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.
ENFORCE
06/02/1993
Recalls and Field Corrections: Drugs -- Class III -- 06/02/1993
June 2, 1993 92-22
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________
PRODUCT Minute Rinse, NAF Mouth Rinse, in 1
gram, 2 gram or 3 gram packets. Recall
#D-269-3.
CODE All lots.
MANUFACTURER Continental Hydrodyne Systems, Inc.,
South Lebanon, Ohio.
RECALLED BY Manufacturer, by letter May 19, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Current Good Manufacturing Practice
deficiencies.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered
Plasma.
Recall #B-267/268-3.
CODE Unit #17GK44037.
MANUFACTURER American Red Cross Blood Services, St.
Paul, Minnesota.
RECALLED BY Manufacturer, (a) by telephone March
30, 1992, and by letter on April 28,
1992; (b) by telephone April 28, 1992,
and by letter May 1, 1992. Firm-
initiated recall complete.
DISTRIBUTION Wisconsin, Minnesota.
QUANTITY 1 unit of each component.
REASON Blood products which tested repeatedly
reactive for the antibody to the
hepatitis C virus encoded antigen
(anti-HCV) were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-269-3.
CODE Unit #C07682.
MANUFACTURER Northern Illinois Blood Bank, Rockford,
Illinois.
RECALLED BY Manufacturer, by telephone November 23,
1992. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, which tested negative
for anti-HIV-2, but was collected from
a donor who previously tested
repeatedly reactive for anti-HIV-2, was
distributed.
_______________
PRODUCT (a) Platelets; (b) Platelets, Pooled.
Recall #B-273/274-3.
CODE Unit numbers: (a) 220471331; (b) Pool
number 91-24.
MANUFACTURER (a) United Blood Services Blood
Systems, Inc., Las Vegas, Nevada; (b)
United Blood Services Blood Systems,
Inc., Cheyenne, Wyoming.
RECALLED BY United Blood Services, Scottsdale,
Arizona, by telephone June 27, 1991,
and July 5, 1991. Firm-initiated
recall complete.
DISTRIBUTION Arizona, Nevada, Wyoming.
QUANTITY (a) 1 unit; (b) 1 pool.
REASON Blood products labeled with incorrect
expiration dates were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________
PRODUCT Source Plasma. Recall #B-264-3.
CODE Unit numbers: EWW788, EWW798, EWW806,
EWW818, EWW819.
MANUFACTURER Sera-Tec Biologicals, Eagle Pass,
Texas.
RECALLED BY Manufacturer, by telephone January 5,
1993. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 5 units.
REASON Blood products untested for viral
markers were distributed.
_______________
PRODUCT (a) Platelets Pheresis; (b)
Granulocytes Pheresis.
Recall #B-265/266-3.
CODE Unit numbers: (a) 17GS49181,
17GS49182, 17GS49183, 17GS49184,
17GS49186, 17GS49187, 17GS49188,
17GS49189, 17GS53176, 17GS53177,
17GS53178, 17GS53179, 17GS53180,
17GS53182, 17GS53184; (b) 17GS49186.
MANUFACTURER American Red Cross Blood Services, St.
Paul, Minnesota.
-2- RECALLED BY Manufacturer, by telephone either on
March 31, 1992, or September 21, 1992;
and by letters dated either April 28,
1992, or September 29, 1992. Firm-
initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY (a) 15 units; (b) 1 unit.
REASON Blood products, incorrectly tested for
viral markers, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Liquid Plasma;
(c) Fresh Frozen Plasma. Recall #B-
270/272-3.
CODE Unit numbers: (a) C09765, L31254,
L31255, L31256, L31257, L31258, L31259,
L31260, L31262, L31263; (b) C09095; (c)
L31254, L31255, L31256, L31257, L31258,
L31259, L31260, L31262, L31263.
MANUFACTURER Northern Illinois Blood Bank, Rockford,
Illinois.
