FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

May 14, 2003
03-20

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Sabra Salads brand Lox Spread (Smoked Nova Scotia Salmon), packed in 7-ounce plastic containers. Recall # F-366-3.
CODE
090102 (on lid).
RECALLING FIRM/MANUFACTURER
Blue and White Food Products Corp., Astoria, NY, by press release on July 19, 2002, and by recall notices dated July 22, 2002. State initiated recall is complete.
REASON
Product was contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
453 - 7 oz. units.
DISTRIBUTION
NY and NJ.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
BOTANAS Mexico's Best Snacks brand "BOTANA DE FIESTA" (Assorted Snacks Spicy), Net wt. 3.0 oz. Recall # F-365-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
La Mexicana Enterprises, Inc., Corona, NY, by press release on February 8, 2001. State initiated recall is complete.
REASON
The product, consisting mainly of shelled peanuts, does not bear an ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
The firm operates on a cash & carry basis so no record was available.

_______________________________
PRODUCT
Natural Treasures TMG Dietary Supplement, Trimethylglycine-Homocystine Manager, 60 capsules. Recall # F-367-3.
CODE
Lot 001TMG9.
RECALLING FIRM/MANUFACTURER
American Supplement Technologies, Inc., Tempe, AZ, by letter on February 28, 2001. Firm initiated recall is complete.
REASON
The dietary supplement contained smaller amount of Vitamin B12 than listed on the label.
VOLUME OF PRODUCT IN COMMERCE
Undetermined.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS I

_______________________________
PRODUCT
Human Tissues for transplantation:
a) Pericardium. Recall # B-0864-3;
b) Femoral Vein with Valve. Recall # B-0865-3;
c) Tibialis Tendon. Recall # B-0866-3;
d) Achilles Tendon. Recall # B-0867-3;
e) Semitendinosus Gracilis Tendon. Recall # B-0868-3;
f) Femoral Popliteal Artery. Recall # B-0869-3;
g) Semitendinosus Tendon. Recall # B-0870-3;
h) Saphenous Vein. Recall # B-0871-3.
CODE
a) Donor #29037, Serial number 6170005;
b) Donor #29976, Serial #6212697,
Donor #58520, Serial #7368056,
Donor #58520, Serial #7368044;
c) Donor #43211, Serial #4294430,
Donor #43211, Serial #4294449,
Donor #57681, Serial #7443417;
d) Donor #57681, Serial #7443400;
e) Donor #43211, Serial #4294453,
Donor #52896, Serial #7069071;
f) Donor #51562, Serial #7094319;
g) Donor #52896, Serial #7068882;
h) Donor #57681, Serial #7440351,
Donor #57681, Serial #7440369,
Donor #58398, Serial #7357499,
Donor #58398, Serial #7357520,
Donor #58398, Serial #7357868.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letter dated February 6, 2003. Firm initiated recall is ongoing.
REASON
Human tissues for transplantation, collected from donors whose companion sample, from a different site, was positive for microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 1 unit;
b) 3 units;
c) 3 units;
d) 1 unit;
e) 2 units;
f) 1 unit;
g) 1 unit;
h) 5 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0912-3.
CODE
Unit number 16GM22225.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH, by letter on February 20, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0913-3.
CODE
Unit number 30GH95330.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by letter on August 27, 2002. 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
PA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0916-3.
CODE
Unit number 18FT36209.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing MI, by letter on August 7, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a reported history of aplastic anemia, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0917-3.
CODE
Unit number 11326-7701.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., El Paso, TX, by letter on March 20, 2001. 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
TX.

_______________________________
PRODUCT
Corneas. Recall # B-0918-3.
CODE
ID numbers IA-2003-02-034R1, IA-2003-02-034L1.
RECALLING FIRM/MANUFACTURER
Iowa Lions Eye Bank, Iowa City, IA, by telephone on February 20, 2003. Firm initiated recall is complete.
REASON
Human corneas, collected from a donor with discordant Hepatitis C Virus antibody (anti-HCV) test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
NC and AZ.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0919-3;
b) Recovered Plasma. Recall # B-0920-3.
CODE
a) and b) Unit number 30GN50964.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by letters on March 21, 2002, and April 23, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA and CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0925-3.
