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
07/17/1990
FDA Enforcement for the week of July 18,1990
FDA ENFORCEMENT REPORT
FOR JULY 18, 1990
July 18, 1990
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: Selected Greek Golden Peppers in Brine, packaged in
5 gallon (30 pound) red plastic barrels labeled in part
Panagiotis Lagiakos Calamata Greece and in 1 gallon
plastic jars with hand lettered labels reading in part
Cosmos Food Ltd. Peperchine Salonika Peppers.
Recall #F-520-0.
Code: Not coded.
Manufacturer: Panagiotis D. Lagiakos, Calamata, Greece.
Recalled by: Cosmos Foods Ltd., Chicago, Illinois, by telephone
April 17, 1990 followed by letter April 18, 1990.
Firm-initiated recall ongoing.
Distribution: Illinois.
Quantity: 51/5 gallon barrels and 36/1 gallon jars were distributed.
Reason: Product contains undeclared sulfites.
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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: SunnyFresh 35 Orange Juice Cocktail, in 64 ounce plastic
bottles. Recall #F-523-0.
Code: All lots manufactured before 3/5/90.
Manufacturer: Juiceland, Inc., Detroit, Michigan.
Recalled by: Manufacturer, by visit beginning March 8, 1990. Firm-
initiated field correction ongoing.
Distribution: Michigan.
Quantity: Unknown.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Leslie Ann brand (a) Candy Corn in 6 ounce bags;
(b) Butter Mints, in 5 ounce bags. Recall #F-524/525-0.
Code: Not coded.
Manufacturer: (a) Henry Heide, New Brunswick, New Jersey;
(b) Richardson Mints, Philadelphia, Pennsylvania.
Recalled by: Becksmith Company, Cincinnati, Ohio by visit June 11, 1990.
Firm-initiated recall ongoing.
Distribution: Ohio, Kentucky.
Quantity: Firm estimates (a) none; (b) 24 bags remain on market.
Reason: Product contains undeclared FD&C Yellow No. 5.
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Product: Oak Lake Farm brand gelatin desserts/salad:
(a) Jewel Parfait, 13-1/2 ounces, a strawberry/lemon
flavored gelatin dessert;
(b) Orange Parfait, 13-1/2 ounces, a gelatin dessert
molded in a plastic container;
(c) Fruit Salad, 21-1/2 ounces, a molded gelatin which
contains fruit cocktail. Recall #F-527/529-0.
Code: All lots containing undeclared FD&C Yellow No. 5.
Manufacturer: Allen Division of J. Marzetti Company, Columbus, Ohio.
Recalled by: Manufacturer, by letter on or about November 29, 1989.
Firm-initiated field correction ongoing.
Distribution: Ohio, Indiana, New York.
Quantity: Unknown.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Lucilles Own Make Candies:
(a) Orange Creams, milk, dark chocolate, 5 or 6 pounds;
(b) Lemon Creams, milk, dark chocolate, 5 or 6 pounds;
(c) Orange Jellies 5 or 6 pounds;
(d) Orange Jellies/Salt Free, 1 pound. Recall #F-530/533-0.
-2-
Code: All lots containing undeclared FD&C Yellow No. 5.
Product codes are used on the bulk box labels only.
The letters used are L through Y omitting V & W
designating month of manufacture.
Manufacturer: Lucilles Own Make Candies, Manahawkin, New Jersey.
Recalled by: Manufacturer, by letter dated April 25, 1990. Firm-
initiated field correction ongoing.
Distribution: New Jersey, Pennsylvania, New York, Maryland, Rhode Island,
New Hampshire, New Mexico, South Carolina, Arizona, North
Carolina, Wisconsin.
Quantity: 33,098 pounds were distributed; firm estimated 5,092
pounds remained on market at time of recall.
Reason: Product contains undeclared FD&C Yellow No. 5.
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Product: Biermann Marzipan, in 8.5 ounce and 34 ounce boxes, a
pecan specialty candy. Recall #F-534-0.
Code: All lots containing undeclared FD&C Yellow No. 5.
Item #B5 (8.1 oz), #B310 (34 oz).
Manufacturer: Biermann Marzipan Company, North Bergen, New Jersey.
Recalled by: Manufacturer, by letter on or about April 24, 1990
followed by telephone. Firm-initiated field correction
ongoing.
Distribution: New York, New Jersey.
