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
10/09/1991
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
Product: Jamaican Orange Soda, in 12 ounce glass bottles.
Recall #F-002-2.
Code: All lots.
Manufacturer: Reggae Imports Ltd., Brooklyn, New York.
Recalled by: Manufacturer, by letter August 29, 1991.
Firm-initiated recall complete.
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Distribution: Firm estimates none remains on the market.
Quantity: Florida, New York.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Ferrous Sulfate Tablets, 325 mg, a food supplement,
in bottles of 100 and 1,000. Recall #F-003-2.
Code: Lot numbers: 0889-3021, 0189-2731, 0190-0421, 2611-0930,
0190-0431, 3781-0970, 1001-0980, 1391-0980, 0781-0980,
1411-0990, 0889-2362, 1189-1751.
Manufacturer: Tishcon Corporation, Westbury, New York.
Recalled by: Manufacturer, by letter May 13, 1991. Firm-initiated
recall ongoing.
Distribution: New York, Pennsylvania.
Quantity: 12,935,200 tablets were distributed.
Reason: Product is subpotent in iron sulfate.
----
Product: Reese brand Canned Flat Anchovies, in 2 ounce cans,
product of Morocco. Recall #F-004-2.
Code: SN204D and SN205D, item #666.
Manufacturer: Sonial, Casablanca, Morocco.
Recalled by: Reese Finer Foods, Inc., Bloomfield, New Jersey, by
letter April 26 and 30, 1991. Firm-initiated recall
ongoing.
Distribution: California, Texas, Illinois.
Quantity: 1,787 cases were distributed; firm estimates none
remains on the market.
Reason: Product contained in swollen and leaking cans.
----
Product: IGA Chunk Light Tuna in Water, in 6 1/2 ounce cans.
Recall #F-005-2.
Code: All lots.
Manufacturer: Star-Kist Foods Canada, Inc., New Brunswick, Canada.
Recalled by: Gateway Foods, Inc., Lacrosse, Wisconsin, by letter
July 19, 1991. Firm-initiated recall complete.
Distribution: Wisconsin, Minnesota, Illinois, Iowa, Michigan.
Quantity: Firm estimates 41,040 cans remain on the market.
Reason: Product is decomposed.
----
COSMETICS
NONE
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HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: E-Solve-2 Erythromycin Topical Solution 2%, in
1 ounce containers. Recall #D-001-2.
Code: Lot numbers G444 and G520.
Manufacturer: Syosset Laboratories Company, Inc., Syosset, New York.
Recalled by: Manufacturer, by letter August 28, 1991. Firm-initiated
recall ongoing.
Distribution: New York, New Jersey, California.
Quantity: 3,664 units of lot G444 and 2,526 units of lot G520
were distributed.
Reason: Potency not maintained through expiration date.
----
Product: Diazepam 2 mg Tablets in 100 count bottles, a Rx drug
under the Major Pharmaceutical Corp. label.
Recall #D-002-2.
Code: Lot numbers: 9E16B, 9K31F, 0K23B, 0M18, 0M18B.
Manufacturer: Halsey Drug Company, Brooklyn, New York.
Recalled by: Manufacturer, by letter July 30, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 2,765 bottles were distributed; firm estimates fewer
than 300 bottles remain on the market.
Reason: Label incorrectly omits the prescription legend.
----
Product: Stool Softener Plus Laxative, gelatin capsule.
Recall #D-008-2.
Code: Lot #C6155E EXP 3/93.
Manufacturer: Pennex Products Company, Inc., Verona, Pennsylvania.
Recalled by: Manufacturer, by letter September 12, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Reason: Bottle label incorrectly identifies product as a stool
softener. Carton label correctly identifies product
as a stool softener plus laxative.
----
Product: Whole Blood. Recall #B-316-1.
Code: Unit #W02547.
Manufacturer: Marathon County Blood Bank, Inc., Wausau, Wisconsin.
