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
10/16/1991
Recalls and Field Corrections: October 10, 1991
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.
CORRECTION: Bufarella brand ricotta cheese, Recall #F-567-1 which
appeared in the October 2, 1991, Enforcement Report
should read:
Manufacturer: Cooperativa Allevatori, Bufalini; Battuglia
(Sa) Italy.
Recalled by: Italfresh Ltd., Port Chester, New York
(importer).
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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.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: (a) Euthroid - 1/2 (Liotrix Tablets, USP) 0.5 grain,
in bottles of 100;
(b) Euthroid - 1 (Liotrix Tablets, USP) 1.0 grain,
in bottles of 100;
(c) Euthroid - 2 (Liotrix Tablets, USP) 2.0 grain,
in bottles of 100;
(d) Euthroid - 3 (Liotrix Tablets, USP) 3.0 grain,
in bottles of 100, a Rx synthetic thyroid supplement
and replacement for the treatment of hypothyroidism.
Recall #D-011/014-2.
Code: Lot numbers: (a) 02509VA Exp 11/91, 05690VA&B EXP 09/92
07820VA EXP 04/92;
(b) 03080VA&B EXP 08/92, 07740VA&B EXP 04/92
03689VA&B EXP 09/91, 08011VA EXP 03/93;
(c) 06700VA EXP 11/92, 05450VA EXP 05/92
024D9VA EXP 12/91, 05420VA EXP 02/92;
(d) 05590VA EXP 09/92, 026N9VA EXP 12/92.
Manufacturer: Parke-Davis, Division of Warner Lambert Company,
Vega Baja, Puerto Rico.
Recalled by: Parke-Davis, Division of Warner Lambert Company,
Morris Plains, New Jersey (distributor/responsible firm),
by letter July 11, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 50,670 bottles; (b) 240,040 bottles; (c) 210,529
bottles; (d) 54,466 bottles were distributed.
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Reason: Subpotent or may not meet potency specifications
through expiration date.
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Product: Hepatitis B Surface Antigen I125 (Human) (Subtypes
ad and ay), AUSAB Radioimmunoassay Test Kit, an
in-vitro diagnostic for the qualitative detection and
semi-quantitation of antibody to hepatitis surface
antigen (Anti-HBs) in serum or plasma.
Recall #B-001-2.
Code: Master Kit: Lot 55059M200 EXP 11/17/91;
Tracer: Lot 55391M101 EXP 11/17/91.
Manufacturer: Abbott Laboratories, Diagnostics Division,
Abbott Park, Illinois.
Recalled by: Manufacturer, by telephone August 2-5, 1991. Firm-
initiated recall complete.
Distribution: Nationwide, Canada, Singapore, Hong Kong, Australia,
Germany.
Quantity: 1,313 kits were distributed.
Reason: Test kit labeled with an incorrect expiration date
was distributed.
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Class III -
Product: Formula 9 Anal Itch Treatment, in 1 ounce plastic tubes,
an OTC anorectal ointment recommended for the temporary
relief of symptoms associated with hemorrhoids or other
rectal/genital conditions. Recall #D-010-2.
Code: All lot numbers.
Manufacturer: Winning Solutions, Inc., Westport, Connecticut.
Recalled by: Manufacturer, by letter September 20, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 3,322 tubes were distributed; firm
estimates 100 units remain on the market.
Reason: Product lacks an expiration date and stability data.
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Product: Red Blood Cells. Recall #B-415-1.
Code: Unit numbers: L88277, L88292, L88293
L88294, L88295, L88297, L88299, L88309, L88332,
L91577, L91582, L91584, L91586, L91617, L91641,
L91644, L91650, L91656, L91657, L91661, L91672,
L91676, L91680, L91698, L91710, L91711, L91718,
L91727, L91732, L91733, L92384, L92393, L92394,
L92404, L92420, L92421, L92422, L92423, L92429,
L92431, L92441, L92443, L92445, L92449, L92453,
L92462, L92463, L92467, L92470, L92472, L92474,
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L92475, L92476, L92483, L92485, L92489, L92491,
L92494, L92497, L92498, L92499, L92501, L92502,
L92503, L92508, L92509, L92512, L92513, L92515,
L92517, L92520, L92525, L92530, L92533, L92534,
L92535, L92539, L92540, L92542, L92544, L92550,
L92552, L92555, L92559, L92567, L92570, L92574,
L92579, L92589, L92590, L92602, L92604, L92606,
L92608, L92615, L92616, L92617, L92619, L92620,
L92634, L92637, L92638, L92648, L92649, L92659,
L93149, L94161, L94358, L94363, L94366, L94370,
L94371, L94375, L95129, L96401, L97904, L98167,
L98172, L98179, L98201, L98206, L98207, L98209,
L98210, L98212, L98213, L98215, L98216, L98217,
L98253, L98261, L98275, L98297, L98304, L98306,
L98308, L98309, L98319, L98325, L98327, L98343,
L98356, L98357, L98364, L98365, L98378, L98380,
L98381, L98387, L98388, L98396, L98400, L98407,
L98408, L98409, L98443, L98447, L98453, L98454,
L98457, L98464, L98477, L98480, L98481, L98482,
L98497, L98504, L98505, L98511, L98514, L98517,
L98519, L98530, L98546, L98547, L98550, L98551,
L98560, L98578, L98579, L98581, L98582, L98584,
L98587, L98588, L98591, L98598, L98604, L98606,
L98637, L98659, L98674, L98687, L98811, L98816,
L99576, L99579, L99686, L99712, L99714, L99717,
L99726, L99733, L99735, L99753, L99758, L99759,
L99766, L99768, L99775, L99776, L99779, L99785,
L99794, L99800.
