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
03/03/1993
Recalls and Field Corrections: Foods -- Class II -- 03/03/1993
MARCH 3, 1993 93-9
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Jalapeno Hot Sauce, in 6 ounce glass bottles. Recall #F-225-3.
CODE None on container.
MANUFACTURER Panola Pepper Corporation, Lake Providence, Louisiana.
RECALLED BY Manufacturer, by telephone and by fax on or about December 10,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Virginia, Minnesota, Texas, Tennessee, Louisiana, Florida.
QUANTITY 4,034 cases (24 bottles per case) were distributed; firm
estimates 947 cases remain on the market.
REASON Product contains undeclared FD&C Yellow #5.
RECALLS AND FIELD CORRECTION: FOODS -- CLASS III
PRODUCT L-Carnitine 250 mg Tablets, under the Rugby and Barth's label.
Recall #F-226-3.
CODE 3841 0921 EXP 12/93 (Rugby & Barth's), 2301-1901 EXP 10/94
(Barth's).
MANUFACTURER Tishcon Corporation, Westbury, New York.
RECALLED BY Manufacturer, by letter November 16, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION New York.
QUANTITY 1,365 units of lot 3841-0921 and 1,017 units of lot 2301-1901
were distributed; firm estimates no product remains on the
market from lot 3841-0921 and 50 units remain on the market
from lot 2301-1901.
REASON Product is subpotent in L-Carnitine, 67.9% of label declaration.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Laxative products under The Rx Place label:
(a) Stool Softener Docusate Sodium 100 mg, 100 softgels, OTC;
(b) Laxative with Stool Softener, Casanthranol and Docusate
Sodium, 100 softgels, OTC. Recall #D-145/146-3.
CODE Lot numbers: (a) 1063-2 EXP 12/93; (b) 1063-4 EXP 1/94.
MANUFACTURER Pharmacaps, Inc., Elizabeth, New Jersey.
RECALLED BY G&W Labs, S. Plainfield, New Jersey (responsible firm), by
letter dated October 27, 1992. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Rhode Island, New Jersey, New York, Pennsylvania.
QUANTITY (a) 1,512 containers; (b) 1,440 containers were distributed.
REASON Main label panels correctly declare ingredients. Side panels
reversed the ingredients of the two products.
PRODUCT Nitrotan, germicidal wound spray, in 4 ounce and 8 ounce
aerosol cans, an OTC for topical use. Recall #D-160-3.
CODE Lots 1000 through 2200.
MANUFACTURER Cramer Products, Inc., Gardner, Kansas.
RECALLED BY Manufacturer, by letter during the first week of November
1992. Firm-initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 52,980 cans were distributed.
REASON Internal mechanism of the aerosol valve may fail, allowing
product leakage.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Red Blood Cells. Recall #B-149-3.
CODE Unit #1093765.
MANUFACTURER Hunter Blood Center, Inc., Clearwater, Florida.
RECALLED BY Manufacturer, by letter March 18, 1992. Firm-initiated recall
complete.
DISTRIBUTION Florida.
QUANTITY 1 unit.
REASON Blood product, which tested negative for all required and
recommended viral markers, but was collected from a donor who
experienced an occupational needle stick exposure approximately
seven months prior to donation, was distributed.
PRODUCT Red Blood Cells. Recall #B-156-3.
CODE Unit numbers: 28025-8994, 28025-8997, 28025-8998, 28025-9000,
28025-1602, 28026-1604, 28026-1607, 28026-1608, 28026-1609.
-2-
MANUFACTURER United Blood Services Blood Systems, Inc., San Angelo, Texas.
RECALLED BY Manufacturer, by visit April 2, 1992. Firm-initiated recall
complete.
DISTRIBUTION Texas.
QUANTITY 9 units.
REASON Red Blood Cells, prepared more than eight hours after the
collection of the Whole Blood units, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT (a) Stainless Steel Smoke Evacuation Vaginal Speculums,
Standard Size;
(b) Stainless Steel Smoke Evacuation Vaginal Speculums, Large
Size. Recall #Z-119/120-3.
