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
07/28/1993

Recalls and Field Corrections: Foods -- Class I -- 07/28/1993

July 28, 1993

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
______________
PRODUCT Whole dry milk, nonfat dry milk, ice cream mixes, and
Soyagen, spray dried and/or packaged since November 4, 1992
at Maple Island, Inc.'s (MII) Wanamingo, Minnesota facility:
(a) MII, et. al. brand Powdered Whole Milk;
(b) MII, et. al. brand Instant Powdered Whole Milk;
(c) MII, et. al. brand Instant Powdered Low Fat Milk.
Recall #F-493/495-3.
(d) MII brand Nonfat Dry Milk;
(e) MII brand Powdered Nonfat Yogurt Mix;
(f) MII brand Ice Cream Mix;
(g) MII brand Shakequik Powdered Ice Milk Mix, Chocolate;
(h) MII brand Shakequik Powdered Ice Milk Mix , Vanilla;
(i) MII brand Nonfat Dry Milk, High Heat, for baking;
(j) MII brand, Nonfat Dry Milk, Low Heat.
Recall #F-499/505-3.
CODE Product Size Lot No.
Maple Island Instant 3.75 lbs 2324, 2325
Nonfat Dry Milk 2353, 3062

USDA Whole Milk (Russia) 5 lbs 3118, 3119
USDA Whole Milk (Russia) 4 lbs 3126, 3127
3130, 3131
3132, 3133
USDA Instant Whole Milk 4 lbs 3117, 3116
(Russia) 3113, 3118
3123
Maple Island Whole Milk 4 lbs R30W1
Powder (generic label)
Maple Island Extra Grade 50 lbs A05W3, A07W3
Spray Process Whole Milk A08W3, A09W3
Powder A10W3, A11W3
A13W3, A14W3
A15W3, A16W3
A17W3, A18W3
A20W3, A21W3
A22W3, A26W3
A27W3, A28W3
S11W2, S27W2
T01W3, T04W3
T05W3, T06W3
T07W3, T12W3
T13W3, T20W3
W02W2, W11W3
W24W3
Maple Island Powdered 5 lbs 3044
Nonfat Yogurt Mix
Maple Island Ice Cream Mix 4, lbs 3125
Shakequik Powdered Ice Milk 5 lbs 2913
Mix-Soft Serve & Milk Shake 423
Mix-Vanilla Flavor (Military) 1323, 2023
2623, 833
1233, 1933
2633
Shakequik Powdered Ice Milk 5 lbs 2633
Mix-Soft Serve & Milk Shake 143
Mix-Chocolate Flavor (Military) 843, 1643
2243, 3043
553
Shakequik Powdered Ice Milk 5 lbs 3029
Mix-Soft Serve & Milk Shake 3044
Mix-Vanilla Flavor 3071, 3085, 2633
Shakequik Powdered Ice Milk 5 lbs 3044
Mix-Soft Serve & Milk Shake 553
Mix-Chocolate Flavor
Nonfat Dry Milk, High Heat, 4 lbs 1733
For Baking Type I Class 3
(Military)
Low Heat Nonfat Dry Milk 4 lbs 17112
Conventional, Type II 18112
Class I (Military) 19112, 3122
333, 433
533, 933
2933, 3033
Nonfat Dry Milk 1 lb 24112
Single Pass Instant (Military) 3133
Nonfat Dry Milk (Instantized) 3 lbs 19112
Type IV (Military) 20112, 3033
543, 643, 843
Denia Powdered Whole Milk 2+ lb 2344, 3007, 3053
3061, 3109, 3127
3141,
Denia Powdered Whole Milk 5 lb 2321, 2328, 2349
3026, 3027, 3036
3050, 3069, 3086
3092, 3111, 3123
3124,
Denia Powdered Whole Milk 1 lb 2336, 2337, 2343
2351, 3008, 3054
3083, 3090, 3097
3111, 3124,
Denia Instant Powdered 4 lbs 2328
Whole Milk 2358, 2363, 3006
3050, 3099, 3144
Denia Instant Powdered 2 lbs 2311
Whole Milk 2318, 2336, 2338
2339, 3015, 3016
3037, 3103, 3141
Denia Instant Powdered 13 oz 2321
Whole Milk 3054
Denia Instant Powdered 2 lbs 2311
Low Fat Milk 3013, 3014, 3015
3037, 3070
3103, 3124
Denia Instant Powdered 13 oz 2315
Low Fat Milk 2366, 3083, 3133
Denia Powdered Low Fat 28 gms T09M3
Milk in pouches
Ryt-Way Foods Redi-Lac 4 lbs 3035
Whole Milk Powder
Sysco Extra Grade Whole Milk 50 lbs S11W2
Powder-26% Butterfat S27W2, T01W3,
T12W3
MANUFACTURER Maple Island, Inc.,Wanamingo, Minnesota.
RECALLED BY Maple Island, Inc., Stillwater, Minnesota, by letters of
June 28-30, 1993, July 2, 1993 and July 6, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 5 million pounds were distributed.
REASON The products were manufactured under conditions in which
they may have become contaminated with salmonella.

