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
07/29/1992
RECALLS AND FIELD CORRECTIONS: July 29, 1992
FOODS - CLASS I
92-31
PRODUCT Frozen Crabmeat, in 1 pound plastic containers.
Recall #F-445-2.
CODE None.
MANUFACTURER M.C. Briggs Shellfish Company, Lamoine, Maine.
RECALLED BY Maine Shellfish Company, Ellsworth, Maine, by telephone June 4,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Maine, New Hampshire, Massachusetts.
QUANTITY 2,706 pounds were distributed.
REASON Product contaminated with Listeria monocytogenes.
PRODUCT Various crabmeat products processed on 7/16/91:
(a) Claw Crabmeat, in 1 pound plastic containers;
(b) Special Crabmeat, in 1 pound plastic containers;
(c) Lump Crabmeat, in 1 pound plastic containers;
(d) Backfin Crabmeat, in 1 pound plastic containers.
Recall #F-446/449-2.
CODE None.
MANUFACTURER Edward's Seafood, Onley, Virginia.
RECALLED BY Manufacturer, by telephone November 4, 1991. Firm-initiated
recall complete.
DISTRIBUTION Maryland, New York, Virginia.
QUANTITY Approximately 620 pounds were distributed.
REASON Products are contaminated with Listeria monocytogenes.
PRODUCT Various crabmeat products, in 1 pound plastic containers,
processed on 10/29/91:
(a) Fresh Claw Crabmeat; (b) Special Crabmeat;
(c) Fresh Lump Crabmeat; (d) Fresh Backfin Crabmeat.
Recall #F-450/453-2.
CODE None.
MANUFACTURER Edward's Seafood, Onley, Virginia.
RECALLED BY Manufacturer, by telephone November 15, 1991. Firm-initiated
recall complete.
DISTRIBUTION New York, Virginia, Washington, D.C.
QUANTITY Approximately 390 pounds were distributed; firm estimates none
remains on the market.
REASON Products were contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
PRODUCT Cotton Club Tropical Delite Fruit Punch Soda, in 2-liter plastic
bottles and in 12 fluid ounce cans. Recall #F-442-2.
CODE All lots.
MANUFACTURER The Cotton Club Bottling Company, Cleveland, Ohio.
RECALLED BY Manufacturer, by telephone June 26, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Ohio, Illinois, New York.
QUANTITY Approximately 5,532 2-liter bottles, 27,035 6-pack cans, and 1,597
12-pack cans were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
PRODUCT (a) Mako Shark, whole dressed, unlabeled; (b) Blacktip Shark,
whole dressed, unlabeled. Recall #F-443/444-2.
CODE None.
MANUFACTURER L.D. Armory & Company, Inc., Hampton, Virginia.
RECALLED BY Manufacturer, by telephone on or about June 23, 1992.
Firm-initiated recall complete.
DISTRIBUTION (a) New Jersey, Virginia, New York, Pennsylvania;
(b) Virginia, Illinois, Ohio, Michigan, Pennsylvania.
QUANTITY (a) 3,290 pounds; (b) 6,497 pounds were distributed.
REASON Product contains high levels of methyl mercury.
PRODUCT (a) Lemon Chicken Sauce labeled as NOH of Hawaii Chinese Lemon
Chicken Sauce mix, in 1-1/2 ounce pouches;
(b) Lemon Chicken Seasoning Mix labeled as NOH made in Hawaii
Chinese Lemon Chicken (Seasoning Mix), in 1 pound and 3 pound
bags. Recall #F-437/438-2.
CODE All lots.
MANUFACTURER Noh Foods International, Honolulu, Hawaii.
RECALLED BY Manufacturer, by stamping FD&C Yellow No. 5 statement on pouches
beginning on or about February 3, 1992. Firm-initiated field
correction ongoing.
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DISTRIBUTION Arizona, California, Hawaii, Maryland, Michigan, Missouri, New
Jersey, Oregon, Vermont, Washington state, New York, Canada, Fiji.
QUANTITY 71,664 1-1/2 ounce pouches and 50 3-pound bags were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
PRODUCT Ultra Slim Fast Chocolate Royale, a weight loss regimen packaged
in 1.16 ounce envelopes. Recall #F-436-2.
CODE Lot #RIPD 1095 A1.
MANUFACTURER Slim Fast Food Company, New York, New York.
RECALLED BY Manufacturer, by letter December 7, 1991. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 27,840 units were distributed.
REASON Product has no ingredient listing.
PRODUCT Mrs. Richardson's Fat Free Fudge Topping. Recall #F-439-2.
