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
05/20/1992
RECALLS AND FIELD CORRECTIONS: May 20, 1992
FOODS -- CLASS I
92-21
PRODUCT Eight patterns of porcelain dinnerware, labeled in Chinese
characters and marked MADE IN CHINA:
(a) Blue flower pattern consisting of plates, spoons, bowls,
soup plates, and condiment dishes;
(b) Red Long-Life Traditional Pattern, consisting of plates,
bowls, soup plates, and condiment dishes;
(c) Red Long-Life Modern Pattern, consisting of plates and
saucers;
(d) Red and White Flower Pattern, consisting of plates and
condiment dishes;
(e) Phoenix Pattern, consisting of spoons, plates, saucers, and
condiment bowls;
(f) Two Fish (also known as Goldfish) Pattern, consisting of
condiment bowls, plates, and spoons;
(g) Lovebird Pattern, consisting of spoons, plates, and bowls;
(h) Old Man and Deer (also known as Longevity) Pattern,
consisting of plates. Recall #F-288/295-2.
CODE All eight patterns are labeled "MADE IN CHINA." In addition,
the Lovebirds and Red Long Life Traditional Patterns have one
of the following three digit numbers stamped on the bottom of
the dinnerware: Lovebirds: "006/024/068/078/150/184/232/276;
Red Long Life Traditional: 025/028/080/090/184/194/208/228/
428/480. Cardboard cartons are coded as follows:
(a) 415; (b) 75229; (c) Not coded; (d) 6308; (e) 6326;
(f) 683114; (g) 681184; (h) 5268.
MANUFACTURER Product of China.
RECALLED BY May Wah Trading Company, Inc., San Francisco, California
(distributor/dealer, by letter December 9, 1991.
Firm-initiated recall ongoing.
DISTRIBUTION California, Washington state, Nevada, Colorado.
QUANTITY Unknown.
REASON Product contains excess levels of leachable lead.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Various flavors of sherbet ice cream: (a) Lemon Sherbet,
packaged in 1 pint plastic containers under the Nancy Grey
label, packaged in 3 gallon cardboard containers, no brand name;
(b) Lime Sherbet, packaged in 1 pint plastic containers under
the Nancy grey label, packaged in 3 gallon cardboard
containers, no brand name;
(c) Rainbow Sherbet, packaged in 1/2 gallon paper containers
under Reinhold's Richtest label, packaged in 1-1/2 gallon
plastic containers, no brand, packaged in 3 gallon cardboard
containers, no brand name. Recall #F-297/299-2.
CODE Not coded. All stock of all three products.
MANUFACTURER Reinhold Ice Cream Company, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by letter April 29, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY Unknown.
REASON Products contain undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Betty Ann Creecy Greens (dry land cress), in 16 ounce cans.
Recall #F-296-2.
CODE Lot numbers: CH1M1/CRES, CH1M2/CRES, CL1M1/CRES, CL1M2/CRES,
CM1M1/CRES, CM1M2/CRES, CN1M1/CRES, CR1M1/CRES, CR1M2/CRES,
CS1M1/CRES, CS1M2/CRES, CT1M1/CRES, CT1M2/CRES, CV1M1/CRES.
MANUFACTURER Monticello Canning Company, Inc., Crossville, Tennessee.
RECALLED BY Manufacturer, by telephone October 30, 1991, followed by letter
October 31, 1991. Firm-initiated recall complete.
DISTRIBUTION Maryland, Tennessee, Virginia, Kentucky, North Carolina, West
Virginia.
QUANTITY 11,433 cases (24 cans per case) were distributed.
REASON Product is contained in cans with seam defects.
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RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Minoxidil Tablets, USP, (a) 2.5 mg; (b) 10 mg, in bottles of
100 and 500, an Rx antihypertensive. Recall #D-339/340-2.
CODE All sizes and All codes.
MANUFACTURER Royce Labs., Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter April 22, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 22,730 100-tablet bottles; (b) 55,384 100-tablet bottles
and 6,469 500-tablet bottles were distributed.
REASON Lack of assurance of bioequivalence and abbreviated new drug
application discrepancies.
PRODUCT (a) Bausch & Lomb brand Pilocarpine HCl 2% Solution, in 15 ml
bottles, sterile Rx ophthalmic;
(b) Hydroproplymethyl Cellulose and Dextran 70 Solution Sterile
Lubricant Eye Drops, in 15 ml bottles. Recall #D-343/344-2.