CODE All product distributed prior to April 21, 1992.
MANUFACTURER Macho International, Pakistan.
RECALLED BY Ellman International, Inc., Hewlett, New York, by letter April
21, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 120 units were distributed.
REASON The underside of the arm of the speculum around the area of the
evacuation tube may oxidize/rust depending on the sterilization
technique used.
PRODUCT I.V. Catheter Extension and Y-Type Extension Sets, single-use
devices which are used on both adults and children:
Baxter brand Catheters: (a) Catalog #2N1190; (b) Catalog
#2N1192; (c) 2N1194;
Medex brand Catheters: (d) MX451-FL, (e) MX453; (f) MX453-L;
(g) MX453-2L, (h) MX453-SL, (i) MX456-L; (j) M458L; (k) MX459;
(l) MX596-C; (m) MX613; (n) MX6251.
Recall #Z-231/244-3.
CODE Lot numbers: (a) 22A07063 through and including 22I10155;
(b) 22A21099 through and including 22I08183;
(c) 22A02014 through and including 22I15051;
(d) 21J23014 through 22E27028;
(e) 21L7126 through 22A23112;
(f) 21J08044 through 22E27173;
(g) 22B18047 through 22E07052;
(h) 21J16050 through 22C16041;
(i) 22B27047 through 22F12040;
(j) 22E21020 through 22E21020;
(k) 22A07048 through 22E14053;
(l) 21K20065 through 22C09109;
(m) 22C04123 through 22D07085;
(n) 22A31064 through 22D13060.
MANUFACTURER Baxter Healthcare Corporation, Deerfield, Illinois.
RECALLED BY Medex, Inc., Hillard, Ohio, by letter October 8, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
-3-
QUANTITY 1,808,783 devices were distributed.
REASON The female luer is cracking and leaking.
PRODUCT Boston Envision Rigid Gas Permeable Daily Wear Contact Lenses
(blue), Part #80168. Recall #Z-261-3.
CODE Lot #0014230.
MANUFACTURER Polymer Technology, Wilmington, Massachusetts.
RECALLED BY Manufacturer, by letter or by telephone November 2, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Ohio, Texas, France, Poland, Yugoslavia.
QUANTITY 51 lenses were distributed.
REASON The lenses were cut as -3.25 D, but were labeled with a power
of -3.00 D.
PRODUCT Jude Medical 9 Fr RediGuard DL 40 cc Intra-Aortic Balloon
Catheter Kit, Catalog #060-0525, containing UMI Cath-Seal
Percutaneous Catheter Introducer (PCI). Recall #Z-262-3.
CODE UMI part #1205-60-3701, lot numbers: 138187, 138188, 138189,
137373, 136333, 137698, 137802, 136829, 137843.
MANUFACTURER Universal Medical Instruments, Ballston, SPA, New York.
RECALLED BY St. Jude Medical, Inc., Chelmsford, Massachusetts. Salesforce
notified hospitals on December 25, 1992, followed by letter
dated January 7, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Florida, Texas, Pennsylvania, Missouri, Michigan, Illinois.
QUANTITY 115 kits were distributed.
REASON The bond between the sheath and hub assembly may separate due
to contact with aqueous solutions.
PRODUCT TENS (Transcutaneous Electrical Nerv Stimulator), a Rx device
distributed under the Dial Away Pain 400 and Synaptic 1000
labels. Recall #Z-327-3.
CODE Serial numbers 101 through 146 (except unit 131).
MANUFACTURER Halleck-Willard, Inc., Fredrick, Colorado.
RECALLED BY Relief From Pain, Inc., Aurora, Colorado, by letter on or about
August 5, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Iowa, California, Michigan, North Carolina, Colorado, New York,
Washington state, Illinois, Nebraska, North Dakota.
QUANTITY 16 units were subject to field correction as of 8/3/92.
REASON Device may deliver a small shock to the patient.
PRODUCT Sterile Mayfield Disposable Skull Pins, used to keep a
patient's head stationary during brain surgery:
(a) Stainless Steel; (b) Stainless Steel with a Polycarbonate
base Recall Z-330/331-3.
