June 18, 2003
03-25
_______________________________
PRODUCT
Oregano (entry # DP4-0231673-2)
packed in 4 x 5 lb. clear-plastic bags. Product of Turkey. Imported through
the Port of Newark, NJ on
10/29/02. Recall # F-398-3.
CODE
All products on the market
at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Castella
Imports, Inc., Farmingdale, NY, by telephone on November 7, 2002. FDA initiated
recall is complete.
REASON Entry was partially distributed
prior to FDA sampling. Subsequent FDA analysis revealed the product was contaminated
with Salmonella
sp. Serotype H.
VOLUME OF PRODUCT IN COMMERCE
2,180 lbs.
(109 cases).
DISTRIBUTION
NY, NJ, CT, MA, MI, OH, MD, and
IL.
_______________________________
PRODUCT
Smoked Salmon Spread
packed in 8 oz. plastic tubs. Net wt. 8 oz.
Recall # F-397-3.
CODE
Expiration date of May 21, 2003.
RECALLING
FIRM/MANUFACTURER
Beck's Smokery, Pompano Beach, FL, by telephone and
letters on March 6, 2003. Florida State initiated recall is complete.
REASON Smoked
Salmon Spread does not list sub-ingredients of mayonnaise,
including eggs.
VOLUME OF PRODUCT IN COMMERCE
3,000/12 tub cases.
DISTRIBUTION
FL
and GA.
_______________________________
PRODUCT
Trober Allen brand
Filled Fruits candy imported from Canada. Net wt. 600 grams. Sold in plastic
bags. Recall
# F-399-3. CODE All lots at the time the recall was initiated.
RECALLING
FIRM/MANUFACTURER
Yankee One Dollar Store, Mechanicville, NY, by memo
dated March 21, 2003. New York State initiated recall is complete.
REASON
The
product contained undeclared certifiable colors - sunset yellow FCF (certifiable
as FD&C Yellow No. 6), allura red AC (certifiable as
FD&C Red No. 40), and brilliant blue FCF (certifiable as FD&C Blue
No. 1).
VOLUME OF PRODUCT IN COMMERCE
2,400 bags.
DISTRIBUTION
NY,
VT, and MA.
________________________________
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced. Recall # B-1121-3; b) Recovered Plasma. Recall # B-1122-3.
CODE
a)
and b)Unit number 35FV06069.
RECALLING FIRM/MANUFACTURER
The
American National Red Cross, Appalachian Region, Roanoke, VA, letter on December
4, 2002, and by facsimile on February 5, 2003, and March 7, 2003. Firm initiated
recall is complete.
REASON
Blood products, that tested negative
for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2),
but were collected from a donor that was subsequently determined to have a previous
reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2
units.
DISTRIBUTION
WV, and MA.
______________________________
PRODUCT
a) Red Blood Cells.
Recall # B-1123-3; b) Platelets, Irradiated. Recall # B-1124-3; c) Recovered
Plasma.
Recall # B-1125-3.
CODE
a), b), and c) unit number T92524.
RECALLING
FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter
and facsimile on January 7, 2003. Firm initiated recall is complete. REASON
Blood
products, that tested negative for viral markers, but were collected from an
ineligible donor due to behavior
known to increase risk of infection with human
immunodeficiency virus (HIV), were
distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
VA,
and Switzerland.
______________________________
PRODUCT
a) Red Blood Cells.
Recall # B-1128-3;
b) Recovered Plasma. Recall # B-1129-3.
CODE
a), and b) unit
number LC22449.
RECALLING FIRM/MANUFACTURER
Inova Health Care
Services, Blood Donor Services, Annandale, VA, by facsimile on December 26
and 27, 2002. 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), were distributed.
VOLUME OF
PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA, and
NJ.
______________________________
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced. Recall # B-1130-3;
b) Fresh Frozen Plasma. Recall # B-1131-3.
CODE
a), and b)
unit number FE82326.
RECALLING FIRM/MANUFACTURER
Inova Health
Care Services, Blood Donor Services, Annandale, VA, by letter on February 3,
2003.
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),
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.
________________________________
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced. Recall # B-1132-3; b) Recovered Plasma. Recall # B-1133-3.
CODE
a)
and b)Unit number 38FM47100.
RECALLING FIRM/MANUFACTURER
The
American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by letter
and facsimile on December 17, 2002, and January 17, 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
2
units.
DISTRIBUTION
IN, and NC.
________________________________
PRODUCT
Recovered Plasma.
Recall # B-1134-3.
CODE
Units 18FQ81523, 18FW26005, and 18FK57162.
RECALLING
FIRM/MANUFACTURER
American Red Cross/Great Lakes Region, Lansing,
MI, by fax on
November 19, 2002.Firm initiated recall is complete.
REASON
Blood
products, collected from a donor who previously tested reactive for the antibody
to hepatitis C virus (anti-HCV), were distributed.
VOLUME OF PRODUCT
IN COMMERCE
3 units.
DISTRIBUTION
NC, and Switzerland.
______________________________
PRODUCT
a) Red Blood Cells.
Recall # B-1138-3; b) Platelets. Recall # B-1139-3.
CODE
a)
Units 13R06522, 13R02468, 13R98495;
b) Units 13R06522, 13R02468.
RECALLING FIRM/MANUFACTURER
American
National Red Cross, Detroit, MI, by letters dated October 31, 2002, November
18, 2002, or November 19, 2002. Firm initiated
recall is complete.
REASON
Blood products, collected from
a donor taking the drug Ridaura, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MI.
______________________________
PRODUCT
a) Red Blood Cells.
Recall # B-1140-3; b) Recovered Plasma. Recall # B-1141-3.
CODE
a),
and b) Unit 1747017.
RECALLING FIRM/MANUFACTURER
Central Indiana
Regional Blood Center, Indianapolis, IN, by letter on March 10, 2002. Firm
initiated recall is complete.
REASON
Blood products, collected
from a donor taking the drug Proscar, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN,
and Switzerland.
______________________________
PRODUCT
a) Red Blood Cells,
Leukoreduced. Recall # B-1142-3; b) Recovered Plasma. Recall # B-1143-3.
CODE
a),
and b) Unit 38W22069.
RECALLING FIRM/MANUFACTURER
American
National Red Cross, Fort Wayne, IN, by letter and fax on December 4, 2002.
Firm initiated
recall is complete.
REASON
Blood products, collected from
a donor taking the drug Imuran, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN,
and NC.
______________________________
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced, Irradiated. Recall # B-1146-3; b) Platelets, Pheresis,
Leukocytes Reduced,
Irradiated. Recall # B-1147-3.
CODE
a) Units 50Z08325, 50Z08329;
b) Unit 50P34773 – part 1.
RECALLING FIRM/MANUFACTURER
American
Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by telephone
on December 10, 2002. Firm initiated recall is
complete.
REASON
Blood products, possibly exposed to inadequate
irradiation, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION
OH.
______________________________
PRODUCT
Red Blood Cells, Leukocytes
Reduced. Recall # B-1150-3.
CODE
Unit 22KM81294.
RECALLING
FIRM/MANUFACTURER
American Red Cross, Penn Jersey, Musser Blood
Center, Philadelphia, PA, by telephone on April 29, 2002. Firm initiated
recall is
complete.
REASON
Blood product, corresponding to a pool
of platelets that was implicated in a transfusion reaction and found to be
contaminated
with
Serratia marcescens, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1
unit.
DISTRIBUTION
PA.
END OF ENFORCEMENT REPORT FOR JUNE 18, 2003
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