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
02/12/1991
FDA Enforcement for the week of February 13, 1991
FDA ENFORCEMENT REPORT
FOR FEBRUARY 13, 1991
February 13, 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.
Product: Medical foods, in 7 ounce size tins:
(a) Maxamaid MSUD, a dietary supplement
for individuals with Maple Syrup Urine disease;
(b) Maximaid XMET, THRE, VAL, ISOLEU, a dietary
supplement for individuals with Methylamalomic Acedemia
or Propionic Acedemia;
(c) Maximaid XMET, a dietary supplement for individuals
with Vitamin B6 non-responsive Hemocystinuria;
(d) Maxamum-XP, a dietary supplement for individuals
with Phenylketonuria. These supplements are supplied in
powdered form and are to be mixed with water so they
may be taken as a drink with a meal. Recall #F-184/187-1.
-1-
Code: Batch numbers: (a) 24103 EXP 1/1/91; (b) 2310 EXP 12/1/90;
(c) 23101 EXP 12/1/90l (d) 23094 and 23095 EXP 12/1/90.
Manufacturer: Scientific Hospital Supplies, Ltd., Liverpool, England.
Recalled by: Ross Laboratories, Columbus, Ohio, by telephone
November 20, 1990. Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: 754 cases (10 tins/case) were distributed.
Reason: Product contains L-tryptophan manufactured by Showa
Denko, which has been shown to be associated with the
development of eosinophilia-myalgia syndrome.
----
Product: Nutritional products:
(a) MSUD-1, Mead Johnson amino acid mixture with
vitamins and minerals, in 17-1/2 ounce cans. The
product is taken orally and is sold in powder form;
(b) PKU-3, Mead Johnson amino acid mixture with
vitamins and minerals, in 17-1/2 ounce cans.
Recall #F-188/189-1.
Code: (a) 4KS12 EXP 2/1/91; (b) 4KS21 EXP 2/1/91.
Manufacturer: Milupa AG, West Germany.
Recalled by: Bristol-Myers Squibb Company, Mead Johnson Nutritional
Group, Evansville, Indiana, by telephone November 29,
1990. Firm-initiated recall ongoing.
Distribution: (a) Georgia; (b) California, Connecticut, Florida,
New York, Tennessee, Texas.
Quantity: (a) 12 cases (2 cans/case); (b) 86 cases (2 cans/case)
were distributed.
Reason: Product contains L-tryptophan manufactured by Showa
Denko, which has been shown to be associated with the
development of eosinophilia-myalgia syndrome.
----
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: Parker's Pride brand Sugar Coated Ball Gum, in
11 ounce bags. Recall #F-155-1.
Code: All lots.
Manufacturer: Hannaford Brothers Company, South Portland, Maine.
Recalled by: Manufacturer, by telephone and letter on or about
December 27, 1990. Firm-initiated recall ongoing.
Distribution: New England area and New York.
Quantity: 46 cases (12 bags/case) were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
-2-
Product: Boraxo hand cleansers, used with or without water
in metal cans which can be opened and inverted to fit
into hand dispensers:
(a) Boraxo Red Label Hand Cleanser, 4 pounds 8 ounces,
product #00354;
(b) Boraxo Waterless Hand Cleanser, 4 pounds 12 ounces,
product #00355;
(c) Boraxo Waterless Hand Cleanser, 16 ounces,
product #00357. Recall #F-190/192-1.
Code: Lot numbers: F160, F180, F210, F220, F250, F260, F270,
F290.
Manufacturer: Innovative Chemical Corporation, Amherst, New York.
Recalled by: The Dial Corporation, Scottsdale, Arizona, by telephone
between July 8 and 11, 1990 followed by letter
August 2, 1990. Firm-initiated recall ongoing.
Distribution: Connecticut, Georgia, Indiana, Kentucky, Iowa, Illinois,
Michigan, New Jersey, Ohio, Oklahoma, Pennsylvania,
Tennessee, Virginia, Wisconsin.
Quantity: 258 cases were distributed; firm estimates none remains
on market.
Reason: Product is contaminated with Pseudomonas maltophilia
bacteria.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Ice Cube Shaped Chocolate Blocks, packaged 48 pieces
per plastic tub. Recall #F-149-1.
Code: All lots.
Manufacturer: Moritz Eiskonfekt GmbH, Hamburg, Germany.
