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
11/18/1992
RECALLS AND FIELD CORRECTIONS: November 18, 1992
FOODS -- CLASS III
92-47
PRODUCT Various 100% fruit juices, in 64 ounce clear plastic bottles:
(a) Apple Cranberry Juice; (b) Raspberry Cranberry Juice;
(c) Naturally Cranberry Juice. Recall #F-105/107-3.
CODE Lot numbers: (a) 615226518 through 615226522;
(b) 616226523, 616226524, 616226600, 616226601;
(c) 614226512 through 614226517.
MANUFACTURER Cliff Star Corporation, Dunkirk, New York.
RECALLED BY Apple & Eye, Inc., Roslyn, New York, by letter dated October
15, 1992. Firm-initiated recall ongoing.
DISTRIBUTION New Jersey, Maryland.
QUANTITY (a) 1,039 cases (8 bottles per case);
(b) 45 cases (8 bottles per case);
(c) 2,739 cases (8 bottles per case) were distributed.
REASON Products are in improperly sealed containers leading to product
fermentation rendering the product unfit for human consumption.
PRODUCT Brown Sugar in transparent 1 and 2 pound plastic bags.
Recall #F-110-3.
CODE None.
MANUFACTURER Halcon Bakers, Inc., Caguas, Puerto Rico.
RECALLED BY Manufacturer, by letter September 9, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Puerto Rico.
QUANTITY 51 cases were distributed.
REASON Product is contaminated with rodent and insect filth.
PRODUCT Holsum brand Crackers in 2.75 ounce plastic bags.
Recall #F-112-3.
CODE None.
MANUFACTURER Halcon Bakers, Inc., Caguas, Puerto Rico.
RECALLED BY Manufacturer, by telephone and by letter September 9, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Puerto Rico.
QUANTITY 200 cases (36 packs per case) were distributed.
REASON Product is contaminated with rodent and insect filth.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
PRODUCT Rehydration Therapy Eye Make-up Remover, in 4 fluid ounce
bottles. Recall #F-101-3.
CODE Batch numbers 300 and 301 stamped on the bottom of bottle.
MANUFACTURER International Beauty Laboratories, Inc., Minneapolis, Minnesota.
RECALLED BY Manufacturer, by telephone and by letter September 5, 1992.
Firm-initiated recall complete.
DISTRIBUTION Texas, Washington state, Canada.
QUANTITY 1,667 bottles were distributed.
REASON Product is contaminated with Pseudomonas and (non-Aeruginosa)
Klebsiella species.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS III
PRODUCT Silky Facial Gel Mask, in 4 ounce jars. Recall #F-104-3.
CODE Lot #3019.
MANUFACTURER Chemolee Labs, Inc., Irving, Texas.
RECALLED BY Manufacturer, by telephone August 1, 1992. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1,006 jars were distributed; firm estimates none remains on the
market.
REASON Product is contaminated with mold.
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RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Various Rx injectable drug products, manufactured by Lyphomed
Div. of Fujisawa USA, Inc.:
(a) Aminophylline Injection, USP, 25 mg/ml; for the relief of
acute bronchial asthma, 10 ml vial, 20 ml vial;
(b) Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 10 ml
vial, 30 ml vial;
(c) Diazoxide Injection, USP, 15 mg/ml, for use in severe
hypertension, 20 ml vial;
(d) Kanamycin Sulfate Injection, USP, equivalent to 500 mg/2
ml, an antibiotic, 2 ml single dose vial;
(e) Kanamycin Sulfate Injection, USP, equivalent to 1 g/3 ml,
an antibiotic, 3 ml single dose vial;
(f) Kanamycin Sulfate Injection, USP, Pediatric, equivalent to
75 mg/2 ml, an antibiotic, 2 ml single dose vial.
Recall #D-057/062-3.
CODE All lots within expiration date.
MANUFACTURER Fujisawa USA, Inc., Melrose Park, Illinois;
and Fujisawa USA, Inc., Grand Island, New York.