CODE
Unit numbers JN0009003, JN0009107, JG0091589, and JG0091837.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on October 26, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
KY.
________________________
PRODUCT
Source Plasma. Recall # B-0926-3.
CODE
Unit numbers 92240940, 92244160, 92248960, and 92293205.
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc. of Chicago, Chicago, IL, by facsimile on January 31, 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
4 units.
DISTRIBUTION
CA.
______________________________
PRODUCT
Source Plasma. Recall # B-0927-3.
CODE
Unit numbers 0530324809, 0530324422, 0530324023, 0530323312, 0530322558, 0530321415, 0530320676, 0530320083, 0530318966, 0530318127, 0530316346, 0530315867, 0530315504, 0530315051, 0530312728, 0530307015, 0530306213, and 0530305109.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL, by facsimile on December 19, 2002.
Manufacturer: ZLB Bioplasma, Inc., Lexington, KY. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
NC.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0928-3.
CODE
Unit numbers 04FR61614 and 04FJ45965.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letters on November 27, 2002, and December 31, 2002. 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.
DISTRIBUTION
NY and MA.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0929-3.
CODE
Unit numbers 04FC01107, 04FC98968, and 04FC96980.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by letter on November 14, 2002. 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
3 units.
DISTRIBUTION
MA and ME.
______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0931-3;
b) Frozen Plasma. Recall # B-0932-3.
CODE
a) and b) units 6957825 and 6957830.
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by letters dated July 29, 2002, and facsimile on July 26, 2002. Firm initiated recall is complete.
REASON
Blood products, which tested negative for anti-HIV-1, HbsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but were collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
a) Platelets. Recall # B-0933-3;
b) Fresh Frozen Plasma. Recall # B-0934-3.
CODE
a) and b) Unit 30GN49418.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Northeastern Pennsylvania Region, Ashley, PA, by letter dated November 6, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was diagnosed with Porphyria Cutanea Tarda, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA and NY.
________________________
PRODUCT
Red Blood Cells Leukocytes Removed. Recall # B-0935-3.
CODE
Units 30GN58272 and 30GH88941.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Northeastern Pennsylvania Region, Ashley, PA, by letter dated November 6, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
______________________________
PRODUCT
Human Tissues for Transplantation Corneas.
Recall # B-0936-3.
CODE
Serial # 01-1383, 01-1384.
RECALLING FIRM/MANUFACTURER
Lions Eye Bank of Central Texas, Manor, TX, by letter dated August 5, 2002. Firm initiated recall is complete.
REASON
Corneas, collected from a donor who had dura mater transplantation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD and Argentina.
______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-0937-3.
CODE
20404-4451 (split product), 20404-4458.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Scottsdale, AZ, by letter dated April 30, 2002. Firm initiated recall is complete.
REASON
Platelets, that were not tested for pH as required by the firm's specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
LA.
______________________________
PRODUCT
Counterfeit EpogenÒ (Epoetin Alfa) labeled as 40,000 U/ ml vials in ten pack boxes. Recall # B-0938-3.
CODE
Lot number P002970; expiration 7/03.
RECALLING FIRM/MANUFACTURER
Tradewinds Trading Co., Inc., Leander, TX, by facsimile dated May 10, 2002. Firm initiated recall is ongoing.
REASON
Counterfeit drug products, with a concentration of active ingredient less than labeled, were distributed.
VOLUME OF PRODUCT IN COMMERCE
335 boxes.
DISTRIBUTION
OH and CA.
______________________________
PRODUCT
Red Blood Cells Leukocytes Removed. Recall # B-0939-3.
CODE
Unit 30GS28441.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by letter on October 4, 2002. and by facsimile on October 2, 2002. Firm initiated recall is complete.
REASON
Blood products, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA, and NJ.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0954-3.
CODE
Unit number 20403-0435.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on April 12, 2002, and by letter on May 3, 2002.
Manufacturer: Blood Systems, Inc., Lafayette LA. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to medication with the drug Aricept, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA and CA.
______________________________
PRODUCT
Whole Blood, Leukocytes Reduced Irradiated.
Recall # B-0958-3
CODE
Unit number 20400-7357.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on November 6, 2001, and by letter on November 28, 2001.
