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
11/11/1992
RECALLS AND FIELD CORRECTIONS: November 11, 1992
FOODS -- CLASS II
92-46
PRODUCT Kraft General Foods Stove Top Stuffing Mix in flexible
cardboard serving canisters:
(a) Stove Top Cornbread One Step Stuffing Mix, in 8 ounce
canisters;
(b) Stove Top Chicken Flavor with Real Chicken Broth One Step
Stuffing Mix, in 8 ounce and 12 ounce canisters.
Recall #F-102/103-3.
CODE 2259D5 0001 through 2267D5 2359.
MANUFACTURER General Foods USA, Dover, Delaware (stuffing)
California Vegetable Concentrates, Modesto, California (celery).
RECALLED BY Kraft General Foods, Inc., Glenview, Illinois, by FAX and
telephone September 25, 1992, followed by visits to be
completed by October 1, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Delaware, Georgia, New York, Pennsylvania, Maryland, Virginia,
North Carolina, South Carolina, Florida, Georgia, Tennessee,
Alabama, Mississippi, Louisiana, Washington, D.C.
QUANTITY 6,818 cases (12 canisters per case) were distributed; firm
estimates that no more than 579 cases remain on the market.
REASON Product contains an ingredient, freeze dried celery, which has
been found positive for salmonella.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Blue Springs brand Pure & Natural Water, in 20 fluid ounce
plastic bottles. Recall #F-100-3.
CODE Codes beginning with 2158, 2181, 2206, 2209, 2234.
MANUFACTURER Blue Springs Water, Inc., Blue Springs, Alabama.
RECALLED BY Manufacturer, telephone. Firm-initiated recall ongoing.
DISTRIBUTION Alabama.
QUANTITY Unknown.
REASON Product is contaminated with non-fecal coliforms, off odor
unfit for human consumption.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Fluorescein Sodium, USP, bulk, in 25 kg, 1 kg, and 100 gram
bottles. Recall #D-051-3.
CODE Lot numbers: FJ116 and GB096.
MANUFACTURER Dysers S. A. L., Segovia, Spain.
RECALLED BY Spectrum Chemical Mfg. Corporation, Gardena, California, by
letter April 17, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Illinois, New Jersey, California, New York, Ohio, Colorado,
Washington state.
QUANTITY 334.21 pounds were distributed.
REASON Presence of small quantities of mercury.
PRODUCT Fluorescein Sodium Injection, in glass ampules, used
intravenously as a diagnostic aid:
(a) 10% Solution; (b) 25% Solution. Recall #D-052/053-3.
CODE Lot numbers and EXP dates: (a) 19221 3/93, 19294 4/93,
19339 6/93, 19377 6/93; (b) 19173 4/93, 19222 3/93,
19273 2/93, 19347 6/93.
MANUFACTURER Walnut Pharmaceuticals, Inc., Los Angeles, California.
RECALLED BY Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana
(formerly Anaheim, California), by letter April 21, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Louisiana, Oklahoma, Canada.
QUANTITY (a) 63,593 units; (b) 54,479 units were distributed.
REASON Presence of small quantities of mercury.
PRODUCT Papaverine-Phentolamine-Prostoglandin-E1 Injectable drug
product. Sold as four 1-cc vials or a single 4-cc vial, a Rx
injectable. Recall #D-054-3.
CODE No lot and or serial number was assigned. A six month
expiration date was handwritten on each computer-generated
label following the manufacture of product (4 cc-vial or 4 1-cc
vials).
-2-
MANUFACTURER Catawba Medical Associates Chartered, Mays Landing, New Jersey.
RECALLED BY Manufacturer, by letter mailed on or about September 14, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 100 4-cc units were distributed.
REASON Product was marketed without new drug approval and with current
good manufacturing practice deficiencies.
PRODUCT Brethaire, Rx bronchodilator aerosol for oral inhalation:
(a) Brethaire - Terbutaline Sulfate Inhalation Aerosol Inhaler,
0.2 mg each metered dose, 7.5 ml (10.5 g). 300 metered
inhalations. Packaged as cartoned canister with mouthpiece.
(b) Brethaire - Terbutaline Sulfate Inhalation Aerosol, 0.2 mg
each metered dose. Refill canister for inhaler 7.5 ml (10.5
g). 300 metered inhalations. Packaged as a cartoned canister
refill. Recall #D-055/056-3.