CODE Part Nos. Lot Nos.
A-1072 52921291, 52915092, 52929592, 52929592A, 52926692,
52927992, 52932492
A-1072S 35505992, 32913292, 52913292, 52931092.
MANUFACTURER Ohio Medical Instrument Company, Cincinnati, Ohio.
-4-
RECALLED BY Manufacturer, by letter January 22, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Germany, Canada, Japan, Spain.
QUANTITY Approximately (a) 58; (b) 439 boxes (12 units per box) were
distributed.
REASON Both products were marketed without an approved 510(k).
PRODUCT Life Pulse High Frequency Ventilator Humidifier Cartridges,
also called patient breathing circuits. Recall #Z-347-3.
CODE Lots 133 - 179.
MANUFACTURER Bunnell, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by letter November 13, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Japan, Korea.
QUANTITY Approximately 11,386 units were distributed.
REASON The cartridges are susceptible to cracking at the hose ports,
which could result in breakage and failure.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Nor-Partigen Control Set I, an in-vitro diagnostic kit, for use
with the monospecific, Nor-Partigen Plates for the quantitative
determination of immunoglobulins in human serum.
Recall #Z-283-3.
CODE Catalog #942001, lot numbers: 20282 EXP 8/90, 20807 EXP 11/90.
MANUFACTURER Behringwerke, AG, Marburg, Germany.
RECALLED BY Behring Diagnostics, Somerville, New Jersey, by letter July 17,
1990. Firm-initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 188 sets were distributed. Firm estimates none remains on the
market, product is expired.
REASON IqM constituent valve of these controls was reading greater
than 15% of its high value. This value is outside its limit of
acceptability for this constituent.
PRODUCT Vacutainer brand SST Blood Collection Tubes. Recall #Z-291-3.
CODE Catalog #6509, lot #2C914 EXP 4/93.
MANUFACTURER Becton Dickinson Vacutainer Systems, Sumter, South Carolina.
RECALLED BY Becton Dickinson Vacutainer Systems, Rutherford, New Jersey, by
telephone and letter dated July 20, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, Canada, England, Japan.
QUANTITY 436,000 units were distributed.
REASON Product may break in the centrifuge due to firecrack defects in
the bottom of the tube.
-5-
PRODUCT Coumatrak Protime Controls, lyophilized whole blood based
control materials for two levels of prothrombin time, normal
and abnormal, packaged in 1 ml vials, for in-vitro use only as
a check on the analytical performance of the Coumatrak Monitor
and Protime Test System. Recall #Z-308-3.
CODE Lot numbers: CPC1L15, CPC1M16, CPC2A01, CPC2A02, CPC2A03,
CPC2B04, CPC2B05, CPC2B06, CPC2E11, CPC2F13.
MANUFACTURER Consolidated Technologies, Inc., Austin, Texas.
RECALLED BY Biotrack, Inc., Mountain View, California, by telephone
November 23, 1992, followed by Fax and letter. Firm-initiated
recall ongoing.
DISTRIBUTION Delaware.
QUANTITY 11,748 boxes (5 vials per box) were distributed.
REASON The controls take longer to clot than the clotting time ranges
on the label.
PRODUCT Ventricular Drainage System, intended for single use, to
facilitate the collection of cerebrospinal fluid (CSF), fluid
injection, CSF sampling and intracranial pressure monitoring:
(a) Ventricular Drainage System, Model 041;
(b) Ventricular Bolt Pressure Monitoring & Drainage Kit,
Model 110-4HC;
(c) Microventricular Bolt Pressure Monitoring & Drainage Kit,
Model 110-HMC. Recall #Z-318/320-3.
CODE Sterilization codes: B2003, B2004, C2002, C2004, F2001, F2002,
G2004.
MANUFACTURER Plasco, Inc., Gurnee, Illinois (component).
RECALLED BY Camino Laboratories, Inc., San Diego, California, by letter
September 1, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Argentina, Italy.
QUANTITY 2,920 units were distributed.
REASON The bushings of the ventricular tubing do not fit properly
which could lead to leakage at the bushing and tubing
connection.