Manufacturer: Blood Systems, Inc., Lafayette LA. Firm initiated recall is complete.
REASON
Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to application of a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0959-3.
CODE
Unit number 20400-7369 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on January 23, 2002.
Manufacturer: Blood Systems, Inc., Lafayette LA. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.
______________________________
PRODUCT
a) Red Blood Cells. Recall B-0960-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0961-3;
c) Platelets Pheresis, Leukocytes Reduced.
Recall # B-0962-3;
d) Red Blood Cells for Manufacture. Recall # B-0963-3;
e) Recovered Plasma. Recall # B-0964-3.
CODE
a) Unit numbers 20402-7968, 20402-7972, 20402-4062,
20402-7966, 20402-7965, 20402-7976, 20402-7971,
20402-7960, 20402-7964, 20402-4060, 20402-7977,
20402-7974, 20402-7969, and 20402-7967; and the
following unit was distributed as two split products:
unit number 20402-7963;
b) Unit numbers 20402-7957, 20402-7970, and 20402-7962;
c) Unit number 20402-3998;
d) Unit number 20402-7973;
e) Unit numbers 20402-7957, 20402-7968, 20402-7972,
20402-4062, 20402-7965, 20402-7976, 20402-7971,
20402-7973, 20402-7960, 20402-6842, 20402-7964,
20402-7970, 20402-7974, 20402-7969, and 20402-7967.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on November 2, 2001, and by letter on December 5, 2001.
Manufacturer: Blood Systems, Inc., Lafayette LA. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 16 units;
b) 3 units;
c) 1 unit;
d) 1 unit;
e) 15 units.
DISTRIBUTION
LA, CA, NV, NY, and Switzerland.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-0861-3;
b) Fresh Frozen Plasma. Recall # B-0862-3;
c) Platelets. Recall # B-0863-3.
CODE
a), b), and c) Unit 113301635.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., El Paso, TX, by telephone on February 18, 2002 and/or letter dated March 5, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had surgery within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX and New Mexico.

________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-0872-3.
CODE
Unit numbers 0598766, 0752277, 0750275, and 0746294; and the following units were distributed as three split products: unit numbers 1149724 and 1148319.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone and letter on April 25, 2001, and by letter on July 19, 2001. Firm initiated recall is complete.
REASON
Blood products that were possibly out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
CA.

________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-0880-3.
CODE
Unit numbers 13FC32327, 13FW02021, 13FW02037, 13FW02018, 13FQ15383, and 13FW02217.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter on January 24, 2003. Firm initiated recall is complete.
REASON
Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
MI.

________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-0881-3;
b) Platelets Pheresis, Irradiated. Recall # B-0882-3.
CODE
a) Unit numbers 13GV33943, 13GV33899, 13GV33952, 13GV33917,
and 13GV33904;
b) Unit numbers 13P90664, 13P90657, and 13P90640.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter on January 24, 2003. Firm initiated recall is complete.
REASON
Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Platelets. Recall # B-0883-3.
CODE
Unit numbers 18FW30736, 18FW30746, and 18FW30747.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on February 28, 2002, and by letter on March 7, 2002. Firm initiated recall is complete.
REASON
Blood products, exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Source Plasma. Recall # B-0884-3.
CODE
Unit JG0091065.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 6, 2001. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which the results of the arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
________________________
PRODUCT
Source Plasma. Recall # B-0885-3.
CODE
Unit JG0089762.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 8, 2001. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which the results of the arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0886-3.
CODE
Unit CNA002888.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 19, 2001. Firm initiated recall is complete.
REASON
Blood product, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0887-3.
CODE
Unit CNG002553.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on February 4, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which the results of the arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0888-3.
CODE
Unit JG0089393.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on February 27, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which the results of the arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0889-3.
CODE
Unit CNA005603.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on November 2, 2001. Firm initiated recall is complete.
REASON
Blood product, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0890-3.
CODE
Unit CNA000019.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on February 22, 2002. Firm initiated recall is complete.
REASON
Blood product, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0891-3.
CODE
Unit CNA003690.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on February 22, 2002. Firm initiated recall is complete.
REASON
Blood product, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0892-3.