Recalled by: Manufacturer, by telephone May 13, 1991, followed by
letter May 23, 1991. Firm-initiated recall complete.
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Distribution: Wisconsin.
Quantity: 1 unit.
Reason: Whole Blood, which tested non-reactive for the antibody
to the human immunodeficiency virus type 1 (anti-HIV-1)
but was collected from a donor who previously tested
repeatably reactive for anti-HIV-1, was distributed.
----
Product: Red Blood Cells. Recall #B-406-1.
Code: Unit numbers: 53GJ19216, 5GJ19217, 53GJ19218, 53GJ19219,
53GZ25374, 53KT24185, 53KT24186, 53KT24188, 53KT24189.
Manufacturer: American Red Cross, Baltimore, Maryland.
Recalled by: Manufacturer, by telephone July 12 and 16, 1990, followed
by letters in February and May 1991. Firm-initiated
recall ongoing.
Distribution: Maryland and Washington, D.C.
Quantity: 9 units.
Reason: Blood products which were prepared in a manner inconsistent
with the firm's standard operating procedures, were
distributed.
----
Product: Whole Blood. Recall #B-410-1.
Code: Unit #22GR64144.
Manufacturer: American Red Cross Blood Services, Philadelphia,
Pennsylvania.
Recalled by: Manufacturer, by telephone February 5, 1991.
Firm-initiated recall complete.
Distribution: Pennsylvania.
Quantity: 1 unit.
Reason: Blood products were distributed which were
collected from a donor who immigrated from a malarial
endemic area.
----
Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-412/413-1.
Code: Unit #53L54794.
Manufacturer: American Red Cross Blood Services, Baltimore, Maryland.
Recalled by: Manufacturer, by letters of January 15, 1991,
April 19, 1991, and August 8, 1991. Firm-initiated
recall ongoing.
Distribution: Maryland.
Quantity: 1 unit of each component.
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Reason: Blood products, which tested non-reactive for the
antibody to the human immunodeficiency virus type 1
(anti-HIV-1) but were collected from a donor who
previously participated in high risk behavior for
HIV, were released.
----
Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-416/417-1.
Code: Unit #01263.
Manufacturer: Southeast Iowa Blood Center, Ottumwa, Iowa.
Recalled by: Manufacturer, by letter April 23, 1991. Firm-inititaed
recall complete.
Distribution: Iowa, Tennessee, New York.
Quantity: 1 unit of each component.
Reason: Blood products, initially reactive for the antibody
to the human immunodeficiency virus type 1 (antv-HIV-1),
were distributed.
----
Product: Source Plasma. Recall #B-419-1.
Code: Unit #N-41981-049.
Manufaturer: Preferred Blood Products, Inc., Fort Worth, Texas.
Recalled by: Manufacturer, by facsimile June 6, 1991. Firm-
initiated recall complete.
Distribution: New York.
Quantity: 1 unit.
Reason: Source Plasma, which tested repeatably reactive for
the antibody to the human immunodeficiency virus type 1
(anti-HIV-1) by EIA and Western Blot positive, was
distributed for further manufacture into injectable
products.
----
Product: Source Plasma. Recall #B-420-1.
Code: Unit numbers: SP 04677, SP 04747, SP 04787, SP 04815,
SP 04859, SP 04884, SP 04912, SP 04960, SP 04984,
70716498, 70717914, 72932995, 72934364, 72936269,
72937426, 73400998.
Manufacturer: Bio-Blood Components, Inc., Shreveport, Louisiana.
Recalled by: Bio-Blood Components, Inc., Memphis, Tennessee, by
telephone June 13, 1991, and by an undated letter
to foreign consignee. Firm-initiated recall ongoing.
Distribution: California, Germany.
Quantity: 16 units.
Reason: Blood components, which tested reactive for hepatitis
B surface antigen (HBsAg) or were collected from donors
who previously tested repeatably reactive for the
antibody to the human immunodeficiency virus, type 1
(anti-HIV-1), were distributed.