Recalled by: Core-Mark International, Portland, Oregon, by letter
November 20, 1990. Firm-initiated recall complete.
Distribution: Oregon, Washington state.
Quantity: Approximately 64 cartons (24 tubs/carton) were distributed;
firm estimates none remains on the market.
Reason: Product is rancid.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
-3-
Class II -
Product: AMI-DECON (Tri-Phen Chlor) Tablets, an Rx antihistamine,
under the Amide label in 1,000 tablet bottles and under
Rugby label in bottles of 100, 500 and 1,000.
Recall #D-174-1.
Code: Lot #90104 EXP 4/92.
Manufacturer: Amide Pharmaceutical, Inc., Little Falls, New Jersey.
Recalled by: Manufacturer, by letters of December 4 and 27, 1990.
Firm-initiated recall ongoing.
Distribution: New York, Florida, New Jersey, Pennsylvania.
Quantity: 6,351 bottles of 100, 720 bottles of 500 and 459 bottles
of 1,000 were distributed.
Reason: Variations in tablet size resulting in subpotency and
superpotency.
----
Product: GHB-PM, Gamma Hydroxybutyric Acid, marketed as an OTC
food supplement promoting hormone stimulation producing
muscle gain and weight loss. Recall #D-175-1.
Code: All lots.
Manufacturer: Ultimate Nutritional Systems, Inc., New Brunswick,
New Jersey.
Recalled by: Ultimate Strength Systems Labs, Inc., Newington,
Connecticut, by telephone in October 1990. Firm-
initiated recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates none remains on the market.
Reason: Product marketed without new drug approval. See
also FDA press release P90-53, November 8, 1990.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma; (d) Recovered Plasma. Recall #B-064/067-1.
Code: Unit numbers: (a) 30G03743, 30G08550, 30G10479,
30G16199, 30G21260, 30G26549, 30G30667, 30G34507,
30G44460, 30G54334, 30G58100, 30G95263, 30H60321,
30H66648, 30J27896, 30J59145, 30X02445, 30Y07026,
30Y14355, 30Y23114;
(b) 30G03743, 30G10479, 30G16199, 30G21260, 30G26549,
30G30667, 30G44460, 30G54334, 30H60321, 30H66648, 30J59145,
30Y14355;
(c) 30G54334, 30J59145, 30Y14355;
(d) 30G03743, 30G08550, 30G10479, 30G16199, 30G21260,
30G26549, 30G30667, 30G34507, 30G44460, 30G58100,
30G95263, 30H60321, 30H66648, 30J27896, 30X02445,
30Y07026, 30Y23114.
Manufacturer: American Red Cross, Ashley, Pennsylvania.
Recalled by: Manufacturer, by letters of June 20, 1990 and
July 3, 1990. Firm-initiated recall ongoing.
Distribution: Pennsylvania, New York, California, Switzerland.
-4-
Quantity: (a) 20 units; (b) 12 units; (c) 3 units; (d) 17 units.
Reason: Blood products which tested non-reactive for the
hepatitis B surface antigen (HBsAg), but were collected
from donors who previously tested repeatably reactive for
HBsAg, were distributed.
----
Product: (a) Red Blood Cells; (b) Platelets, Pooled;
(c) Fresh Frozen Plasma; (d) Recovered Plasma, Pooled;
(e) Recovered Plasma. Recall #B-068/072-1.
Code: (a) Unit numbers: 1101724, 2242713, 4406632, 4415127,
4427019, 4437211, 4442565, 6609353;
(b) Pool numbers: LP01077 (includes unit 1101724), LP5320
(includes unit 4427019), LP6797 (includes unit 2242713),
LP9259 (includes 4442565);
(c) Unit #4406632;
(d) Pool numbers: 8803746 (includes unit 6609353),
8806391 (includes unit 4427019), 8811952 (includes
unit 2242713), 8815612 (includes unit 4437211),
8820403 (includes unit 4442565);
(e) Units 1101724, 4415127.
Manufacturer: The Blood Center of Central Iowa, Des Moines, Iowa.
Recalled by: Manufacturer, by letters beginning September 7, 1990.
Firm-initiated recall ongoing.
Distribution: Iowa, California, Florida, Illinois.
Quantity: (a) 8 units; (b) 4 units; (c) 1 unit; (d) 5 units;
(e) 2 units.