CODE
Unit JA0009721.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on February 22, 2002. Firm initiated recall is complete.
REASON
Blood product, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0893-3.
CODE
Unit JG0054154.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on February 22, 2002. Firm initiated recall is complete.
REASON
Blood product, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0894-3.
CODE
Unit JG0083828.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on February 22, 2002. Firm initiated recall is complete.
REASON
Blood product, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0895-3.
CODE
Unit number 18FK74463.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on February 20, 2003 and by facsimile on February 21, 2003. Firm initiated recall is complete.
REASON
Blood product possibly exposed to unacceptable shipping temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0905-3.
CODE
Unit numbers 16364-0706 and 16363-7777.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on September 24, 2001, and by letter on January 15, 2002.
Manufacturer: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood products, that did not have the additive solution included in the time frames established by the manufacturer, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL, and MS.
______________________________
PRODUCT
Red Blood Cells. Recall # B-0906-3.
CODE
Unit number 16363-7727.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on January 22, 2002.
Manufacturer: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0914-3.
CODE
Unit numbers 30LE03287 and 30GN53626.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on March 26, 2002, and by letters on April 2 and 5, 2002. Firm initiated recall is complete.
REASON
Blood products, that were found to be out of specification for red blood cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.
________________________
PRODUCT
Platelets. Recall # B-0915-3.
CODE
Unit numbers 30GL27842, 30GL27894, 30GL27896, 30GL27897, 30GL27888, 30GL27890, 30GL27898, 30GL27899, 30GL27880, 30GL27882, 30GL27883, 30GL27887, 30GL27851, 30GL27852, 30GL27853, 30GL27838, 30GL27846, 30GL27847, 30GL27850, 30GL27845, 30GL27892, 30GL27893, 30GL27878, 30GL27891, 30GT11350, 30GT11347, 30GT11348, 30GL27833, 30GL27836, 30GL27837, 30GL27844, 30GK04587, 30GL27831, 30GT11340, 30GT11337, 30GT11333, 30GL27867, 30GL27868, 30GL27866, 30GL27855, 30GL27857, 30GL27858, 30GL27861, 30GL27859, 30GL27854, 30GL27834, 30GL27871, 30GK04593, 30GK04594, 30GK04586, 30GT11331, 30GT11326, 30GT11327, 30GT11323, 30GT11324, 30GT11325, and 30GT11321.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on June 25, 2002, and by letters on July 1, 2002, and August 2, 2002. Firm initiated recall is complete.
REASON
Blood products, that exceeded the firm's specification for the time without agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
57 units.
DISTRIBUTION
PA, and NY.
______________________________
PRODUCT
Source Plasma. Recall # B-0921-3.
CODE
Unit number JG0090593.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 7, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0922-3.
CODE
Unit number JG0096967.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 8, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0923-3.
CODE
Unit number JG0055640.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 4, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0924-3.
CODE
Unit number JG0089269.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 4, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0930-3.
CODE
Unit number 30GW23296.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by letters on April 12, 2002. Firm initiated recall is complete.
REASON
Blood product, that tested negative for the antibody to hepatitis C virus (anti-HCV), but was not properly quarantined after the receipt of subsequent repeatedly reactive anti-HCV results for the donor of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
______________________________
PRODUCT
Recovered Plasma. Recall # B-0940-3.
CODE
Unit 30GS28441.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by letter on October 4, 2002. and by facsimile on October 2, 2002. Firm initiated recall is complete.
REASON
Blood products, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA, and NJ.
______________________________
PRODUCT
Source Plasma. Recall # B-0949-3.
CODE
Unit number JG0050286.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 19, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose responses to the health history screening questions were not recorded properly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0950-3.
CODE
Unit number JG0080420.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 5, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose responses to the health history screening questions were not recorded properly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0951-3.
CODE
Unit number CNA006265.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 7, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose responses to the health history screening questions were not recorded properly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0952-3.
CODE
Unit number CNA002181.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 5, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose responses to the health history screening questions were not recorded properly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Source Plasma. Recall # B-0953-3.
CODE
Unit number CNA001940.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 19, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose responses to the health history screening questions were not recorded properly, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
______________________________
PRODUCT
Recovered Plasma. Recall # B-0955-3.
