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.

July 23, 1997 97-30

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Welsh Farms Ice Cream in 3 gallon bulk
containers: a) Heavenly Hash Ice Cream;
b) French Vanilla Ice Cream.
Recall #F-513/514-7.
CODE a) All date codes prior to 7/19/96 or 20196;
b) All date codes prior to 8/5/96 or 21896.
MANUFACTURER Welsh Farms, Inc., West Caldwell, New Jersey.
RECALLED BY Welsh Farms, Inc., Long Valley, New Jersey, by
letter dated August 30, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION New York, New Jersey, Pennsylvania.
QUANTITY a) 147 cans were distributed; firm estimated
that 100 units remained on market at time of
recall initiation; b) 2,315 cans were
distributed; firm estimated that 100 units
remained on market at time of recall
initiation.
REASON a) The product does not bear an ingredient
statement and contains undeclared egg albumin
and almonds. b) The product does not bear an
ingredient statement and contains undeclared
egg yolks.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT No-No brand a) Salsa Diet; b) Sesame Salted
Diet Tortilla Corn Flatbread, net weight 4.5
ounce. (125.6g cans). Recall #F-493/494-7.
CODE All codes and serial numbers.
MANUFACTURER Falcone's Cookieland Ltd, Brooklyn, New York.
RECALLED BY Wedgie Dietetic Foods, Inc., Brooklyn, New
York, by Fax on June 2, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION New York, New Jersey, Maryland, Pennsylvania,
Massachusetts.
QUANTITY a) 135 cases; b) 171 cases were distributed.
REASON The product contains wheat flour but fails to
declare this fact on the ingredient panel.

_______________
PRODUCT Bossea brand smoked fish product, vacuum
packed and individually packaged in plastic,
and were of various weights:
a) Bossea brand Smoked Mackerel (Whole &
Fillet)
b) Bossea brand Smoked Herring
c) Bossea brand Smoked Eel
d) Bossea brand Smoked Whitefish
e) Bossea brand Smoked Rainbow Trout.
Recall #F-506/510-7.
CODE Smoked Whole Mackerel Code: 2087, date(s)
unknown;
Smoked Mackerel Fillet Code: 2078, date(s)
unknown;
Smoked Herring Code: 2005, date(s) unknown;
Smoked Eel Code: 2082, date(s) unknown;
Smoked Whitefish Code: 2081, date(s) unknown;
Smoked Rainbow Trout Code: 2017, "Dec18 96",
"Not To Be Sold Or Consumed After DEC 29,96".
MANUFACTURER Bos Smoked Fish, Inc., Woodstock, Ontario,
Canada.
RECALLED BY Brooklyn Imports Inc., Brooklyn, New York, by
visit on. Completed recall resulted from
sample analysis and followup by the New York
Department of Agriculture and Markets.
DISTRIBUTION New York, New Jersey, Connecticut, Michigan,
Illinois, Virginia, Pennsylvania,
Massachusetts.
QUANTITY 932.6 pound for all five products were
distributed.
REASON The products contain sodium nitrite, an
unapproved food additive.

-2-_______________
PRODUCT Jerusalem World Pure Foods brand Turnip
Pickle, a refrigerated, pickled turnip food
product in clear glass quart (32 ounce) jar.
Recall #F-515-7.
CODE All product - The firm began coding the
product as of June 11, 1997 with the Julian
date.
MANUFACTURER Jerusalem Natural Foods, Inc., Redford,
Michigan.
RECALLED BY Manufacturer, by telephone or visit by the end
of June 1997. Firm-initiated recall ongoing.
DISTRIBUTION Michigan and Ohio.
QUANTITY Approximately 40 cases (12 quarts per case).
REASON The product contains D&C Red No. 19, an
unapproved color additive.

