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
10/23/1991
Recalls and Field Corrections: October 23, 1991
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: Ready to Drink Iced Coffee in 8.5 fluid ounce cans.
Recall #F-006-2.
Code: Exp. Mar. 23. 91 stamped on the bottom of the cans.
Manufacturer: King Car Food Industrial Company, Ltd., Taipei, Taiwan.
Recalled by: J. Sun Enterprises, Inc., Honolulu, Hawaii, by
telephone February 7, 1991. Firm-initiated recall
complete.
Distribution: Hawaii.
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Quantity: 1,150 cartons (24 cans per carton) were distributed.
Reason: Product contains nonpermitted food additive, stevia.
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Product: Frozen Swordfish Fillets (10/60 lbs) individually
packaged in plastic bags labeled "Product of Singapore".
Recall #F-008-2.
Code: None.
Manufacturer: Product of Singapore.
Recalled by: Tri Marine International, San Pedro, California, by
telephone September 12, 1991. Firm-initiated recall
ongoing.
Distribution: California, Colorado, Massachusetts, Ohio, Washington state.
Quantity: 1,300 filets were distributed; FDA estimates that 75%
of the product remains on the market.
Reason: Product contains excessive mercury levels.
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Product: Blue Boy Pickled Beets, in 16 ounce glass jars.
Recall #F-009-2.
Code: Lot #L28306.
Manufacturer: Comstock Michigan Fruit Division, Leichester, New York.
Recalled by: Comstock Michigan Fruit Division, Rochester, New York,
by letter August 14, 1991. Firm-initiated recall ongoing.
Distribution: New York, Pennsylvania.
Quantity: 1,094 cases (12 jars per case) were distributed.
Reason: Product contains glass particles.
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Product: Polar 1 liter and 2 liter Pineapple Soda;
Silver Spring 2 liter Pineapple Flavored Soda.
Recall #F-010-2.
Code: All lots manufactured prior to and including 7/24/91 with
lot numbers less than and including 20592 (1 liter);
All lots manufactured prior to and including 6/3/91
with lot numbers less than and including 2154 (2 liter);
All lots manufactured prior to and including 6/3/91
with lot numbers less than and including 2154 (Silver
Spring 1 liter).
Manufacturer: Polar Corporation, Worcester, Massachusetts.
Recalled by: Manufacturer, by letter September 18, 1991. Firm-
initiated recall ongoing.
Distribution: Massachusetts, New York, Connecticut, Vermont, Maine,
New Hampshire, Rhode Island.
Quantity: Firm estimates 200 cases of 1 liter bottles, 200 cases
of 2 liter bottles and no 2 liter Silver Spring
pineapple soda remains on the market.
Reason: Product contains undeclared FD&C Yellow No. 5.
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Product: Fresh Mako Shark, unlabeled, packed in bulk.
Recall #F-011-2.
Code: None.
Manufacturer: Unknown.
Recalled by: Kaelbel Wholesale, Inc., Pompano Beach, Florida, by
telephone August 20, 1991 followed by letter September 5,
1991. Firm-initiated recall complete.
Distribution: Pennsylvania, New Jersey, Delaware, Georgia.
Quantity: Firm estimates none remains on the market.
Reason: Product contains excessive mercury levels.
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Product: Pucker's Taffy, artificial apple flavor, green in
color, in 0.4 ounce wax paper packages.
Recall #F-015-2.
Code: Not coded. All shipments made between January 1, 1991
through September 5, 1991.
Manufacturer: McGraw Candies, Inc., Farmersville, Texas.
Recalled by: Manufacturer, by telephone September 9, 1991, followed
by letter September 18, 1991. Firm-initiated field
correction ongoing.
Distribution: Illinois, Ohio, Oregon, Massachusetts, Michigan,
Montana, New York, Texas, Utah, Washington state, Wyoming.
Quantity: 43,440 pieces were distributed; firm estimates
that 6,400 pieces were on the market when recall
was initiated.