CODE Lot numbers: 1911210 EXP OCT 93, 2911210 EXP 10 93, 3911210
EXP OCT 93,
MANUFACTURER Riker Laboratories, Inc., Northridge, California.
RECALLED BY CIBA-Geigy Corporation, Summit, New Jersey, by letter August
21, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 96,500 canisters were distributed.
REASON Reports of coughing, throat irritation and reduced efficacy.
UPDATES Recall #D-234/D-235-2, manufactured by Lyphomed, Division of
Fujisawa USA, Inc., which appeared in the March 4, 1992
Enforcement Report has been extended as follows:
(a) Lyphomed Sodium Chloride Injection, USP, Concentrated
23.4%, 4 mEq/ml, Must Be Diluted Prior to IV Administration,
Preservative Free; 30 ml. single dose vial, recall extended to
include lot #311378.
Recall #D-503/518-2, manufactured by Lyphomed, Division of
Fujisawa USA, Inc., which appeared in the September 16, 1992
Enforcement Report has been extended as follows:
Recall #D-505-2: Cyanocobalamin Injection, USP, 1,000 mcg/ml; 1
ml vials, has been extended to include lot 320053.
Various Rx injectables, Recall #D-024/041-3, manufactured by
Lyphomed, Division of Fujisawa USA, Inc., which appeared in the
October 28, 1992 Enforcement Report has been extended as
follows:
Recall #D-028-3, Calcium Gluconate Injection, USP, 10%, has
been extended to include 50 ml vial, lot numbers 301065, 301067.
Recall #D-029-3, Lidocaine Hydrochloride Injection, USP, 4% (40
mg/ml), has been extended to include lot number #300735.
-3-
Recall #D-030-3, Lidocaine Hydrochloride Injection, USP, 2% (20
mg/ml), has been extended to include 20 ml vials, and 30 ml
vials, lot numbers 310980, 310763;
Recall #D-032-3, Mannitol Injection, USP, 25%, has been
extended to include lot numbers 300006, 300284, 300285, 300414,
300416, 310204, 310967, 320009, 320272;
Recall #D-034-3, Sodium Chloride Injection, USP Concentrated,
23.4%, has been extended to include lot numbers 300945, 300946,
301062, 301381, 301382, 310066, 310481;
Recall #D-035-3: Sodium Chloride Injection, USP, 0.9%, has been
extended to include 2 ml vials, lot numbers 300823, 300824,
300826, 301086, 301087, 301088, 301424, 310358, 310359, 310360,
310374, 310377, 310511, 310514, 320604, 320720;
Recall #D-037-3, Sterile Water for Injection, USP, has been
extended to include 5 ml glass, lot #311174;
50 ml glass, lot numbers 300953, 301458, 310310;
100 ml glass, lot numbers 300959, 300962, 310209;
Recall #D-041-3, Dextrose Injection, USP, 50%, has been
extended to include lot #301154.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Amsco Spordi Strips, used in chemical vapor sterilizers to
determine the adequacy of the sterilization process.
Recall ##Z-005-3.
CODE All lots.
MANUFACTURER Amsco Medical Products, Division, Erie, Pennsylvania.
RECALLED BY Oral Microbiology Lab, University of North Carolina School of
Dentistry, Chapel Hill, North Carolina, by letter November 5,
1991. Firm-initiated recall complete.
DISTRIBUTION North Carolina, Kansas, Maine, Virginia.
QUANTITY Unknown.
REASON The device has been marketed without an approved 510(k)
premarket notification.
PRODUCT Express 550 Software, Versions: 2.1, 2.11, 2.12, 2.2, 2.31
used in conjunction with the 550 Express Chemistry Analyzer.
Recall #Z-019-3.
CODE All lots of version 2.1, 2.11, 2.12, and 2.2 software shipped
prior to 8/23/91 and all of version 2.31 software shipped prior
to 1/30/92.
MANUFACTURER Ciba Corning Diagnostics Corporation, Oberlin, Ohio.
RECALLED BY Manufacturer, by telephone followed by letter August 23, 1991.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,837 analyzers with the recalled software were distributed.
