doses and 0180TM, towers containing 20 blister
cards, each holding 6 doses.
c) IVERHART Plus lot number 03048 and 03049 (large)
tablets, 0170DL, display containing 10 boxes, each with
a blister card holding 6 doses and 0180TL, tower
containing 20 blister cards, each holding 6 doses.
RECALLING FIRM/MANUFACTURER
Virbac AH, Inc., Fort Worth, TX, by fax on November 19, 2003. Firm initiated recall is ongoing.
REASON
The firm is recalling 4 lots of IVERHART Plus Flavored Chewables due to contamination of Minocycline, a FDA approved human drug which has not been approved in species other than humans.
VOLUME OF PRODUCT IN COMMERCE
1,179,840 tablets.
REASON
Nationwide.

_______________________________
PRODUCT
The recalled product is a liquid packaged in a plastic bottle with the following labeling: DVM brand ChlorhexiDerm Shampoo, 4% Chlorhexidine, in 8 oz, 12 oz, and one gallon plastic container sizes. The label has the NDC number 47203-687-08. Recall # V-019-4.
CODE
Lot numbers V2F075A (8 oz.), V2F075C (12 oz.), and V2F075B (one gallon).
RECALLING FIRM/MANUFACTURER
DVM Pharmaceuticals, Miami, FL, by letter on July 24, 2003. Firm initiated recall is ongoing.
REASON
The recalled shampoo may be subpotent for its active ingredient based on stability study results.
VOLUME OF PRODUCT IN COMMERCE
22,192
REASON
Nationwide and Internationally.

_______________________________
PRODUCT
Fort Dodge Nolvasan Antiseptic Ointment, 1% Chlorhexidine acetate in a Hydrophilic Ointment base which contains 10% stearyl alcohol, packaged in 16-oz. jars. Recall # V-020-4.
CODE
371530, 371531, 371533, 371534, and 371535, all bearing an expiration date of SEP03.
RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories, Inc., Fort Dodge, IA, by telephone on August 26, 2003. Firm initiated recall is ongoing.
REASON
Out-of-specification assay result as the 15-month stability test point.
VOLUME OF PRODUCT IN COMMERCE
9,107 jars.
REASON
Nationwide.

END OF ENFORCEMENT REPORT FOR February 11, 2004

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