Reason: Blood components drawn from a donor with a history
of hepatitis were distributed.
----
Product: Recovered Plasma. Recall #B-078-1.
Code: Unit #3041406.
Manufacturer: J.K. & Susie L. Wadley Research Institute and Blood
Bank, Dallas, Texas.
Recalled by: Manufacturer, by letter June 15, 1989. Firm-initiated
recall ongoing.
Distribution: Texas, New Jersey, New York.
Quantity: 1 unit.
Reason: Blood component collected from a donor with a history
of cancer was distributed.
----
Product: Recovered Plasma. Recall #B-089-1.
Code: Unit #43K20475.
Manufacturer: American Red Cross, Waco, Texas.
Recalled by: Manufacturer, by telephone June 2, 1990 followed by
letter November 2, 1990. Firm-initiated recall ongoing
Distribution: Switzerland.
Quantity: 1 unit.
-5-
Reason: Blood component tested non-reactive for anti-HIV-1
but was collected from a donor who previously tested
repeatably reactive for anti-HIV-1 was distributed.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Platelets, Pheresis;
(d) Cryoprecipitated AHF; (e) Recovered Plasma.
Recall #B-092/096-1.
Code: Unit numbers: (a) 35G75905, 35M02170; (b) 35G75905;
(c) 35P02263; (d) 35M02170; (e) 35G75905.
Manufacturer: American Red Cross, Roanoke, Virginia.
Recalled by: Manufacturer, by telephone on or about October 12 and
25, 1988, March 21, 1990 and April 20, 1990.
Firm-initiated recall ongoing.
Distribution: Virginia, West Virginia, California, Ohio.
Quantity: (a) 2 units; (b) 1 unit; (c) 1 unit; (d) 1 unit;
(e) 1 unit.
Reason: Blood products collected from donors who 1)
participated in high risk behavior; 2) had taken
anti-malaria prophylaxis during a visit to an area
endemic for malaria; or 3) reported a fever and sore
throat the evening after donating, were distributed.
----
Class III -
Product: Merthiolate (Thimerosal, USP) 1:1,000 Topical Solution
No 45, in 16 ounce glass bottles, an OTC antiseptic
product. Recall #D-173-1.
Code: All lots.
Manufacturer: Eli Lilly and Company, Indianapolis, Indiana.
Recalled by: Manufacturer, by letter December 13, 1990. Firm-
initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 73,827 bottles were distributed.
Reason: Product does not meet USP specifications for pH.
----
Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-090/091-1.
Code: Unit numbers: 43G50149, 43J61601.
Manufacturer: American Red Cross, Waco, Texas.
Recalled by: Manufacturer, (a) by telephone June 2 & 6, 1990 followed
by letter June 22, 1990 and July 2, 1990; (b) telephone
June 2, 1990 followed by letters of July 6, 1990.
Firm-initiated recall ongoing.
Distribution: Texas, California.
Quantity: 2 units of each component.
-6-
Reason: Blood components which tested non-reactive for the
human-immunodeficiency virus type 1 (anti-HIV-1)
but were collected from donors who previously tested
repeatably reactive for anti-HIV-1 were distributed.
----
Product: Red Blood Cells. Recall #B-097-1.
Code: Unit #35G08068.
Manufacturer: American Red Cross, Roanoke, Virginia.
Recalled by: Manufacturer, by telephone March 20, 1990. Firm-
initiated recall complete.
Distribution: Virginia.
Quantity: 1 unit.
Reason: Red Blood Cells collected from a donor who had taken
anti-malaria prophylaxis during a visit to an area
endemic for malaria, were distributed.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Ohmeda Care Plus Incubator. Recall #Z-204-1.
Code: All serial numbers.
Manufacturer: Ohmeda, Columbia, Maryland.
Recalled by: Manufacturer, by letter January 7, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 2,000 - 3,000 units were distributed.
Reason: The handholes may accidentally be opened if an infant
kicks the handhole cover with sufficient force.
The infant may then fall through the open handhole.
----
Product: (a) Castle M/C 3671 EO Gas Sterilizer (with aeration);
(b) Castle M/C 3622 Steam Sterilizer (gravity);
(c) Castle M/C 3633 Steam Sterilizer (high vacuum).
Single and double door, power and manual door models
are affected. Recall #Z-206/208-1.