PRODUCT Nova Stat Profile Control, Level 2:
(a) Nova Catalog #13425 (Baxter Catalog #B6352-49) Stat Profile
Control Level 2;
(b) Nova Catalog #13427 (Baxter Catalog #B6352-51) Stat
Profile Control Multipak with Glucose;
(c) Nova Catalog #13428 Stat Profile Control QAP Multipak;
Recall #Z-321/323-3.
CODE Catalog Nos. Lot Nos.
(a) 13425 2706 Level 2
(b) 13427 2655 Level 1, 2706 Level 1, 2707 Level 3
(c) 1324-QAP 2655 Level 1, 2706 Level 2, 2707 Level 3.
Note: Level 2 product only was mislabeled.
MANUFACTURER Nova Bio Medical, Waltham, Massachusetts.
RECALLED BY Manufacturer, by telephone during August 26-31, 1992, and
letter/fax August 31, 1992. Firm-initiated recall complete.
-6-
DISTRIBUTION Nationwide and international.
QUANTITY (a) 23 boxes of 30; (b) 508 boxes of 30; (c) 20 boxes of 30
ampoules were distributed.
REASON Some ampoules labeled as containing Level 2 control actually
contained Level 1 control.
PRODUCT Concise Strep A Kit, an in-vitro diagnostic assay used for the
qualitative determination of Group A Streptococcus antigen from
throat swabs. Recall #Z-324-3.
CODE Catalog Nos. Lot Nos. EXP Date
4512 290963 1/13/93
291003 1/20/93
291004 1/20/93
291006 1/20/93
291007 1/20/93
4513 290792 12/16/92
MANUFACTURER Pacific Biotech, Inc., San Diego, California.
RECALLED BY Hybritech, Inc., San Diego, California, by letter December 2,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,265 kits were distributed.
REASON The product will produce a false positive result.
PRODUCT Total Iron and Total Iron Binding Capacity (TIBC) Test Kit.
Recall #Z-325-3.
CODE Kit lot numbers: 10318 (30 tests each kit) and 10319 (240
tests each kit), EXP 9/92. Binding reagent lot #10335
(code 1030).
MANUFACTURER Bio-Analytic Laboratories, Inc., Palm City, Florida.
RECALLED BY Manufacturer, by fax or by telephone May 22, 1991.
Firm-initiated recall complete.
DISTRIBUTION Michigan, Mexico, Egypt, Turkey.
QUANTITY 10 kits were distributed.
REASON One of the reagents in the kit is precipitating.
PRODUCT Repliplate Cathra 256 mcg/ml Sulfisoxazole (SUL) antibiotic
susceptibility test plate, used to check the susceptibility of
disease-causing bacteria to antibiotics. Recall #Z-328-3.
CODE Lot 11102 SUL256 of plates in lot 11102 ABS3 of the sets of
plates.
MANUFACTURER AutoMed, Inc., Arden Hills, Minnesota.
RECALLED BY Manufacturer, by telephone December 11, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Canada.
QUANTITY 80 sets containing 1 sulfisoxazole plate per set were
distributed.
REASON The plates were contaminated.
PRODUCT Testosterone Test Standard, a component of the RSL 1251
Testosterone Test Kit, which detects the total unconjugated
form of this steroid, for in-vitro diagnostic use only.
Recall #Z-326-3.
-7-
CODE Catalog #07189130, lot #RTS9203, EXP 10/1/93.
MANUFACTURER ICN Biomedicals, Inc., Costa Mesa, California.
RECALLED BY Manufacturer, by letter October 12, 1992. Firm-initiated
recall complete.
DISTRIBUTION California, Illinois, Indiana, New Jersey, Pennsylvania, Texas,
Washington state, Wisconsin.
QUANTITY 228 sets were distributed.
REASON Lack of product stability when stored above the recommended
-15C.
PRODUCT Abbott TestPack Plus hCG-Combo Test Kits, List #3A60, a
self-performing immunoassay in-vitro diagnostic designed for
the qualitative determination of human chorionic gonadotropin
(hCG) in urine and serum for early detection of pregnancy.
