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.

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December 29, 2004
04-52

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________________
PRODUCT
Source Plasma. Recall # B-0211-5.
CODE
Units: F-22778-011, F-27249-011, F-27788-011, F-28189-011, F-29064-011, F-29389-011, F-30075-011, F-30763-011, F-31180-011, F-31764-011, F-32149-011, F-34888-011, F-35337-011.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by fax on June 13, 2003.
Manufacturing Firm: Alpha Therapeutic Corporation, Portland, OR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had body piercing within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-0232-5.
CODE
Unit FH36178.
RECALLING FIRM/MANUFACTURER
Innova Health Care Services, Blood Donor Services, Annandale, VA, by letter dated May 23, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who disclosed travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets, Irradiated. Recall # B-0266-5.
CODE
Unit number: 6476013.
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Inc., Lakeland, FL, by letter, dated August 22, 2004. Firm initiated recall is complete.
REASON
Blood product, which was not tested for CMV, but was labeled as negative for CMV, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0301-5.
CODE
Units FM06460, LV35600, KE60846, LR49385, LV41492, FW19484, GV51671, FW09111, GR45703, KM08839, KE59573, KE58537, KK63543, LV33128 KK66061, KK64767, KK62526, KK61537, KM08784, KS74757.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile transmission dated March 15, 2004. Firm initiated recall is complete.
REASON
Failure to quarantine blood products that tested negative for viral markers, but were collected from donors who subsequently tested positive.
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0302-5.
CODE
Units 02GWIF8588 02GWIF9603 02GWIG0344 02GWIG1184 02GWIG5246 02GWIG6103 02GWIG8980 02GWIG9411 02GWIH0638 02GWIH1039 02GWIH2846 02GWIH3547 02GWIH4067 02GWIH5227 02GWIH5658 02GWIH6928 02GWIH8496 02GWIH8751 03GWIA0675 03GWIA0973 02GWIF1496.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Green Bay, WI, by letter dated February 19, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor taking Proscar, was distributed
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
MI, and Austria

_______________________________
PRODUCT
Source Plasma. Recall # B-0303-5.
CODE
Units 02GWIE4535, 02GWIE7937, 02GWIF9334, 02GWIF9939, 02GWIG2465.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Green Bay, WI, by letter dated March 12, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0304-5.
CODE
Unit 4223950.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on March 16,
2004. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0311-5;
b) Platelets, Leukocytes Reduced.
Recall # B-0312-5.
CODE
a) Units (85 units) 13FY94501, 13FY94502,
13FY94503, 13FY94504, 13FY94505, 13FY94506,
13FY94507, 13FY94510, 13FY94512, 13FY94513,
13FY94515, 13FY94516, 13FY94518, 13FY94519,
13FY94521, 13FY94522, 13FY94523, 13FY94525,
13FY94526, 13FY94527, 13FY94528, 13FY94529,
13FY94530, 13FY94531, 13FY94532, 13FY94533,
13FY94536, 13FY94537, 13FY94539, 13FY94540,
13FY94541, 13FY94542, 13FY94543, 13FY94544,
13FY94545, 13FY94546, 13FY94547, 13FY94548,
13FY94549, 13FY94551, 13FY94553, 13FY94554,
13FY94555, 13FY94556, 13FY94557, 13FY94558,
13FY94560, 13FY94561, 13FY94562, 13FY94563,
13FY94564, 13FY94565, 13FY94566, 13FY94567,
13FY94568, 13FY94571, 13FY94572, 13FY94573,
13FY94574, 13FY94575, 13FY94576, 13FY94577,
13FY94578, 13FY94579, 13FY94580, 13FY94584,
13FY94586, 13FY94589, 13FY94591, 13FY94593,
13FY94594, 13FY94595, 13FY94597, 13FY94598,
13FY94599, 13FY94600, 13FY94601, 13FY94603,
13FY94604, 13FY94606, 13FY94609, 13FY94610,
13FY94611, 13FY94612 13FY94613;
b) Units 13FY94501, 13FY94503, 13FY94506,
13FY94513, 13FY94514, 13FY94516, 13FY94520,
13FY94522, 13FY94524, 13FY94525, 13FY94526,
13FY94528, 13FY94529, 13FY94530, 13FY94531,
13FY94532, 13FY94533, 13FY94536, 13FY94542,
13FY94543, 13FY94545, 13FY94546, 13FY94548,
13FY94551, 13FY94557, 13FY94558, 13FY94562,
13FY94567, 13FY94578, 13FY94579, 13FY94580,
13FY94588, 13FY94589, 13FY94591, 13FY94595,
13FY94598, 13FY94599, 13FY94601, 13FY94604,
13FY94606, 13FY94609, 13FY94610, 13FY94611,
13FY94612, 13FY94613.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on November 10, 2003, and by letter dated November 28, 2003. Firm initiated recall is complete.
REASON
Blood products, collected with the use of expired iodine scrubs, were distributed.
VOLUME OF PRODUCT IN COMMERCE
130 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Human Corneas for Transplantation. Recall # B-0339-5.
CODE
Tissues: OB-2004-03-29-1 L-01 & OB-2004-03-29-2 R-01.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tissue Banks International, Baltimore, MD, by letter dated May 31, 2004.
Manufacturer: Medical Eye Bank of Maryland & Washington Eye Bank, Baltimore, MD,. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested repeatedly reactive for antibodies to Hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
NJ, and DC.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0359-5.
CODE
Unit number: L86063.
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rockford, IL, by facsimile and letter, dated September 21, 2004. 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
IL.

