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
03/18/1992
Recalls and Field Corrections: March 18, 1992
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.
Product: Chopped Garlic in soybean oil, in 32 ounce plastic
containers. Recall #F-137-2.
Code: None. All production.
Manufacturer Redi Spice Company, doing business as Redi Garlic,
Miami, Florida.
Recalled by: Manufacturer, by telephone January 24, 1992. Firm-
initiated recall complete.
Distribution: Florida.
Quantity: Approximately 40 cases (12 containers per case) were
distributed.
Reason: Product was inadequately acidified to preclude
C. Botulinum toxin.
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Product: Salt Cured Dried Uneviscerated Fish. Recall #F-187-2.
Code: None.
Manufacturer: Huron Trading Company, Kwai Chung NT, Hong Kong.
Recalled by: A.D. Chan Trading Corporation, Brooklyn, New York, by
visit January 16, 1992. Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 15 cases were distributed.
Reason: Potential for Clostridium Botulinum.
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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.
Product: (a) Orange Sherbet, in 3 fluid ounce and 4 fluid ounce
cup style containers;
(b) Orange Cream Bars, 3 fluid ounces. Recall #F-181/182-2.
Code: All products coded with Julian dates of 330 or below.
Manufacturer: Nafzinger's Ice Cream, Archbold, Ohio.
Recalled by: Manufacturer, by telephone on or about December 10, 1991,
followed by letter December 12, 1991. Firm-initiated recall
complete.
Distribution: Ohio, Kentucky, Indiana, Michigan, Illinois, Florida.
Quantity: (a) 3,400 12-count cartons of the 3 ounce cups and
15,500 12-count cartons of the 4 ounce cups;
(b) 2,600 12-count cartons of the 3 ounce bars and
2,200 24-count (bulk) cartons were distributed;
firm estimates none remains on the market.
Reason: Products contains undeclared FD&C Yellow No. 5.
----
Product: Premium Cascade Hearth Cream Cheese Bowties, Danish
pastries, 12 ounces. Recall #F-184-2.
Code: JAN 1.
Manufacturer: Langendorf Baking Company of Seattle, Seattle, Washington.
Recalled by: Manufacturer. Firm-initiated recall complete.
Distribution: Washington state.
Quantity: 80 units were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
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Product: No Cholesterol Corn Muffin Mix, in 50 pound paper bags.
Recall #F-185-2.
Code: Lot #2 13091 is stamped on the label. Product #107008
is printed on the label.
Manufacturer: Puratos Corporation, Cherry Hill, New Jersey.
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Recalled by: Manufacturer, by letter December 20, 1991. Firm-initiated
recall complete.
Distribution: Illinois.
Quantity: 3 bags were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Microwaveable Refried Beans, in 11.5 ounce glass jars.
Recall #F-186-2.
Code: Lot #1A07M1.
Manufacturer: Morgan Foods, Austin, Indiana.
Recalled by: Thomas J. Lipton Company, Englewood Cliffs, New Jersey,
by letter and by telephone January 11, 1991. Firm-
initiated recall ongoing.
Distribution: Northeast, The South, including Pennsylvania, Ohio,
Indiana, Colorado, New Mexico, Texas, California, Utah.
Quantity: 4,931 Cases (12 jars per case) were distributed.
Reason: Product is contaminated with glass.
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Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: (a) Calypso Punch Drink, 18.3 fl oz.; (b) Pineapple Orange
Drink, 19 fl oz.; (c) Tropical Fruit Punch Drink, 18.3
fl oz.; (d) Passion Fruit Drink, 19 fl oz.
All drinks are under the Grace label. Recall #F-138/141-2.
Code: Lot numbers: (a) 8E1E, 12F1A; (b) 11F1A;
(c) 10E1A, 7G1A, 17G1A; (d) 5F1A.
Manufacturer: Grace Kennedy Company, Ltd., Kingston, Jamaica.
Recalled by: Jamaica Producers Mkt. Wholesale Distributor USA, Inc.,
Brooklyn, New York (importer), by telephone and letter
September 30, 1991, followed by visit. Firm-initiated
recall complete.