______________
PRODUCT Sherwood Medical brand (a) Propac Modular Protein
Supplement, packaged in 12.3 ounce cans; (b) Sumacal Modular
Carbohydrate Supplement, packaged in 14 ounce cans.
Recall #F-507/508-3.
CODE Products manufactured since November 4, 1992, at Maple
Island, Inc's (MII) Wanamingo, Minnesota Facility. Lot
numbers: (a) 965064; (b) 964934, 964935.
MANUFACTURER Maple Island, Inc., Wanamingo, Minnesota.
RECALLED BY Sherwood Medical Company, St. Louis, Missouri, by letter
June 30, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY Since approximately 3/10/93, approximately 2,900 cans of
Sumacal, lot 964934 and 2,100 cans Sumacal, lot #964935,
were distributed. Since approximately 6/3/93, approximately
800 cans Propac have been distributed.
REASON The products were manufactured under conditions in which
they may have become contaminated with salmonella.

______________
PRODUCT SeaRock brand West Coast Cooked and Peeled Shrimp Meat in 5
pound plastic tubs. Recall #F-539-3.
CODE CS4193.
MANUFACTURER Washington Crab Producers, Inc., Westport, Washington.
RECALLED BY Manufacturer, by Fax May 11, 1993. Firm-initiated recall
complete.
DISTRIBUTION Washington state, Oregon, California.
QUANTITY 7,914.5 pounds were distributed.
REASON The product is contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
========================
______________
PRODUCT Chocolate Flavored Diet Bar, 78 gm, for use as part of the
recalling firm's diet plan product line. Recall #F-540-3.
CODE NOV 1693A.
MANUFACTURER Nellson Candies, Inc., Irwindale, California.
RECALLED BY Uni-Vite, Inc., Carlsbad, California, by letter May 7, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 222 cases (16 bars per cases) were distributed.
REASON Product contains glass fragments.

______________
PRODUCT Individually Wrapped Candies, in 16 ounce bags, dark green
in color with a leaf shape and mint aroma. Recall #F-541-3.
CODE None.
-4-MANUFACTURER Pena Produce Corporation, Bronx, New York (importer).
RECALLED BY Importer, by telephone June 3, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION New York.
QUANTITY 300 cases were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.

_______________
PRODUCT Herdez brand Salsa Casera, mild, 12 ounces.
Recall #F-542-3.
CODE Production code K283ESM1ML printed on top lid and package
code 208271 on the long side of box container.
MANUFACTURER Herdez, S.A. de C.V. Baja California, Mexico.
RECALLED BY Festin Foods Corporation, Carlsbad, California, by letters
of January 19, 1993, and April 6, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION California, Arizona.
QUANTITY 1,244 cases were distributed.
REASON Product is contaminated with glass.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
=======================
______________
PRODUCT Ancef, sterile Cefazolin Sodium (Lyophilized) equivalent to
1 gram Cefazolin, packaged in glass vials of 1 gram/100 ml,
10 units per packer and 4 packers per outside shipper.
Recall #D-296-3.
CODE Lot #4703A37.
MANUFACTURER Smith Kline Beecham Pharmaceuticals, Conshohocken,
Pennsylvania.
RECALLED BY Manufacturer, by telephone June 26, 1993, followed by letter
and visit. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 14,170 units were distributed.
REASON Some shipping cases are mislabeled as 10 gram. The
immediate and intermediate labels are correct as 1 gram.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
===================
______________
PRODUCT (a) Platelets; (b) Recovered Plasma. Recall #B-321/322-3.
CODE Unit #60X28358.
MANUFACTURER American Red Cross Blood Services, Miami, Florida.
RECALLED BY Manufacturer, by telephone and by Fax June 19, 1991. Firm-
initiated recall complete.
DISTRIBUTION Florida, California.
QUANTITY 1 unit of each component.
REASON Blood products, corresponding to a unit of Red Blood Cells
which was possibly contaminated with microorganisms, were
distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
======================
______________
PRODUCT Genesys Gamma Camera for Nuclear Medicine, Models 2129-
3011A. Recall #Z-563-3.
CODE All 2129-3011A Cameras.
MANUFACTURER ADAC Laboratories, Milpitas, California.
RECALLED BY Manufacturer, by visit beginning June 1, 1992, and by
telephone June 1, 1992. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide, Europe, Indonesia, China.
QUANTITY 317 units.
REASON Wear occurs in the older Genesys Gamma Camera's ACME head
screw assemblies resulting in reduced friction. If the loss
of friction is significant and mechanical failure occurs at
a point that disengages the germotor which drives the
detector in and out, the detector could then coast downward
with gravity.