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0390-5.
CODE
Units 007FT07142, 007FT07147, 007FT07161, 007FT07162 (split unit), and 007FT07163.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tucson, AZ, by telephone
and by letter dated September 11, 2004. Firm initiated
recall is complete.
REASON
Blood products, which were labeled as leukoreduced without having been tested for a residual white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
AZ.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0392-5.
CODE
Unit number: 6531616.
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Inc., Lakeland, FL, by telephone on March 1, 2004, and by letter, dated August 26, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0396-5.
CODE
Unit number: 6534732.
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Inc., Lakeland, FL, by letter, dated August 24, 2004. Firm initiated recall is complete.
REASON
Platelet pheresis unit, associated with a positive bacterial culture, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
a) Red Blood Cells, Irradiated. Recall # B-0398-5;
b) Red Blood Cells, Leukocytes Removed, Irradiated.
Recall # B-0399-5.
CODE
a) Unit number: FE70215;
b) Unit number: FE63069.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by letter, dated November 9, 2004. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for Cytomegalovirus (CMV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Platelets. Recall # B-0400-5.
CODE
Unit number: 6552613, Platelet pool number 6550670.
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Inc., Lakeland, FL, by letter, dated September 1, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Platelets. Recall # B-0401-5.
CODE
Unit number: 6558707.
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Inc.Lakeland, FL, by telephone on July 26, 2004, and by letter, dated August 21, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0402-5;
b) Recovered Plasma. Recall # B-0403-5.
CODE
a) and b) Unit number: 6435252.
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Inc., Lakeland, FL,by letter, dated August 26, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Switzerland and FL.