_______________
PRODUCT Keebler Classic Collection French Vanilla
Creme Sandwich Cookies, in 12 ounce, 24 ounce,
and 300 count boxes. Recall #F-516-7.
CODE All product manufactured prior to April 9,
1997 with shift codes "A", "B" and "C". The
shift code precedes the three digit Julian
date code of production for those cookies
made in 1997 (021A made on 1/21/97, first
shift), and follows the Julian date code for
those cookies made in 1996 (B366 made on
12/31/96, second shift). Product made since
April 9, 1997 do not contain the FD&C Yellow 5
Lake, and have the shift codes "D", "E" and
"F".
MANUFACTURER Pate Foods, South Beloit, Illinois.
RECALLED BY Keebler Company, Elmhurst, Illinois, by
memorandum dated April 10, 1997. Firm-initiated field correction (relabeling)
completed.
DISTRIBUTION Nationwide.
QUANTITY 31,504 cases were distributed.
REASON Product contained undeclared FD&C Yellow No. 5
Lake.

_______________
PRODUCT No-No brand Diet Tortilla Corn Flatbreads
Everything (Sesame-Poppy-Onion-Garlic), net
weight 4.5 ounces (125.6g). Recall #F-517-7.
CODE All codes and serial numbers.
MANUFACTURER Falcone's Cookieland Ltd., Brooklyn, New York.
RECALLED BY Wedgie Dietetic Foods, Inc., Brooklyn, New
York, by letter on June 24, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Maryland, New York, Pennsylvania, Minnesota,
Massachusetts, Florida.
-3-QUANTITY 618 cases (12 units per case) were sold since
January 1997.
REASON The product contains wheat flour but fails to
declare wheat flour on the label.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Hickory Farms Melt Away Mints packed in 16
ounce containers:
a) Hickory Farms Melt Away Mints packed in 16
ounce clear plastic bags and in 16 ounce
Hickory Farms nostalgic tins
b) Hickory Farms Mini Melt Away Mints, packed
in 16 ounce clear plastic bags.
Recall #F-511-512-7.
CODE All codes are subject to recall - catalog
numbers: regular sized mints in bags - #4750;
mini mints in bags - #5959; regular mints
packed in nostalgic tins - #7820.
MANUFACTURER Plantation Candies, Inc., Telford,
Pennsylvania.
RECALLED BY Hickory Farms, Inc., Maumee, Ohio, by
facsimile on May 20, 1997, followed by E-mail
on May 22, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 341,492 containers were distributed.
REASON The product contains undeclared certified
colors, FD&C Blue No. 1 and FD&C Red No. 3.

_______________
PRODUCT Aloe Ginseng Cranberry Beverage, in 1 liter
bottles. Recall #F-518-7.
CODE 705H02.
MANUFACTURER Health One's, Brooklyn, New York.
RECALLED BY Natural Group, Inc., Modesto, California, by
telephone. Firm-initiated recall completed on
or about June 26, 1997.
DISTRIBUTION California.
QUANTITY Firm estimates none remains on the market.
REASON The product contained undeclared dextrose.

RECALLS AND FIELD CORRECTIONS: DRUGS --
CLASS III ==========
_______________
PRODUCT Mexiletine Hydrochloride Capsules, 250 mg, Rx
orally active antiarrhythmic used for the
treatment of documented life-threatening
ventricular arrhythmias, in 100 capsule
bottles. Recall #D-228-7.
CODE Lots 100860A, 100861A, 101262A, 104912C.

-4-MANUFACTURER Novopharm Ltd., Toronto, Canada.
RECALLED BY Novopharm USA, Inc., Schaumburg, Illinois, by
letter dated July 9, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,401 bottles were distributed; firm estimated
that 25 percent of product remained on market
at time of recall initiation.
REASON Incorrect labeling -- Some bottles of 250 mg
capsules are labeled as containing 150 mg
capsules.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-792/793-7.
CODE Unit #2357219.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter dated December 4,
1995. Firm-initiated recall completed.
DISTRIBUTION Indiana and Pennsylvania.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
whose spouse has a history of hepatitis C.

_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-1035/1036-7.
CODE Unit #S27628.
MANUFACTURER Irwin Memorial Blood Centers, San Francisco,
California.
RECALLED BY Manufacturer, by letter dated March 14, 1996.
Firm-initiated recall completed.
DISTRIBUTION California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
was listed on the State Deferred Donor
Registry.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1039/1040-7.
CODE Unit #41GT71886.
MANUFACTURER American Red Cross Blood Services, Birmingham,
Alabama.
RECALLED BY Manufacturer, by letter on or about April 16,
1996. Firm-initiated recall completed.
DISTRIBUTION Alabama.
QUANTITY 1 unit of each component was distributed.