Code: Serial Nos: 47832 47833 47834 47835 47988, 47989 47990
47991 47992 47993 47994 47995 47996 47997
47998 47999
48001 48326 48327 48328 48329 48330 48331
48332 48333 48334 48337 48338 48345 48863
48866 48867
-7-
49325 49326 49327 49332 49333 49335 49336
49338 49607 49609 49610 49612 49613 49614
49615 49616 49618 49621 49622 49623 49624
49625 49626 49627 49628, 49629 49630 49925
49926 49927 49928 49929 49930 49931 49932
49933 49934 49937
50042 50151 50152 50158 50157 50212 50215
50216 50218 50224 50225 50226 50228 50229
50230 50231 50232 50233 50235 50554 50555
50556 50557 50559 50560 50561 50563 50565
50566 50567 50568 50569 50572 50573 50853
50866 50867 50869 50870 50871 50872 50873
50874 50875 50876 50877 50878 50880 50881
50882 50883 50884 50885
51024 51107 51108 51109 51111 51112 51113
51115 51116 51117 51118 51119 51121 51172
51323 51324 51325 51327 51329 51332 51335
51336 51337 51338 51339 51340 51341 51342
51566 51567 51568 51572 51574 51575 51576
51577 51578 51579 51580 51582 51585 51882
51883 51884 51885 51886 51887 51889 51892
51893 51894 51895 51896
681189 681926.
Manufacturer: MDT Biologic Company, Rochester, New York.
Recalled by: Manufacturer, by visit beginning on or about
December 18, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 178 units were distributed.
Reason: The doors may open under pressure. There is a potential
for very high pressure release of steam, parts or contents
of device, and a potential exposure to ETO.
----
Product: Model TCT-600XT CT Scanners, computed tomography x-ray
systems. Recall #Z-210-1.
Code: All serial numbers.
Manufacturer: Toshiba Corporation, Tokyo, Japan.
Recalled by: Toshiba America Medical Systems, Inc., Tustin, California,
FDA approved the firm's corrective action plan
January 18, 1991. Firm-initiated field correction ongoing.
Distribution: Nationwide.
Quantity: Approximately 15 units were distributed.
Reason: Noncompliance with performance standards for x-ray
products in that the radiation dose was found to be lower
than specified by the firm.
----
-8-
Product: Alpha III MGF 110 Mammography System. Recall #Z-213-1.
Code: Serial numbers: A31504, A31505, A31508, A31509, A31510,
A31511, A31513, A31514, A31515, A31516, A31517, A31520,
A31522, A31523, A31525, A31536, A31537, A31539, A31540,
A31548.
Manufacturer: Instrumentarium Imaging, Inc., Milwaukee, Wisconsin.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan February 4, 1990. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: 20 units subject to field correction.
Reason: Noncompliance with performance standard for x-ray
products in that labeling, x-ray field size indication
and information to be provided to users is inadequate.
----
Product: Model 46-903825GXX MVP Control Console, used for
general purpose radiographic and fluoroscopic x-ray
procedures. Recall #Z-214-1.
Code: Serial numbers: Units with serial numbers less than 6200.
Manufacturer: G.E.-CGR Espanola SPA, Madrid, Spain.
Recalled by: General Electric Company, Milwaukee, Wisconsin.
FDA approved the firm's corrective action plan
November 6, 1990. Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: 538 units were distributed.
Reason: Noncompliance with performance standards for x-ray
products due to inadequate indication of AEC (automatic
exposure control) exposures and inability to select backup
time if not configured properly at installation.
----
Product: Collimators: (a) Model D-50M-M;
(b) Model D-50M-MF; (c) Model DMF-150.
Recall #Z-221/223-1.
Code: Serial numbers: (a) 1650 through 4272 (not inclusive);
(b) 4271 through 5153 (not inclusive);
(c) DMFl4036 through 14223 (not inclusive).
Manufacturer: Dial-X Instruments, Inc., Copiague, New York.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan December 17, 1990. Firm-initiated field correction
ongoing.
Distribution: Nationwide and international.
Quantity: 1,062 units were distributed.
Reason: Noncompliance with performance standards for x-ray products
in that the x-ray field extends beyond the edge of the
image receptor.