______________
PRODUCT ADAC Labs, Genesys Gamma Camera, Model 21219-3011A, for
nuclear medicine. Recall #Z-564-3.
CODE All serial numbers of Model 2129-3011A, Revision F7 and
below.
MANUFACTURER ADAC Laboratories, Milpitas, California.
RECALLED BY Manufacturer, by visit February 22, 1992. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide, Europe, Indonesia, China.
QUANTITY 298 units.
REASON A problem exists within the radius drive mechanism of the
camera. A drive shaft of one unit broke and could have
fallen and hit a patient. It was determined that the lack
of lubrication of bearings caused a mechanical failure which
caused the bolts, securing the camera's detector, to weaken
and break under extreme load.

______________
PRODUCT Software Option Pegasys/ARC Acquisition SW V1.81 Rev A.
Software is used with the ADAC ARC-300 Digital Nuclear
Imaging System Device. The software was distributed all
under ADAC labels in each of the following software
packages: 9200 - 0184 Software Option, PEG/ARC SWV 1.81,
Rev. A; 9200 - 0185A Software Update, PEG/ARC SWV 1.81, Rev
A; 9200 - 0174 Software Option, ARC Camera V 1.75, Rev A.
Recall #Z-565-3.
CODE No lot or serial numbers are involved. The software is
identified as V 1.81 - Revision A.
MANUFACTURER ADAC Laboratories, Milpitas, California.
RECALLED BY Manufacturer, by letter July 25, 1991. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 43 packages were distributed.

REASON The Gamma Camera for Imaging the patient will continue to
carry out full or partial instructions causing the camera to
move unexpectedly while the computer is storing the
acquisition.

______________
PRODUCT ACS Digoxin Test Kits: (a) ACS Digoxin Combos, 50 Test Kit
Part #672249; (b) ACS Digoxin Combos, 300 Test Kit Part
#672248, used to monitor heart arrhythmias.
Recall #Z-589/590-3.
CODE Lot numbers: (a) 09810 EXP 6/6/92, 10805 EXP 6/11/92,
10806 EXP 6/6/92, 11206 EXP 6/11/92; (b) 09811 EXP 6/6/92,
06605 EXP 6/6/92, 09809 EXP 6/11/92.
MANUFACTURER Ciba Corning Diagnostics, Corporation, E. Walpole,
Massachusetts.
RECALLED BY Manufacturer, by telephone and by Rapidfax dated May 11,
1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Australia, Italy, Finland, England, Belgium,
Canada, Venezuela.
QUANTITY 292 kits were distributed.
REASON Discrepant values exist between the ACS Digoxin method and
reference methods. The readings vary erratically, either
higher or lower than the reference standards.

______________
PRODUCT Serono hCG Maiaclone, used for the quantitative
determination of human chorionic gonadotropin in serum and
plasma and the qualitative determination of hCG in serum,
plasma and urine:
(a) 150 Test Kit Part #472402; (b) 300 Test Kit Part
#472400. Recall #Z-611/612-3.
CODE Lot numbers: (a) 14140, 14790, 14459;
(b) 14144, 14465, 14793, 14796.
MANUFACTURER Serono Diagnostics S.A., Swtizerland.
RECALLED BY Ciba Corning Diagnostics Corporation, E. Walpole,
Massachusetts, by telephone August 21, 1991. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,049 kits were distributed.
REASON The products may yield falsely high test results with
certain types of patient samples. Inaccurate false test
results lead to an error in diagnosis and treatment.