-5-REASON Blood products tested repeatedly reactive for
the hepatitis B surface antigen (HBsAg), and
were subjected to additional retesting which
was negative.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1041/1042-7.
CODE Unit #41FY80886.
MANUFACTURER American Red Cross Blood Services, Birmingham,
Alabama.
RECALLED BY Manufacturer, by letter on August 28, 1996.
Firm-initiated recall completed.
DISTRIBUTION Alabama.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
traveled to an area considered endemic for
malaria.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-1043/1045-7.
CODE Unit numbers: a) 41GM21295, 41LF44653; b)
41LF44653; c) 41GM21295, 41LF44653.
MANUFACTURER American Red Cross Blood Services, Birmingham,
Alabama.
RECALLED BY Manufacturer, by letters between April 16,
1996, and December 12, 1996. Firm-initiated
recall completed.
DISTRIBUTION Alabama, California.
QUANTITY a) 2 units; b) 1 unit; c) 2 units were
distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), but were collected from
donors who previously tested repeatedly
reactive for anti-HIV-1, Western blot
negative.

_______________
PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF;
c) Plasma; d) Recovered Plasma.
Recall #B-1046/1049-7.
CODE Unit numbers: a) 41FV24002, 41GJ37198,
41GJ37527, 41GW08651, 41GW08967, 41KC09277,
41KC09610; b) 41GJ37198, 41GJ37527;
c) 41GJ37527; d) 41FV24002, 41GJ37198,
41GW08651, 41GW08967, 41KC09277, 41KC09610,
41LG53711.
MANUFACTURER American Red Cross Blood Services, Birmingham,
Alabama.

-6-RECALLED BY Manufacturer, by letters between April 16,
1996, and December 12, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Alabama, California, Puerto Rico.
QUANTITY a) 7 units; b) 2 units; c) 1 unit; d) 7 units
were distributed.
REASON Blood products tested negative for the
antibody to the hepatitis C virus encoded
antigen (anti-HCV), but were collected from
donors who previously tested repeatedly
reactive for anti-HCV.

_______________
PRODUCT "Blood Bank Control System" Software Program
Recall #B-1051-7.
CODE Software version 4.0.
MANUFACTURER Blood Bank Computer Systems, Inc., Auburn,
Washington.
RECALLED BY Manufacturer, by Fax on June 6, 1997. Firm-initiated field correction completed.
DISTRIBUTION California, Florida, Illinois, Kansas,
Pennsylvania, Texas, Washington state.
QUANTITY 14 users in the U.S. which have software
version 4.0 installed.
REASON Computer software contains programming errors
which could result in the release of
unsuitable blood products.

_______________
PRODUCT Source Plasma. Recall #B-1062-7.
CODE Unit #HP99771.
MANUFACTURER Interstate Blood Bank, Inc., Chicago,
Illinois.
RECALLED BY Manufacturer, by letter dated May 9, 1997.
Firm-initiated recall completed.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
received a tattoo within 12 months of
donation.

_______________
PRODUCT Platelets. Recall #B-1063-7.
CODE Unit #29443-7417.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on May 13, 1997.
Firm-initiated recall completed.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Platelets were prepared from a donor who had
taken aspirin within 3 days of donation.

-7-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-1001-7.
CODE Unit numbers: 4416104, 4422379, 4422395,
4434783 6740379 6740383 7014364
7014369 7014371 7014372 7014376
7074039 7188153 7192601 7195848
7229463 7247817 7296027 7351673
7369616 7376155 7376914 7378155
7386207 7389603 7394208 7396337
7581829 7591522 7591546 7635770
7638517 7638526 7638533 7638538
7638756 7648751 7652746 7652754
7655203 7655206 7655210 7665257.
MANUFACTURER New York Blood Services, also known as New
York Blood Center, New York, New York.
RECALLED BY Manufacturer, by letter dated January 9, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION New York and New Jersey.
QUANTITY 43 units collected from 3/95 to 11/96 were
distributed.
REASON Blood products contain the preservative Adsol
but not labeled as containing that
preservative.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-1013/1015-7.
CODE Unit #1337776.
MANUFACTURER Central Kentucky Blood Center, Lexington,
Kentucky.
RECALLED BY Manufacturer, by telephone and letters on
December 13, 1996. Firm-initiated recall
completed.
DISTRIBUTION Kentucky and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a
therapeutic donor with hemochromatosis.