CODE
Unit number 20403-0435.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on April 12, 2002, and by letter on May 3, 2002.
Manufacturer: Blood Systems, Inc., Lafayette LA. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to medication with the drug Aricept, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA and CA.
________________________
PRODUCT
Platelets. Recall # B-0956-3.
CODE
Unit numbers 20399-5233, 20399-5235, 20399-5236, 20399-5237, 20399-5238, 20399-5240, 20399-5241, 20399-5244, 20399-5249, and 20399-5251.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on February 22, 2001, and by letter on May 5, 2001.
Manufacturer: Blood Systems, Inc., Lafayette LA. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood stored at incorrect temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
LA.
______________________________
PRODUCT
Whole Blood. Recall # B-0957-3.
CODE
Unit number 20400-7357.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on November 6, 2001.
Manufacturer: Blood Systems, Inc., Lafayette LA. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
______________________________
PRODUCT
Source Plasma. Recall # B-0965-3.
CODE
Unit number 62480888.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Lakewood, WA, by facsimile on May 20, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
______________________________
PRODUCT
Red Blood Cells. Recall # B-0982-3.
CODE
Unit number 1159676.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter on June 13, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
______________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-0986-3.
CODE
Unit number 21KZ08403 (included in pool #6851).
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on May 8, 2002,and by letter on May 20,2002. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that should have been designated as a traumatic collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OR.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

______________________________
PRODUCT
1) Arnold Dry Cow Mineral. Product labeled in part:
ARNOLD DRY COW MINERAL***Calcium (min) 14.50%. Product
sold in 50 lb bags. Recall # V-057-3;
2) Arnolds Min Bulk Bag - No label. Recall # V-058-3;
3) Badlands Close-Up Mineral. Product labeled in part:
Badlands Close-up Mineral***Crude Protein***Contents:
Dried Condensed Extracted Glutamic Acid Fermantation
products. Product sold in 50 lb bags. Recall # V-059-3;
4) Benton B. Product labeled in part: Benton B, Calcium
(min) 17.50%. Product sold in 50 lb. Bags.
Recall # V-060-3;
5) William Hess Custom Mineral. The product is sold in 50
lb bags. Recall # V-061-3;
6) Calcium Carbonate sold in 50 lb bags with the following
labels: a) Brace 2 to 1 Mineral;
b) Catlin 2 to 1 Minera;
c) Roy Darling Custom Mineral;
d) W. M. Golden Feeder Blend 22 w/4Plex;
e) W. M. Golden Feeder Blend 5;
f) MacKnight 22-8-6 Dairy Mineral;
g) NYP 100;
h) Nu-Feeds 10%;
i) PSU #4 Trace Base;
j) Riverhaven Farm;
k) Purina Pack;
l) Sam Esh Custom Mineral;
m) Shaffers 80; and
n) Snyder Custom Mineral.
Recall # V-062-3;
7) Buck Shot. Product labeled in part: BUCK SHOT Minerals
in Percent. The product is sold in 50 lb bags.
Recall # V-063-3;
8) Catlin 4 to 1 Mineral. Product labeled in part: Catlin
4 to 1 Mineral, Mineral Content. The product is sold in
50 lb bags. Recall # V-064-3;
9) Cochecton 50. The product is sold in 2500 lb bags.
Recall # V-065-3;
10) Dicalcium Phosphate sold in 50 lb bags under the
following labels: a) Custom Hog;
b) Equine Supreme. (Horse Mineral plus Biotim & Zinpro;
c) Eugene Hall Custom Mineral;
d) Faihopity Custom Mineral;
e) Keebler's 14%;
f) Martin's B Mineral; and
g) Pig Mineral Plus Lysine.
Recall # V-066-3;
11) EE Miller 2 to 1. The product is sold in 50 lb bags.
Recall # V-067-3;
l2) Ewuine Plus. Product labeled in part: Equine Plus,
(Horse Mineral), Directions for use: Add to feed. The
product is sold in 50 lb bags. Recall # V-068-3;
13) Mono-ammonium sold in 50 lb bags under the following
labels: a) Hemlock Valley Close up; and
b) Hemlock Valley Far Off. Recall # V-069-3;
14) Hynes 100X. The product is sold in 50 lb bags.