RECALLED BY Fujisawa USA, Inc., Melrose Park, Illinois, by letter October
29, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Bahamas, Nigeria, Nicaragua, Hong Kong, Canada,
Peru, Belize.
QUANTITY Firm estimates: (a) 341,715 vials; (b) 215,306 vials;
(c) 3,554 vials; (d) 27,645 vials; (e) 126,942 vials; (f) 1,816
vials remain on the market.
REASON Abbreviated new drug application discrepancies.
PRODUCT Rx liquid bronchodilators used for the treatment of symptoms of
asthma:
(a) PBI Oxtriphylline Pediatric Syrup, 50 mg/5 ml, in 16 fluid
ounce amber plastic bottles;
(b) Theophylline and Guaifenesin Liquid, in 16 fluid ounce
amber plastic bottles, packaged under the following labels:
PBI Theocolate Liquid; Theolate liquid; Q.B. Liquid.
Recall #D-063/064-3.
CODE Lot numbers: (a) 18970, 19302; (b) 18895, 19374.
MANUFACTURER Pharmaceutical Basics, Inc., Morton Grove, Illinois.
RECALLED BY Manufacturer, by letter dated October 30, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Tennessee, New York, Michigan, Puerto Rico, Virginia, North
Carolina, Illinois, Kentucky, Connecticut, Pennsylvania,
California, Florida, Alabama, New Jersey, Missouri, South
Dakota, Ohio, Indiana, Mississippi.
QUANTITY Firm estimates (a) 50 bottles; (b) 350 bottles remain on the
market.
REASON Preservative system not effective through expiration date.
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PRODUCT Nifedipine Softgel Capsules USP, (a) 10 mg; (b) 20 mg, in
bottles of 100, 300, Rx drug used for vasopastic angina and
chronic stable angina, under the following labels: Chase, H.L.
Moore Drug Exchange, Martec, Qualitest, Rugby, Lemmon, United
Research Laboratories, Warner Chilcott, Genetco, Major,
Goldline, Geneva Generics, Best Generics, Schein, Bioline.
Recall #D-065/066-3.
CODE (a) All lots with an expiration date prior to and including
April 1993, plus nine additional lots: 512119 EXP 5/93, 512219
EXP 5/93, 512319 EXP 5/93, 512419 EXP 5/93, 512519 EXP 5/93,
513019 EXP 5/93, 561819 EXP 5/93, 562419 EXP 5/93, 563319 6/93;
(b) Lot numbers: 493819, 517419, 505719, 517519, 505819,
517619, 505919.
MANUFACTURER Chase Laboratories, Inc., Newark, New Jersey.
RECALLED BY Manufacturer, by letter dated September 14, 1992, and by
telephone. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates: (a) 3 million capsules remain on the market;
(b) none remains on the market.
REASON Lack of assurance to meet compendial dissolution requirements.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Model WS-110 Workstation using an Everlase Model M48-2 CO2
Laser. Recall #Z-1253-2.
CODE Serial number: Undetermined.
MANUFACTURER Coherent General, Inc., Sturbridge, Massachusetts.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
August 12, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Noncompliance with performance standards for laser products in
that the safety interlock system failed to prevent replacement
of removed or displaced portions of the protective housing,
i.e., the operator access doors, when the safety interlock
circuit is overridden, as required.
PRODUCT Aesculap Vario Aneurysm Clip Appliers, mini and standard size,
used to apply an aneurysm-clip for temporary or permanent
occlusion of cerebral aneurysm;
(a) Model FE-502T; (b) Model FE-512T. Recall #Z-014/015-3.
CODE All product was involved, no lot or serial numbers are used.
MANUFACTURER Aesculap AG, Federal Republic of Germany.
RECALLED BY Aesculap, Inc., South San Francisco, California, by letter
dated October 25, 1991. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 54 units; (b) 139 units were distributed; firm estimates 12
devices remain on the market.
REASON The appliers did not release the aneurysm clip because the
width of the jaws did not allow the clips to seat properly.
