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
10/21/1992
RECALLS AND FIELD CORRECTIONS: October 21, 1992
FOODS -- CLASS II
92-43
PRODUCT Fresh tuna, unlabeled, varying weights ranging from 61 pounds
to 216 pounds: (a) Yellow Fin Tuna; (b) Big Eye Tuna.
Recall #F-538/539-2.
CODE None.
MANUFACTURER Phillips Seafood, Inc., Point Pleasant, New Jersey.
RECALLED BY Manufacturer, by telephone May 21, 1992. Firm-initiated recall
complete.
DISTRIBUTION New Jersey, Rhode Island, Massachusetts, Maryland.
QUANTITY 12 units were distributed; firm estimates none remains on the
market.
REASON The product is decomposed and contains histamines.
PRODUCT Mushrooms, in 4 ounce cans, under Eastwind and Parade labels.
Recall #F-094-3.
CODE Lot #CMPS 1518.
MANUFACTURER S.K. Foods, Inc., Bangkok, Thailand.
RECALLED BY Connell Foods, Inc., Westfield, New Jersey, by telephone July
14, 1992, and by letter July 15, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION New York.
QUANTITY 3,000 cases (24 cans per case) were distributed; firm estimates
that no more than 10 percent remains on the market.
REASON Product is contaminated with Staphylococcus enterotoxin.
PRODUCT Leslie Ann brand: (a) Mint Pastels, in 4 ounce cellophane
bags; (b) Candy Corn, in 5 ounce cellophane bags.
Recall #F-096/097-3.
CODE None.
MANUFACTURER Becksmith Company, Cincinnati, Ohio.
RECALLED BY Manufacturer, by memorandum August 28, 1992. Firm-initiated
field correction (relabeling) complete.
DISTRIBUTION Ohio, Kentucky, Indiana.
QUANTITY Since June 1, 1992, the firm has distributed no bags of the
candy corn, and 72 bags of the mint pastels. The firm also
estimates that 6 bags of mint pastels remain on the market.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT (a) Pfeiffer brand Ranch Dressing, in 8 ounce glass bottles;
(b) Marzetti brand Ranch Dressing, in 8 ounce glass bottles.
Recall #F-092/093-3.
CODE Lot numbers: (a) 1-20-93; (b) 1-25-93.
MANUFACTURER Pfeiffer Foods, Wilson, New York.
RECALLED BY T. Marzetti Company, Columbus, Ohio, by letter dated August 21,
1992. Firm-initiated recall complete.
DISTRIBUTION (a) Florida, New Jersey, New York, Texas; (b) Iowa, Missouri,
Wisconsin, West Virginia, Ohio.
QUANTITY (a) 947 cases (12 bottles per case); (b) 942 cases (12 bottles
per case were distributed.
REASON Products are contaminated with Lactobacillus bacteria.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Therapy Bayer Enteric Aspirin, 325 mg, in 50 and 100 count
bottles, and in 7-pack sample packages, an OTC analgesic.
Recall #D-015-3.
CODE Lot numbers: 1C404R, 1E409R, 1F411, 1H415, 1H422, 1J420 (50
count); 1C404R, 1D405R, 1D407R, 1E410R, 1F411, 1F413, 1H415,
1H419, 1H421, 1H422, 1H423, 1J420 (100 count), 1D405R, 1D406R,
1E408R (7 pack sample).
MANUFACTURER Sterling Winthrop, Myerstown, Pennsylvania.
RECALLED BY Sterling Health, Division of Sterling Winthrop, Inc., New York,
New York, by letter dated September 15, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7,674 7-pack sample were distributed, firm estimates 350,000
bottles of 50 and/or 100 tablets remain on the market.
REASON Product does not meet dissolution specifications through
expiration date.
-2-
PRODUCT Flutex Cream 0.1%, (Triamcinolone Acetonide Cream, USP, 0.1%),
in 4 ounce tubes, a Rx drug. Recall #D-016-3.
CODE Lot #G216 EXP 8/93.
MANUFACTURER Syosset Laboratories Company, Inc., Syosset, New York.
RECALLED BY Manufacturer, by telephone August 27, 1992. Firm-initiated
recall complete.