Quantity: 195 cases (24 boxes/case) of 8-1/2 ounce boxes and
25 cases (10 boxes/case) of 34 ounce boxes were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Fantis brand Yellow Egg Dye in paper envelope.
Recall #F-535-0.
Code: Not coded.
Manufacturer: Tricon Colors, Inc., Elmwood Park, New Jersey.
Recalled by: Fantis Foods Inc., Carlstadt, New Jersey (repacker/
responsible firm), by telephone followed by letter
April 4, 1990. Firm-initiated recall ongoing.
Distribution: Eastern and midwestern United States.
Quantity: 614 envelopes were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
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Product: Holsum Bakers of Puerto Rico brand Premium Tiger Buns,
21.5 ounces. Recall #F-537-0.
Code: ABR01 SELL by ABR5.
Manufacturer: Holsum Bakers of Puerto Rico, Toa Baja, Puerto Rico.
Recalled by: Manufacturer, by letter April 3, 1990 Firm-initiated
recall ongoing.
Distribution: Puerto Rico.
Quantity: This lot consisted of 650 units; firm estimates none
remains on market.
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Reason: Product contained undeclared FD&C Yellow No. 5.
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Product: Fruit Flavored Gelatin, in 3 ounce plastic cups.
Recall #F-538-0.
Code: JUNE 6, 1990.
Manufacturer: Alonso Corporation, Bayamon, Puerto Rico.
Recalled by: Manufacturer, by visit followed by letter mailed April
11, 1990. Firm-initiated field correction ongoing.
Distribution: Puerto Rico.
Quantity: 115 cases (12 units/case) were distributed; firm estimated
300 cases remained on market at time of recall.
Reason: Product contains undeclared FD&C Yellow No. 5.
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Product: Crystal Clear brand Spring Water, in 16 fluid ounce
plastic bottle. Recall #F-539-0.
Code: Lot #088A.
Manufacturer: West Lynn Creamery, Lynn, Massachusetts.
Recalled by: Manufacturer, by telephone April 18, 1990. Firm-initiated
recall complete.
Distribution: Vermont.
Quantity: 125 cases (12 bottles/case) were distributed.
Reason: Product has ained fish-smell or taste/burning sensation
due to sodium hydroxide contamination.
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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.
NONE
COSMETICS
Class I -
NONE
Class II -
Product: (a) Mennen Baby Magic Rich N'Creamy Baby Oil, in 2 ounce,
9 ounce and in 12 ounce bottles;
(b) Mennen Baby Magic Rich N'Creamy Baby Oil and Aloe,
in 9 ounce plastic bottles. Recall #F-541/542-0.
Code: Lot numbers: (a) 7JN, 8JN, 8NJ2 (9 oz); 8324 (12 oz);
28JK (2 oz); case codes: J14JN, J16JN, J19JN, J20JN, J21JN,
J10JP, J11JP, J12JP, J14JP;
(b) 9107, 9108, 9109 (case); 9107, 91072, 91073, 91074, 9108,
91092, 91083, 91084, 9109, 91092, 91093, 91094 (bottles).
Manufacturer: The Mennen Company, Morristown, New Jersey.
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Recalled by: Manufacturer, by telephone April 12, 1990 followed by
letter April 20, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Approximately (a) 40,000; (b) 180,000 units remain
on market.
Reason: Products are contaminated with Pseudomonas cepacia.
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Class III -
Product: Makismo Hair Groom and Conditioner, in 2 ounce bottles.
Recall #F-540-0.
Code: Lot #09408.
Manufacturer: Majestic Drug Company, Bronx, New York.
Recalled by: Manufacturer, by visit. Firm-initiated recall ongoing.
Distribution: South American countries.
Quantity: 9,288 bottles were distributed.
Reason: Product is contaminated with Pseudomonas cepacia.
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HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Platelets. Recall #B-159-0.
Code: Unit #8015648.
Manufacturer: Broward Community Blood Center, Inc., Lauderhill, Florida.
Recalled by: Manufacturer, by telephone January 24, 1990. Firm-initiated
recall complete.
Distribution: New Jersey.
Quantity: 1 unit was distributed.
Reason: Blood product which tested repeatably reactive for the
antibody to the human T-lymphotropic virus type I
(anti-HTLV-I) was distributed.
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Class III -
NONE
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Advantx and Non-Advantx 8835 and 8535 Spot Film Devices.
Recall #Z-670/671-0.
Code: All units shipped before November 15, 1989.