CODE Lot numbers: (a) 0312; (b) 0363.
MANUFACTURER Pharmafair, Inc., Hauppauge, New York.
RECALLED BY Manufacturer, by letter October 24, 1991. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 8,886 bottles; (b) 3,030 bottles were distributed; firm
estimates none remains on the market.
REASON Lack of assurance of sterility.
PRODUCT Ephedrine Hydrochloride 50 mg Sustained Release Tablets, in 20
tablet and 60 tablet packets, promoted for weight loss.
Recall #D-345-2.
CODE Not coded. All product.
MANUFACTURER G & J Enterprise, Pascagoula, Mississippi (repacker).
RECALLED BY Repacker, by visit between April 20 and 24, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Mississippi.
QUANTITY Firm estimates 2,000 tablets remain on the market.
REASON Product marketed without new drug approval.
PRODUCT Various Rx and OTC repacked drugs, in unit-dose packages.
Recall #D-346-2.
CODE Products within expiration period which had been unit-dose
repacked by Pharmaceutical Services of Middle Tennessee, Inc.
MANUFACTURER Pharmaceutical Services of Middle Tennessee, Inc., Nashville,
Tennessee (repacker).
RECALLED BY Repacker, by telephone March 24, 1992, followed by letter dated
March 25, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Tennessee.
QUANTITY 721,869 repacked units were distributed.
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REASON Current good manufacturing practice deficiencies.
PRODUCT Azamacort Inhaler, 20 gram, metered-dose aerosol unit, an Rx
drug for the control of the symptoms of bronchial asthma.
Recall #D-348-2.
CODE Lot #BHP060.
MANUFACTURER Sterling Pharmaceutical, Barceloneta, Puerto Rico.
RECALLED BY Rhone Poulenc Rorer Pharmaceuticals, Inc., Fort Washington,
Pennsylvania, by telephone April 28, 1992, followed by letter
April 29, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 31,552 units were distributed.
REASON Presence of foreign oil matter.
PRODUCT Fluphenazine Decanoate Injection, 25 mg/ml, in 5 ml multiple
dose vials, an Rx SVP antipsychotic. Recall #D-350-2.
CODE Lot numbers: 110727 EXP 5/92, 110740 EXP 5/92, 110745 EXP
5/92, 110787 EXP 6/92, 110807 EXP 6/92, 110835 EXP 6/92, 110880
EXP 6/92, 110910 EXP 7/92.
MANUFACTURER Lyphomed, Division of Fujisawa USA, Inc., Melrose Park,
Illinois.
RECALLED BY Manufacturer, by letter May 8, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 27,152 units were distributed.
REASON Subpotency.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Oxygen USP, Compressed Medical Gas transfilled into E, D, 40,
50 and 60 cu foot cylinders. Recall #D-341-2.
CODE None.
MANUFACTURER Olympic Ambulance, Inc., doing business as Olympic Oxygen
Service, Sequim, Washington.
RECALLED BY Manufacturer, by telephone beginning April 30, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Washington state.
QUANTITY 20 cylinders were distributed.
REASON Current good manufacturing practice deficiencies.
PRODUCT Acetaminophen with Codeine Tablets, 300 mg acetaminophen and 60
mg codeine phosphate per tablet, a schedule C-III narcotic oral
analgesic, unit dose packaged with 20 tablets per card. Recall
#D-342-2.
CODE Lot #2C704 EXP 3/94.
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MANUFACTURER Barr Laboratories, Inc., Pomona, New York.
RECALLED BY UDL Laboratories, Inc., Rockford, Illinois (repacker), by
telephone April 7, 1992. Firm-initiated recall ongoing.
DISTRIBUTION California, New Jersey, Michigan, Pennsylvania.
QUANTITY 111 unit cartons of 100 tablets were distributed; firm
estimates none remains on the market.
REASON Product fails content uniformity specifications.
PRODUCT Maximum Strength Enteric Coated Aspirin Tablets, 500 mg,
packaged in 60 tablet bottles, under the following labels:
Hook's, Peoples, Brooks, United Supermarket, Fays, Schein,
Taylor, Rite Aid, Thrifty, Silver Saver. Some bulk product was
also involved which was sold to Great Lakes Co., but shipped to
Crown Drug Co. for repacking. Recall #D-347-2.