----
-9-
Product: Medi-Tech Tegwire, a single lumen, teflon-coated
guidewire with a non-compliant polyethylene terephthalate
(PET) balloon mounted at the distal tip, recommended for
percutaneous transluminal angioplasty of the iliac, femoral
and renal arteries:
(a) Order #11-102; (b) Order #11-103;
(c) Order #11-104; (d) Order #11-105;
(e) Order #11-106; (f) Order #11-107; (g) Order #11-108;
(h) Order #11-109. Recall #Z-224/231-1.
Code: Description: (a) TW 3-2/100; (b) TW 3-4/100;
(c) TW 4-2/100; (d) TW 4-4/100; (e) TW 5-2/100;
(f) TW 5-4/100; (g) TW 6-2/100; (h) TW 6-4/100.
Manufacturer: Medi Tech Division of Boston Scientific Corporation,
Watertown, Massachusetts.
Recalled by: Manufacturer, by letter January 9, 1991. Firm-initiated
field correction ongoing.
Distribution: Nationwide and international.
Quantity: Firm estimates: 4,800 units distributed in 1989 of the
old design with no caution label and 4,250 units
distributed in 1990 of the old design with caution label.
Reason: Catheter breaks may occur. The firm is sending an
advisory letter to users which warns them not to use a
diagnostic catheter as a guiding catheter and to avoid
any approach which involves crossing the aortic
bifurcation and to discontinue use of the product if it
kinks for any reason.
----
Product: Renalin Cold Sterilant for dialysis use, in .946 liter
size plastic bottles. The product is diluted with
water to make a solution which is used to clean and
sterilize dialysis equipment. Recall #Z-237-1.
Code: Lot #0S123.
Manufacturer: Minntech Corporation, Minneapolis, Minnesota.
Recalled by: Manufacturer, by letter September 20, 1990 followed by
telephone September 24, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide.
Quantity: 162 cases (12 quarts/case) were distributed.
Reason: Premature degradation of active ingredients.
----
Class III -
Product: CAL 3 Calibration Standard for TCM, a 17.3 liter compressed
gas cylinder, for use as a calibration standard for the
firm's Transcutaneous TCM3 Monitor. Recall #Z-209-1.
Code: Lot numbers CC30K96 and CE02K96.
Manufacturer: Puritan Bennett Corporation, Lenexa, Kansas.
-10-
Recalled by: Radiometer America, Inc., Westlake, Ohio, by telephone
June 28 through July 5, 1990, followed by letter July 9,
1990. Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: 37 units were distributed.
Reason: The cylinders were labeled as and actually contained 12%
oxygen but were supposed to contain 21% oxygen.
----
Product: Beckman "AMY 200" Amylase Reagent, Part #442775,
an in-vitro diagnostic product for use on Beckman
"Synchron CX4 and CX5" analyzer systems, for the
quantitative determination of amylase in serum or plasma.
Recall #Z-212-1.
Code: Lot numbers: M004063 EXP 11/30/90; M006048 EXP 01/31/91;
M007210 EXP 02/28/91.
Manufacturer: Beckman Instruments, Inc. Carlsbad, California
Recalled by: Beckman Instruments, Inc., Brea, California by letters
of 10/22/90 and 11/19/90. Firm-initiated recall ongoing.
Distribution: Nationwide and international
Quantity: 2,237 units.
Reason: The product may exhibit test recoveries higher than
labeled specifictions.
----
Product: Coumatrak Protime Test System, Protime Reagent Cartridges,
Order #0300, an in-vitro diagnostic for determination of
prothrombin time. Recall #Z-234-1.
Code: Lot numbers: P802H37 EXP 7/91, P802J58 EXP 9/91,
P802K59 EXP 9/91, P802K61 EXP 10/91, P802K62 EXP 10/91,
P802K63 EXP 10/91 and P802K64 EXP 10/91.
Manfacturer: BioTrack, Inc., Mountain View, California.
Recalled by: Manufacturer, by letter January 9, 1991 and by mailgram
January 14, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 2,560 cartons containing 25 cartridges were distributed.
Reason: Package integrity failures may produce falsely high
prothrombin times.
----
Product: Beckman AST Reagent, intended for use with the Beckman
"ASTRA" or "SYNCHRON AS" Analyzer Systems, an in-vitro
diagnostic for the quantitative determination of
aspartate amino transferase (AST) activity in serum:
(a) Part #661960 supplied in 250 determination cartridges);
(b) Part #660680, supplied in 100 determination cartridges.
