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
08/14/1990
FDA Enforcement for the week of August 15, 1990.
FDA ENFORCEMENT REPORT
FOR AUGUST 15, 1990
August 15, 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.
NONE
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: Roberto's Low Moisture Mozzarella Fresca Cheese,
processed into the shape of a ball which has a net
weight of 8 ounces. Recall #F-567-0.
Code: Individual balls are uncoded, cases may be coded 2-7.
Manufacturer: A. Roberto Cheese Factory, Inc., East Canton, Ohio.
Recalled by: Manufacturer, by visit May 21, 1990. Firm-
initiated recall complete.
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Distribution: Ohio.
Quantity: 20 cases (24 balls/case) were distributed; firm estimates
none remains on market.
Reason: Product is contaminated with E. coli.
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Product: "Mallard Pond" Porcelain Salad Plates, 7-1/2 inches
in diameter, with a duck and floral pattern on a black
background. Recall #F-568-0.
Code: Item number 40/254.
Manufacturer: Chunicki Toki K.K., Nagoya, Japan.
Recalled by: Fitz & Floyd, Carrollton, Texas, by letter May 18, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 288 plates were distributed.
Reason: Product contains excessive levels of leachable lead.
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Product: Generic Creamy Peanut Butter, in 64 ounce plastic tubs.
Recall #F-570-0.
Code: 1441.
Manufacturer: Preferred Products, Inc., Chaska, Minnesota.
Recalled by: Manufacturer, by letter June 13, 1990. Firm-initiated
recall ongoing.
Distribution: Alabama, Colorado, Indiana, Louisiana, Minnesota,
Mississippi, Montana, Ohio, Pennsylvania, Wisconsin.
Quantity: 752 cases (6 tubs/case) were distributed.
Reason: Product exceeds the established FDA action level for
aflatoxin.
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Product: (a) Shepherd's Pie; (b) Goulash, both products are
packed in 4 inch aluminum pie plates, net weight
unknown. Recall #F-571/572-0.
Code: (a) 2102, Pull Date 5/2/90; (b) 2101, Pull Date 5/5/90.
Manufacturer: Patrick's Food Service, Inc., Plattsburgh, New York.
Recalled by: Manufacturer, by telephone on or about May 10, 1990
followed by letter dated May 10 and 12, 1990.
Firm-initiated recall ongoing.
Distribution: Vermont, New York.
Quantity: (a) 102 units; (b) 122 units were distributed; firm
estimates none remains on market.
Reason: Salmonella contamination.
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Product: Skim Milk in gallon, 1/2 gallon and quart containers
and Half & Half in quart containers. Recall #F-576-0.
Code: Pull date May 30.
Manufacturer: Mathis Dairy, Decatur, Georgia.
Recalled by: Manufacturer, by telephone May 22, 1990 followed by
letter. Firm-initiated recall complete.
Distribution: Georgia, Florida.
Quantity: Approximately 3,274 gallons of skim milk and approximately
252 gallons of Half & Half was distributed.
Reason: Products contain beta lactam residue.
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Product: Various imported ceramicware pieces (VM pattern):
(a) 8 ounce Mug; (b) 16" Serving Bowl;
(c) 12.5" Plate/Service; (d) 10" Plate/Dinner;
(e) 8" Plate/Salad; (f) 7" Pasta Bowl. Recall #F-579/584-0.
Code: Not coded.
Manufacturer: Nicola Fasano, Italy.
Recalled by: Rosanna Imports, Inc., Seattle, Washington (importer), by
telephone June 18, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,624 pieces were imported; firm estimates 682 pieces
remain in circulation.
Reason: Products contain excessive levels of leachable lead.
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Product: Various sesame seed products in 50 pound bags:
(a) Recleaned Natural Sesame Seed;
(b) White Hulled Sesame Seed;
(c) Toasted Hulled Sesame Seed;
(d) Washed Natural Sesame Seed;
(e) Toasted Washed Natural Sesame Seed.