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: Granulated Garlic, net weight 10.5 ounces, packed in
plastic, screw top bottles. Recall #F-013-2.
Code: None.
Manufacturer: Central Foods & Extracts, Inc., Brooklyn, New York.
Recalled by: Manufacturer, by letter dated April 23, 1991.
Firm-initiated recall ongoing.
Distribution: New Jersey.
Quantity: 20 cases (12 bottles per case) were distributed.
Reason: Product contains 78 percent cereal.
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Product: Bottled Natural Spring Water in a clear flexible
plastic bottle, 12 ounces, 1 liter and 1.5 liter
sizes. Recall #F-014-2.
Code: All lots from C2791 through F1891. This represents
March 27, 1991 through June 18, 1991.
Manufacturer: Halstead Bottling Company, Cumberland Gap,
Tennessee.
Recalled by: Tetron Springs Beverage Company, Dunwoody, Georgia,
by telephone June 19, 1991. Firm-initiated recall
ongoing.
Distribution: Alabama, Georgia, Louisiana, Michigan, North Carolina,
South Carolina, Tennessee.
Quantity: 12,000 cases of 12 1.5-liter bottles, 4,000 cases
of 12 1-liter bottles and 7,000 cases of 24 12-ounce bottles)
were distributed.
Reason: Product contains algae.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma. Recall #B-003/005-2.
Code: Unit #E00026-7.
Manufacturer: St. John's County Blood Bank, Inc., St. Augustine,
Florida.
Recalled by: Manufacturer, by letter April 12, 1991. Firm-initiated
recall ongoing.
Distribution: Florida.
Quantity: 1 unit of each component.
Reason: Blood products from donors who previously tested
repeatably reactive for the human immunodeficiency
virus, type 1 (anti-HIV-1) were distributed.
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Product: (a) Red Blood Cells; (b) Platelets. Recall #B-008/009-2.
Code: Unit #1093196.
Manufacturer: New York Blood Center, Inc., New York, New York.
Recalled by: Manufacturer, by letter and telephone December 5, 1990.
Firm-initiated complete.
Distribution: New York.
Quantity: 1 unit of each component.
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Reason: Blood products, which tested non-reactive for the
antibody to the human T-lymphotropic virus type I
(anti-HTLV-I), but were drawn from a donor who
previously tested repeatably reactive for anti-HTLV-I
on two or more occasions, were distributed for
transfusion.
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Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma; (d) Recovered Plasma. Recall #B-010/013-2.
Code: Unit numbers: (a) 30H16766, 30H93931;
(b) 30H93931; (c) 30H93931; (d) 30H16766.
Manufacturer: American Red Cross, Ashley, Pennsylvania.
Recalled by: Manufacturer, by letter August 2, 1990. Firm-initiated
recall ongoing.
Distribution: Pennsylvania and Switzerland.
Quantity: (a) 2 units; (b) 1 unit; (c) 1 unit; (d) 1 unit.
Reason: Blood products, drawn from donors with a history
of or exposure to hepatitis, were distributed.
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Product: Red Blood Cells. Recall #B-016-2.
Code: Unit #03FF04600.
Manufacturer: American Red Cross, Atlanta, Georgia.
Recalled by: Manufacturer, by telephone June 3, 1991. Firm-initiated
recall complete.
Distribution: Georgia.
Quantity: 1 unit.
Reason: Blood product which tested repeatably reactive for
the antibody to the hepatitis C virus (anti-HCV)
was distributed.
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Class III -
Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-006/007-2.
Code: Unit #J13014-5.
Manufacturer: St. John's County Blood Bank, Inc., St. Augustine,
Florida.
Recalled by: Manufacturer, by letter February 14, 1991. Firm-initiated
recall complete.
Distribution: Florida.
Quantity: 1 unit of each component.
Reason: Blood products from donors who previously tested
repeatably reactive for the human immunodeficiency
virus, type 1 (anti-HIV-1), were distributed.