RECALL #Z-329-3.
CODE Lot numbers: 53136M100, 53591M200.
MANUFACTURER Abbott Laboratories, North Chicago, Illinois.
RECALLED BY Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois, by telephone June 25-July 1, 1991, followed by
letters dated June 25, 1991. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Canada, Costa Rica, Dominican Republic, Venezuela,
Australia, Germany, Hong Kong.
QUANTITY 1,338 20-test kits and 1,868 40-test kits were distributed;
firm estimates none remains on the market.
REASON Some clinical specimens could give false positive results.
PRODUCT Concise Strep A In-Vitro Diagnostic Kits, intended for the
qualitative determination of group a streptococcus antigen from
throat swabs. Recall #Z-334-3.
CODE Lot numbers 291913 EXP 5/17/93, 291941 EXP 5/17/93,
291943 EXP 4/28/93.
MANUFACTURER Hybritech, Inc., San Diego, California.
RECALLED BY Manufacturer, by letter October 7, 1992, and by telephone.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 773 kits were distributed.
REASON The wrong revision directions for use were packaged with the
kit.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS III
PRODUCT Super Pet Capsules (Pycnogenol for animals), an anti-aging
nutritional supplement, in bottles of 120. Recall #V-018-3.
CODE All lots.
MANUFACTURER Norwest Marketing Company, Pacoima, California.
RECALLED BY Reseau International, Cincinnati, Ohio, by letter sent during
the week of January 11, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Bermuda.
QUANTITY 933 bottles of tablets and 234 bottles of capsules were
distributed.
REASON Product is an unapproved new animal drug.
-8-
MEDICAL DEVICE SAFETY ALERT
PRODUCT Therascan Beam Data Acquistion System, an accessory for
radiation treatment planning systems -- computerized
workstations used to calculate and determine appropriate
radiation treatment programs for doctors to administer to
cancer patients. Safety Alert #N-025-3.
CODE Serial numbers: BDAS-004, BDAS-006, BDAS--007, BDAS-009,
BDAS-010, BDAS-011, BDAS-013, BDAS-014, BDAS-015, BDAS-016,
BDAS-019, BDAS-021, BDAS-022, BDAS-023, BDAS-025, BDAS-029,
BDAS-030, BDAS-033, BDAS-034, BDAS-035, BDAS-036, BDAS-038,
BDAS-039, BDAS-040, BDAS-042.
MANUFACTURER Theratronics International, Ltd., (formerly Atomic Energy of
Canada, Ltd.,) Kanata, Ontario, Canada; Theratronics
International, Ltd., Carrollton, Texas.
ALERTED BY Manufacturer, by User Bulletin BDAS UB 80-006, dated December
15, 1992.
DISTRIBUTION Arkansas, California, Georgia, Florida, Michigan, Montana,
North Carolina, North Dakota, New York, Ohio, Texas, Virginia,
Wisconsin.
QUANTITY 25 units were distributed.
REASON Radio-frequency interference produced by the magnetrons of some
linear accelerators may affect electrometer operation and give
distorted readings.
INJUNCTION:
PRODUCT Various seafood products.
CHARGE The seafood is adulterated and misbranded in that it is
decomposed in whole or in part, or is otherwise unfit for
food due to rancidity, dehydration, or freezer burn; it has
been prepared, packed, or held under insanitary conditions
whereby it may have become contaminated with filth, or
whereby it may have been rendered injurious to health; and,
it is offered for sale under the name of another food.
DEFENDANTS Impex Shrimp & Fish Company, Inc., and Bernard M. Kane, Elk
Grove Village, Illinois.
FILED December 30, 1992, U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #92C 8399,
INJ 1312.
MASS SEIZURE:
PRODUCT Oxygen, USP and Nitrous Oxide, USP (92-596-608/9).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture, processing,
and holding do not conform to and are not operated and
administered in conformity with current good manufacturing
practice regulations.
FIRM Grand Rapids Welding Supply Co., Grand Rapids, Michigan.