CODE Lot numbers: K6019E, J6074D, J6073D (Hook's);
K6107D, K6019E, J6074D, K6220D, H6237D, J6073D, J6072D, A6040E
(Peoples); H6112D, H6237D, H6111D (Brooks); H6112D (United
Supermarket); K6019E, J6074D, J6073D (Fays); K6019E, J6074D,
K6220D, H6235D (Schein); H6111D, H6112D, H6113D (Taylor);
H6112D, H6113D, H6235D, H6236D, H6237D, J6072D (Rite Aid);
A6041E, K6019E, J6074D, K6220D, H6235D, J6073D, H6111D, 6041E
(Thrifty); 6041E (Silver Saver); K6106D, K6107D, K6108D,
K6109D, K6219D, K6220D, L6189D, L6190D, L6191D, A6040E (bulk).
MANUFACTURER LNK International, Hauppauge, Long Island, New York.
RECALLED BY Pennex Products Company, Inc., Verona, Pennsylvania, by
telephone and by letter dated March 18, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 30,000 bottles were distributed.
REASON Product fails dissolution specifications.
PRODUCT Amiloride HCl and Hydrochlorothiazide 5 mg/50 mg, in bottles of
100 and 1,000, used for hypertension, under the following
labels: Royce, Goldline, Genetco, Martec, Qualitest Products,
and United Research Labs. Recall #D-349-2.
CODE Lot numbers IJ1127, IJ1128, IJ1129, IJ1130.
MANUFACTURER Royce Labs, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter April 23, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Florida, New York, Missouri, Alabama, Pennsylvania.
QUANTITY 3,288 1,000-tablet bottles and 31,888 100-tablet bottles were
distributed under the private labels. Amount distributed under
own (Royce) label is unknown.
REASON Use of unapproved processor for hydrochlorothiazide raw
material.
PRODUCT OTC Analgesic Combination marketed as "HI-VALUE Relief for Pain
adult strength pain reliever analgesic", in 100 tablet
bottles. Recall #D-351-2.
CODE Lot 901037.
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MANUFACTURER C-B Laboratories, Inc., Harrisburg, North Carolina.
RECALLED BY Manufacturer, by telephone. Firm-initiated recall ongoing.
DISTRIBUTION California, Texas.
QUANTITY 6,264 bottles were distributed.
REASON Product degradation.
UPDATE Recall #D-321-2, which appeared in the April 29, 1992
Enforcement Report should read: Amphotericin B for Injection,
USP, Preservative Free, 50 mg/vial.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Source Plasma. Recall #B-289-2.
CODE Unit numbers: E-46047-091, E-46339-091, E-46389-091,
E-46415-091, E-46453-091, E-46490-091, E-46531-091, E-46568-091.
MANUFACTURER Community Plasma of Dallas, Inc., Casa Grande, Arizona.
RECALLED BY Manufacturer, by telephone and facsimile August 5, 1991.
Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY 8 units.
REASON Source Plasma, which tested negative for hepatitis B surface
antigen (HBsAg) and the antibody to human immunodeficiency
virus type 1 (anti-HIV-1), but were collected from a donor who
previously tested reactive for either HBsAg or anti-HIV-1, were
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
UPDATES Recall #B-192-2, Reagent Red Blood Cells Resolve Panel B Cell
#22, which appeared in the April 8, 1992 Enforcement Report is
a Class III Recall.
Recall #B-219-2, Surgiscreen Reagent Red Blood Cells, which
appeared in the April 8, 1992 Enforcement Report should read:
MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan, New
Jersey.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Lifestream Centrifugal Pump Motor Drive, Model 2100 MD, used
during cardiopulmonary bypass procedures. Recall #Z-259-2.
CODE LOt #501230-03.
MANUFACTURER St. Jude Medical, Inc., Chemlsford, Massachusetts.
RECALLED BY Manufacturer, by telephone. Firm-initiated recall ongoing.
DISTRIBUTION Florida, Texas, China.
QUANTITY 3 units were distributed.
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REASON The device may fail due to failure of the motor drive.
Reworked units may have had magnet pole failure which caused
the motor rotor to lock-up.
