FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and
Drug Administration,
U.S. Public Health Service, Department of Health and Human
Services. It contains information
on actions taken in connection with agency regulatory
activities.
December 8, 1999 99-49
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________
PRODUCT
Requip (Ropinirole Hydrochloride) 1 mg tablets, in bottles of
100, Rx for the treatment of Parkinsonís disease.
NDC #0007-4892-20. Recall #D-112-0.
CODE
LOT NUMBERS EXP. DATES
716550 9/30/99
716410 10/31/99
716420 10/31/99
716560 10/31/99
717810 1/31/00
769070 6/30/00
768910 6/30/00
769340 6/30/00
779810 6/30/00
779820 6/30/00
779830 6/30/00
779840 7/31/00
002446 11/30/99
002447 11/30/99
003351 1/30/00
003352 1/31/00
004019 2/28/00
004102 2/28/00
004906 3/31/00
004907 3/31/00
005399 4/30/00
005727 4/30/00
006293 4/30/00
006294 4/30/00
007003 5/31/00
007004 5/31/00
007496 5/31/00
007497 5/31/00
007816 5/31/00
007902 5/31/00
007817 6/30/00
007903 6/30/00.
MANUFACTURER
SmithKline Beecham Pharmaceuticals, Crawley, West Sussex RH102QJ.
RECALLED BY
SmithKline Beecham Pharmaceuticals, Philadelphia, Pennsylvania,
by letter on October 6, 1999. Firm-initiated recall ongoing.
DISTRBUTION
Nationwide.
QUANTITY
Approximately 20,000 bottles were distributed.
REASON
Tablets have been found to fade from green to yellow, making it
difficult to distinguish between strengths or could cause the
wrong product to be dispensed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________
PRODUCT
a) Red Blood Cells; b) Cryoprecipitated AHF
Recall #B-178/179-0.
CODE
Unit #6661043.
MANUFACTURER
Central Florida Blood Bank, Inc., Orlando, Florida.
RECALLED BY
Manufacturer, by letter dated September 5, 1996. Firm-initiated
recall complete.
DISTRBUTION
Florida.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products tested negative for anti-HCV, but were collected
from a donor who previously tested reactive for Hepatitis C.
________
PRODUCT
a) Red Blood Cells, Irradiated; b) Recovered Plasma.
Recall #B-185/186-0.
CODE
Unit #9642321.
MANUFACTURER
Central Florida Blood Bank, Inc., Orlando, Florida.
RECALLED BY
Manufacturer, by letter dated August 3, 1995. Firm-initiated
recall complete.
DISTRBUTION
Florida.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products tested negative for the antibody to the human
immunodeficiency virus type 1 (HIV-1), but were collected from a
donor who previously tested repeatedly reactive for the antibody,
Western Blot negative.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-188/189-0.
CODE
Unit Numbers 8604912, 8604643.
MANUFACTURER
Central Florida Blood Bank, Inc., Orlando, Florida.
RECALLED BY
Manufacturer, by letter dated April 30, 1997 or May 5, 1997.
Firm-initiated recall complete.
DISTRBUTION
Florida.
QUANTITY
2 units of each component were distributed.
REASON
Blood products tested negative for the antibody to the human
immunodeficiency virus type 1 (HIV-1), but were collected from a
donor who previously tested repeatedly reactive for the antibody,
Western Blot negative.
________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-190/191-0.
CODE
Unit #1343973.
MANUFACTURER
Central Florida Blood Bank, Inc., Orlando, Florida.
RECALLED BY
Manufacturer, by facsimile on October 5, 1998. Firm-initiated
recall complete.
DISTRBUTION
Florida.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of
cancer.
_______
PRODUCT
Red Blood Cells. Recall #B-192-0.
CODE
Unit Number 3154761.
MANUFACTURER
Central Florida Blood Bank, Inc., Orlando, Florida.
RECALLED BY
Manufacturer, by letter dated September 6, 1996. Firm-initiated
recall complete.
DISTRBUTION
Florida.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had previously been
deferred for IV drug use.
________
PRODUCT
Red Blood Cells, Leukocyte Reduced. Recall #B-193-0.
CODE
Unit #2772335.
MANUFACTURER
Central Florida Blood Bank, Inc., Orlando, Florida.
RECALLED BY
Manufacturer, by telephone on September 20, 1996. Firm-initiated
recall complete.
DISTRBUTION
Florida.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Platelets. Recall #B-201-0.
CODE
Unit #6705688.
MANUFACTURER
Central Florida Blood Bank, Inc., Orlando, Florida.
RECALLED BY
Manufacturer, by telephone on July 31, 1997. Firm-initiated
recall complete.
DISTRBUTION
Florida.
QUANTITY
1 unit was distributed.