----
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Product: DuPont Human T Lymphotropic Virus Type I ELISA
Microtiter Test Kits. Recall #B-421-1.
Code: Lot numbers: 542T1101 EXP 4/11/91, and 546T1154
EXP 6/3/91.
Manufacturer: E.I. Dupont De Nemours and Company, Inc., Medical
Products Department, Glasgow, Delaware.
Recalled by: E.I. Dupont De Nemours and Company, Inc., Medical
Products Department, Wilmington, Delaware, by telephone
and by letter February 15, 1991. Firm-initiated recall
ongoing.
Distribution: Nationwide and Brussells.
Quantity: 23 2-plate kits and 120 5-plate kits for lot 542T1101,
108 2-plate kits, 100 5- plate kits, and 31 25-plate
kits of lot 546T1154 were distributed; firm estimates
none remains on the market.
Reason: A small number of wells in the microplates of the
Human T Lymphotropic Virus Type I test kits were
found to leak.
----
Product: Platelets. Recall #B-422-1.
Code: Unit numbemrs: (a) 2148585 and 2148593.
Manufacturer: Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
Recalled by: Manufacturer, by letter May 15, 1991. Firm-initiated
recall complete.
Distribution: Indiana.
Quantity: 2 units.
Reason: Blood products, labeled with incorrect expiration
dates, were distributed.
----
CORRECTION: Code section for Recall B-338/342-1, blood products
distributed by American Red Cross, Wichita, Kansas,
which appeared in the July 31, 1991 Enforcement Report
has been amended:
Platelets, Recall #B-342-1 - delete
units 02P10261, 02P09905, and 02P10666.
----
Class III -
Product: Valumag Plus Extra Strength, in 12 fluid ounce bottles,
an OTC liquid antacid/anti-gas product, under the Valumed
and Moore Medical Corp. label. Recall #D-003-2.
Code: Lot #ID006.
Manufacturer: KC Pharmaceuticals, Ponoma, California.
Recalled by: Moore Medical Corporation, New Britain, Connecticut, by
letter September 19, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
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Quantity: Approximately 140 bottles were distributed.
Reason: Label mix-up. Rear panel is label used for regular
Valumag Plus.
----
Product: Conjugated Estrogens Tablets, USP, (a) 0.3 mg;
(b) 0.625 mg; (c) 1.25 mg; (d) 2.5 mg, in 100, 500, and 1,000
tablet bottles, Rx drugs administered
orally for the treatment of the symptoms of menopause,
postmenopausal osteoporosis and breast swelling after
pregnancy, under the following labels: Zenith, Bioline,
Major, Geneva Generics, Goldline, I.D.E. - Star Brand,
H.L. Moore, Schein, Darby (Rugby, with Zenith imprint),
U.R. L., Darby (Rugby, with Rugby imprint), Qualitest.
Recall #D-004/007-2.
Code: All lots.
Manufacturer: Zenith Laboratories, Inc., Northvale, New Jersey.
Recalled by: Manufacturer, by telephone and letters March 6, 7, 1991
and by letter dated April 12, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: FDA estimates that less than 10% of products remain
on the market.
Reason: Some lots do not meet stability specifications through
expiration date.
----
Product: Aristocort Forte Parenteral (Sterile Triamcinolone
Diacetate Suspension 40 mg/ml), in 1 ml vials.
Recall #D-009-2.
Code: Control #311-800 EXP 6/94, Product #4450-24.
Manufacturer: Lederle Parenterals, Inc., Carolina, Puerto Rico.
Recalled by: Manufacturer, by letter on or about October 7, 1991.
Firm-initiated recall ongoing.
Distribution: Illinois.
Quantity: Approximately 20,518 units were distributed.
Reason: Some 1 ml size vials were packaged in unit cartons
which incorrectly identify the size of the vial
as 5 ml.
----
Product: Platelets; (b) Plasma; (c) Recovered Plasma.
Recall #B-407/409-1.