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Product: (a) Red Blood Cells; (b) Liquid Plasma.
Recall #B-014-015-2.
Code: Unit #N19305.
Manufacturer: Northern Illinois Blood Bank, Rockford, Illinois.
Recalled by: Consignee notified firm about the labeling error July 17,
1991. Recall complete.
Distribution: Illinois.
Quantity: 1 unit of each component.
Reason: Blood products with incorrect expiration dates were
distributed.
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Product: Red Blood Cells. Recall #B-024-2.
Code: Unit numbers: KG21798, KG21799, KG21802, KG21804, KG21805.
Manufacturer: Richmond Metropolitan Blood Services, Inc.,
Richmond, Virginia.
Recalled by: Manufacturer, by telephone July 16, 1991. Firm-initiated
recall complete.
Distribution: Virginia.
Quantity: 5 units.
Reason: Blood products with incorrect expiration dates were
distributed.
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DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Aspen Labs Needle Electrode, a sterile, single-use, prescription
device used in an electrosurgical generator
power source for electrosurgery. Recall #Z-009-2.
Code: Catalog #60-0182-001, lot numbers: A049105, A059105,
A069105, A079105, B049105, B059105.
Manufacturer: Aspen Labs, a subsidiary of CONMED Corp., Englewood,
Colorado.
Recalled by: Manufacturer, by letter September 13, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada, Korea.
Quantity: Approximately 1,890 cases (40 units per case) were
distributed; firm estimates 1,566 cases remain on
the market.
Reason: The sterility has been compromised due to possible loss
of package integrity.
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Class III -
Product: Calibration Gas Standard for Calibration of Blood Gas
Analyzers and Systems, 21% 02/N2 Lot #060931, ED Cylinders,
20 STD cu ft (560 std liters). Labeling states that product
was manufactured for MGC, Medical Graphics Corp.
Recall #Z-030-2.
Code: Lot #060931.
Manufacturer: Scott Medical Products Inc., Scott Specialty Gases
Division, Plumsteadville, Pennsylvania.
Recalled by: Manufacturer. The cylinders were returned to Scott
Medical on or about April 16, 1991. They were correctly
labeled on April 22, 1991 and then returned to Medical
Graphics Corp. Firm-initiated recall complete.
Distribution: Minnesota.
Quantity: 21 cylinders were distributed.
Reason: Cylinders containing 21% 02/N2 gas were labeled as
containing 21% C02/N2 gas.
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VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Wayne Waynextra for Swine #4 Brand Medicated M-4G,
used as a sole ration for the reduction of cervical
abscesses, treatment of bacterial swine enteritis,
maintenance of weight gains, growth promotion and
increased feed efficiency in swine. Recall #V-001-2.
Code: Item #H464-1K.
Manufacturer: Continental Grain Company, Mendota, Illinois.
Recalled by: Continental Grain Company, Vernon Hills, Illinois, by
letter September 17, 1991. Firm-initiated recall ongoing.
Distribution: Illinois, Indiana, Minnesota, Iowa, Wisconsin.
Quantity: 298 bags were distributed; firm estimates 10 bags
remain on the market.
Reason: Feed was found to be subpotent in sulfamethazine.
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Class III -
NONE
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Medical Device Safety Alerts:
Product: Colorado MicroDissection Needle, a non-sterile,
single-use device which connects with an electrosurgical
generator power source, and is used in electrosurgery.
Safety Alert #M-001-2.
Code: All catalog numbers.
Manufacturer: Colorado Biomedical, Inc., Evergreen, Colorado.
Alerted by: Manufacturer, by letter September 16, 1991.
Distribution: Nationwide, Sweden, England, Canada, Mexico, France,
Korea, Japan.
Quantity: Unknown.
Reason: Over use or abuse of this single use needle was
causing the insulation to wear off and expose bare metal.
This could result in electric sparks which might damage
the tissue and or burn the patient.
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