REASON
Blood product, which tested positive for unexpected antibodies,
was labeled as being negative for unexpected antibodies.
________
PRODUCT
Red Blood Cells. Recall #B-202-0.
CODE
Unit Number 15006-5292.
MANUFACTURER
Blood Services, Lubbock, Texas.
RECALLED BY
United Blood Systems, Inc., Scottsdale, Arizona, by telephone on
August 15, 1999, and by letter dated
September 21, 1999. Firm-initiated recall complete.
DISTRBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood products were collected from a donor who reported taking
the drug Asacol (mesalamine).
________
PRODUCT
Platelets, Pheresis, Leukoreduced. Recall #B-207-0.
CODE
Unit Number 04FP45664 - split unit.
MANUFACTURER
American Red Cross, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by telephone on June 28, 1999, and by letter dated
July 6, 1999. Firm-initiated recall complete.
DISTRBUTION
Massachusetts
QUANTITY
1 unit was distributed.
REASON
Blood products, which had high platelet counts, were
distributed.
________
PRODUCT
Red Blood Cells, Leukoreduced. Recall #B-208-0.
CODE
Unit Numbers 04KS36131 and 04KS36136.
MANUFACTURER
American Red Cross, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by telephone on May 5, 1999, and by letter dated
June 1, 1999. Firm-initiated recall complete.
DISTRBUTION
Massachusetts.
QUANTITY
2 units were distributed.
REASON
Blood products had no documentation of having been leukoreduced.
_______
PRODUCT
Red Blood Cells. Recall #B-209-0.
CODE
Unit #04F57231.
MANUFACTURER
American Red Cross, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by letter on August 13, 1999 and September 2, 1999.
Firm-initiated recall complete.
DISTRBUTION
Massachusetts.
QUANTITY
1 Unit was distributed.
REASON
Blood product was collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Plasma, Liquid; c) Recovered Plasma.
Recall #B-210/212-0.
CODE
Unit Numbers: a) 04C97984, 04GK23684, 04GK25686, 04GK29178; b)
04GK25686; c) 04C97984, 04GK23684, 04GK29178.
MANUFACTURER
American Red Cross, New England Region, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by letters dated July 8, 1999 and August 9, 1999.
Firm-initiated recall complete.
DISTRBUTION
Massachusetts.
QUANTITY
a) 4 units; b) 1 unit; c) 3 units.
REASON
Blood products were collected from a donor with a history of
hepatitis.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-213/214-0.
CODE
Unit Numbers 04FC66562.
MANUFACTURER
American Red Cross, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by letter dated August 2, 1999, and July 23, 1999.
Firm-initiated recall complete.
DISTRBUTION
Connecticut and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of
cancer.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-215/216-0.
CODE
Unit #04H78912.
MANUFACTURER
American Red Cross, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by letters dated July 14, and 19 1999. Firm-
initiated recall complete.
DISTRBUTION
Massachusetts and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of
cancer.
________
PRODUCT
Source Plasma. Recall #B-217-0.
CODE
Unit Numbers 970257848, 970257785, 970257598, 970257509,
970256220, 970256076, 970255919.
MANUFACTURER
SeraCare, Inc., Boise, Idaho.
RECALLED BY
Manufacturer, by letter on letter, dated May 14, 1998. Firm-
initiated recall complete.
DISTRBUTION
New Jersey.
QUANTITY
7 units were distributed.
REASON
Blood products were not quarantined after one donor tested
reactive for anti-HCV, and another donor provided post donation
information regarding having been incarcerated.
________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Frozen
Plasma, For Research Use Only. Recall#B-219/221-0.
CODE
Unit Numbers a) J29412, J28813, J28743, J28801, J28747, J28794,
J28816, J28756, J32367, J32368; b) J29412, J28801, J28816,
J28794, J28813, J28756; c) J29877, J29936, J29967.
MANUFACTURER
UCLA Medical Center Blood Bank, Los Angeles, California.
RECALLED BY
Manufacturer, by letter dated October 15, 1999 and November 3,
1999. Firm-initiated recall complete.
DISTRBUTION
California.
QUANTITY
a) 10 units; b) 6 units; c) 3 units were distributed.
REASON
Blood products were not tested for viral markers in accordance
with the test kit manufacturers instructions.
________
PRODUCT
Red Blood Cells. Recall #B-222-0.
CODE
Unit #20272-1964.
MANUFACTURER
Blood Systems, Inc., Lafayette, Louisiana.
RECALLED
Blood Systems, Inc., Scottsdale, Arizona, by letter dated
September 9, 1998. Firm-initiated recall complete.
DISTRBUTION
Louisiana.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
Platelets, Pheresis. Recall#B-223-0.