PRODUCT Laparoscopy Graspers, hand held manual instruments used during
laparoscopic surgery:
(a) LA1300, Large Jaw Grasper, Monopolar, serrated large jaw
for grasping or blunt dissection;
(b) LA1305, Alligator Jaw Grasper with Ratchet, insulated
shaft, used for gallbladder retraction;
(c) LA1310, Small Jaw Dissector, Monopolar, rounded serrated
jaw for dissection and grasping;
(d) LA1320, Bullet Nose Dissector, Monopolar, conical, serrated
jaw for fine dissection in difficult areas;
(e) LA1340, Long Jaw Dissector, Monopolar, long, tapered,
serrated jaws for precise dissection in a variety of sites;
(f) LA1350, Atraumatic Grasper/ Dissector, Monopolar, smooth,
rounded jaws for atraumatic grasping or dissection.
Recall #Z-465/470-2.
CODE Lot numbers QG, QH, QI, QJ for catalog LA1305; All lots, QA
thru RC for catlog numbers LA1300, LA1310, LA1320, LA1340,
LA1350.
MANUFACTURER Baxter Healthcare Corporation, St. Louis, Missouri.
RECALLED BY Baxter Healthcare Corporation, V. Mueller Division, Niles,
Illinois, by letters dated February 20, 1991 and March 30,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Finland, Italy, Belgium.
QUANTITY (a) 96; (b) 859; (c) 470; (d) 253; (e) 466; (f) 227 units were
distributed.
REASON The upper portion of the jaw may break due to weakness of the
metal.
PRODUCT Sunquest and Alisun Series Tanning Beds and Booths. Recall
#Z-471/472-2.
CODE Serial numbers: None.
MANUFACTURER Alisun America, Ltd., McHenry, Illinois.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
April 21, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide
QUANTITY 19,707 units were distributed.
REASON Noncompliance with the performance standard for sunlamp
products in that the label and user instructions contained
multiple (10-20) ultraviolet lamp type designations; and failed
to have adequate exposure schedules, labels, and user
instructions for the lamp types being used in the devices.
PRODUCT Model G150 Laser Rangefinder, used for distance measuring of
various scientific and industrial applications.
Recall #Z-473-2.
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CODE Serial numbers: None.
MANUFACTURER Optech systems Corporation, Downsview, Ontario, Canada (T.
Hasek Associates, Ltd., Reno, Nevada).
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
April 20, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION California, Massachusetts, Michigan.
QUANTITY 4 units were distributed.
REASON Noncompliance with the performance standard for laser products
in that its emission levels were in excess of the intended
class of the product (Class (I).
PRODUCT Simpson Coronary Atherocath SCA-LP, low profile, 7F, a
directional coronary atherectomy catheter used for the
selective excision and retrieval of atherosclerotic lesions in
coronary arteries and vein drafts. Recall #Z-483-2.
CODE Catalog #LP-70-40-09. Lot numbers: 112881, 112891, 112901,
EXP 4/92.
MANUFACTURER Devices for Vascular Intervention, Inc., Temecula, California.
RECALLED BY Devices for Vascular Intervention, Inc., Redwood City,
California, by letter January 17, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Pennsylvania, Alabama, Florida, Massachusetts, North Carolina,
Ohio, California, Illinois, Indiana, New Jersey, Maryland, New
Mexico, South Carolina, Washington state, Mississippi,
Michigan, Washington, D.C., Germany, The Netherlands.
QUANTITY 135 units were distributed.
REASON Urethane cracking may result in detachment of the nosecone as
well as fragmentation of urethane.
PRODUCT Puritan Bennett Microprocessor Ventilators containing T-Level
Software: (a) Model 7200a and (b) Model 7200sp.
Recall #Z-673/674-2.
CODE All units shipped between 11/15/90 and 2/6/91.
MANUFACTURER Puritan Bennett Corporation, Carlsbad, California.
RECALLED BY Manufacturer, by letter February 21, 1991. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,295 units were distributed.
REASON There is an inconsistency between the operator manual labeling
and the alarm function. When the T-level software is in use,
the low exhaled tidal volume alarm monitors mandatory breaths
in the SIMV mode.
PRODUCT A.O.R. (Alvarado Orthopedic Research) Universal Alignment Arm,
Catalog #00-5061-066-00, for use at the beginning of knee
replacement operations to align the head (ball) of the femur
with the ankle to determine the exact location for placement of
the knee components. Recall #Z-676-2.
CODE Lot #79887500.
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MANUFACTURER Carr Metal Products, Indianapolis, Indiana.
RECALLED BY Zimmer, Inc., Warsaw, Indiana (packager), by letter February
19, 1991. Firm-initiated recall complete.