REASON A situation exists with the communications option on the 550
Express Clinical Chemistry Analyzer that 1) can cause invalid
patient results to be transmitted without an error flag and 2)
can cause incorrect patient results to be transmitted.
-4-
PRODUCT Intermed brand Urinary Drainage Bag with Sterile Fluid
Pathway. Recall #Z-020-3.
CODE Catalog #6220, lot #4646.
MANUFACTURER Intermed, Inc., El Paso, Texas.
RECALLED BY Intermed, Inc., Sparta, New Jersey, by telephone August 12,
1992, followed by letter August 17, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 117 units were distributed; firm estimates none remains on the
market.
REASON One pallet of this lot was shipped prior to sterilization.
PRODUCT Select Shoulder Primary Humeral Component Template Set
(1000-03-500); (b) Select Shoulder System Modular Humeral
Component 10 mm Template (1000-03-502). Recall #Z-021/022-3.
CODE All lots shipped prior to 6/12/92.
MANUFACTURER Intermedics Orthopedics, Inc., Austin, Texas.
RECALLED BY Manufacturer, by telephone and bulletin March 27, 1992,
followed by letter June 12, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 566 sets; (b) 192 templates were distributed.
REASON The template set of six templates is labeled "10%
magnification" when the templates in the set are actually drawn
to require "20% magnification" and the 10 mm template
(1000-03-502) is labeled to be 220 mm long, but is actually 200
mm long.
PRODUCT Saturne Medical Therapy Linear Accelerator Models 41, 42, and
43 with Software Version V1.32, produced electron beam impulses
for patient treatments to kill cancer cells.
Recall #Z-023/025-3.
CODE All units with software version V1.32.
MANUFACTURER GE-CGR (formerly Thomson CGR), Buc (Paris), France.
RECALLED BY General Electric Company, Medical Systems Division, Waukesha,
Wisconsin, by sending a Urgent Safety Notice November 5, 1991.
Firm-initiated field correction complete.
DISTRIBUTION Georgia, Kansas, New York, South Carolina.
QUANTITY 5 units were distributed.
REASON Due to a software defect, it is possible, under certain
circumstances, to administer a treatment without the automatic
wedge filter in position even though the device was set for
treatment with the wedge filter and the information displayed
on the operator console shows the wedge filter is in use.
PRODUCT Scimed Triguide Coronary Guiding Catheters:
(a) Model 7F/AL1 SH (7 French, Amplatz Left, with Side Holes);
(b) Model 7F/AR1 SH (7 French, Amplatz Right, with Side
Holes). Recall #Z-026/027-3.
CODE Lot numbers: (a) 72191Y; (b) 72192F.
MANUFACTURER Scimed Life Systems, Inc., Plymouth, Minnesota.
RECALLED BY Scimed Life Systems, Inc., Maple Grove, Minnesota, by visit on
or about September 2, 1992. Firm-initiated recall complete.
-5-
DISTRIBUTION Tennessee, Ohio, Florida, Indiana, New Jersey, New York,
Louisiana, Oklahoma, Texas, Minnesota, Wisconsin.
QUANTITY (a) 20 units; (b) 18 units were distributed.
REASON Catheters labeled as 7F/AL1 SH (7French, Amplatz Left, with
Side Holes) were found to contain 7F/AR1 SH (7French, Amplatz
Right, with Side Holes) and vice versa.
PRODUCT True Fit Myelogram Tray with nine-holed aspiration cannula and
spinal needle. Recall #Z-047-3.
CODE Lot K1K387R.
MANUFACTURER Baxter Health Care Corporation, Kingstree, South Carolina.
RECALLED BY Baxter Health Care Corporation, Pharmaseal Division, Valencia,
California, by telephone August 5 & 6, 1992, followed by letter
dated August 4, 1992. Firm-initiated recall complete.
DISTRIBUTION California, Florida, Illinois, Kentucky, Michigan, Mississippi,
New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, West
Virginia.
QUANTITY 700 trays (35 can of 20 units per carton) were distributed.
REASON The trays were sterilized, then reworked without being
resterilized.