CODE
Unit Numbers 20271-6871, 20272-9771-02.
MANUFACTURER
Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona.
DISTRBUTION
Illinois and Louisiana.
QUANTITY
2 units were distributed.
REASON
Blood products had unacceptable platelet counts.
________
PRODUCTS
Platelets, Pheresis. Recall #B-224-0.
CODE
Unit #20273-3674-01.
MANUFACTURER
Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on October
14, 1998, and by letter dated October 28, 1998. Firm-initiated
recall complete.
DISTRBUTION
Louisiana.
QUANTITY
1 unit was distributed.
REASON
Blood product had an unacceptable platelet count.
________
PRODUCT
Platelets, Pheresis. Recall #B-225-0.
CODE
Unit #20275-2038-01.
MANUFACTURER
Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on March
16, 1999, by telephone on March 16, 1999 and by letter dated
April 8, 1999. Firm initiated recall complete.
DISTRBUTION
Louisiana.
QUANTITY
1 unit was distributed.
REASON
Blood products had an unacceptable platelet count.
________
PRODUCT
Platelets, Pheresis. Recall #B-226-0.
CODE
Unit Numbers: 15006-1130-01, 1506-1130-02.
MANUFACTURER
United Blood Services, Lubbock, Texas.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated August
6, 1999. Firm-initiated recall complete.
DISTRBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood products had an unacceptable platelet count.
________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-227/228-0.
CODE
Unit Numbers 19237-2461, 19237-9041; b) 19237-2461.
MANUFACTURER
United Blood Services, Reno, Nevada.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated March
31, 1999 and May 21, 1999. Firm-initiated recall complete.
DISTRBUTION
Nevada.
QUANTITY
a) 2 units; b) 1 unit were distributed.
REASON
Blood products were collected from a donor taking the drug
Zyprexa (Olanzapine).
________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukoreduced.
Recall #B-231/232-0.
CODE
Unit Numbers a) 21KM03667; b) 21KM01402.
MANUFACTURER
American Red Cross, Bend, Oregon.
RECALLED BY
American Red Cross, Portland, Oregon, by letters dated August 12,
1999, September 17, 1999. Firm-initiated recall complete.
DISTRBUTION
Oregon, California.
QUANTITY
a) 1 unit; b) 1 unit was distributed.
REASON
Blood products was collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
Red Blood Cells. Recall #B-233-0.
CODE
Unit Number 21GC58532.
MANUFACTURER
American Red Cross, Portland, Oregon.
RECALLED BY
Manufacturer, by letter dated August 12, 1999. Firm-initiated
recall complete.
DISTRBUTION
Washington state.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
Red Blood Cells. Recall #B-234-0.
CODE
Unit #21KL06049.
MANUFACTURER
American Red Cross, Portland, Oregon.
RECALLED BY
Manufacturer, by letter dated June 25, 1999 and July 29, 1999.
Firm-initiated recall complete.
DISTRBUTION
California, Michigan.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
Red Blood Cells. Recall #B-235-0.
CODE
Unit Numbers 21KL08793, 21KJ13423.
MANUFACTURER
American Red Cross, Portland, Oregon.
RECALLED BY
Manufacturer, by letters dated July 29, 1999. Firm-initiated
recall complete.
DISTRBUTION
Washington state, Oregon.
QUANTITY
2 units were distributed.
REASON
Blood products were collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
Red Blood Cells. Recall #B-236-0.
CODE
Unit Numbers 20272-6938.
MANUFACTURER
Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letters dated
September 22, 1998, and February 16, 1999. Firm-initiated recall
complete.
DISTRBUTION
Tennessee.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-237/238-0.
CODE
Unit Numbers a) 20272-8613; b) 20272-3362.
MANUFACTURER
Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated
September 9, 1998. Firm-initiated recall complete.
DISTRBUTION
Texas.
QUANTITY
a) 1 unit; b) 1 unit.
REASON
Blood products were collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
Platelets, Pheresis. Recall #B-240-0.
CODE
Unit Numbers 04GP40543(P1), 04GP40543(P2).
MANUFACTURER
American Red Cross, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by telephone on August 10, 1999, and by letter
dated August 27, 1999. Firm-initiated recall complete.
DISTRBUTION
Pennsylvania, West Virginia.
QUANTITY
2 units were distributed.
REASON
Blood products had unacceptable platelet counts.
________
PRODUCT
Recovered Plasma. Recall #B-243-0.
CODE
Unit Number 20277-1635.
MANUFACTURER
Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated July
12, 1999 and August 31, 1999. Firm-initiated recall complete.
DISTRBUTION
Switzerland.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected in a manner that compromised the
sterility of the unit.