______________
PRODUCT MFHD Formatter, Model 46-308179P2, used with GE nuclear
medicine systems, and for making hardcopy film images of
video output. Recall #Z-615-3.
CODE All serial numbers.
MANUFACTURER Camtronix Ltd. Medical Systems, Hartland, Wisconsin.
RECALLED BY GE Medical Systems, Waukesha, Wisconsin, by letter September
22, 1992. Firm-initiated field correction complete.
DISTRIBUTION Nationwide and international.

QUANTITY 150 units were distributed.
REASON Possible display of incorrect information. When the MFHD
Formatter is connected to two different systems, using the
video A and B inputs, some incorrect patient and image
information may be left on the film.

______________
PRODUCT Various sterile devices: (a) Snap Kovers, sterile products
used in surgical procedures to establish a sterile barrier
between the operating site and any instruments-of usage
(non-sterile) that may be used in this surgical procedure;
(b) Decanting Devices - Bag Decanter, Vial Decanters and
Transfer Device, sterile devices used in decanting sterile
I.V. solutions to patients;
(c) Drape Sheets, sterile devices used to establish a
sterile barrier between patient and operating site during
surgery. Recall #Z-617/619-3.
CODE (a) All product sizes and lot numbers shipped prior to April
6, 1993 that do not have a reference label sticker
identified as "reference*C-9XXXX" affixed to the dispenser
side of each product box;
(b) Bag Decanters -- Product #10-102. All product shipped
prior to April 6, 1993 with a lot number lower than 92651.
Vial Decanter - Product #10-106. All product shipped prior
to April 6, 1993 with a lot number lower than 9245;
Transfer Devices - Product #10-108. All product shipped
prior to April 6, 1993 with a lot number lower than 9223.
(c) Drape Sheets - All product sizes/styles and lots that
are in labeled pouches which were shipped prior to April 6,
1993, and do not have a reference label sticker identified
as "Reference*C-9XXXX" Affixed to the dispenser side of each
product box.
MANUFACTURER Advance Medical Designs, Inc., Marietta, Georgia.
RECALLED BY Manufacturer, by letter April 12, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Labeling of some product as sterile prior to undergoing
sterilization process making the product nonsterile.

______________
PRODUCT Westmed Pacing Coil, temporary bipolar epicardial pacing
device, Product #WPC-1. Recall #Z-648-3.
CODE Catalog #WPC-1, lot numbers: 5001, 5002, 36530, 7005,
11054.
MANUFACTURER West Med, Osborne Park, Western Australia.
RECALLED BY Deknatel, Inc., Fall River, Massachusetts, by telephone and
by letter dated January 29, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 2,456 units were distributed.
REASON Some of the electrodes fail to conduct.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
=====================
______________
PRODUCT Magic T4 Standards and Kits, used for the quantitative
determination of thyroxine in serum or plasma:
(a) Magic T4 Standard Part #472304;
(b) Magic T4 Kits Part #472300;
(c) Magic T4 Kits Part #472318;
(d) Magic T4 Kits Part #472349. Recall #Z-591/594-3.
CODE Kits contain standard lot #03109.
MANUFACTURER Ciba Corning Diagnostics Corporation, E. Walpole,
Massachusetts.
RECALLED BY Manufacturer, by telephone and by Rapidfax. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,008 units and 933 vials sold as part of kits were
distributed.
REASON The product is unstable and may deteriorate. The standards
had lower or higher values, which may cause a potential for
inaccurate test results.