DISTRIBUTION California, Georgia.
QUANTITY 79 units were distributed.
REASON 80 gram size was mislabeled as 4 ounces.
PRODUCT Blue Lightning Therapeutic Rub, an OTC analgesic balm, in 8
ounce jars. Recall #D-017-3.
CODE Lots #H311 EXP 1/94.
MANUFACTURER Syosset Laboratories, Company, Inc., Syosset, New York.
RECALLED BY Manufacturer, by letter September 25, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Florida, Virginia, Georgia, Maryland, New York, Louisiana.
QUANTITY 1,586 units were distributed.
REASON Product contains 2% menthol. Label incorrectly declares 4%.
PRODUCT Thioridazine HCl Oral Solution, USP (Concentrate) 100 mg/3.4
ml, a Rx oral psychotropic used for the management of
manifestations of psychotic disorders. Recall #D-018-3.
CODE Lot #202606 EXP 8/93, 204609 EXP 2/94, 205614 EXP 2/94.
MANUFACTURER Pharmaceutical Basics, Inc. (PBI), Morton Grove, Illinois.
RECALLED BY Xactdose, Inc., South Beloit, Illinois, by letter October 5,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 734 cartons (10 cups per tray, 10 trays per carton) were
distributed; firm estimates 75 cartons remain on the market.
REASON Product fails stability specifications for color prior to
expiration date.
PRODUCT Chlorpromazine HCl Oral Concentrate, USP, 100 mg/3.4 ml, an
oral psychotropic used for the management of manifestations of
psychotic disorders, in 3.4 ml unit dose cups. Recall #D-019-3.
CODE Lot numbers: 202608 EXP 12/93, 206602 EXP 12/93.
MANUFACTURER Roxane Labs., Inc., Columbus, Ohio.
RECALLED BY Xactdose, Inc., South Beloit, Illinois, by letter September 29,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 492 cartons (10 cups per tray, 10 trays per carton) were
distributed; firm estimates 75 cartons remain on the market.
REASON The solution reacted with the aluminum foil cups causing
leakage.
-3-
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT (a) Whole Blood; (b) Red Blood Cells. Recall #B-439/440-2.
CODE Unit numbers: (a) S66253; (b) S68115, S68116.
MANUFACTURER San Diego Blood Bank, San Diego, California.
RECALLED BY Manufacturer, by telephone September 30, 1991, and December 30,
1991. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY (a) 1 unit; (b) 2 units.
REASON Blood products labeled with incorrect expiration dates were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Medionics QC Transfer Sets, sterile, Rx quick connect device
used between the patient line and tubing set during peritoneal
dialysis: (a) Medionics' Catalog #QT008C, Abbott List #2661;
(b) Medionics' Catalog #QT-008CA, Abbott List #21662.
Recall #Z-1257/1258-2.
CODE Lot numbers:
Medionics Abbott
(a) 910520 through 911120 54-026J2 through 61-009J2
(b) 910626 55021J2.
MANUFACTURER Medionics International, Inc., Markham, Ontario, Canada.
RECALLED BY Abbott Laboratories, Hospital Products Division, Abbott Park,
Illinois, by letter February 6, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 9,400 sets; (b) 418 sets were distributed; firm estimates
none remains on the market.
REASON Sets may develop a leak at the distal connection site when
connected to the Abbott Cycler Set or Biocap Y-set.
PRODUCT Marathon Guiding Catheter, Model 77-160S-8F, JL5.0 STD.
Recall #Z-008-3.
CODE Lot #2D0563-4037.
MANUFACTURER Baxter Healthcare Corporation, Edwards LIS Division, Irvine,
California.
RECALLED BY Manufacturer, by letter July 13 and 14, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Alabama, Arizona, California, Georgia, Hawaii, Illinois,
Kansas, Louisiana, Michigan, Minnesota, Missouri, New Jersey,
Pennsylvania, Tennessee, Tesas, Wisconsin, France, Japan,
Belgium, Israel.
QUANTITY 212 units were distributed. FDA estimates that very little
product remains on the market.