Recall #Z-240/241-1.
Code: Lot numbers and EXP dates:
(a) L004024 9/91, L002083 8/91, L902095 8/90,
L902074 8/90, L902034 8/90, L902015 EXP 7/90;
(b) L902134 8/90, L005014 10/91, L001225 7/91,
L007094 1/92.
-11-
Manufacturer: Beckman Instruments (Caribe), Inc., Naguabo, Puerto Rico.
Recalled by: Beckman Instruments, Inc., Brea, California, by letters of
August 22, 1990 and September 26, 1990. Firm-initiated
recall ongoing.
Distribution: Washington, D.C., Alaska, Hawaii, North Dakota or
South Dakota, California, Florida and international.
Quantity: (a) 10,806; (b) 7,141 units were distributed.
Reason: The product may not meet its labeled performance
specifications. This may cause lower than expected
blank absorbence which generates DRR (dynamic range
reduced) flags and prevents successful loading of the
reagent cartridge, and inability to maintain quality
control for the reagent within expected ranges.
----
Product: Beckman "Paragon" Serum Protein Electrophoresis (SPE)
Kits, intended for the diagnostic determination of proteins
in human serum, cerebrospinal fluid, and urine:
(a) Part #655900 (100 determinations);
(b) Part #446004 (500 determinations). Recall #Z-242/243-1.
Code: Kit Lot No. Gel Lot No. GEL EXP date
(a) M004006 M003205 09/30/91
M003186 M003225 10/31/91
M004117
M003218 M004002 09/30/91
M004141 M004032 10/31/91
M003187 M004003 10/31/91
M004118
M004119
M003190 M004034 10/31/91
(b) M003226 M003226 09/30/91
M004054 M004054 10/31/91
M004055 M004055 10/31/91.
Manufacturer: Beckman Instruments, Inc., Carlsbad, California.
Recalled by: Beckman Instruments, Inc., Brea, California, by letters
of September 24, 1990 and October 24, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 98,390 kits were distributed.
Reason: The product did not perform to its labeled specification
which may cause a slightly enlongated pattern that is
not well defined on the gel.
----
VETERINARY PRODUCTS
NONE
-12-
Seizure Actions Filed:
Product: Disposable Latex Examination Gloves (91-672-865).
Charge: Quality falls below that which it purports or
represents to possess because article contains holes
and the distributor is not registered.
Firm: Northeast Dental Supply, Inc., Rochester and
Pittsford, New York.
Filed: December 26, 1990 - U.S. District Court for the
Western District of New York; Civil #CIV 90-1321T,
FDC #66009.
----
Product: Anchovies (90-471-353/354).
Charge: Adulterated - Olive oil was substituted for anchovies
fillets.
Firm: Tzetzo Bros. Inc., Buffalo, New York.
Filed: January 15, 1991 - U.S. District Court for the
Western District of New York; Civil #CIV-91-0024-A,
FDC #66005.
----
Product: Surgical Instruments -- 3-1/2 inch Hartman Mosquito
Hemostatic Forceps and 5-1/2 inch Kelly Hemostatic
forceps (91-575-442/443 and 90-575-462/463).
Charge: Adulterated - Quality falls below established standards
for surgical instruments. Labeled or invoiced
as stainless steel, they are misbranded and do not conform
to established standards for stainless steel surgical
instruments.
Firm: Transworld Medical Supply, chicago, Illinois.
Filed: January 9, 1991 - U.S. District Court for the
Southern District of Illinois, Eastern Division; FDC #65937.
----
Product: Farbital Compound with Codeine #310 (90-576-652).
Charge: Product is a new drug marketed without an approved
New Drug Application.
Firm: Anabolic Inc., Irvine California for Major Pharmaceutical
Corporation, Chicago, Illinois.
Filed: December 28, 1990 - U.S. District Court for the
Northern District of of Illinois, Eastern division;
Civil #90C 7502, FDC #65939.
----
Product: Farbital Compound with Codeine #310 (90-552-363).
Charge: Product is a new drug marketed without an approved
New Drug Application.
Firm: Anabolic Inc., Irvine California for Major Pharmaceutical
Corporation, Chicago, Illinois.
Filed: January 24, 1991 - U.S. District Court for the District
of Nebraska; Civil #91 00023, FDC 65939.