Serial numbers: Non-Advantx 8835 SFD Model --
46-250302G1 (all units), 46-250302G2 (all units),
46-250302G3 (all units);
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Advantx 8835 SFD Model 46-250302G4 (all units),
8535 SFD Model 46-250302G5 (all units),
8835 SFD Model 46-250302G6 (all units),
8535 SFD Model 46-250302G7 (all units),
8835 SFD Model 46-250302G8 (early production),
Non-Advantx 8835 SFD Model 46-250302G9 (early production),
Advantx 8535 SFD Model 46-250302G10 (early production),
Non-Advantx 8535 SFD Model 46-250302G11 (early production).
Manufacturer: General Electric Company, Milwaukee, Wisconsin.
Recalled by: FDA approved the firm's corrective action plan May 29,
1990. Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: 1,110 were distributed.
Reason: Noncompliance with performance standard for x-ray
products in that the x-ray transmission through the
primary protective barrier exceeds the acceptable
limits.
----
Product: Model Rainbow 1AF Laser Projector, used for laser
light shows. Recall #Z-692-0.
Code: Serial #10001.
Manufacturer: Laser Fantasy, Redmond, Washington.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan June 11, 1990. Firm-initiated field correction
ongoing.
Distribution: Indiana.
Quantity: 1 unit was distributed.
Reason: Noncompliance with performance standard for laser products
in that labeling and wiring are inadequate.
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Product: Latex condoms, lubricated and non-lubricated:
(a) Saxon Ultra-Thin, 1 dozen per box;
(b) Saxon Wet-Lubricated, 1 dozen per box;
(c) Saxon Spermicidal with Nonoxynol-9, 1 dozen per box;
(d) Gold Circle Coin, 6 coins/box. Recall #Z-699/702-0.
Code: Lot numbers: (a) 24D03, 15H94, 15E04, 27D03, 2D02, 2D03;
(b) 23H91; (c) 1H91; (d) 27G93.
Manufacturer: Safetex Corporation, Colonial Heights, Virginia.
Recalled by: Manufacturer, by letter beginning on or about
June 18, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: (a) 938 gross; (b) 138 gross; (c) 12 gross;
(d) 168 gross were distributed.
Reason: The tested condoms failed water leak test.
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Product: Medicon/Aequitron respiration/Heart Rate Monitors:
(a) Medicon Medical Inc., Model 8200 Infant
Respiration/Heart Rate Monitor;
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(b) Aequitron Medical Inc., Model 8200 Infant
Respiration/Heart Rate Monitor;
(c) Aequitron Medical Inc., Model 9200 Respiration/Heart
Rate Monitor;
(d) Aequitron Medical Inc., Model 9500 Respiration/Heart
Rate Monitor;
(e) Aequitron Medical Inc., Model 9550 Respiration/Heart
Rate Monitor. These monitors are Rx devices used to
detect and alarm in the event of low or high heart rates
and to detect and alarm in the event of apnea.
Recall #Z-710/714-0.
Code: All serial numbers.
Manufacturer: Aequitron Medical, Inc., Plymouth, Minnesota.
Recalled by: Manufacturer, by letter June 23, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 47,092 units were distributed.
Reason: The monitors exhibit a sensitivity to electromagnetic
interference (EMI) which could cause a failure to alarm in
the event of apnea.
----
Product: Conmed Pleura - Gard Chest Drainage System, a sterile Rx
device used for drainage of the thoracic or mediastinal
cavity. Recall #Z-717-0.
Code: Catalog #660-1668, Lot #CME 739 (on cases only)
EXP 12 MAR 93.
Manufacturer: Conmed Corporation, Utica, New York.
Recalled by: Manufacturer, by telephone May 17-18, 1990. Firm-initiated
recall ongoing.
Distribution: California.
Quantity: 3 cases (5 pouches/case) were distributed.
Reason: The sterility of the device may be compromised due to
pin holes on inside of pouch.
----
Product: Beta 3000M Mobile and Fixed Site Magnetic Resonance
Imaging Scanner, used in production of images of
multiple planes in the head and body. Recall #Z-718-0.
Code: All units installed prior to 3/23/89.
Manufacturer: Fonar Corporation, Melville, New York.
Recalled by: Manufacturer, by memorandum January 19, 1989 followed by
visit. Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: 121 units are currently in operation; 23 units have
been retorfitted.