CODE Lot numbers: 2Q09D, 2Q30D, 2Q20E, 2Q03F, 2Q07E.
MANUFACTURER Richardson Foods Corporation, Macedon, New York.
RECALLED BY The Quaker Oats Company, Chicago, Illinois, by telephone June
26-29, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,649 cases (12 jars per case) were distributed.
REASON Product is contaminated with mold.
PRODUCT Beech-Nut Stages II Mixed Vegetables, in 4.5 ounce jars sold
individually, in multi-packs and in Vegetable Variety 4-packs.
Recall #F-440-2.
CODE Jar code: E0827*#### 23 10MAR94 (* = letter, #### = military
time), case code: 08-2310E MAR94;
Vegetable Variety 4-pack:
Jar Code Case Code
2427P SEP 93 81-2427P SEP 93
2501P SEP 93 81-2501P SEP 93
2519P SEP 93 81-2519P SEP 93.
MANUFACTURER Beech-Nut Nutrition Corporation, Canajoharie, New York;
Anchor Glass, Connellsville, Pennsylvania (glass manufacturer).
RECALLED BY Beech-Nut Nutrition Corporation, Division of Ralston Purina, St.
Louis, Missouri, by letter June 23, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION East and Mid-west United States, Puerto Rico.
QUANTITY 10,410 cases (24 jars per case) of the individual jars and 2,351
cases of variety packs were distributed.
REASON Product is in defective glass jars which may cause discoloration
of the product.
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PRODUCT Western Family brand Macaroni & Cheese Dinner, in 7.25 ounce
cardboard carton boxes. Recall #F-441-2.
CODE X0312A.
MANUFACTURER Borden/Merlino's Macaroni, Kent, Washington.
RECALLED BY Western Family Foods, Inc., Tigard, Oregon, by letter May 15,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Oregon.
QUANTITY 1,067 cases (24 boxes per case) were distributed.
REASON Product is contaminated with metal shavings.
PRODUCT Lemonade Flavor Gatorade Thirst Quencher, in 64 fluid ounce
plastic bottles. Recall #F-454-2.
CODE Lot #021A2A.
MANUFACTURER Quaker Oats Company, Oakland, California.
RECALLED BY Manufacturer, by letter May 14 and 22, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION California, Hawaii, Guam.
QUANTITY 1,250 cases were distributed; firm estimates none remains on the
market.
REASON Product is contaminated with mold.
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
PRODUCT Euthroid Tablets (Liotrix, USP), in bottles of 100, a Rx thyroid
hormone drug replacement: (a) 1.0 grain; (b) 2.0 grain; (c) 3.0
grain. Recall #D-432/434-2.
CODE All lots.
MANUFACTURER Warner-Lambert, Inc., Vega Baja, Puerto Rico.
RECALLED BY Parke-Davis Division of Warner Lambert Company, Morris Plains, New
Jersey, by letter April 30, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 134,208 bottles; (b) 99,495 bottles; (c) 33,929 bottles were
distributed; firm estimates (a) 6,870 bottles; (b) 6,150 bottles;
(c) 2,325 bottles remain on the market.
REASON Potency not assured through expiration date.
PRODUCT Disopyramide Phosphate Capsules, 100 mg, in bottles of 100, a Rx
drug indicated for the treatment of ventricular arrhythmias.
Recall #D-435-2.
CODE Lot #1C331CI EXP 4/93.
MANUFACTURER Barr Pharmaceuticals, Inc., Northvale, New Jersey.
RECALLED BY Barr Pharmaceuticals, Inc., Pomona, New York, by letter December
9, 1991. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,535 bottles were distributed.
REASON Product does not meet dissolution specifications.
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UPDATE Adenocard (adenosine) 3 mg/ml, Recall #D-398-2, manufactured by
Lyphomed, Division of Fujisawa USA, Inc., which appeared in the
June 24, 1992 Enforcement Report has been extended to include lot
numbers 320398, 320081, and 320249.
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
PRODUCT Dexamethasone Elixir, USP, 0.5 mg/ml, in 120 ml bottles, a Rx oral
anti-inflammatory. Recall #D-431-2.
CODE Lot numbers: 118793 EXP 6/92, 288793 EXP 11/92, 189793 EXP 5/93,
190793 EXP 1/94, 290793 EXP 7/94, 191793 EXP 4/95.
MANUFACTURER Organon, Inc., West Orange, New Jersey.
RECALLED BY Manufacturer, by letter March 18, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 38,175 bottles were distributed; firm estimates 1,000 bottles
remain on the market.