Recall # V-070-3;
15) Jim Stine (Roe) - No label. Recall # V-071-3;
16) Vitamin E Supplement sold in 50 lb bags under the
Judson's Anemia Plus label. Recall # V-072-3;
17) Kevin Potter Custom. The product is sold in 50 lb
bags. Recall # V-073-3;
18) Mineral oil sold in 50 lb bags under the Lutz 15 label.
Recall # V-074-3;
19) Dicalcium & Monocalcium Phosphate (Decoquinate 771
grams per ton) sold in 65 lb bags under the MacKnight
21-5 Calf Premix D label. Recall # V-075-3;
20) Martin's Dairy Mineral III Se. The product is sold in
50 lb bags. Recall # V-076-3;
21) Calcium Phosphate sold in 50 lb bags under the Martin's
M Mineral label. Recall # V-077-3;
22) Vitamin & Mineral sold in 50 lb bags under the NBC 15
in 1 label. Recall # V-078-3;
23) Nu-Min Biotics (8oz). Recall # V-079-3;
24) Nu-Feeds All Phosphate. Recall # V-080-3;
25) Monoamonium Phosphate, sold in 50 lb bags under the Roe
Dry Base label. Recall # V-081-3;
26) Yeast Culture Pack with B Vitamins sold in 50 lb bags
under the Super R Start 2 to 50 label.
Recall # V-082-3;
27) Trace II. Labeled as Nuffeds Sulfate trace mineral
base, ingredients: Zinc oxide. Recall # V-083-3;
28) Monensin Calcium (min) 12.0, sold in 50 lb bags under
the Arnolds Heifer Mineral with Rumensin label. Product
labeled as ARNOLDS HIEFER MINERAL with RUMENSIN,
(Type B medicated), Active Drug Ingredient Monensin,
Calcium (min) 12.0. Recall # V-084-3;
29) Beef Mineral with Bovatec. Product sold in 50 lb bags.
Recall # V-085-3;
30) Beef Mineral with Rumensin. Product labeled as in BEEF
MINERAL with RUMENSIN, (medicated), Calcium (min) 18.0.
The product is sold in 50 lb bags. Recall # V-086-3;
31) Monensin sold in 50lb bags. Product labeled as
CHAMPDALE HEIFER MINERAL with RUMENSIN, (Type B
medicated), Active Drug Ingredient: Monensin.
Recall # V-087-3;
32) Dicalcium Phosphate, sold in 50 lb bags. Product
labeled as HEIFER 75 with BOVATEC (50''S), (medicated).
Recall # V-088-3;
33) Monensin. Product labeled as HEIFER with RUMENSIN,
(Type B medicated), Active Drug Ingredient: Monensin.
Recall # V-089-3;
34) Dicalcium Phosphate, sold in 50 lb bags. Product
labeled as HEIFER MINERAL with BOVATEC (50''S),
(medicated) Recall # V-090-3;
35) Lasalocid, Potassium Sulfate sold in 50 lb bag. Product
labeled as LUTZ HEIFER 25 with BOVATEC,
(medicated)***Active Drug Ingredient: Lasalocid.
Recall # V-091-3;
36) Lasalocid, Dicalcium Phosphate, sold in 50 lb bags.
Product labeled as Martins Mineral with Bovatec,
(medicated), Active Drug Ingredient: Lasalocid,
Contents: Dicalcium Phosphate. Recall # V-092-3;
37) Salt, Moncalcium Phosphate sold in 2000 bags under the
Butterville Heifer with Rumensin label.
Recall # V-093-3;
38) Recall # V-094-3;
39) Vitamin A Palmitate, sold in 50 lb bags under the
following labels: a) Arnold 2:1 Mineral mix;
b) Arnolds Mineral; c) Gary Hall Custom Mineral; and
d) Jim Steppe. Recall # V-095-3;
40) Recall # V-096-3.
41) Dolomitic Limestone, sold in 50 lb bags under the
following labels: a) John De Fresne Dry Cow;
b) Mauganville Vita-Plus;
c) Nu-Feeds 1 to 1;
d) Nu-Feeds 2 to 1;
e) Nu-Feeds 3 To 1;
f) Nu-Feeds 4 To 1;
g) Ownbrook Custom Mineral;
h) Swine Premix; and
i) Nu-Feeds T.V.M. 70.