Distribution: Maryland, New Jersey, Massachusetts, New York, Florida.
Quantity: Approximately 1,050 cases were distributed; firm
estimates none remains on the market.
Reason: Product is contaminated with nitrates and cans are
detinning.
----
Product: Martha Mead Irregular Pieces Yellow Cling Peaches in light
syrup, in 29 ounce cans. Recall #F-183-2.
Code: Lot numbers: 1193X/SLS4, 1193X/SLS5.
Manufacturer: Del Monte Corporation, Kingsburg, California.
Recalled by: Aldi, Inc., Batavia, Illinois, by memorandum January 22,
1992, and February 12, 1992. Firm-initiated recall
ongoing.
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Distribution: Iowa, Illinois, Indiana, Ohio.
Quantity: 651 cases (24 cans per case) were distributed; firm
estimates none remains on the market.
Reason: Product has an off-odor and off-taste.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: K-Pec with Attapulgite, in 8 ounce and 12 ounce bottles,
an antidiarrheal. Recall #D-265-2.
Code: Lot numbers: 107109, 109109.
Manufacturer: Hi-Tech Pharmacal Company, Inc., Amityville, New York.
Recalled by: Manufacturer, by telephone followed by letter dated
January 6, 1992. Firm-initiated recall ongoing.
Distribution: Florida, Michigan, New York, Pennsylvania, South
Carolina, Virginia.
Quantity: 1,714 8-ounce units and 16,536 12-ounce units were
distributed.
Reason: Microbiological contamination.
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Class III
Product: Ascorbic Acid Injection 500 mg/ml, in 50 ml amber glass
bottles, a Rx drug under the Americal Pharmaceuticals,
GY&N, and PRL labels. Recall #D-263-2.
Code: Lot #19089 EXP 9/92.
Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California.
Recalled by: Manufacturer, by letter September 26, 1991. Firm-
initiated recall ongoing.
Distribution: California, Texas, Arizona, Louisiana.
Quantity: 4,327 units were distributed.
Reason: Edetate disodium ingredient is superpotent.
----
Product: Podoben (Podophyllin Resin), a dark brown liquid in
amber screw cap 5 ml vials, a Rx drug under the
Maurry Biological and Americal Pharmaceuticals labels.
Recall #D-264-2.
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Code: Lot numbers: 17980, 18108, 18172 (Maurry); 18173,
18398, 18607, 18692, 18810, 18883, 18944, 19098, 19115
(Americal).
Manufacturer: Walnut Pharmaceuticals, Inc., Anaheim, California.
Recalled by: Manufacturer, by letter September 20, 1991. Firm-initiated
recall ongoing.
Distribution: Louisiana.
Quantity: 49,441 units were distributed; firm estimates 8,000 units
remain on the market.
Reason: Product does not meet USP ingredient specifications.
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Product: Plasma. Recall #B-124-2.
Code: Unit numbers: 40LG00301, 40LG00302.
Manufacturer: American Red Cross Blood Services, Peoria, Illinois.
Recalled by: Consignee notified firm by telephone November 18, 1991.
Firm-initiated recall complete.
Distribution: Missouri.
Quantity: 2 units.
Reason: Plasma, prepared more than six hours after collection of
the Whole Blood units and labeled as Fresh Frozen Plasma,
was distributed.
----
Product: (a) Whole Blood; (b) Red Blood Cells; (c) Platelets.
Recall #B-177/179-2.
Code: Unit numbers: (a) 0167946; (b) 0167947, 0167950, 0167953;
(c) 0162263, 0162264, 0162265, 0162271, 0162276, 0162277,
0162281, 0162287, 0162305, 0167947, 0167950, 0167953,
0167956.
Manufacturer: Blood Bank of Delaware, Inc., Newark, Delaware.
Recalled by: Manufacturer, by telephone December 17, 1991. Firm-
initiated recall complete.
Distribution: Delaware.
Reason: Blood products, untested for the antibody to hepatitis B
core antigen (anti-HBc), were distributed.