REASON Potency not assured through expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated AHF; (d)
Fresh Frozen Plasma; (e) Platelets, Expired; (f) Source
Leukocytes; (g) Recovered Serum, Pooled; (h) Recovered Plasma,
Pooled; (i) Recovered Plasma. Recall #B-321/329-2.
CODE Unit numbers: (a) 31E47653, 31E50822, 31E54643, 31E58497,
31E77117, 31E88219, 31GF07596, 31H19743, 31H25115, 31K43232,
31R03000, 31R07694, 31Y29951, 31Y30306, 31Y43061;
(b) 31E47653, 31E54643, 31E58497, 31E88219, 31H19743, 31Y30306;
(c) 31E77117, 31E88219, 31GF07596, 31H25115, 31R03000, 31R07694,
31Y29951, 31Y30306, 31Y43061;
(d) 31E47653, 31H19743; (e) 31E50822;
(f) 31E77117, 31GF07596, 31H19743;
(g) 91RB03104 (included unit 31E88219), 90RB1309-1, (unit
31E77117), 89RB3003-1 (unit 31Y29951), 88RB0711-1 (unit 31E50822),
and 88RB3006-1 (unit 31H19743);
(h) 90RB1209-1 (included unit 31E77117);
(i) 31C83835, 31C94569, 31E50822, 31E54425, 31E54643, 31E57114,
31E58497, 31E77117, 31E88175, 31E88219, 31GF07596, 31H25115,
31K43232, 31R03000, 31R07694, 31R73519, 31R86823, 31S91377,
31Y29951, 31Y30306, 31Y43061.
MANUFACTURER American Red Cross Blood Services, Buffalo, New York.
RECALLED BY Manufacturer, by letters dated February 20 and April 16, 1992, for
all products except recovered plasma; and by letters dated
February 13, 1992, April 21 and 22, 1992 for Recovered Plasma.
Firm-initiated recall ongoing.
DISTRIBUTION New York, Washington, D.C., California, Ohio, Oklahoma, South
Carolina, Massachusetts, Switzerland.
QUANTITY (a) 15 units; (b) 6 units; (c) 9 units; (d) 2 units; (e) 1 unit;
(f) 3 units; (g) 5 units; (h) 1 unit; (i) 21 units.
-5-
REASON Blood products, which tested negative for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), but were collected
from donors who previously tested repeatedly reactive for
anti-HIV-1, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
PRODUCT Red Blood Cells. Recall #B-357-2.
CODE Unit #16E16849, 16E16852.
MANUFACTURER American Red Cross, Columbus, Ohio.
RECALLED BY Consignee returned mislabeled units to firm November 16, 1990.
Units were relabeled with correct date and reshipped to hospital.
Recall complete.
DISTRIBUTION Ohio.
QUANTITY 2 units.
REASON Blood products labeled with an incorrect expiration date were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
PRODUCT Portable liquid oxygen therapy units:
(a) Silox 1.2 portable Liquid Oxygen Unit;
(b) Care-Ease II 1.2 Portable Liquid Oxygen Unit.
Recall #Z-882/883-2.
CODE Serial numbers: (a) 469126001 - 469126064;
(b) 719117001 - 719140040.
MANUFACTURER Minnesota Valley Engineering, Inc., New Prague, Minnesota.
RECALLED BY Manufacturer, by fax December 20, 1991. Firm-initiated field
correction ongoing.
DISTRIBUTION Germany, France.
QUANTITY (a) 50 units; (b) 248 units were distributed.
REASON Devices may leak liquid oxygen.
PRODUCT Sterile Equipment Covers, marketed under the name Cover Ups, a
polyethylene plastic bag with an elastic band which is used to
cover a wide variety of operating room equipment in hospitals.
Recall #Z-884-2.
CODE All shipments made prior to 5/19/92.
MANUFACTURER American Medical Products, Cartersville, Georgia.
RECALLED BY Manufacturer, by letter dated June 17, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 4,420 units were distributed.
REASON The firm knowingly shipped the device labeled as sterile without
the product undergoing a sterilization procedure.
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PRODUCT Nonin Pulse Oximeter, Model 8604-FO which monitors arterial
hemoglobin oxygen saturation and pulse rate. Recall #Z-885-2.
CODE Serial numbers of 65444 or less.
MANUFACTURER Nonin Medical, Inc., Plymouth, Minnesota.
RECALLED BY Manufacturer, by letter June 19, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 336 units.
REASON A design problem may cause abnormally high arterial blood oxygen
saturation readings.