Reason: The bed slab of the scanner may catch the patient's
fingers.
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Product: (a) Medicon/Aequitron Model 8200 Infant Respiration/Heart
Rate Monitor;
(b) Aequitron Model 9200 Respiration/Heart Rate Monitor.
Products are Class II Rx devices used to detect and alarm
in the event of low or high heart rates; and to detect and
alarm in the event of apnea. Recall #Z-719/720-0.
Code: Serial numbers: (a) 050000 through 067016;
(b) 352791 through 361828.
Manufacturer: Aequitron Medical, Inc., Plymouth, Minnesota.
Recalled by: Manufacturer, by letter June 23, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Switzerland, Taiwan, Brazil, Denmark, Canada,
West Germany.
Quantity: (a) 12015; (b) 9,037 units were distributed.
Reason: The devices have a potential for an apnea alarm reset
condition which may result in the failure of the
monitor to continuously alarm during an apnea event.
----
Product: Ultramark 6 CAD for the Ultramark 6 System, used to
make various assessments of the heart. Ultramark 6 CAD
is a cardiac analysis option added to an Ultramark 6 System.
Recall Z-721-0.
Code: Serial numbers: 102929, 102850, V102302, 102429A,
G102363, 102848, 102834A, 102959, 102865, 102806C,
102931, 102872, G102190, 102786C, 102836, V102826,
102737A.
Manufacturer: Nova Microsonics, Mahwah, New Jersey (software).
Fijitsu Ltd., Inc., Kawasaki, Japan (hardware).
Recalled by: Advanced Technology Laboratories, Bothell, Washington,
by telephone October 13, 1989 followed by letter
October 17, 1989. Firm-initiated field correction complete.
Distribution: Nationwide.
Quantity: 17 units were distributed.
Reason: The software calculation package does not prevent the
use of the data/calculations in 6 specific operational
modes of the cardiac analysis package in which this data
or calculations would display a scaling error.
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Product: Redy Lines Plasmapheresis Kit, indicated for use in
performing therapeutic plasma exchange to remove
circulating plasma components or protein bound toxins.
Recall #Z-722-0.
Code: Lot #ATOC-15, product #41335 (kit),
Lot #L0A012, "insert part number 409-0012-01 REV E"
(BloodAet).
Manufacturer: Organon Teknika, Oklahoma City, Oklahoma (kit).
Recalled by: Manufacturer, by telephone and by letter April 12, 1990.
Firm-initiated recall complete.
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Distribution: California, Florida, Missouri, Mississippi, New York, Ohio.
Quantity: 19 cases (5 kits/case) were distributed.
Reason: The portion which connects to the Curesis plasmafilter
has a tapered blood port connector. As a result, it is
impossible to connect these bloodsets to the Curesis
plasma filter without altering the set.
----
Class III -
Product: Coulter Electronics Dacos Cuvets, a plastic device used in
conjunction with a Dacos Chemistry Analyzer for in-vitro
diagnostic tests. Recall #Z-703-0.
Code: CMS #096-537 (distributor code), catalog #6603624;
part #1016508; lot numbers 010709 through 071109.
Manufacturer: Tech Plastics, Inc., Tempe, Arizona (contract mfr.).
Recalled by: Coulter Electronics, Hialeah, Florida, by letter March
14, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, England, West Germany, France, Japan, Italy.
Quantity: 140,000 units were distributed.
Reason: Certain lots have an unacceptable wall thickness
at the bottom seam.
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Product: Seralyzer Multicomponent Calibrator Kit. The product is
a kit of three vials each of a HI and a LO calibrators used
to establish calibration parameters in Seralyzer analyzers.
The Seralyzer is a reflectance photometer which reads any
of several reagent strips. Recall #Z-715-0.
Code: Lot #0016119B EXP 11/90.
Manufacturer: Miles Inc., Diagnostics Division, Mishawaka, Indiana.
Recalled by: Miles Inc., Diagnostics Division, Elkhart, Indiana, by
letter March 19, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 70,000 kits were distributed; firm estimated 3,000 kits
were in distribution channels when the recall was
initiated.
Reason: Packages of the device may contain vials of high
calibrator material requiring reassignment of values
different from values found in the original package insert.
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Product: Lyse S(R) II Lytic Reagent, in 500 ml bottles, for
in-vitro diagnostic use. Recall #Z-716-0.
Code: Lot #101318F2. Only the product labeled as Lyse III is
under recall.