Code: Unit numbers: (a) 53GJ19216 through 53J19219, 53GZ25374,
53KT24185, 53KT24186, 53KT24188;
(b) 53GJ19217 through 53GJ19219, 53GZ25374;
(c) 53KT24185, 53KT24186, 53KT24188, 53KT24189.
Manufacturer: American Red Cross, Baltimore, Maryland.
Recalled by: Manufacturer, by letter May 1 and 2, 1991.
Firm-initiated recall ongoing.
Distribution: Maryland and Washington, D.C.
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Quantity: (a) 8 units; (b) 5 units; (c) 4 units.
Reason: Blood products which were prepared in a manner
inconsistent with the firm's standard operating
procedures, were distributed.
----
Product: Whole Blood. Recall #B-411-1.
Code: Unit #22GY19068, 22KE26416, 22KE34112, 22KE34148.
Manufacturer: American Red Cross Blood Services, Philadelphia,
Pennsylvania.
Recalled by: Manufacturer, by telephone August 15 and 20, 1990,
November 11, 1990 and January 8, 1991.
Firm-initiated recall complete.
Distribution: New Jersey, Pennsylvania.
Quantity: 4 units.
Reason: Blood products were distributed which were
collected from a donor whose hematocrit was below the
acceptable limit for donor suitability; or labeled with
incorrect expiration dates.
----
Product: Recovered Plasma. Recall #B-414-1.
Code: Unit numbers: 28928, 28934, 28954.
Manufacturer: Terrebonne General Hospital, Houma, Louisiana.
Recalled by: Manufacturer, by telephone August 9, 1991.
Firm-initiated recall complete.
Distribution: Florida.
Quantity: 3 units.
Reason: Recovered Plasma, which tested initially reactive
for hepatitis B surface antigen (HBsAg) and
non-reactive by a single repeat test, were, distributed.
----
Product: Plasma Protein Fraction. Recall #B-418-1.
Code: Unit #28360381AA.
Manufacturer: Hyland Division, Baxter Healthcare Corporation,
Glendale, California.
Recalled by: Manufacturer, by letter November 26, 1990.
Firm-initiated recall complete.
Distribution: Kentucky.
Quantity: 2,645 vials were distributed.
Reason: Plasma Protein Fraction (PPF) vials, which were
placed in unit boxes labeled Albumin, were distributed.
----
Product: Red Blood Cells. Recall #B-423-1.
Code: Unit #2264161.
Manufacturer: Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
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Recalled by: Consignee notified recalling firm by letter
May 15, 1991. Firm-initiated recall complete.
Distribution: Indiana.
Quantity: 1 unit.
Reason: Blood products, labeled with incorrect expiration dates,
were distributed.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
Product: Micross-SL PTCA dilatation catheters, for use in
coronary angioplasty:
(a) Catalog #53300;
(b) Catalog #53250. Recall #Z-1044/1045-1.
Code: Lot numbers: (a) D1101 EXP 6/11/92;
(b) D2301 EXP 7/25/92, D2402 EXP 7/25/92.
Manufacturer: Datascope Corporation, Montvale, New Jersey.
Recalled by: Datascope Corporation, Angioplasty Division, Oakland,
New Jersey, by telephone on or about April 24, 1991
followed by visit and by memorandum, May 3, 1991 to
European consignees. On or about April 26, 1991,
firm sent letter to all consignees. Firm-initiated
recall complete.
Distribution: Nationwide and international.
Quantity: 82 units were distributed; firm estimates none
remains on the market.
Reason: The balloon can fail to inflate during use due to
cracks in the Y-Fitting, and the Y-Fitting is subject
to leakage.
----
NONE
Class II -
Product: The "ROSE" Chair, 2000 Series, used as a geriatric
or patient chair for relief of strain. Recall #Z-1093-1.
Code: None. March 1986 - December 1989 production.
Manufacturer: ADD Interior Systems, Inc., Los Angeles, California.