_______________
PRODUCT Hyp Rho-D Brand Immune Globulin (Human).
Recall #B-1020-7.
CODE Lot #621P15E, 621P15F.
MANUFACTURER Bayer Corporation, Clayton, North Carolina.
RECALLED BY Manufacturer, by letter on June 27, 1997.
Firm-initiated recall completed.
DISTRIBUTION Nationwide and international.
QUANTITY 41,190 doses were distributed.
REASON Immune Globulin tested subpotent.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-1034-7.
CODE Unit #3099670.
-8-MANUFACTURER Gulf Coast Regional Blood Center, Houston,
Texas.
RECALLED BY Manufacturer, by Fax on February 10, 1997.
Firm-initiated recall completed.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product was not frozen within eight
hours of collection.

_______________
PRODUCT Recovered Plasma. Recall #B-1038-7.
CODE Unit #41GF45735.
MANUFACTURER American Red Cross Blood Services, Birmingham,
Alabama.
RECALLED BY Manufacturer, by letter on June 10, 1996.
Firm-initiated recall completed.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red
Blood Cells which was implicated in a
transfusion reaction.

_______________
PRODUCT Red Blood Cells. Recall #B-1050-7.
CODE Unit #49J71353.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by telephone on April 10, 1997.
Firm-initiated recall completed.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
health history screening was inadequately
performed.

_______________
PRODUCT Platelet Pheresis, Leukodepleted.
Recall #B-1065-7.
CODE Unit #40P52343.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone and fax on March
12, 1997. Firm-initiated recall completed.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Unlicensed blood product was distributed
without obliteration of U.S. license.

-9-RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT Non-Fiber Optic High Speed Dental Handpieces:
a) Catalog No. 750044, Tradition Non-Fiber
Optic Handpiece with conventional chuck (with
wrench)
b) Catalog No. 780044, Traditional L Non-fiber
Optic Handpiece with Power Lever chuck
(wrenchless). Recall Z-674/675-7.
CODE All with date code E127 through E227.
MANUFACTURER Midwest Dental Products (Dentsply), Des
Plaines, Illinois.
RECALLED BY Manufacturer, by letter dated May 29, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and China.
QUANTITY 444 handpieces were distributed.
REASON Some of the hand pieces may have loose fitting
water spray tubes which may fall out during
use, and be swallowed or aspirated.

_______________
PRODUCT Advantage EMG System, Model A100, an
electromyogram device used to measure and
record electrical activity associated with
skeletal muscle. Recall #Z-687-7.
CODE All serial numbers.
MANUFACTURER Advantage Medical, London, Ontario, Canada.
RECALLED BY Manufacturer, by letter dated May 12, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 89 units were distributed.
REASON The device could cause an electrical burn to
the patient.

_______________
PRODUCT GDXI Anatomically Correct Lifeline Patient
Cable w/Leadwires, Model No. 14081 - Type A,
an anatomically correct Lifeline Patient Cable
to a Siemens 15 Pin Connector with lead wires,
for ECG monitoring in general practitioner
settings. Recall #Z-726-7.
CODE Lot numbers of the cable/leadwire: C02105CH,
C02504CH, and C02505CH. NOTE: The finished
device kit is NOT identified with lot
numbers.
MANUFACTURER Graphic Controls Corporation, Cherry Hill, New
Jersey.
RECALLED BY Graphic Controls Corporation, Buffalo, New
York, by letter dated May 16, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 301 sets were distributed.

-10-REASON The lead wires were placed incorrectly into
the cable, which caused the lead location to
be mislabeled.