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Product: Platelets. Recall #B-180-2.
Code: Unit numbers: 17GP37632, 17GR52544.
Manufacturer: American Red Cross, St. Paul, Minnesota.
Recalled by: Manufacturer, by telephone December 4, 1991, followed
by letter dated December 27, 1991. Firm-initiated
recall complete.
Distribution: South Dakota, Minnesota.
Quantity: 2 units.
Reason: Platelets, prepared greater than eight hours after
collection of the Whole Blood units, were distributed.
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DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Buchbinder OmniFlex Coronary Balloon Dilatation Catheters:
(a) Model No. 00-020-20;
(b) Model No. 00-020-25;
(c) Model No. 00-020-30;
(d) Model No. 00-020-35. Recall #Z-367/370-2.
Code: Lot numbers: (a) P002583, P002584, P002585, P002586,
P002587, P002588, P002615, P002616;
(b) P002754, P002755, P002757, P002760;
(c) P002368, P0023699, P002370, P002371, P002380, P001473;
(d) P002459, AP000215, AP000225.
Manufacturer: Medtronic Interventional Vascular Division, San Diego,
California.
Recalled by: Medtronic Interventional Vascular Division, Minneapolis,
Minnesota, by letter August 21, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Japan, Hong Kong, Europe.
Quantity: 611 catheters were distributed.
Reason: The packaging pouches may develop holes during handling
and compromise the sterility of the devices. In addition,
lot numbers AP000215, AP000225 and P001473 had incorrect
expiration dates.
----
Product: Coulter Sample Stand II. Recall #Z-374-2.
Code: Serial numbers: T0800521 through T1200883.
Manufacturer: Coulter Electronics, Inc., Hialeah, Florida.
Recalled by: Manufacturer, by letter beginning September 10, 1991.
Firm-initiated recall ongoing.
Distribution: New York, California, Georgia, New Jersey, Indiana,
Pennsylvania, Illinois, Virginia, Michigan, Missouri.
Quantity: 14 units were distributed.
Reason: An operator received an electrical shock while changing
an aperture tube with the sampling stand turned off at the
rear.
----
Class III -
Product: Coulter Counter Automated Hematology Test Instruments used
to count and size blood components. Recall #Z-371/373-2.
Code: Model Numbers: T540, T660, T890.
Manufacturer: Coulter Electronics, Inc., Hialeah, Florida.
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Recalled by: Manufacturer by letter mailed beginning September 12,
1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 1,515 units were distributed domestically and the
international distribution is unknown.
Reason: Specimen tubes can be broken during automated testing.
----
Product: Surgical Suture, green braided, silicone coated 2-0
polyester, USP, 30 inches (75 cm). Suture is attached
with two D-14, cutting end taper needles, one at each
end. Recall #Z-375-2.
Code: Lot numbers: 0591/180 EXP 12/95.
Manufacturer: Lukens Medical Corporation, Rio Rancho, New Mexico.
Recalled by: Manufacturer, by FAX July 31, 1991. Firm-initiated
recall complete.
Distribution: Liechtenstein.
Quantity: 35 dozen sutures were distributed.
Reason: Needles with a taper point were attached instead of
needles with an end cutting taper.
----
Product: Surgical Suture, stainless steel, monofilament, 6 or 7 USP,
18 inches (45 cm). Suture is supposed to be attached with
one C-15, 1/2 circle, end cutting taper needle.
Recall #Z-376-2.
Code: Lot #JA122 EXP 6/96, JA102 EXP 6/96.
Manufacturer: Lukens Medical Corporation, Rio Rancho, New Mexico.
Recalled by: Manufacturer, by verbal communication. Firm-initiated
recall complete.
Distribution: New Jersey.
Quantity: 59 dozen of lot JA122 and 36 dozen of lot JA102 were
distributed.
Reason: A reverse cutting needle is attached rather than cutting
taper needle.