______________
PRODUCT ACS Multicalibrator B2 & B4 Packs, used as a high and low
calibrator for the ACS system for different assayed
products: (a) B2 Pack Part #672171; (b) B6 Pack Part
#672181. Recall #Z-595/596-3.
CODE Product manufactured from lot 12 of Multicalibrator B: Part
#672171, 2-Pack Lot Nos: 06205, 06914, 07311, 07615 EXP
7/16/92; Part #672181, 6-pack lot #06206 EXP 7/16/92.
Product manufactured from lot 13 of Multicalibrator B: Part
672171 - 2 Pack lot numbers: 09201, 10406, 13304, 16801,
18101 EXP 10/18/92.
Part #672181, 6 pack lot numbers: 09202, 10407, 13303,
18102 EXP 10/18/92.
Product manufactured from lot 16 of Multicalibrator B: Part
#672171 2 Pack lot numbers: 27913, 28006 EXP 6/21/93; Part
#672181 - 6 Pack lot numbers: 27914, 28005 EXP 6/21/93.
MANUFACTURER Ciba Corning Diagnostics Corporation, E. Walpole,
Massachusetts.
RECALLED BY Manufacturer, by telephone on or about March 1992 and by
Rapidfax. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 721 kits were distributed.
REASON The high control values are in the range of 26, not the
required 28.3 ACS test values. These high commercial
controls may result in misdiagnosis of patients for Thyroid
Stimulating Hormone (TSH).
______________
PRODUCT Magic T3 Uptake Radioassay, used for the assessment of
unsaturated thyroxine binding proteins (T3-Uptake) in serum:
(a) Magic T3 Uptake Radioassay Standards Part #472289;
(b) Magic T3 Uptake Radioassay Standards Part #472322;
(c) Magic T3 Uptake Radioassay Kit Part #472320.
Recall #Z-597/599-3.
CODE Lot of Standard 02722; kit lot (made with lot 02722) 28308;
Lot of Standard 12722; Kit lot (made with lot 12722) 29608.
MANUFACTURER Ciba Corning Diagnostics Corporation, E. Walpole,
Massachusetts.
RECALLED BY Manufacturer, by telephone between November 3-6, 1992, and
by Rapidfax November 3, 1992. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,210 kits of standards 741 and 702 kits of standards 624
were distributed.
REASON Product has low control values that may result in a decrease
in patient and control values of approximately 6%. This
shift causes a potential for inaccurate test results.

______________
PRODUCT ACS/TSH Assay, an in-vitro diagnostic:
(a) ACS/TSH Assay Combos, 50 test kit Part #672221;
(b) ACS/TSH Assay Combos, 300 Test Kit Part #672220.
Recall #Z-600/601-3.
CODE ACS TSH Combos, 50 test Part #672221, Lot #01602 EXP
5/16/92, 01508 EXP 5/16/92.
ACS TSH Combos, 300 Test Part #672220, lot #01527 EXP
5/16/92, #02711 EXP 5/16/92.
ACS TSH Combos, 50 test Part 672221, lots 32208, 33001,
33609, 34306 EXP 8/9/93.
ACS TSH Combos, 300 test Part #672220, lots 32105, 32801,
32907, 33007, 34304 EXP 8/9/93.
MANUFACTURER Ciba Corning Diagnostics Corporation, E. Walpole,
Massachusetts.
RECALLED BY Manufacturer, by telephone February 26, 1992, and by
Rapidfax March 2, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Germany, France, Hong Kong, Canada, Belgium,
Italy, Australia, Sweden.
QUANTITY 3,882 kits were distributed; firm estimates none remains on
the market.
REASON Testing commercial control recoveries of this product ran
higher than the firm's specification. This causes a
potential for inaccurate TSH test results.

______________
PRODUCT Magic MAB TSH Control, in 10 ml vials, low control, used for
the quantitative determination of thyroid stimulating
hormone in serum. Recall #Z-602-3.
CODE Part #472368, lot #02882.
MANUFACTURER Ciba Corning Diagnostics Corporation, E. Walpole,
Massachusetts.
RECALLED BY Manufacturer, by telephone November 12, 1992. Firm-
initiated recall complete.
DISTRIBUTION New Jersey, Indiana, Florida, New Hampshire, Minnesota.
QUANTITY 10 vials were distributed.
REASON The product was mislabeled with values of 0.11 + or - 0.6
uIU/ml. The correct value should have been 0.11 + or - 0.06
uIU/ml. This mislabeling may result in inaccurate quality
control test results.

______________
PRODUCT Magic Ferritin Bulk Antibody and Tracer, used for the
quantitative determination of ferritin in serum and plasma.
Recall #Z-603-2.
CODE Bulk antibody - lot 11231, bulk tracer lot #01341R, combo
lot 14903.
MANUFACTURER Ciba Corning Diagnostics Corporation, E. Walpole,
Massachusetts.
RECALLED BY Manufacturer, by telephone March 31, 1991. Firm-initiated
recall complete.
DISTRIBUTION Colorado, Texas, Arizona.
QUANTITY 114 units were distributed.
REASON The antibody did not meet the high dose hook claim (60,000)
mg/ml as stated in the product insert. This may result in
inaccurate test results for the quantitative determination
of ferritin in serum and plasma.