_______________
PRODUCT Cathcor Remote 20 Inch Monitor, used with
Siemens Cathcor System, an ECG recording
device. Recall #Z-740-7.
CODE Part numbers 61-61-942 and 08-99-019. All
units.
MANUFACTURER Siemens-Elema AB, Life Support Systems
Division, Solna, Sweden.
RECALLED BY Siemens Medical Systems, Inc., Danvers,
Massachusetts, by letter on November 5, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON The monitor used in a cardiac catheterization
disconnected from the base pedestal and fell,
causing injury.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Clinitek Atlas Reagent Pak, Product #5015,
used with Clinitek Atlas Automated Urine
Chemistry Analyzer. Recall #Z-727-7.
CODE Lot #1A044017.
MANUFACTURER Bayer Corporation, Elkhart, Indiana.
RECALLED BY Manufacturer, by telephone on May 9, 1997,
followed by letter. Firm-initiated recall
completed.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 768 units were distributed.
REASON The ketone reagent pad is missing in some of
the strips in this lot.

_______________
PRODUCT 1.0mm TI Burr Hole Cover, Model #420.900, used
to cover a hole drilled into skull bone so as
to result in a flush surface with no recesses
or indentations and give a better cosmetic
appearance. Recall #Z-737-7.
CODE Lot #A3FN421.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes (USA), Paoli, Pennsylvania, by E-mail
April 23, 1996. Firm-initiated recall
completed.
DISTRIBUTION Nationwide and Canada.
QUANTITY 80 units were distributed; firm estimates none
remains on the market.
REASON The 1.0MM Burr Hole Cover was labeled as a
1.5MM Burr Hole Cover.
-11-_______________
PRODUCT TDx/TDxFLx Estriol Reagent Pack, List No.
9112-60, used with either Total Estriol
Calibrators (lists 9112-01) or Free Estriol
Calibrators (list 9118-01) in a Fluorescence
Polarization Immunoassay (FPIA) in-vitro
estriol or free estriol in human serum, plasma
or urine. Recall #Z-738-7.
CODE Lot Nos. 22109Q100, 23635Q100, 25589Q100, and
26075Q100.
MANUFACTURER Abbott Health Products, Inc., Barceloneta,
Puerto Rico.
RECALLED BY Abbott Laboratories, Diagnostics Division,
Abbott Park, Illinois, by letter on July 2,
1997. Firm-initiated recall ongoing.
DISTRIBUTION California, Kentucky, Georgia, Illinois,
Indiana, Louisiana, Maryland, West Virginia,
Ohio, Pennsylvania, Texas, and international.
QUANTITY 1,226 reagents packs were distributed; firm
estimated that 10 percent remained on market
at time of recall initiation.
REASON Storage of the antibody S reagent for extended
time at elevated temperatures can cause heat
stressing which results in depressed
millipolarization values and display of the
printed error code "PO Too Small" during
calibration.

_______________
PRODUCT Quidel QuickVue Chlamydia Test, Catalog No.
B006. Recall #Z-739-7.
CODE Lot Nos. B006 J04501, B006 J04801, B006
J04802, B006 J06901, B006 J08001, B006 J09001,
B006 J10601, and B006 J11201.
MANUFACTURER Quidel Corporation, San Diego, California.
RECALLED BY Manufacturer, by telephone and by letter dated
May 21, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,809 (30 tests/kit) kits were distributed.
REASON Faint or no results are obtained with the
positive control solution.

_______________
PRODUCT Siemens 12 Lead ECG Patient Cable and Cable
Kit, used with the Siemens Cathcor Equipment
an ECG recording device:
a) 12 Lead ECG Patient Cable, Part No.
0899300.
b) 12 Lead ECG Cable Kit, Part No. 0899399.
Recall #Z-741/742-7.
CODE Lot #R0823.
MANUFACTURER ConMed Corporation, Utica, New York.

-12-RECALLED BY Siemens Medical Systems, Inc., Danvers,
Massachusetts, by letters on May 23, 1997, and
June 5, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 184 cables were distributed.
REASON The indicator tabs for the Left Arm (LA) and
Left Leg (LL) leads are reversed.

-13-

END OF ENFORCEMENT FOR JULY 23, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for