RECALLED BY Manufacturer, by telephone November 23,
1992. Firm-initiated recall complete.
DISTRIBUTION Illinois, California.
QUANTITY (a) 10 units; (b) 1 unit; (c) 9 units.
REASON Blood products, which either was
untested for the antibody to hepatitis
C virus encoded antigen (anti-HCV);
were untested for syphilis; or were
labeled with the incorrect expiration
date, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-275-3.
CODE Units 101854651 and 220471331.
MANUFACTURER United Blood Services, Las Vegas,
Nevada; and United Blood Services,
Scottsdale, Arizona.
RECALLED BY United Blood Services, Scottsdale,
Arizona, by telephone June 11, 1991,
and July 5, 1991. Firm-initiated
recall complete.
DISTRIBUTION Arizona, Nevada, Wyoming.
QUANTITY 2 units.
REASON Blood products labeled with incorrect
expiration dates were distributed.
_______________
PRODUCT Platelets. Recall #B-276-3.
CODE Unit #7295019.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by telephone February 3,
1993, and by letter dated February 18,
1993. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product containing antibody to
the CD antigen (anti-CD or anti-G), but
labeled as negative for unexpected
antibodies, was distributed.
-3- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________
PRODUCT Cobe Hardshell Filtered and unfiltered,
sterile disposable Cardio-pulmonary
bypass oxygenators and reservoirs:
(a) Catalog #050202-000 CMS 30-HVRF
Oxygenator (filtered);
(b) Catalog #050204-000 CMS 30-HVR
Oxygenator (unfiltered);
(c) Catalog #050252-000 HVRF 3700
Reservoir (filtered);
(d) Catalog #050253-000 HVR 3700
Reservoir (unfiltered).
Recall #Z-499/502-3.
CODE All lot numbers manufactured up to and
including 01Y6002, where 01 is the
month (January), and Y is the year 1993
(x is 1992).
MANUFACTURER Cobe Cardiovascular, Inc., Arvada,
Colorado.
RECALLED BY Manufacturer, by letter dated January
13, 1993. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 54,600 units were
distributed.
REASON Arterial and venous sample lines are
reversed.
_______________
UPDATE Coburn Intraocular Lens, Recall #Z-
479/483-3, manufactured by Storz
Ophthalmics, Inc., which appeared in
the April 28, 1993 Enforcement Report
should read:
Model Control Model Control
62 J24037 72N I37815
62UV I03421 72N J31033
72 I35316 120UV I02133
72N I26903 120UV I02143
72N I35425 120UV I09005
72N I36205 120UV I09931
72N I36227 120UV I09933.
SEIZURES:
_______________
PRODUCT Unimycin (veterinary
penicillin/dihydrostreptomycin
combination antibiotic) (93-573-098/9).
CHARGE Adulterated - The articles purport to
be and are represented as a drug, the
name of which is recognized in an
official compendium, and their strength
falls below the standard set forth in
such compendium.
FIRM Universal Cooperatives, Inc., Eagan,
Minnesota.
FILED May 12, 1993; U.S. District Court for
the District of
Minnesota; CivIL #4-93-483, FDC #66708.
SEIZED May 14, 1993 - goods valued at
approximately $258,000.
_______________
PRODUCT Pecan pieces (93-509-718, et al.).
CHARGE Adulterated - The article has been
prepared and packed under insanitary
conditions whereby it may have become
contaminated with filth.
-4-
FIRM Orangeburg Pecan Company, Orangeburg,
South Carolina.
FILED April 22, 1993; U.S. District Court for
the District
of South Carolina, Columbia Division;
Civil #5-93-0932-6,
FDC #66697.
SEIZED May 10, 1993 - goods valued at
approximately $15,600.
-5-
END OF ENFORCEMENT REPORT FOR JUNE 2, 1993. BLANK
PAGES MAY FOLLOW
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