Manufacturer: Aurora Area Blood Bank, Aurora, Illinois.
Recalled by: Manufacturer, by telephone February 13, 1991.
Firm-initiated recall complete.
Distribution: Illinoid, Indiana.
Quantity: 215 units; firm estimates none remains on the market.
Reason: Red Blood Cells, which had Optisol (AS-5) additive
solution added greater than 24 hours post collection,
were distributed.
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Product: Red Blood Cells. Recall #B-002-2.
Code: Unit #R63104.
Manufacturer: Mississippi Valley Regional Blood Center,
Davenport, Iowa.
Recalled by: Consignee notified firm June 16, 1991. Recall complete.
Distribution: Illinois.
Quantity: 1 unit.
Reason: Blood product labeled with an incorrect expiration
date and an incorrect anticoagulant/preservative solution
was distributed.
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DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
Product: Ohmeda Logic 07 Ventilator Non-Rebreathing Valves and
the Valve's Rubber Membrane, Part #6570-0009-200,
a pneumatically powered device used for emergency and transport
mechanical ventilation. Recall #Z-962/964-1.
Code: All units.
Manufacturer: Ohmeda Maurepas Cedex, France.
Recalled by: Ohmeda, Madison, Wisconsin, by telephone beginning on
August 13, 1991, followed by letter August 21, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 8,907 non-rebreathing valves and 1,923 replacement
blue valve membranes were distributed.
Reason: The blue membrane can dislodge from its seat during
ventilation. This could cause either inadequate
ventilation or aspiration of the membrane.
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Class II -
Product: (a) Laser Fault Analyzer - Model LFA-308;
(b) Laser Cutter - Model LCM-308. Recall #Z-831/832-1.
Code: None.
Manufacturer: Florod Corporation, Gardena, California.
Recalled by: Manufacturer. FDA approved the firm's corrective action plan
July 2, 1991. Firm-initiated field correction ongoing.
Distribution: California, Indiana, Colorado.
Quantity: 3 units were distributed.
Reason: Noncompliance with performance standards for laser
products in that the laser emission levels exceeded limit
of the product class (Class I laser product).
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Product: Sengstaken (Blakemore Type) Esophageal Varcies Tubes,
used to treat esophageal bleeding:
(a) Product #9160-14; (b) Product #9161-14;
(c) Product #9162-20; (d) Product #9163-20;
(e) Product #9164-16; (f) Product #9166-20;
(g) Product #9166-16; (h) Product #9167-18;
(i) Product #9168-18. Recall #Z-1035/1043-1.
Code: Sterilization dates between September 1987 and August 1990.
Manufacturer: Warne Surgical Products Ltd., Armagh, N. Ireland, UK.
Recalled by: Rusch Inc., Duluth, Georgia, by letter October 23, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, Uruguay.
Quantity: 422 units were distributed.
Reason: The balloon may deteriorate due to aging of the product.
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Class III -
NONE
VETERINARY PRODUCTS
NONE
Injunction Action Filed:
Against: Fairhaven Cooperative Flour Mill, Inc., and Ward D.
Fay, President, and Bill G. Distler, Vice President,
Bellingham, Washington.
Product: Various types of wheat and wheat flour (91-535-186).
Charge: Products were held under insanitary conditions whereby
they may have become contaminated with filth.
Filed: August 15, 1991 - U.S. District Court for the
Western District of Washington; Civil #91-1151WD,
INJ #1257.
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Against Marshall Warehouses, Inc., and Charles P. Marshall,
President, Jerome, Idaho.
Product: Various types of beans and wheat (91-543-870-878).
Charge: Products consist in whole or in part of a filthy
substance. In addition, these foods were held under
insanitary conditions whereby they may have become
contaminated with filth.
Filed: July 18, 1991 - U.S. District Court for the District of
Idaho; Civil #91-0329, INJ #1250.
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Seizure Actions Filed:
Product: IQF Lobster Tails (91-534-071).
Charge: Adulterated - Products have been glazed with ice to increase
bulk or weight and consist in part of a
decomposed substance. Misbranded - Label fails to bear
an accurate statement of net quality of contents.
Firm: Shipper - Sysco Intermountain, Salt Lake City, Utah;
Consignee - Rainier Ice and Cold Storage, Inc., Seattle,
Washington; and Held for the Account of Mid-Pac,
Seattle, Washington.
Filed: August 27, 1991 - U.S. District Court for the
Western District of Washington; Civil #91-1195,
FDC #66242.
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Product: Latex Examination Gloves (91-612-933).
Charge: Adulterated - Quality falls below that which it purports
or represents to possess because article contains holes.
Firm: Cypress Medical Products, Inc., McHenry, Illinois.
Filed: September 30, 1991 - U.S. District Court for the Northern
District of Illinois, Western Division; Civil #91 C 20285,
FDC #66272.
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