_______________________________
PRODUCT
Source Plasma. Recall # B-0413-5.
CODE
Units 00MWID9823, 00MWIE0337, 0IMWIB0712, 01MWIB1876,
01MWIB2268, 01MWIB3291, 01MWIB3732, 01MW/B8070,
01MWIB9526, 00MWIEI136, 00MWIEI742, 00MWIE2933,
00MWIE3725, 00MWIEA240, 00MWIE5362, 00MWIE5619,
00MWIE6778, 00MWlE7072, 00MWIE8245, 00MWIE8565,
00MWIF2603, 00MWIF3231, 00MWIF4364, 00MWIF5485,
00MWIF5850, 00MWIG0528, 00MWIG1289, 00MWIG2848,
00MWIG3914, 00MWIG4190, 00MWIG5188, 00MWIG5459,
01MWIA2949, 01MWIA5697, 01MWIA9163, 01MWIB0219,
01MWIB4756, 01MWIB5164, 01MWIB6591, 01MWIB7625,
and 01MWIB9066.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, LP, Menasha, WI, by letter dated January 24, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
41 units.
DISTRIBUTION
MI, and Austria.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
Recall # B-0416-5;
b) Fresh Frozen Plasma. Recall # B-0417-5.
CODE
a) and b) Unit 0841732.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by letter dated September 18, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had engaged in multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0418-5.
CODE
Unit 1210201.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by letter dated January 16, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0313-5.
CODE
Unit 13FC13407.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southeastern Michigan Region,
Detroit, MI, by telephone on July 7, 2004, and by letter
dated July 13, 2004. Firm initiated recall is complete.
REASON
Red Cells, mislabeled as to antigen typing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Platelets Pheresis. Recall # B-0395-5.
CODE
Unit E85732.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by facsimile on May 10, 2002. Firm initiated recall is complete.
REASON
Blood product, collected in an expired collection bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0397-5.
CODE
Units 02GWID7351, 02GWID7924, 02GWID8832, 02GWIE0390, 02GWIE3203, 02GWIE3808, 02GWIE4756, 02GWIE5355, 02GWIE6269, 02GWIE6945, 02GWIE7851, 02GWIE8613, 02GWIF0708, 02GWID9502, 02GWIE2376.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Green Bay, WI, by facsimile on March 10, 2003.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units.
DISTRIBUTION
MI, and Austria.

_______________________________
PRODUCT
Platelets. Recall # B-0411-5.
CODE
Unit 4146156.
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St. Petersburg, FL, by facsimile on April 14, 2004. Firm initiated recall is complete.
REASON
Blood product, incorrectly tested for Cytomegalovirus (CMV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0412-5.
CODE
Units Z00677, Z00678, Z00679, Z00680, Z00681, Z00682, Z00683, Z00684, Z00685, Z00686.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter dated January 7, 2002. Firm initiated recall is complete.
REASON
Blood products, which were shipped at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
CA.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

_______________________________
PRODUCT
a) Hi-Tek Rations Horse Nuggets***Performance***
Net Wt. 40 lb (18.14 kg). Recall # V-006-5;
b) Hi-Tek Rations***Aqua-Tek***Quality Floating
Fish Food***Net Wt. 50 Lbs (22.68kg). Product
is packed in paper bags in amounts specified.
Recall # V-007-5.
CODE
a) Lot # 073128;
b) Lot #071202.
RECALLING FIRM/MANUFACTURER
HI-TEK Rations, Inc., Dublin, GA, by letter on September
17, 2004. Firm initiated recall is ongoing.
REASON
Product may contain prohibited ruminants; however, label does not have required caution statement.
VOLUME OF PRODUCT IN COMMERCE
10 tons.
DISTRIBUTION
AL, GA, NC, SC, WV.

_______________________________
PRODUCT
a) Hartz Advanced Care Hydrocortisone Spray.
Item Number 32700-94752. Recall # V-008-5;
b) Hartz Advanced Care Hydrocortisone Shampoo.
Item number 32700-94751. Recall # V-009-5;
c) Hartz Advanced Care Hydrocortisone spot with
Aloe. Item number 32700-98464. Recall # V-010-5;
d) Hartz Advanced Care Once-A-Month Capsule
Wormer Products. Item Numbers:
32700-84346 ‚ Once-A-Month Wormer for Puppies,
32700-84345 - Once-A-Month Wormer for Dogs
32700-84348 - Once-A-Month Wormer for Large Dogs
32700-84347 - Once-A-Month Wormer for Kittens
and Cats. Recall # V-011-5;
e) Hartz Advanced Care Liquid Wormer: Item number
32700-95122. Recall # V-012-5.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Hartz Mountain Corp., Secaucus, NJ, by letter on October 26, 2004. Firm initiated recall is ongoing.
REASON
Products do not meet manufacturing GMP requirements.
VOLUME OF PRODUCT IN COMMERCE
2,048,318.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR December 29, 2004

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