PRODUCT (a) Natural-Knee Revision Femoral Stems with straight stems:
Catalog No. 6200-16-001 - 12.5 mm x 125 mm length
Catalog No. 6200-16-002 - 12.5 mm x 200 mm length
Catalog No. 6200-16-003 - 10.5 mm x 125 mm length
Catalog No. 6200-16-004 - 10.5 mm x 200 mm length
Catalog No. 6200-16-005 - 14.5 mm x 125 mm length
Catalog No. 6200-16-006 - 14.5 mm x 200 mm length
(b) Natural-Knee Revision Femoral Stems with curved stems:
Catalog No. 6200-16-017 - 10.5 mm x 250 mm length
Catalog No. 6200-16-018 - 12.5 mm x 250 mm length
Catalog No. 6200-16-019 - 14.5 mm x 250 mm length.
These stems are used in conjunction with the Natural-Knee
Revision femoral component of the Natural-Knee Revision System
to replace a diseased or otherwise dysfunctional knee joint.
Recall #Z-048/049-3.
CODE Catalog No. 6200-16-001 - Lots 11369, 14194, 14242, 14244,
47185, 47685, 49085, 49086, 49087, 73736, 73886, 73887, 75050,
75051, 75052, 75053, 76400, 76401, 76402, 76737, 76738, 78541,
78542, 78545, 78839, 78840, 78841
Catalog No. 6200-16-002 - Lots 11262, 14195, 14245, 41134-A,
43381, 45169, 46542, 47187, 49088, 49089, 49301, 70059,
70059-A, 70517, 70518, 70519, 71891, 71892, 71893, 75054,
75055, 75056, 76403, 76739, 76989, 78096, 78543, 78546, 78926,
78927
Catalog No. 6200-16-003 - Lots 22702, 22703, 22704, 22705,
76408, 76409, 76983, 76990, 78580, 78581, 78582
Catalog No. 6200-16-004 - Lots 22710, 22711, 22712, 22712-A,
22713, 22713-A, 73892, 73893, 73894, 78087, 78088, 78583,
78584, 78585
-6-
Catalog No. 6200-16-005 - Lots 22706, 22707, 22708, 47186,
49093, 49094, 49712, 72693, 73888, 74677, 74678, 74679, 74679,
76741, 76742, 76742, 77343, 77344, 78090, 78842, 78843, 78928,
79171
Catalog No. 6200-16-006 - Lots 22714, 22715, 47686, 47986,
47986-A, 49090, 49091, 49741, 49742, 72529, 72692, 73889,
73939, 73940, 73940-A, 74680, 76405, 76406, 76407, 76740,
76988, 78091, 78092, 78093, 78094, 78844, 78929
Catalog No. 6200-16-017 - Lots 25297, 25947, 41366, 41366-A,
42064, 42064-A, 71740, 73890, 73891, 73938, 78089, 78586, 78587
Catalog No. 6200-16-018 - Lots 23641, 25298, 25298-A, 41138,
48793, 71741, 74675, 74676, 78095, 78544
Catalog No. 6200-16-019 - Lots 23642, 25345, 25343-A, 26066,
26066-A
MANUFACTURER Intermedics Orthopedics, Inc. (IOI), Austin, Texas.
RECALLED BY Manufacturer, by telephone September 2, 1992, followed by
letter September 9, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 852 units were distributed; firm estimates 429 units remain on
the market.
REASON Devices may be one half centimeter longer than labeled.
PRODUCT Argyle 18 French Ferguson Left Vent Catheters: (a) Sterile,
Catalog No. 8888-590018;
(b) Non-sterile, Catalog No. 5558-590013;
(c) Non-sterile, Catalog No. 5558-590021. Recall #Z-050/052-3.
CODE (a) All lots up to and including 443954;
(b) All M46- lot numbers up to and including 1310;
(c) All M47- lot numbers up to and including 5430.
MANUFACTURER Sherwood Medical, Argyle, New York.
RECALLED BY Sherwood Medical Company, St. Louis, Missouri, by telephone
beginning October 14, 1992, followed by letter of October 14,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 48,000 units; (b) 13,000 units; (c) 18,900 units were
distributed.
REASON The devices may contain a hole or channel which could allow
blood or air leakage at the proximal end.
PRODUCT Latex Examination Gloves, small or medium. Recall #Z-055-3.
CODE None.
MANUFACTURER Unknown. Made in Taiwan.