REASON The device was labeled as a "JL5.0" catheter (Judkins-left, 5.0
cm width) but contained a "JL4.0" catheter.
-4-
PRODUCT Foursight Visual Systems Model 4 Laser Projector.
Recall #Z-013-3.
CODE Serial #001.
MANUFACTURER Crystal Cathedral, Garden Grove, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
September 23, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Noncompliance with performance standard for laser products in
that the removable lasers incorporated in the projector are not
certified to be in compliance with the performance standard;
the portions of the protective housing designed to be removed
for user maintenance are not safety interlocked; there is no
user information that complies with the performance standard;
and there are no certification or identification labels as
required.
PRODUCT UroView Fluoroscopic Urology System. Recall #Z-016-3.
CODE Serial numbers: Undetermined.
MANUFACTURER OEC-Diasonics, Salt Lake City, Utah.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
August 17, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 53 units were distributed.
REASON Noncompliance with the performance standard for diagnostic
x-ray products in that it failed to meet the primary protective
barrier-limitation of useful beam as required.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
PRODUCT Tiguvon brand of Fenthion Cattle Insecticide Pour-on, in 1
gallon metal containers, for the control of grubs and lice on
cattle. Recall #V-003-3.
CODE Lot numbers: 440045, 440068, 440094, 440046, 440069, 440095,
440047, 440073, 440100, 440048, 440078, 440101, 440052, 440082,
440102, 440053, 440084, 440103, 440054, 440092, 440104, 440065,
440093, 440121.
MANUFACTURER Miles, Inc., Animal Health Products Division, Shawnee Mission,
Kansas.
DISTRIBUTION Nationwide.
QUANTITY 144,000 1-gallon cans distributed.
REASON Product becomes subpotent prior to end of 36-month expiration
date.
MEDICAL DEVICE SAFETY ALERTS:
PRODUCT Autotransfusion System, Model AT1000, used to collect, clean
and return blood to a patient during surgery.
Safety Alert #M-001-3.
-5-
CODE All serial numbers.
MANUFACTURER Electromedics, Inc., Englewood, Colorado.
ALERTED BY Manufacturer, by letter August 24, 1992.
DISTRIBUTION Nationwide, Australia, Germany.
QUANTITY 409 units were distributed.
REASON Centrifuge bowl may crack during operation.
INJUNCTION:
PRODUCT Crabmeat (92-652-513).
CHARGE Adulterated - The crabmeat contains a filthy substance,
indicated by the presence of E. coli, and by the presence of
blow flies (calliphoridae), and is further adulterated in that
it has been prepared, packed, or held under insanitary
conditions whereby it may have become contaminated with filth.
AGAINST Seafood, Inc. of Henderson, Louisiana, and Pamela A.
Friedman, Charles J. Friedman, and Steven LeGrand.
FILED Complaint, September 29, 1992; Consent Decree of Permanent
Injunction, October 8, 1992; U.S. District Court for the
Western District of Louisiana, Lafayette-Opelousas Division;
Civil #92-1819, INJ 1305.
SEIZURES:
PRODUCT Canned sardines (92-664-536).
CHARGE Adulterated - The product consists in whole or in part of a
decomposed substance.
FIRM Shimaya Shoten, Ltd., Honolulu, Hawaii.
FILED October 1, 1992; U.S. District Court for the District
of Hawaii; Civil #92 00639 SPK, FDC #66606.
SEIZED October 7, 1992 - goods valued at approximately $11,600.
PRODUCT Various articles of food (92-667-308).
CHARGE Adulterated - Four lots of product contain various elements
of filth, including insects, insect fragments, feather
barbules, and rodent and other animal hair.
Misbranded - One lot contains artificial coloring, a yellow
carotenoid color additive, and the product label fails to
state that fact.
FIRM Seasia/Uwajimaya, Inc., Seattle, Washington.
FILED August 18, 1992; U.S. District Court for the Western
District of Washington; Civil #C92-1296, FDC #66452.
SEIZED August 24, 1992 - goods valued at approximately $6,000.
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END OF ENFORCEMENT REPORT FOR OCTOBER 21, 1992. BLANK PAGES MAY
FOLLOW.
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