Manufacturer: Coulter Diagnostics, Florence, Kentucky.
Recalled by: Coulter Electronics, Inc., Hialeah, Florida, by letter
dated February 9, 1990. Firm-initiated recall ongoing.
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Distribution: Nationwide.
Quantity: 587 bottles were distributed.
Reason: Mislabeled -- Some cartons of Lyse II contained Lyse III
and that some Lyse II had been labeled as Lyse III.
----
Product: Coulter STKS with Auto-Reporter 3 Printer. The STKS
system functions as a quantitative, automated hemotology
analyzer and leukocyte differential counter for use in
clinical laboratories. Recall #Z-723-0.
Code: Catalog numbers: 6604024, 6604025, 6604026, 6604137,
6604138, 6604370, 6604371 and part numbers 6604388, 6704657.
Manufacturer: Coulter Electronics, Hialeah, Florida.
Recalled by: Manufacturer, by letter March 21, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide and international.
Quantity: 181 units were distributed.
Reason: When running a sample which has an identifier that is
equivalent to the identifier of a previously run sample,
the device may print results of the prior sample instead
of results of the sample being run.
----
Product: Table of Assigned Values for 4C (R) Plus Normal Cell
Control which accompanies the Tri-Pack Coulter Counter
Cell Contol, for in-vitro diagnostic use. Recall #Z-724-0.
Code: Lot numbers 430 and 430F EXP 6/6/90.
Manufacturer: Coulter Diagnostics, Hialeah, Florida.
Recalled by: Manufacturer, by letter April 4, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide, Canada, Australia.
Quantity: 877 kits (lot 430) and 175 bottles (lot 430F) were
distributed.
Reason: Table of assigned values for the 4C (R) Plus Normal
Cell Control contains erroneous lymphocyte percent and
number values.
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RECLASSIFICATION NOTE: Recall #Z-543-0, Cobe BRAT (Baylor Rapid Autologous
Transfusion System), which appeared in the May 2, 1990
Enforcement Report as a Class II recall has been
reclassified as a Class III.
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VETERINARY PRODUCTS
Class I -
NONE
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Class II -
Product: (a) High Potency Multi-B Complex Injection, an Rx veterinary
product in 100 ml and 250 ml bottles, under the Veterinary
Laboratories, Inc, Champion Pharmaceutical Products, Inc.,
The Butler Company, Durvet, Inc., and Agri Laboratories, Ltd.
labels;
(b) Vitamin B Complex Forte, an Rx veterinary product in
100 ml and 250 ml bottles, under the Vedco Inc label.
Recall #V-050/051-0.
Code: Lot numbers: (a) 900382; (b) 900077.
Manufacturer: Veterinary Laboratories, Inc., Lenexa, Kansas.
Recalled by: Manufacturer, by letter May 29, 1990. Firm-initiated
recall ongoing.
Distribution: (a) Nationwide; (b) Missouri.
Quantity: (a) 6,588 units (100 ml) and 4,538 units (250 ml);
(b) 3,695 units (100 ml) and 2,868 units (250 ml) were
distributed.
Reason: Products were found to be significantly subpotent in vitamin
B12.
----
Class III -
NONE
Medical Device Safety Alerts:
Product: (a) Medicon Medical Inc., Model 8200 Infant Respiration/Heart
Rate Monitor;
(b) Aequitron Medical Inc., Model 8200 Infant
Respiration/Heart Rate Monitor;
(c) Aequitron Medical Inc., Model 9200 Respiration/Heart
Rate Monitor;
(d) Aequitron Medical Inc., Model 9500 Respiration/Heart
Rate Monitor;
(e) Aequitron Medical Inc., Model 9550 Respiration/Heart
Rate Monitor. Safety Alert #M-059/063
Code: All serial numbers.
Manufacturer: Aequitron Medical, Inc., Plymouth, Minnesota.
Alerted by: Manufacturer, by June 23, 1990.
Distribution: Nationwide and international.
Quantity: Approximately (a) 5,000; (b) 24,750; (c) 14,825;
(d) 1,458; (e) 1,034 units were distributed.
Reason: Firm's June 23, 1990 letters alert Apnea Monitoring
Coordinators of the potential of a "NO ALARM" condition for
these monitors possibly due to electromagnetic interference
(EMI). This letter also provided a fix. A letter addressed
"Dear Parent" was included, which provided cautionary
information and instructions to follow.