RECALLED BY Dental & Physicians Supply, De Pere, Wisconsin, by letter dated
October 5, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Florida, Illinois, Indiana, Michigan, Ohio, Pennsylvania,
Wisconsin.
QUANTITY 200 boxes (100 gloves per box) were distributed from December
1990 to May 1991.
-7-
REASON The gloves' packaging labels were inadequately labeled, and
were repacked from gloves that were sold to the repacker as
industrial/non-medical latex gloves without a quality control
history.
PRODUCT Electric Bed Pendants (hand controls), used to operate electric
hospital beds:
(a) Part No 51000M220, 4-Way Standard Volt Pendant;
(b) Part #51000M221, 6-Way Standard Volt Pendant.
Recall #Z-057/058-3.
CODE All bed pendants distributed between January 1, 1986 and
December 31, 1987. These pendants accompanied electric beds
with the model numbers: 5108-1, 5308-1, 5409-1, 5108-3,
5308-3, 5409-3.
MANUFACTURER Harvard Interiors Manufacturing Company, Arnold-Tenbrook,
Missouri (pendant). Mobilite Corporation, Division of
Invacare), Sanford, Florida (bed).
RECALLED BY Invacare Corporation, Elyria, Ohio, by letters of November 8,
1991, to dealers and users and November 11, 1991, to
purchasers. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Panama, Italy, Sweden.
QUANTITY Approximately 33,066 pendants were distributed.
REASON The wire portion can become frayed at its point of entry into
the pendant housing which can present a potential for
electrical shock and/or fire.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Performance Knee Modular Tibial Tray Insert. Recall #Z-018-3.
CODE Catalog #7614-15-080, lot #009247.
MANUFACTURER Kirschner Medical Corporation, Fair Lawn, New Jersey.
RECALLED BY Kirschner Medical Corporation, Timonium, Maryland, by letter
dated July 8, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Missouri, New York, New Hampshire, Texas, Washington, state,
Kentucky, Minnesota, Illinois, Michigan, Maryland, Italy,
France, Belgium, Canada.
QUANTITY 31 trays were distributed.
REASON A packaging mix-up; an Integrity Acetabular Cup Liner may have
inadvertently been misplaced into the Tibial Insert package.
PRODUCT Bausch & Lomb Trial Contact Lenses used for fitting disposable
and planned replacement contact lenses, blister pack.
Recall #Z-028-3.
CODE Lot numbers: I058847 (on blister pack), I058181 (on Carton).
MANUFACTURER Bausch & Lomb, Inc., Rochester, New York.
RECALLED BY Manufacturer, by telephone September 25, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 156 cartons were distributed, all in September 1992; firm
estimates 95% of the product remains on the market.
REASON The carton labeling (Lot No. I058181 with 8.4 b.c. and -4.50
Diopter) does not agree with the correct blister pack labeling
(Lot No. I058847 with 8.7 b.c. and -0.50 Diopter).
-8-
PRODUCT Rapi Tex RF New, an in-vitro diagnostic reagent for the
detection and semi-quantitative determination of rheumatoid
factors in human serum or plasma. Recall #Z-029-3.
CODE Catalog #OWHS21, lot #193812A EXP 1/27/93.
MANUFACTURER Behringwerke AG, Marburg, Germany.
RECALLED BY Behring Diagnostics, Inc., Somerville, New Jersey, by telephone
May 19, 1992, followed by letter dated June 4, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 181 units were distributed; firm estimates 91 units remain on
the market. As of August 3, 1992, 90 of the distributed units
had been returned by consignees.
REASON The package insert did not contain directions for tests
designed for the U.S. market only. It was distributed with the
"International Version" instead of the "U.S. version".
PRODUCT Round Shank Reciprocating Surgical Saw Blades, used in oral
surgery, typically on the lower jaw:
(a) Round Shank Reciprocating Surgical Saw Blade 23 x 5 mm;
(b) Round Shank Reciprocating Surgical Saw Blade 17 x 4 mm.
Recall #Z-031/032-3.
CODE Product Nos. Lot Nos.
(a) 00-5053-052-00 28261500,
(b) 00-5053-051-00 28259200.
MANUFACTURER Hall Surgical, Div. of Zimmer, Carpinteria, California.