PRODUCT In-vitro Diagnostic Screening Test for the presence of amniotic
fluid and transport swabs (with and without medium) used in the
diagnosis of various types of diseases:
(a) Amniotest, PL901; (b) PC108C-Plastic Swab Amies Clear;
(c) PC114C-Plastic Swab Amies/w/Charcoal;
(d) PC136C-Plastic Swab Chlamydia Medium;
(e) PC147C-Plastic Swab Liquid Medium;
(f) PC148C-Aluminum Swab Liquid Medium;
(g) PC140C-Plastic Swab Liquid Amies;
(h) PC144C-Plastic Swab Liquid Medium;
(i) PC190C=Flexwire Swab Amies Clear;
(j) PC110C-Aluminum Amies Clear. Recall #Z-886/895-2.
CODE Lot numbers: (a) 1999, 1637; (b) 392090; (c) 122764,
(d) 12218; (e) 14741; (f) 14841; (g) 392094; (h) 14441; (i)
392096; (j) 122760.
MANUFACTURER Pro-Lab Diagnostics, Round Rock, Texas.
RECALLED BY Manufacturer, by letters dated April 30, 1992 and June 18, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION New York, Texas, Michigan, Washington state.
QUANTITY 9 Amniotest and 181 transport swabs were distributed.
REASON The device has been marketed without an approved 510(k) premarket
notification.
PRODUCT Rifton Swing Frame , Catalog #E451, also used with 10 other
Swings:
(a) Swing Frame, Catalog #E451;
(b) Net Swing, Catalog #E42;
(c) Adjustable Chair Swing, Catalog #E43;
(d) Platform Swing, Catalog #E44;
(e) Platform Swing, Catalog #E46;
(f) Toddler Chair Swing, Catalog #E47;
(g) Complete Bolster Swing, Catalog #E48;
(h) Hammock Chair Swing, Catalog #E49;
(i) 8" Diameter Bolster Swing, Catalog #E4808;
(j) 10" Diameter Bolster Swing, Catalog #E4810;
(k) 12: Diameter Bolster Swing, Catalog #E4812.
Recall #Z-871/881-2.
CODE All units.
MANUFACTURER Hutterian Bretheren in New York, Inc., Rifton, New York.
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RECALLED BY Manufacturer, by letter mailed the first week of June 1992.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Canada, England, Hong Kong.
QUANTITY 505 units were distributed.
REASON The bearing used to fasten the swing to the frame may fail.
UPDATE MRT-35 Magnetic Resonance Imaging System using Software Version
4.01C, Recall #Z-815-2, which appeared in the July 2, 1992
Enforcement Report should read:
RECALLED BY Manufacturer, by letter March 30, 1990. Firm-initiated field
correction complete.
SEIZURES
PRODUCT Chunk Light Tuna Fish (92-556-042).
CHARGE Adulterated - The product consists in part of decomposed tuna
fish; and the product is pet food which has been relabeled as
human food, thus concealing its inferiority.
Misbranded - The product is offered for sale under the name of
another food.
FIRM Seaboard Tampa Terminals, Tampa, Florida.
FILED May 22, 1992 - U.S. District Court for the Middle District of
Florida; Civil #92-685-Civ-T-15(B), FDC #66437.
SEIZED May 27, 1992 - goods valued at approximately $50,000.
PRODUCT Therapeutic massagers (92-646-872).
CHARGE Adulterated - The products are class III devices which do not have
in effect the required approved premarket approval application.
Misbranded - The products' labeling represents and suggests that
the articles are effective for treating serious disease
conditions, which statements, representations, and suggestions are
false and misleading and otherwise contrary to fact. In addition,
the products' labels do not bear adequate directions for use; nor
does it bear adequate warnings against use in those pathological
conditions where the divices' use may be dangerous to health.
Further, premarket notification covering the devices was not filed
as required.
FIRM Cosmosan, Inc., Staten Island, New York.
FILED June 25, 1992 - U.S. District Court for the Eastern District of
New York; Civil #CV-92-2987, FDC #66445.
SEIZED July 9, 1992 - goods valued at approximately $20,000.
PRODUCT Fish fillets (92-667-394).
CHARGE Adulterated - The fillets consist in whole or in part of
decomposed fish.
-8-
FIRM Faros Seafoods, Inc., Tacoma, Washington.
FILED June 22, 1992 - U.S. District Court for the Western District of
Washington; Civil #C92-5278B, FDC #66460.
SEIZED June 25, 1992 - goods valued at approximately $5,265.
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END OF ENFORCEMENT REPORT FOR JULY 29, 1992. BLANK PAGES MAY FOLLOW.
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