Recall #F-585/589-0.
Code: L2-08-90, L2-10-90, L2-12-90, L2-13-90, L2-16-90;
L2-20-90, L2-21-90, L2-23-90, L2-26-90, L3-90.
Manufacturer: Sesame Products, Inc., Paris, Texas.
Recalled by: McCormick & Company, Inc., Hunt Valley, Maryland, by
telephone April 7, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 8,156 bags (407,800 pounds) were distributed; firm
estimates 304,288 pounds remain on market.
Reason: Products are contaminated with Lindane/BHC and DDT.
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Product: Fresh Marlin, bulk 10 pound chunks. Recall #F-590-0.
Code: Not coded.
Manufacturer: Coopemontecillos, Santa Jose, Costa Rica.
Recalled by: Robert-Orr Sysco Food Services, Nashville, Tennessee
(dealer), by telephone June 13, 1990. Firm-initiated
recall ongoing.
Distribution: Tennessee, Alabama.
Quantity: Approximately 338.4 pounds.
Reason: Decomposition/histamine contamination.
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Product: Diamond Crystal Reduced Calorie Mayonnaise (low sodium),
in 32 ounce glass jars. Recall #F-594-0.
Code: Use by NOV. 18 90H.
Manufacturer: Holsum Foods, Waukeshe, Wisconsin.
Recalled by: Diamond Crystal Specialty Foods, Wilmington, Massachusetts,
by letter May 15, 1990. Firm initiated recall ongoing.
Distribution: California, Washington state, Oregon, Texas.
Quantity: Approximately 300 cartons (12 jars/carton) were distributed.
Reason: Product is contaminated with Lactobacillus, yeast and
anaerobic organisms.
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CORRECTION: The following replaces information for Recall #F-538-0
which appeared in the July 18, 1990 Enforcement Report:
Product: Assorted Fruit Flavored Ice in plastic bags, labeled in
part, "Alaskito Sabores Surtidos Barras Para Congelar."
Recall #F-538-0.
Code: None.
Manufacturer: Alonso Corporation, Bayamon, Puerto Rico.
Recalled by: Manufacturer, by letter April 19, 1990. Firm-initiated
field correction ongoing.
Distribution: Puerto Rico.
Quantity: 900 cases were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
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Fruit Flavored Gelatin, which appeared in the July 18, 1990
Enforcement Report as Recall #F-538-0 should read:
Product: El Pinguino brand Fruit Flavored Gelatin. Recall #F-591-0.
Code: June 6, 1990.
Manufacturer: Parajon Corporation, Bayamon, Puerto Rico.
Recalled by: Manufacturer, by letter April 11, 1990. Firm-initiated field
correction ongoing.
Distribution: Puerto Rico.
Quantity: 115 cases were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
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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: Big Bite Deep Sea Frozen Lobster Tails, in 33.31 pound
cases. Recall #F-566-0.
Code: Lot numbers: 8774, 8400.
Manufacturer: Niagara Frontier Service, doing business as Tops
Markets, Buffalo, New York.
Recalled by: Manufacturer, by letter May 19, 1990. Firm-initiated
recall ongoing.
Distribution: New York, Pennsylvania.
Quantity: 46 cases were distributed.
Reason: Product contains undeclared sulfites.
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Product: Lilly brand vitamin-mineral preparations:
(a) Dibasic Calcium Phosphate with Vitamin D Capsules,
in bottles of 100;
(b) Calcium Gluconate with Vitamin D Capsules, in
bottles of 100. Recall #F-577/578-0.
Code: Lot numbers EXP dates:
(a) 2NK98A 6/1/90
2PS87A 10/1/90
3AH18B 3/1/91
3AX50A 5/1/91;
(b) 2NK99A 8/1/90
2AZ88A 4/1/91.
Manufacturer: Eli Lilly & Company, Indianapolis, Indiana.