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Product: Vital-Vue brand surgical aspiration tips, used to
provide irrigation, suction and illumination during deep
cavity surgery: (a) Model 7120; (b) Model 7220;
(c) Model 7240; (d) Model 7312; (e) Model 7440.
Recall #Z-383/387-2.
Code: All units having 6 digit lot numbers starting with
0, 1, 7, 8, or 9.
Manufacturer: Davis and Geck, Tijuana, B.C., Mexico.
Recalled by: Davis and Geck, San Diego, California, by letter August
21, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
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Quantity: 32,353 units were distributed; firm estimates little
product remains on market.
Reason: Device packaging may develop holes or slits in handling,
thereby compromising the sterility of the device.
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Product: (a) Immunodot Autoimmunity Screening Panel 1, Kit; (b)
Immunodot Thyroid Autoimmunity Panel, Kit.
Recall #Z-388/389-2.
Code: Lot numbers: (a) S080068, S100031, S080070, S090071,
S100032; (b) S100067, S100068.
Manufacturer: General Biometrics, Inc., San Diego, California.
Recalled by: Manufacturer by letter January 2, 1992. Firm-initiated
recall ongoing.
Distribution: California, Florida, Georgia, Illinois, Indiana, Kentucky,
Massachusetts, Mississippi, New York, Ohio, Pennsylvania,
Washington state.
Quantity: 2,730 units were distributed.
Reason: The conjugate was not performing as expected.
----
Product: Coulter MAXM Hematolgy System, used to test various
blood parameters. Recall #Z-390-2.
Code: Lot numbers: 000000 through T30148, T30154-56,
T30167, T30186, excluding T15003, T15012, T15016.
Manufacturer: Coulter Electronics, Inc., Hialeah, Florida.
Recalled by: Manufacturer by letter mailed beginning August 5, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 29 units (domestic), 82 units (international) were
distributed.
Reason: If the power to the product was lost (power failure, system
reset or instrument turned off), when the power was
restored the waste level sensor defaults to the off status.
----
Product: A549 Human Lung Carcinoma Cells, Recall #Z-391-2.
Code: Lot #1140, Catalog #B1029-73B.
Manufacturer: Baxter Diagnostics, Inc., Bartels Diagnostics Division,
Issaquah, Washington.
Recalled by: Manufacturer by telephone September 22, 1989, followed by
letter September 21, 1989. Firm-initiated recall ongoing.
Distribution: Florida, Pennsylvania, California, Illinois, Missouri,
Iowa.
Quantity: 291 units were distributed.
Reason: Reports of yellow-orange media that was turbid and the
appearance of bacteria under microscopic examination.
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Product: Coulter STKS and Automated Hematology Diagnostic Test
Instrument, used to test various blood composition
parameters. Recall #Z-392-2.
Code: All serial numbers for catalog numbers 6604024,
6604025, 6604026.
Manufacturer: Coulter Electronics, Inc., Hialeah, Florida.
Recalled by: Manufacturer by letter beginning November 13, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 1,003 units distributed (domestic). International
distribution is unknown.
Reason: Two software anomalies exist which affect the laboratory
defined limit and/or assay values when Standard
International reporting unit formats are selected.
----
Product: Herpes Simplex Virus (HSV) Antigen Control Slide.
Recall #Z-393-2.
Code: Catalog #B1029-49, Lot #1237.
Manufacturer: Baxter Diagnostics, Inc., Bartels Diagnostic Division,
Issaquah, Washington.
Recalled by: Manufacturer by letter October 31, 1989. Firm-initiated
recall ongoing.
Distribution: Michigan, Pennsylvania, Tennessee, Oregon, Texas,
Washington state, Minnesota, Indiana, North Carolina,
California, Montana, Iowa.
Quantity: 24 packs of 10 slides were distributed.
Reason: Retention testing of antigen control slides showed 50%
of slides failed with weak or negative staining of the
positive MRC-5 cells.
----
Product: STD Staple 1.25 cm Short w/Spikes, used for reattachment
of soft tissue to bone as part of a total joint
replacement. Recall #Z-426-2.
Code: Lot #24623.