DISTRIBUTION California, Wisconsin, West Virginia, Illinois.
QUANTITY 6 units were distributed.
REASON The graduations of the metal scale used in the alignment arm
are not deep enough to show on x-ray.
PRODUCT Adfuse Infusion Pumps, designed to release solutions of drug at
the rate of 60 ml per 30, 50, or 90 minutes, depending on the
model: Product #AF6030; (b) Product #AF6050, 7FS001, AF6050-SK;
(c) Product #6090. Recall #Z-677/679-2.
CODE All lot numbers.
MANUFACTURER Healthtek, Inc., Nevada City, California.
RECALLED BY Manufacturer, by FAX and letter March 28, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Germany Australia, The Netherlands.
QUANTITY Approximately 30,000 units were distributed; firm estimates
9,500 units remain on the market.
REASON The devices are subject to leakage, erratic infusion rates, and
have been distributed without an approved 510(k) for the use of
the drugs labeled or for the design changes.
PRODUCT Puritan Bennett Display Panel, Monitor Screen, an accessory for
the Model 7200 Series Microprocessor Ventilator.
Recall #Z-681-2.
CODE All Puritan Bennett 7202 Display monitors shipped between
October 17, 1990 and March 13, 1991.
DISTRIBUTION Nationwide and international.
QUANTITY 527 units were distributed; firm estimates 150 units remain on
the market.
REASON Product may contain a defective printed circuit board which may
cause the screen to go blank.
PRODUCT Laserex Transcutaneous Electrical Nerve Stimulator (TENS-1000),
an Rx device used externally for pain management.
Recall #Z-682-2.
CODE All units.
MANUFACTURER Laserex Technologies, Unley, Australia.
RECALLED BY Laserex, Inc., Scottsdale, Arizona, by letter January 31,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Arizona, California, Florida, New Jersey, Texas, Mexico.
QUANTITY 1,570 units were distributed.
REASON The device has been marketed without an approved 510(k)
premarket notification.
PRODUCT Medi-Trace ECG electrodes for use as patient monitoring
electrodes during electrocardiographic monitoring procedures:
(a) Offset Dx ECG Electrodes; (b) S'Offset ECG Electrodes.
Recall #Z-683/684-2.
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CODE All lot numbers between 12181 and 12272. Specific lot numbers
are as follows: (a) 12181, 12182, 12191, 12192, 12201, 12202,
12211, 12212, 12241, 12242, 12251, 12252, 12261, 12262, 12271,
12272;
(b) 12182, 12183, 12191, 12192, 12201, 12202, 12211, 12212,
12221, 12241, 12242, 12251, 12252, 12261, 12262, 12271, 12272.
MANUFACTURER Graphic Controls Corporation, Methuen, Massachusetts.
RECALLED BY Graphic Controls Corporation, Buffalo, New York, by letter
January 7, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 402,296 electrodes; (b) 321,475 electrodes were distributed.
REASON The trace quality of the electrodes may be compromised. The
electrodes may produce more noise, artifact or baseline
wandering in their tracings than is usual with these products.
PRODUCT Richard Wolf Irrigation and Suction Spatula, Catalog
#E8383.801, a medical device designed for the instillation and
aspiration of fluid for lavage purposes during laparoscopy, and
assisting in the dissection and removal of the gallbladder.
Recall #Z-685-2.
CODE All units.
MANUFACTURER Richard Wolf Medical Instruments, Vernon Hills, Illinois.
RECALLED BY Manufacturer, by letter dated January 10, 1992. Firm-initiated
recall ongoing.
DISTRIBUITON Nationwide.
QUANTITY 107 units were distributed.
REASON An electrical current may travel to the trumpet valve of the
spatula, creating the potential for an electrical shock to the
user.
UPDATE Recall #Z-522/523-2, Coulter Automated Hematology Analyzers,
Models JT2 and JT3, which appeared in the April 15, 1992
Enforcement Report should read:
REASON: Due to software anomalies, if the power is
interrupted, two conditions may occur upon restoration of power
which can cause the device to generate erroneous results. One
result is the dilution of a specimen if the needle has pierced
the specimen, but has not retracted when the power is
interrupted. The second is that calibration factors may be
lost and the instrument automatically reset to default
conditions. Firm-initiated field correction complete.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Calibration Gas Cylinder labeled as 7% C02, 7% 02, Balance N2,
used in the calibration of blood gas analyzers during
production at CIBA-Corning. Recall #Z-552-2.