Recalled by: Manufacturer, by letter May 16, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: (a) 9,680 bottles; (b) 5,776 bottles were
distributed.
Reason: Products are subpotent. Vitamin D level is either below
80% of label declaration or decreasing and may fall below 80%
before product expiration date.
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Product: Vinegar (clear) in clear plastic 16 ounce bottles
with a white plastic cap and white label with black
print which reads in part: "Bohio Vinagre**Con No Menos
De 4 Gramos De Acido Acetico Subasta Numero: S.F.
89-04=94 **Empacado Por Henframar Corp., San Juan,
PR**, Recall #F-592-0.
Code: Subasta Numero: S.F. 89-094 printed on the bottle's label
and shipping case.
Manufacturer: Henframar Corporation, Bayamon, Puerto Rico.
Recalled by: Manufacturer, by telephone May 9, 1990. Firm-initiated
recall ongoing.
Distribution: Puerto Rico.
-5-
Quantity: 2,000 cases (24 bottles/case) were distributed.
Reason: Dilute acetic acid was packaged as vinegar containing
floating particulate matter.
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Product: Land-O-Lakes, Extra Grade Sweet Dairy Whey Dry Sweet Whey
in 50 pound bags. Recall #F-593-0.
Code: Product code 27231, lot #0069.
Manufacturer: Alto Golden Guernsey Dairy Cooperative, Waupun, Wisconsin.
Recalled by: Land O' Lakes, Inc., Arden Hills, Minnesota (distributor),
by telephone on or about May 21, 1990. Firm-initiated
recall complete.
Distribution: Ohio, Wisconsin.
Quantity: 3,150 bags were distributed.
Reason: Product is contaminated with pieces of rubber and
fiber sheeting possibly originated with a conveyer belt.
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HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Clonidine Hydrochloride Tablets, USP, (a) 0.1 mg;
(b) 0.2 mg; (c) 0.3 mg, in 100, 500 and 1,000 tablet bottles,
an Rx drug for the treatment of hypertension, under the
following labels: Interpharm, Genetco, J.J. Balan, United
Research Laboratories, Best Generics, Gen-King Products.
Recall #D-334/336-0.
Code: All lots within expiration date.
Manufacturer: Interpharm, Inc., Plainview, New York.
Recalled by: Manufacturer, by telephone June 28-29, 1990 followed by
letter July 2, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 9,459,200; (b) 11,396,700; (c) 2,976,000 tablets
were distributed; firm estimates 25 to 30 percent remains
on market.
Reason: Lack of assurance of bioequivalency and Abbreviated New
Drug Application (ANDA) discrepancies.
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Class III -
NONE
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
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Class II -
Product: USCI Disposable Tandem Y-Adapter and Insertion Tool,
packed in a single unit tyvec pouch. The Tandem Y-
Adapter is a device which attaches to a guiding
catheter or balloon introducer hub allowing access of one
or more dilatation system components used during a
transluminal coronary angioplasty procedure.
Recall #Z-769-0.
Code: Item #009200, lot numbers: 528951, 528952, 08CA0060,
08DA0256, 08DA0454, 08DA1779, 08DA1780, 08DA2083,
08EA0032, 08EA1377, 08EA1378, 08EA1382, 08EA1383,
08EA1384.
Manufacturer: USCI Division, C.R. Bard, Inc., Billerica, Massachusetts.
Recalled by: Manufacturer, by letter July 27, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Ireland.
Quantity: 5,624 units were distributed; firm estimates 3,974
units remain on market.
Reason: The sealing gasket under the cap has a potential of
becoming lodged in the adapter body after the cap has
been tightened and then loosened, thereby restricting
access to the port.
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Product: Sterile custom medical trays:
(a) Tray No. A60291A Sterile Custom Tray Packing
Laceration Pak;
(b) Tray No. A1044 Sterile Custom Tray Packaging
Custom Suture;
(c) Tray No. A612152, 10 X-Ray Sponges and Safety Pin;
(d) Tray No. A4046 Sterile Custom tray Packaging Suture
Removal. Recall #Z-770/773-0.