Manufacturer: Techmedica, Inc., Camarillo, California.
Recalled by: Manufacturer by telephone January 30, 1991 with follow-up
letter April 25, 1991. Firm initiated recall complete.
Distribution: California, Michigan, Pennsylvania, Japan.
Quantity: 19 bone staples were distributed.
Reason: Mislabeled. The units were labeled as 500-032 (.775"
length short), but actually contained 500-012 (1.090"
length long) staples.
----
Product: Arnett-TMP Malleable L Plate 22mm Right, Part No. 911-1282,
used for facial reconstructive surgery. Recall #Z-427-2.
Code: Lot #27379.
Manufacturer: Techmedica, Inc., Camarillo, California.
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Recalled by: Manufacturer by letters July 12, 1991. Firm-initiated
recall complete.
Distribution: California, Florida, Georgia, Minnesota, Pennsylvania
Texas.
Quantity: 40 units were distributed.
Reason: The L plates are labeled as part 911-1282 (22mm) but
actually contain part 911-1242 (18mm).
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Product: (a) Arnett-TMP Bone Screws 2.0 x 4mm, Part 912-1042;
(b) TMP Bone Screw 2.0 x 5mm, Part 912-1052 used in
facial reconstructive surgeries. Recall #Z-431/432-2.
Code: Lot numbers: (a) 25709; (b) 25710.
Manufacturer: Techmedica, Inc., Camarillo, California.
Recalled by: Manufacturer by letter April 26, 1991. Firm-initiated
recall complete.
Distribution: Arizona, California, Georgia, Louisiana, New York,
Oregon, Texas, Ohio.
Quantity: (a) 68 units; (b) 100 units were distributed.
Reason: Mislabeled. The product labels were switched.
----
Product: Arnett-TMP Bone Screw 2.0 x 4mm, Part 912-1042, used in
facial reconstructive surgeries. Recall #Z-433-2.
Code: Lot #27680.
Manufacturer: Techmedica, Inc., Camarillo, California.
Recalled by: Manufacturer by letter May 29, 1991. Firm initiated
recall complete.
Distribution: Arizona, California, Florida, Georgia, Louisiana,
North Carolina, Oregon, Tennessee, Virginia.
Quantity: 95 units were distributed.
Reason: The screws are labeled as part 912-1042 (4mm long screw),
but actually contain 5mm long screws.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Counterfeit Drug Product - 1% Ivomec and Ivomec-F
Injection for cattle. Recall #V-019-2.
Code: NBC-110, TBC-022 (1% Ivomec);
SBC-056, SBC-064, SBC-126, SBC-128 (Ivomec-F).
Manufacturer: Lextron, Inc., Greeley, Colorado.
Recalled by: Manufacturer, by letters of January 28, 1992, and
February 12, 1991, by joint press release from Merck and
Lextron February 19, 1992, and by letter February 21, 1992.
Firm-initiated recall ongoing.
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Distribution: States west of the Mississippi.
Quantity: Firm estimats 1,000 bottles remain on the market.
Reason: This product is a counterfeit version of the 1% Ivomec
and Ivomec-F manufactured by Merck & Company.
----
Product: Primidone Tablets, 250 mg, in 100 and 1,000 tablet
bottles, under the Techamerica and Butler labels.
Recall #V-022-2.
Code: Lot #0712P08 EXP 7/94.
Manufacturer: Fermenta Animal Health Company, Elwood, Kansas.
Recalled by: Manufacturer, by letter October 17, 1991. Firm-
initiated recall ongoing.
Distribution: Nationwide.
Quantity: 306 100-tablet bottles, 252 1,000-tablet bottles
(Techamerica) and 720 100 tablet bottles (Butler)
were distributed.
Reason: Product is contaminated with mold.
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Medical Device Safety Alerts:
Product: IVAC PCAinfuser Model 310, provides instrument-assisted
fluid and drug delivery for post-surgical and chronic
pain patients. Safety Alert #M-034-2.
Code: All serial numbers for model 310 PCA Infusers
manufactured prior to safety alert (letter issued
1/26/90) are affected.