FILED February 3, 1993; U.S. District Court for the Western
District of Michigan; Civil #1:93CV88, FDC #66634.
SEIZED February 3, 1993 - goods valued at approximately $28,035.
-9-
SEIZURES:
PRODUCT Frozen seafood - raw trim, Alaskan pollock portions, and
surfburger patties (92-661-970/2).
CHARGE Adulterated - Some of the articles consist in whole or in
part of decomposed seafood, and are unfit for food because
they are rancid. Misbranded - Some of the articles' labels
fail to bear the common or usual name of the foods; and one
of the articles is fabricated from two or more ingredients
and the label fails to bear the common or usual name of each
ingredient.
FIRM Americold Corporation, Chicago, Illinois.
FILED December 23, 1992; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #92C 8400,
FDC #66632.
SEIZED December 30, 1992 - goods valued at approximately $5,600.
PRODUCT Seafood - Pacific whiting and whiting portions (92-661-564).
CHARGE Adulterated - Both articles consist in part of a
decomposed substance, and one of the articles is otherwise
unfit for food because it is rancid.
FIRM Impex Shrimp and Fish Company, Elk Grove Village, Illinois.
FILED December 23, 1992; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #92C 8398,
FDC #66639.
SEIZED December 30, 1992 - goods valued at approximately $11,400.
PRODUCT Frozen peeled and deveined shrimp (92-609-381).
CHARGE Adulterated - The article consists in whole or in
part of decomposed shrimp.
FIRM Ala-Maid Seafood Co., Inc., Whistler, Alabama.
FILED December 11, 1992; U.S. District Court for the Southern
District of Alabama, Southern Division; Civil #92-1038-RV-M,
FDC #66638.
SEIZED December 14, 1992 - goods valued at approximately $1,392.
PRODUCT Frozen flounder fillets and cooked and peeled shrimp
(93-650-993/4).
CHARGE Adulterated - The articles consist in whole or in
part of decomposed seafood, and one of the articles is
otherwise unfit for food because it is rancid.
FIRM Imperial Foods, Inc., Smyrna, Tennessee.
FILED December 23, 1992; U.S. District Court for the Middle
District of Tennessee, Nashville Division; Civil #3-02-1141,
FDC #66647.
Seized: December 30, 1992 - goods valued at approximately $4,433.
-10-
PRODUCT Various drugs (92-550-769 et al.).
CHARGE New drug - The articles are unapproved new drugs.
Misbranded - the articles' labeling is false and
misleading, and fails to bear adequate directions for the
user for which they were intended.
FIRM Research Health Care, New Troy, Michigan.
FILED January 15, 1993; U.S. District Court for the Western
District of Michigan; Civil #1:93CV39, FDC #66613.
Seized: February 1, 1993 - goods valued at approximately $4,100.
PRODUCT Gentamicin Sulphate B.P. (for veterinary use) (93-661-157).
CHARGE Misbranded - The article's label fails to bear adequate
directions for the use for which it is intended.
FIRM British Airways Cargo Terminal, Des Plaines, Illinois.
FILED February 3, 1993; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #93C 0703,
FDC #66674.
SEIZED February 4, 1993 - goods valued at $6,500.
PRODUCT Microwave hyperthermia units (92-663-235 & 92-684-342).
CHARGE Adulterated - The articles are class III medical devices
which do not have in effect the required approved
premarket approval applications.
Misbranded - The articles' labeling is false and misleading,
and does not bear adequate directions for use for the
purposes for which they were intended; and, notice or other
information respecting the articles was not filed as
required.
FIRM HBCI, Inc., doing business as Valley Cancer Institute,
Los Angeles, California, and stored to the account of HBCI
at E-Z Storage, Culver City, California.
FILED September 4, 1992 - U.S. District Court for the Central
District of California; Civil ##CV925435 HLH(Dx) &
CV925436 HLH(Dx), FDC #66485 & #66497.
SEIZED September 23, 1992 - six units valued at $1.5 million.
-11-
END OF ENFORCEMENT REPORT FOR MARCH 3, 1993. BLANK PAGES MAY
FOLLOW.