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PRODUCT Motor Drive Unit (MDU) used to drive the firm's coronary and
peripheral cutting catheters used in therapeutic vascular
catheter techniques. Recall #Z-056-3.
CODE Catalog #CA4100, Lot #121191.
MANUFACTURER Devices For Vascular Intervention, Inc., Temecula, California.
RECALLED BY Devices For Vascular Intervention, Inc., Redwood City,
California, by direct contact to affected accounts August 24,
1992, followed by letter August 25, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Australia.
QUANTITY 199 units were distributed. As of 9/18/92, 46 units were
returned.
REASON Device fails to function as intended in that it could run too
slowly or fail to run when the activation switch is engaged.
PRODUCT Gown Packs, each pack contains sterile fabric gown and an
absorbent towel. Recall #Z-087-3.
CODE G-121.
MANUFACTURER Repak Surgical Enterprises, Mason, Ohio.
RECALLED BY Repak Surgical Enterprises, Cincinnati, Ohio, by telephone June
22, 1992. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 165 packs were distributed; firm estimates none remains on the
market.
REASON The sterility of the gowns had been compromised as evidenced by
the lack of adequate sterilization.
PRODUCT Trac-Wright System Drive Unit, Model TW-1, formerly called the
Kensey Catheter System Unit, Model KC1, a portable drive system
that controls and drives the rotation of arterial catheters
used to pulverize plaque and blood clots in the lower
extremities of the body. Recall #Z-088-3.
CODE Kensey Catheter, Model KC1: Catalog #450-110, English (North
American), Catalog #450-110F, French; Catalog #450-110G, German;
Catalog #450-110I, Italian; Catalog #450-110U, English
(European); Trac-Wright catalog numbers: T450-1100 and
11008/11, 11013/16, 11018/21, 11023/26, 11002/06, 11028/33,
11035/36, 11039/40, 11043/44, 11047, 11050/51, 11053/54, 11057.
Cordis/Europa brand (all shipped to Europe or Argentina)
Language Serial Number
English 61001 - 61028
61039 - 61062
German 31001 - 31021
31028 - 31029
French 41001 - 41015
41019 - 41042
41048 - 41070
Italian 71001 - 71002
Spanish 51001 (shipped to Argentina)
MANUFACTURER Electronic Technologies, Inc., Fort Atkinson, Wisconsin.
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RECALLED BY Dow Corning Wright, Miami Lakes, Florida, by letter February
1991. Firm-initiated field correction complete.
DISTRIBUTION California, Florida, Pennsylvania, Michigan, Arizona, Illinois,
Nevada, Iowa, Texas, Virginia, Connecticut, New York, Mexico,
Canada.
QUANTITY Firm estimates all units were corrected.
REASON There is potential for motor adapters to become clogged with
contrast media.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Branemark System Titanium Fixture, 4 mm x 15 mm, a sterile
endosseous implant for jawbone anchored teeth or bridgework.
Recall #Z-030-3.
CODE Batch # on ampule - 500462 on peel package: 89 May E03 EXP
5/94.
MANUFACTURER Nobelpharma AB, Gothenburg, Sweden.
RECALLED BY Nobelpharma USA, Inc., Chicago, Illinois, by telephone
September 18 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 350 implants were distributed; firm estimates 35 implants
remain on the market.
REASON The packaging labeled as a 4 mm x 15 mm implant may actually
contain a 4 mm x 18 mm implant.
PRODUCT a-Amylase Reagent, used with Ciba Corning's System 103 Analyzer
to determine the quantity of a-Amylase in serum. Recall
#Z-085-3.
CODE Lot numbers: K34MK, K35MK, L24MK, K36MK, L25MK, L68MK, K37MK,
K33MK.
MANUFACTURER Ciba Corning Diagnostics Corporation, Oberlin, Ohio.
RECALLED BY Manufacturer, by sending technical notice and a copy of the
revised Application parameters to all consignees on December
18, 1991. Firm-initiated recall complete.
DISTRIBUTION Nationwide, England, Malaysia, Switzerland, Venezuela, Canada,
Japan.