Recall # V-097-3;
42) Vitamin A Palmitate, sold in 50 lb bags under the
following labels: a) Knittle & Frey 1 to 1;
b) Knittle & Frey 2 to 1; c) Knittle & Frey 3 to 1;
d) L & K Mineral Plus; and e) L & K 15 Premix.
Recall # V-098-3;
43) Vitamin A Palmitate, sold in 50 lb bags under the
following labels: a) MF-25 Vitamin/Trace Base;
b) NYP 20; c) NYP 25 Layer; d) NYP 25 Starter/Grower;
e) Nu-Feeds 22-11-4. Recall # V-099-3.
CODE
1) Lot Number 02-249;
2) No codes;
3) Lot Number 02-762;
4) No codes, product identified by trade name only;
5) No codes, product identified by trade name only;
6) The following lot numbers are for the corresponding
label: a) Identified by trade name only;
b) Identified by trade name only;
c) Identified by trade name only;
d) No codes;
e) No codes;
f) Lot number 02-668;
g) No codes;
h) Identified by trade name only;
i) Lot number 02-661;
j) Lot number 02-602;
k) Lot number 02-758;
l) Lot number 02-723;
m) Lot number 02-754; and
n) Lot number 02-820.
7) No codes product identified by trade name only;
8) No codes product identified by trade name only;
9) Lot number 02-744;
10) The following lot numbers are for the corresponding
label: a) identified by trade name only;
b) Lot number 02-543;
c) Lot Number 02-635;
d) No codes;
e) Lot number 01-12110;
f) no codes; and
g) Lot number 02-692.
11) No codes, product identified by trade name only;
12) No codes, product identified by trade name only;
13) The following lot numbers are for the corresponding
labels: a) Lot number 02-485; and
b) Lot number 02-486;
14) Lot number 02-703;
15) No codes;
16) Lot number 02-653;
17) Lot number 02-700;
18) No codes;
19) Lot number 02-669;
20) Lot number 02-541;
21) Lot number 02-726;
22) No codes, product identified by trade name only;
23) No codes;
24) No codes;
25) Lot number 02-691;
26) Lot number 02-026;
27) No codes;
28) Lot number 02-485;
29) Lot number 02-059;
30) Lot number 02-554;
31) No codes;
32) Lot number 02-267;
33) Lot number 02-697;
34) Lot number 161;
35) Lot number 01-1482;
36) Lot number 02-727;
37) Lot number 02-765;
38) The following lot numbers are for the corresponding
labels: a) Lot Number 759; b) Lot Number 02-764;
c) Lot Number 02-733 ; d) Lot Number 02-617;
e) Lot Number 02-579; and f) Lot 02-763;
39) The following lot number are for the corresponding
labels: 1) Lot Number 02-652; 2) Lot Number 02-005;
3) Lot Number 02-753; and 4) Lot Number 02-529;
40) The following lot numbers are for the corresponding
labels: a) No codes; b) Lot number 02-305; and
c) lot number 02-258;
41) The following lot numbers are for the corresponding
labels: a) Lot number 01-1264; b), c), e), and h) no
codes product identified by trade name only;
d) Lot number 02-413; f) Lot number 02-717;
g) Lot number 02-636; and i) Lot number 02-750;
42) The following lot numbers are for the corresponding
labels: a), b), and c) no codes product identified by
trade name only; d) Lot Number 02-742; and
e) Lot Number 02-761;
43) The following lot number are for the corresponding
labels: a) Lot Number 02-557; b) no codes;
c), d), and e) no codes product identified by trade
name only.
RECALLING FIRM/MANUFACTURER
NuFeeds, Inc., Lemon, PA, by on site visit on January 21, 22, 24, 2003, February 3, 5, 24, 2003, and March 17, 2003.
Firm initiated recall is complete.
REASON
Possible dioxin contamination.
VOLUME OF PRODUCT IN COMMERCE
39,574 bags.
DISTRIBUTION
PA, NY, and MD.

END OF ENFORCEMENT REPORT FOR MAY 14, 2003

###


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