______________
PRODUCT The Immophase (125I) Folate Radioassay, used for the
quantitative determination of N5-methyltetrahy-drofolic
acid(MTHFA) in serum, plasma and red blood cells:
(a) Immophase B12 Folate Combined Kits Part # 474272
(b) Immophase Separate B12 Kits Part # 474276
(c) Immophase Separate Folate Kits Part # 474273
(d) Baxter B12/Folate Kits Part # 474781
(e) Baxter (Japanese) B/12 Folate Combined Kit Part # 474787
(f) B/12 Folate Standards Part # 474267
(g) B/12 Folate Controls Part # 474271.
Recall #Z-604/610-3.
CODE Lot numbers: (a) 20101, 18003, 22307, 23502, 23309, 24001;
(b) 20602, 23402; (c) 18001, 20601, 23405; (d) 17907,
17907A, 20502, 23407; (e) 20503, 23410; (f) 01900; (g) 1160,
11620A, 01900.
MANUFACTURER Ciba Corning Diagnostics Corporation, E. Walpole,
Massachusetts.
RECALLED BY Manufacturer, by telephone and by Fax Spetember 27, 1990.
Firm-initiated recall complete.
DISTRIBUTION Nationwide, Japan, France.
QUANTITY Firm estimates none remains on the market.
REASON B-12 values were 15/20% low in the deficient and
indeterminate range of the assay. This instability results
in a potential for inaccurate test results.

____________
PRODUCT The Magic T3 (125I) Radioimmunoassay, intended for the
quantitative determination of triiodothyronine (T3) in serum
or plasma: (a) Standards Part #472308; (b) Kit Part
#472305. Recall #Z-613/614-3.
CODE Lot numbers: (a) 10151, 10631; (b) Standard lot #10151, Kit
lots 02907, 05901, 08603; Standard Lot #10631, Kit lots
08405, lots 10206. 10705, 11302, 11508.
MANUFACTURER Ciba Corning Diagnostics Corporation, Medfield,
Massachusetts.
RECALLED BY Ciba Corning Diagnostics Corporation, E. Walpole,
Massachusetts, by telephone between May 30, 1991 and June 4,
1991, and by Fax May 30, 1991. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY Standards lot 10151 were either shipped as standards (513
units) or part of a kit as follows: Lot 02907 - 98 kits;
05901 - 741 kits; 08603 - 617 kits. Total 1,456.
Total standards shipped from lot 10151 - 513.
Standards lot 10631 were either shipped as standards (589
units) or as part of a kit as follows: Lot 08405 - 20 kits;
10206 - 29 kits; 10709 - 35 kits; 11302 - 22 kits; 11508 581
kits. Total 687 kits. Standards shipped from lot 10631 =
589.
REASON The 0.25 ng/dl standard value of certain lots was
misassigned and caused a poor backfit. This low standard
may result in inaccurate test results.

SEIZURES:
================================================================
______________
PRODUCT Frozen shrimp (93-652-674/80).
CHARGE Adulterated - The articles consist in whole or in part of
decomposed shrimp.
FIRM D'Iberville Cold Storage, D'Iberville, Mississippi.
FILED June 30, 1993; U.S. District Court for the Southern District
of Mississippi, Southern Division; Civil #1:93-CV-319RR;
FDC #66738.
SEIZED July 6, 1993 - goods valued at approximately $6,000.

______________
PRODUCT Top Gel antiseptic deodorant soap (93-675-436).
CHARGE New drug - The article is an unapproved new drug.
Misbranded - The article's label fails to bear a quantity of
contents statement, the established name of each of the
active ingredients, adequate directions for use, and the
article has not been listed as required.
FIRM Wacar Imports, Inc., Orange, New Jersey.
FILED June 11, 1993; U.S. District Court for the District of New
Jersey; Civil #93-2534(AJL); FDC #66702.
SEIZED July 2, 1993 - goods valued at approximately $8,000.

______________
PRODUCT Latex examination gloves (93-671-083).
CHARGE Adulterated - The article's quality falls below that which
it purports or is represented to possess, since the defect
rate of the gloves exceeds the permissible rate.
Misbranded - The article is in package form and the label
does not contain the name and place of the business of the
manufacturer, packer, or distributor.
FIRM Biomedical Innovations, Inc., Blacklick, Ohio.
FILED June 8, 1993; U.S. District Court for the Southern District
of Ohio, Eastern Division; Civil #C2-93-568; FDC #66729.
SEIZED June 18, 1993 - goods valued at approximately $2,770.

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END OF ENFORCEMENT REPORT FOR JULY 28, 1993. BLANK PAGES MAY FOLLOW.
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