________
PRODUCT
a) Red Blood Cells, Leukoreduced; b) Recovered Plasma. Recall
#B-245/246-0.
CODE
Unit Number 04KK06368.
MANUFACTURER
American Red Cross, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by letters dated September 1 and 3, 1999. Firm-
initiated recall complete.
DISTRBUTION
Maine, California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from an unsuitable donor.
________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-248/249-0.
CODE
Unit Numbers: a) 01Y25374; b) 01Y25364, 01Y25366, 01Y25368,
01Y25370, 01Y25371.
MANUFACTURER
American Red Cross Blood Services, Rochester, New York.
RECALLED BY
Manufacturer, by telephone on March 11, 1999, and by facsimile on
March 24, 1999. Firm-initiated recall complete.
DISTRBUTION
New York.
QUANTITY
a) 1 unit; b) 5 units were distributed.
REASON
Blood products were incorrectly tested for syphilis and ALT.
________
PRODUCT
Platelets. Recall #B-250-0.
CODE
Unit #01GC22607.
MANUFACTURER
American Red Cross Blood Services, Syracuse, New York.
RECALLED BY
Manufacturer, by telephone on November 24, 1998, and by letter
dated November 30, 1998. Firm-initiated recall complete.
DISTRBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Blood product corresponded to a unit of Red Blood Cells that was
positive for Serratia liquifaciens.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________
PRODUCT
a) Red Blood Cells; b) Platelets Pheresis.
Recall #B-147/148-0.
CODE
Unit Numbers: 03LN17915, 03LW17769, 03FQ14238, 03FQ14240; b)
03LL11727, 03FG15515, 03LQ14704.
MANUFACTURER
American National Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY
Manufacturer, by telephone on April 20, 1999, and by letter dated
May 20, 1999. Firm-initiated recall complete.
DISTRBUTION
Georgia.
QUANTITY
a) 4 units; b) 3 units were distributed.
REASON
Blood products were not tested for the anti-HIV-1 Antigen in
accordance with the test kit manufacturer's instructions.
________
PRODUCT
Whole Blood, CPDA-1. Recall #B-194-0.
CODE
Unit #3176568.
MANUFACTURER
Central Florida Blood Bank, Inc., Orlando, Florida.
RECALLED BY
Manufacturer, by telephone on October 25, 1996.
DISTRBUTION
Florida.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall #B-239-0.
CODE
Unit Numbers 6115399, 6115412.
MANUFACTURER
The Community Blood Center, Incorporated, Appleton, Wisconsin.
RECALLED BY
Manufacturer, by telephone June 10, 1999. Firm-initiated recall
complete.
DISTRBUTION
Wisconsin.
REASON
Blood products were labeled with extended expiration dates.
________
PRODUCT
Platelets. Recall #B-241-0.
CODE
Unit #11322-5194.
MANUFACTURER
United Blood Services, El Paso, Texas.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated August
31, 1999. Firm-initiated recall complete.
DISTRBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood product, prepared from a unit of whole blood identified as
a difficult draw.
________
PRODUCT
Platelets. Recall #B-242-0.
CODE
Unit #20276-6440.
MANUFACTURER
Blood Systems, Inc., Lafayette, Louisiana.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letters dated March
18, 1999, and May 4, 1999. Firm-initiated recall complete.
DISTRBUTION
Louisiana.
QUANTITY
1 unit was distributed
REASON
Blood product was prepared from a unit of whole blood identified
as a difficult draw.
________
PRODUCT
Ragweed Mix GS, (Giant and Short) Antigen E, labeled as 320
units/ml, 40,000 PNU mL, in 50 ml vial. Recall #B-244-0.
CODE
Lot #J99E9462.
MANUFACTURER
Bayer Corporation, Pharmaceutical Division, Elkhart, Indiana.
(U.S. Distributor)
RECALLED BY
Hollister-Stier Laboratories, LLC, Spokane, Washington, by
telephone on October 27 and 28, 1999, and by letter on November
1, 1999. Firm-initiated recall ongoing.
DISTRBUTION
New Jersey, Washington D.C.
QUANTITY
18 vials were distributed.
REASON
Allergenic extracts with an Antigen E value of 107.56 units/mL
were labeled as having an Antigen E content of 320 units/mL.
_______
PRODUCT
Recovered Plasma. Recall #B-251-0.
CODE
Unit #01GC22607.
MANUFACTURER
American Red Cross Blood Services, Syracuse, New York.
RECALLED BY
Manufacturer, by telephone on November 24, 1998, and by letter
dated November 30, 1998. Firm-initiated recall complete.
DISTRBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product corresponded to a unit of red blood cells that was
positive for Serratia liquifaciens.
END OF ENFORCEMENT REPORT FOR DECEMBER 8, 1999.
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