RECALLED BY Manufacturer, by letter August 24, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION California, Connecticut, Florida, Iowa, Idaho, Illinois,
Indiana, Minnesota, Missouri, Ohio, Pennsylvania, South
Carolina, Utah, Virginia, Singapore, Japan, England, Australia,
France, Hong Kong.
QUANTITY 80 units (40 units each lot) were distributed.
REASON The blades marked as 00-5053-052-00, 23 x 5 mm were actually
00-5053-051-00, 17 x 4 mm blades and vice versa.
PRODUCT Concise in-vitro diagnostic kits:
(a) "Concise" Strep A Immunochromatographic Assay Kit, Catalog
04512 (25 Test);
(b) "Concise" Strep A Immunochromatographic Assay Kit, Catalog
04513 (50 Test);
(c) "Concise" Mono Color Immunochromatographic Assay, Catalog
4551 (10 Test);
(d) "Concise" Mono Color Immunochromatographic Assay, Catalog
4550 (25 Test);
(e) "Concise" HCG-Urine Immunochromatographic Assay, Catalog
4139 (25 Test). Recall #Z-033/037-3.
CODE Lot numbers:
(a) 290007, 290011, 290012, 290112, 290113, 290114, 290115,
290116, 290117, 290232, 290233, 290234, 290235, 290266,
290379, 290380, 290381, 290382, 290383, 290384, 290385,
-9-
290428, 290429, 290430, 290454, 290455, 290456, 290457,
290458, 290521, 290522, 290523, 290524, 290525, 290526,
290527, 290528, 290529, 290530, 290531, 290532, 290533,
290838, 290839, 290840;
(b) 290009, 290010, 290111, 290387, 290426, 290459, 290534,
290535;
(c) 290308;
(d) 290309, 290311, 290312, 290313, 290314, 290560, 290561,
290562, 290677, 290678, 290679, 290680, 290681, 290825;
(e) 290307, 290478, 290479, 290480, 290481, 290660, 290661,
290727.
MANUFACTURER Pacific Biotech, Inc., San Diego, California.
RECALLED BY Hybritech, Inc., San Diego, California, by letter August 14,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 36,680 kits were distributed; FDA estimates that
little product remains on the market.
REASON Defective pouch seals may lead to deterioration of test
components which could cause invalid test results.
PRODUCT King Systems brand Non-conductive 1/2 liter Breathing Bag with
22 mm O.D. x 15 mm I.D. fitting. Recall #Z-046-3.
CODE Lot number 559032.
MANUFACTURER King Systems Corporation, Noblesville, Indiana.
RECALLED BY Manufacturer, by telephone between April 15, 1992 and May 15,
1992. Firm-initiated recall complete.
DISTRIBUTION Colorado, Ohio, Illinois.
QUANTITY 10 cases (30 bags per case) were distributed.
REASON The 22 mm O.D. x 15 mm adaptor fitting may be missing.
INJUNCTION
Product: Meat from Dairy Cows with Illegal Antibiotic Residues
(92-567-555/556).
CHARGE Adulterated - Food products from dairy animals at slaughter
contained new animal drugs in excess of legal tolerances and
were therefore unsafe.
DEFENDANTS George Plantenga, an individual, doing business as Western Sky
Dairy, a corporation, Corona, California.
FILED July 14, 1992, Complaint; July 16, 1992, Consent Decree of
Permanent Injunction; U.S. District Court for the Central
District of California; Civil # 92-4186-RSWL(EEx), INJ 1289.
-10-
SEIZURE:
PRODUCT Veterinary opthalmic solutions and anthelmintic capsules
(92-684-004).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the products' manufacture, processing,
packing, and holding do not conform to and are not operated and
administered in conformity with current good manufacturing
practice regulations.
New animal drug - The product, WORM CAPS, is an unapproved new
animal drug.
FIRM Cardinal Laboratories, Inc., Azusa, California.
FILED October 2, 1992; U.S. District Court for the Central District
of California; Civil #92-5966-AAH(CTx), FDC #66489.
SEIZED October 15, 1992 - goods valued at approximately $35,000.
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END OF ENFORCEMENT REPORT FOR NOVEMBER 11, 1992. BLANK PAGES MAY
FOLLOW.
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