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CODE Lot #150619 EXP 3/92.
MANUFACTURER Scott Medical Products, Inc., Scott Specialty Gases Division,
Plumsteadville, Pennsylvania, by letter February 19, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit.
REASON Product actually contains 5% C02, 12% 02, and balance N2.
PRODUCT LEEP RediKit for LOOP Electrosurgical Excision Procedure, a
single use prescription device which is used in conjunction
with other devices in the removal of lesions of the cervix and
similar minor gynecological surgery procedures.
Recall #Z-675-2.
CODE Lot numbers: 0691, 10709, 10724, 10805L, 10922L, 11112L,
10918L, 10919L, 10920L, 10921L, 10923L, 10924L, 10925L, 11108L,
11112L, 11118L, 11119L, 11121L, 11125L, 11127L, 11203L, 11204L,
11209L, 11211L, 11214L, 11215L, 20106L, 20115L, 20123L, 20204L,
20205L, 20303L, 20306L, 20311L, 20316L. CooperSurgical label
identifies the product as reorder #6060; the Euro-Med private
label identifies the product as reorder #LEEP-5.
MANUFACTURER Astra Pharmaceutical Products, Inc., Westborough,
Massachusetts, (supplier of the defective xylocaine (2%) with
Epinephrine (1:100,000) component).
RECALLED BY Cooper Surgical, Inc., Shelton, Connecticut, by letter April
3-6, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 13,352 kits were distributed.
REASON A component of the kits, 2% Xylocaine Injection Cartridge with
Epinephrine 1:100,000, may contain subpotent epinephrine. The
drug component has been recalled by the manufacturer, ASTRA
Pharmaceutical Products, Inc. (Recall #D-286/287-2).
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
PRODUCT Counterfeit Drug Product - 1% Ivomec and Ivomec-F Injection for
cattle. Recall #V-039-2.
CODE NBC 110 OCT 92.
MANUFACTURER Tampa Independent Dairy Farmer's Association, Tampa, Florida
(distributor).
RECALLED BY Distributor, by visit in January 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Florida, Georgia.
QUANTITY 500 bottles were distributed.
REASON Counterfeit drug product.
PRODUCT Counterfeit Drug Product - 1% Ivomec and Ivomec-F Injection for
cattle, in 500 ml bottles. Recall #V-040-2.
CODE All codes that contain one or more of the counterfeit
characteristics.
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MANUFACTURER Poultry Health Service of Florida, Inc., Jacksonville, Florida
(distributor).
RECALLED BY Distributor, by visit and by letter during February/March
1992. Firm-initiated recall ongoing.
DISTRIBUTION Florida.
QUANTITY 1,651 bottles were distributed.
REASON Counterfeit drug product.
SEIZURES:
PRODUCT Oxygen USP (92-609-471).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the manufacture, processing, packing, and
holding do not conform to and are not operated and administered
in conformity with current good manufacturing practice
regulations.
FIRM Superior Medical Supply, Inc., Villa Park, Illinois.
FILED May 6, 1992 - U.S. District Court for the Northern District of
Illinois, Eastern Division; Civil #92C2980; FDC #66428.
SEIZED May 7, 1992 - oxygen, valued at approximately $18,764.
DISPOSITIONS: INJUNCTION
AGAINST Vital Health Products, Ltd., a corporation, and Conrad E.
LeBeau, an individual.
PRODUCT Hydrogen peroxide products (90-564-146, et al.).
CHARGE New drug - Manufacturing, packaging, or distributing hydrogen
peroxide products, and other related products with no approved
new drug application in effect for such products;
Misbranded - Promoting, labeling, advertising, or representing
that hydrogen peroxide products are safe and effective in the
cure, mitigation, treatment, or prevention of human disease,
with no approved new drug application in effect for such
products.
FILED April 12, 1991 - Complaint; March 16, 1992 - Decision and
Order; U.S. District Court for the Eastern District of
Wisconsin; Civ. #91-C-363; INJ #1243.
DISPOSITION The government's motion for summary judgment was granted and
the corporation and its president have been permanently
enjoined from promoting and selling hydrogen peroxide products
for use in the treatment of serious diseases, including AIDS
and cancer.
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END OF ENFORCEMENT FOR MAY 20, 1992. BLANK PAGES MAY FOLLOW.
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