QUANTITY 553 kits were distributed.
REASON The lag time for the a-Amylase reagent was omitted from the
insert accompanying the product. If a lag time is not entered
when using the System 103 Analyzer, the system defaults.
PRODUCT a-Amylase Reagent, used in conjunction with the Ciba Corning
System 103 Analyzer to determine the quantity of a-Amylase in
serum. Recall #Z-086-3.
CODE Lot numbers: H57MK, K34MK, K35MK, L24MK, M34MK, H58MK, K36MK,
L25MK, L68MK, K33MK, H59MK, K37MK, L26MK.
MANUFACTURER Ciba Corning Diagnostics Corporation, Oberlin, Ohio.
RECALLED BY Manufacturer, by letter March 3, 1992. Firm-initiated recall
complete.
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DISTRIBUTION Nationwide and international.
QUANTITY 1,377 kits were produced.
REASON An elevated Amylase measurement occurs when the total Bilirubin
determination is run before the Amylase determination.
PRODUCT Model 570 Analyzer Software, Version 9, used in the 570
Alliance Chemistry Analyzer catalog #1456x4, and the 570
Alliance Chemistry Analyzer with ISE Electrolyte Module,
catalog #1456x3. These devices are used to perform a variety
of laboratory and hospital applications. Recall #Z-090-3.
CODE All version 9 software.
MANUFACTURER Shimadzu Corporation, Kyoto, Japan.
RECALLED BY Ciba Corning Diagnostics Corporation, Oberlin, Ohio, by
telephone May 24, 1991, followed by letter June 3, 1991.
Firm-initiated field correction complete.
DISTRIBUTION New York, Ohio, Maryland, New Jersey, North Carolina,
Connecticut, Iowa, Georgia, Venezuela, Canada, Mexico,
Malaysia, England, Singapore.
QUANTITY 33 units were distributed.
REASON Under certain conditions, incorrect pipetting of reagents could
occur.
INFORMATION:
AGAINST Oasis Trading Company, Inc., a corporation, and Ted L.C.
Kuo, owner and officer of firm, Hillside, New Jersey.
CHARGE Mr. Kuo was charged and plead guilty to two counts of
shipping adulterated edible oil (oil labeled as 100% pure
peanut oil was in fact partially or totally soybean oil) in
interstate commerce. He was fined $5,000 and placed on
probation for two years.
Oasis Trading was charged and plead guilty to five counts of
shipping adulterated edible oil (again, oil labeled as 100%
pure peanut oil was in fact partially or totally soybean
oil) in interstate commerce. The corporation was fined
$30,000 for each count ($150,000) and placed on probation
for two years.
FILED September 11, 1992.
SENTENCING November 4, 1992 - U.S. District Court for the District of
New Jersey; Criminal #92-3234C-01, FDC #65706.
INJUNCTION:
PRODUCT Vitamin, mineral, herbal and glandular products (89-528-927).
CHARGE Unapproved therapeutic claims were made for the products.
Defendants: Enzymatic Therapy, Inc., and Terry Lemerond, et al., Green
Bay, Wisconsin.
FILED November 5, 1992 - U.S. District Court for the District of
Wisconsin; Civil #91-C-1174, INJ #1232.
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SEIZURE:
PRODUCT Photofluorographic x-ray system (92-443-320).
CHARGE Adulterated - The product is a class III medical device
which does not have in effect the required approved
premarket approval application.
Misbranded - The product labeling fails to bear adequate
directions for use, and notice or other information
respecting the device was not filed as required by statute.
FIRM Zephyrhills Chiropractic Clinic, Zephyrhills, Florida.
FILED September 18, 1992; U.S. District Court for the Middle
District of Florida, Tampa Division; Civil #92-1350-CIV-
T-17(C), FDC #66495.
SEIZED September 28, 1992 - goods valued at approximately $40,000.
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END OF ENFORCEMENT REPORT FOR NOVEMBER 18, 1992. BLANK PAGES MAY
FOLLOW.
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