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.

January 1, 2003
03-01

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

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PRODUCT
Below are varieties of fruit pies, all 25 oz., and all labeled "J.Horner's".
1) Lattice-Top Apple Pie (Baked) UPC 96220 05429. Recall # F-110-3;
2) Cherry Pie
a) Lattice-Top (Baked) UPC 96220 05423;
b) Retail UPC 96220 05422;
c) Food Service UPC 96220 06722. Recall # F-111-3.
3) Blueberry Pie (Baked);
a) Lattice - UPC 96220 05403;
b) UPC 96220 05402. Recall # F-112-3.
4) Boysenberry Pie (Baked) UPC 96220 05404. Recall # F-113-2.
5) No Sugar Added Apple Pie (Baked) UPC 96220 05409. Recall # F-114-3.
6) Peach Pie (Baked) UPC 96220 05414. Recall # F-115-3.
7) Strawberry Rhubarb Pie (Baked) UPC 96220 05418. Recall # F-116-3.
CODE
1) Lot No's 2002103, 2002120, 2002172, 2002201, 2002269, and 2002290;
Lot No's 2001305, 2001307, 2001311, and 2002164.
2) a) Lot No's 2002103, 2002137, 2002201, 2002269, 2002270, 200273, 2002290, and 2002291.
b) Lot No's 2001296, 2001307, 2001319, 2001341, 2001355, and 2002162.
c) Lot No's 2002121, 200220, and 2002247.
3) a) Lot No's 2002103, 2002120, 2002121, 2002137, 2002201, and 2002271.
b) Lot No's 2001305, 2001307, 2001311, and 2001341.
4) Lot No's 2001305, 2001307, 2001311, 2001342, and 2001355.
5) Lot No's 2001305, 2001311, and 2001341.
6) Lot No's 2001305, 2001307, and 2001341.
7) Lot No's 2001305, 2001307, and 2001341.
RECALLING FIRM/MANUFACTURER
Recalling Firm: VICORP Restaurants, Inc., Denver, CO, by letter on October 25, 2002.
Manufacturer: Vicom Inc., Chaska, MN. Firm initiated recall is complete.
REASON
Frozen pie products contained undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
3324 pies.
DISTRIBUTION
CA, MN and MO.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_____________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-0314-3.
CODE
Units 107285050, 107301261, 107314546, 107307188.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on May 30, 2002. Firm initiated recall is complete.
REASON
Blood products, which were below the firm's specification for product volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION AZ.

_____________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-0316-3.
CODE
Units 107257323, 107268811(Split unit), 107251198.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on May 31, 2002 and by letter dated June 25, 2002. Firm initiated recall is complete.
REASON
Blood products, which were below the firm's specification for product volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
AZ.

_____________________________
PRODUCT
Red Blood Cells, Leukoreduced, Recall # B-0317-3.
CODE
Units 10727-4474, 10729-7670.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on June 5, 2002 and by letter dated June 25, 2002. Firm initiated recall is complete.
REASON
Blood products, which were below the firm's specification for product volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AZ.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0318-3.
CODE
Unit number 53FE72562.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letters dated August 26, 2002 and September 26, 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
Washington DC

____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0319-3;
b) Platelets, Recall # B-0320-3;
c) Fresh Frozen Plasma, Recall # B-0321-3.
CODE
a); b) and c) Unit number 53FN75872.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letters dated April 26, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
Washington DC and MD.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0322-3;
CODE
Unit number 29KF16940;
RECALLING FIRM/MANUFACTURER
The American National Red Cross,Mid-Atlantic Region, Norfolk, VA, by letters and fax on April 12 and 22, 2002. 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
1 unit.
DISTRIBUTION
NC and CA.

_____________________________
PRODUCT
a) Red Blood Cells, Leukoreduced, Recall # B-0326-3;
b) Recovered Plasma, Recall # B-0327-3.
CODE
a) and b) Unit 29FV51912.
RECALLING FIRM/MANUFACTURER
American Red Cross, Mid-Atlantic Region Blood Services, Norfolk, VA, by telephone on March 4, 2002 and by letter dated March 11, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health history screening was not adequately performed, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.

_____________________________
PRODUCT
Recovered Plasma, Recall # B-0328-3.
CODE
Units 53GR45262, 53GM31597.
RECALLING FIRM/MANUFACTURER
American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter on July 18, 2002 and September 26, 2002. 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
2 units.
DISTRIBUTION
CA.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0329-3;
b) Platelets, Recall # B-0330-3.
CODE
a) Unit T91364;
b) Unit T91364 - pooled Platelet ID # - P13903.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone and letter dated November 26, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria and being treated for pernicious anemia, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WI.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0342-3.
CODE
Unit number 33GE52670.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT, by letter on October 3, 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
CT.

_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0343-3.
CODE
Unit number 32KP25958 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Badger-Hawkeye Region, Madison, WI, by letter on April 30, 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
IL.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0344-3;
b) Platelets, Leukocytes Reduced, Recall # B-0345-3.
CODE
a) and b) Unit number 17KX83926.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, St. Paul, MN, by letter on April 30, 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
MN.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0346-3.
CODE
Unit number 17KW43154.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, St. Paul, MN, by letter on February 26, 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
CA.

_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0347-3.
CODE
Unit number 17FZ53601.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, St. Paul, MN, by letter on February 15, 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
MA.

_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0348-3;
b) Recovered Plasma, Recall # B-0349-3.
CODE
a) and b) Unit number 17KV11561.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, St. Paul, MN, by letters on December 13 and 14, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MA and CA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

____________________________
PRODUCT
Recovered Plasma, Recall # B-0323-3.
CODE
Unit number 29KF16940.
RECALLING FIRM/MANUFACTURER
The American National Red Cross,Mid-Atlantic Region, Norfolk, VA, by letters and fax on April 12 and 22, 2002. 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
1 unit.
DISTRIBUTION
NC and CA.

_____________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-0324-3;
b) Plasma, Recall # B-0325-3.
CODE
a) and b) Unit number 29KY11650.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region,Norfolk, VA, by telephone and letter July 8 and 15, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Sulfasalazine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC and NY.

_____________________________
PRODUCT
Recovered Plasma, Recall # B-0331-3.
CODE
Unit T91364.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone and letter dated November 26, 2001. Firm initiated recall is complete
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria and being treated for pernicious anemia, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.

END OF ENFORCEMENT REPORT FOR JANUARY 1, 2003
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