Manufacturer: IVAC Corporation, San Diego, California.
Alerted by: Manufacturer, by letter January 26, 1990.
Distribution: Nationwide.
Quantity: 2,213 units were distributed.
Reason: A change in the dimensions of Becton Dickinson & Company's
60 ml syringe, which is used in the IVAC PCAinfuser, can
cause the infuser to incorrectly detect the appropriate
syringe size, and if this occurs and is not noted upon
start-up of the device, it could result in an overinfusion.
----
Seizure actions Filed:
Product: Ice Poppies, Lemon-Lime Flavor (91-620-851/2).
Firm: American Food Products, Inc., Cincinnati, Ohio.
Charge: Adulterated - The articles contain an unsafe
color additive (Yellow #5).
Filed: February 24, 1992 - U.S. District Court for the
Southern District of Ohio, Western Division; Civil
#C-1-92-144, FDC #66361.
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Seized: February 28, 1992; 8/55 gallon drums and 276 cases
valued at $1,458.
----
Product: Oxygen, USP (92-633-278/90).
Firm: Northern Welding & Supply Company, Wausau, Wisconsin.
Charge: Adulterated - The methods used in, and the facilities
and controls used for, their manufacture, packing, and
storage are not in conformity with current good
manufacturing practice regulations.
Filed: February 15, 1992 - U.S. District Court for the Western
District of Wisconsin; Civil #92C-0109-S, FDC #66362.
Seized: February 26, 1992; 242 steel cylinders and 728,305
cubic feet of oxygen, valued at approximately $17,700.
----
Product: Mako Shark Steaks (92-573-167/169).
Firm: Christian Salveson Company, Hopkins, Minnesota.
Charge: Adulterated - The articles contain an added poisonous and
deleterious substance, methyl mercury, which may render
them injurious to health.
Filed: March 6, 1992 - U.S. District Court for the District of
Minnesota; Civil #4C-92CN228, FDC #66391.
Seized: March 10, 1992 - 36/10-lb. cases of 8-oz. mako
(shark) steaks and 36/10-lb. cases of 6-oz. shark
steaks valued at $2,412.
----
Mass Seizures:
Product: Oxygen, USP (92-642-816/370).
Firm: Breathco, Inc., Springboro, Ohio.
Charges: Adulterated - The methods used in, and the facilities and
controls used for, the packing and holding do not conform to
and are not operated and administered in conformity with
current good manufacturing practice regulations.
Filed: February 18, 1992; U.S. District Court for the
Southern District of Ohio; Western Division; Civil
#C-1-92-126, FDC #66350.
Seized: March 2, 1992; oxygen, USP, in cylinders, in
stationary vehicle mounted tanks, and in a bulk
holding tank, valued at $95,000.
----
Product: "Sterile" Contact Lens Wetting Solutions (91-679-130).
Firm: Sherman Pharmaceuticals, Inc., Abita Springs, Louisiana.
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Charge: Adulterated - The methods used in, or the facilities or
controls used for, the manufacture, processing, packing,
or holding do not conform to or are not operated or
administered in conformity with current good manufacturing
practice regulations.
Misbranded - Information required to be submitted
under the Medical Device Reporting regulations was
not submitted.
Filed: March 4, 1992 - U.S. District Court for the Eastern
District of Louisiana; Civil #92-0786-6, FDC #66332.
Seized: March 10, 1992; goods valued at $350,000.
----
Disposition of Injunction:
Product: Liquid Injectable Silicone (91-647-465).
Firm: Orentreich Medical Group, a partnership, and Norman
Orentreich, M.D., Michael A. Kalman, M.D., and
David S. Orentreich, M.D., individuals.
Charges: Adulterated -- Product is a class III medical
device for which there is no approved premarket
approval application, and defendants' use is not
covered by an approved investigational device
exemption.
Filed: March 5, 1992 - U.S. District Court for the Southern
District of New York; Civil #CV92-1468(PPG), INJ #1277.
Disposition: Consent Decree signed March 5, 1992.
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