Code: Sterile Lot #1670.
Manufacturer: Carapace, Inc., Broken Arrow, Oklahoma.
Recalled by: Manufacturer, by telephone March 28, 1990 followed by
letter April 9, 1990. Firm-initiated recall complete.
Distribution: California, Illinois, Oklahoma, Texas.
Quantity: Firm estimates none remains on market.
Reason: Certain instruments in these trays may have developed rust
following sterilization process.
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Product: Occucoat Hydroxypropylmethylcellulose Kit, containing, a
viscoelastic solution used during anterior ophthalmic
cataract/intraocular lens (IOL) surgery to maintain
the shape of the eye following cataract extraction and
as a lubricant to protect tissues against irritation
during surgery.. Recall #Z-775-0.
Code: Product #M685EL, sterile lot #0005 EXP 4/91.
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Manufacturer: Storz Ophthamics, Inc., Clearwater, Florida.
Recalled by: Manufacturer, by telephone April 12, 1990 followed by
letter. Firm-initiated recall complete.
Distribution: Nationwide, Brazil.
Quantity: 6,697 kits were distributed.
Reason: The cannulas of the syringe may leak.
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Product: QSI 9000 EEG Normative Data Base for Analyzing EEG
(electroencephalogram) records. Recall #Z-776-0.
Code: Not applicable.
Manufacturer: Quantified Signal Imaging, Inc., Toronto, Ontario/
Boulder, Colorado.
Recalled by: Manufacturer, by letter on or about July 18, 1990.
Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 30 units were distributed to domestic
accounts, international distribution is unknown.
Reason: The device was marketed without required premarket
approval authorization. Firm is revising labeling to
indicate that the device should not be used for
diagnosing clinical conditions such as Tumor, Schizophrenia,
Alzheimer's Disease, Head Injury or Obsessive-Compulsive
Disorders and that the data base should not be used as a
sole means of analyzing EEG records.
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Class III -
Product: Davol Reliavac PVC Silicone Drain, medium large, 3/16"
O.D. x 12.5" hole pattern, paque stripe, single-use
sterile, packed in a single unit tyvec pouch, 10 to a
a case. The intent of the product is removal of blood, pus,
and other types of exudate from a surgical wound.
Recall #Z-764-0.
Code: Product #003468-0; Lot #21A05R01.
Manufacturer: Davol Inc., Lawrence, Kansas.
Recalled by: Davol Inc., Cranston, Rhode Island, by telephone July 9, 1990
followed by letter. Firm-initiated recall ongoing.
Distribution: Oregon, Georgia, Indiana, Pennsylvania, Oklahoma,
Japan, Hong Kong.
Quantity: 240 units were distributed; firm estimates 82 units
remain on market.
Reason: The product in the package is not the product described
on the package label. The product described on the label
is a 3/16" drain whereas the product in the package is 1/4".
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Product: ABL brand QCheck Reagent Quality Control Panels, product
consists of plastic trays containing dried chemicals
intended for the quality control of reagents used to
differentiate microorganisms. Recall #Z-774-0.
Code: Catalog #247-969, lot #81E0292.
Manufacturer: Austin Biological Labs, Inc., Austin, Texas.
Recalled by: Manufacturer, by telephone June 5, 1990. Firm-initiated
recall ongoing.
Distribution: Illinois, Ohio, Michigan, Florida, Washington state, Texas,
Georgia, New York, Washington, D.C., Kentucky, California,
New Mexico, Massachusetts, Missouri, Maryland, Colorado,
Puerto Rico.
Quantity: 584 kits were distributed.
Reason: The indole substrate (well No. 2 of the 10 well tray)
may breakdown and give variable results.
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VETERINARY PRODUCTS
NONE