Recalled by: Manufacturer, by letters January to March 1990 and
January to March 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 11,767 chairs were distributed.
-9-
Reason: The fastener threaded inserts (nuts) used in the
manufacture of these chairs were found to be of low
hardness contained extensive defects which could result
in the loosening or breaking of the mounting screws,
causing the chair seat to separate from the chair base
and falling to the floor while in use by the patient.
----
Product: Baxter Fenwal Sepacell R-500 Leukocyte Removal Sets,
sterile, nonpyrogenic fluid paths:
(a) Sepacell R-500 Leukocyte Removal Administration Set
for Red Cell Transfusion, Product Code 4C2442, intended
for leukocyte depletion of two units of red blood cell
products by direct (bedside) in-line filtration during
transfusion;
(b) Sepacell R-500 Leukocyte Removal Recipient Set for Red
Cell Transfusion, Product Code 4C2443, intended for
leukocyte depletion of one unit of red blood cell product
by direct (bedside) in-line filtration during transfusion;
(c) Sepacell R-500 Leukocyte Removal Recipient Set for Red
Cell Transfusion, Product Code 4C2451, intended for leukocyte
depletion of two units of red blood cell products by
direct (bedside) in-line filtration during transfusion.
Recall #Z-1125/1127-1.
Code: All lots.
Manufacturer: Baxter Healthcare Corporation, Round Lake, Illinois;
Baxter Healthcare Corporation, Mountain Home, Arkansas.
Recalled by: Baxter Healthcare Corporation, Deerfield, Illinois, by
letter August 12, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, Belgium, Mexico.
Quantity: (a) 24,696 sets; (b) 1,998 sets; (c) 8,221 sets were
distributed; firm estimates very little of the product
remains on the market.
Reason: There may be instances of slowing or stoppage of blood
flow associated with these devices.
----
Product: Inspiratory and/or Expiratory Rubber Valves for the
pneumatics section of the Servo Ventilator Models
900/B/C/D/E. The valves may have been purchased with
the Servo Ventilator or as part of an exchange kit.
Recall #Z-1128-1.
Code: The Servo Ventilators containing these valves are
Servo Ventilator 900C, product #69 32 552, Servo
Ventilator 900D, part # 90 98 492, and Servo Ventilator
900E, part number 96 19 073. The rubber valves in the
exchange kits bear part numbers 96 19 925 and 90 05 141,
and all valves except those bearing lot numbers 6-6, 7-5,
01-0 and all unmarked valves.
Manufacturer: Siemens Life Support Systems, Inc., Schaumburg, Illinois.
-10-
Recalled by: Manufacturer, by letter October 29, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 20,500 valves were distributed; firm estimates none
remains on the market.
Reason: The rubber valve can disconnect from the metal pipe
that secures the valve to the inspiratory or expiratory
channel of the pneumatics section of the ventilator,
which would result in partial or complete loss of the
preset minute volume and/or pressure.
----
UPDATE NOTICE: Recall #Z-951-1, Preview Strep A In-Vitro EIA-Type
Diagnostic Test Kit, and Recall #Z-1048-1, Preview Urine
hCG In-Vitro Diagnostic Pregnancy Kit, which appeared
in the September 25, 1991, Enforcement Report are
completed recalls.
----
CORRECTION: Power Cables used with the Siemens Digicam LHP Laser
Imager and DuPont LINX Laser Imager, which appeared
in the August 28, 1991 Enforcement Report should
read: Recall #Z-950-1.
----
Class III -
NONE
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Turkey Starter with Furazolidone (pellet form), in
50 pound bags. Recall #V-092-1.
Code: Lot numbers: 351 and 366
Manufacturer: Kent Feeds, Inc., Mason, Michigan.
Recalled by: Manufacturer, by telephone April 9, 1991 and May 16,
1991. Firm-initiated recall complete.
Distribution: Michigan.
Quantity: 155 bags were distributed.
Reason: Product is subpotent.
----
Class III -
NONE
####
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