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
03/10/1993
Recalls and Field Corrections: Foods -- Class I -- 03/10/1993
MARCH 10, 1993 93-10
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
PRODUCT Cold Smoked Sable Fish, air-packed in cardboard boxes, each
piece weighing between 8 ounces to 1 pound. Recall #F-231-3.
CODE None.
MANUFACTURER Tauber's Fish Company, Brooklyn, New York.
RECALLED BY Manufacturer, by letter December 21, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION New York.
QUANTITY 250 pounds were distributed; firm estimates none remains on the
market.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT Porcelain Tea Set, 13 pieces for children. Friendly Home
Parties Catalog #323. The set includes a covered teapot, 4
cups, 4 saucers, covered sugar, creamer, pink floral design.
Recall #F-228-3.
CODE Uncoded. The product is identified with Soma International
Item #5544. Some boxes may also contain a sticker which states
item #323 Porcelain Tea set.
MANUFACTURER Chazhou Ceramics Wholesale Department, Guangdong, China, under
the name of: Pretty Port Ltd., Tuen Num, N.T. Hong Kong.
RECALLED BY Friendly Home Parties, Inc., Albany, New York, by letter
November 2, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,400 sets were distributed; firm estimates 1,200 sets remain
on the market.
REASON Product contains excessive leachable lead.
PRODUCT Jalapeno Hot Sauce, in 6 ounce glass bottles. Recall #F-230-3.
CODE Finished product packaging is not coded. Chef Han's private
labeled product lot numbers: 296911, 049921, 056921, 098921,
162921, 163921, 217921, 303921.
MANUFACTURER Chef Hans' Gourmet Foods, Inc., Monroe, Louisiana.
RECALLED BY Manufacturer. Firm-initiated recall ongoing.
DISTRIBUTION Arkansas, Arizona, California, Florida, Louisiana, Illinois,
Michigan, Mississippi, Nevada, North Carolina, Ohio, South
Carolina, Texas, Tennessee, Wisconsin.
QUANTITY 3,655 cases (24 bottles per case) were distributed; firm
estimates 925 cases remain on the market.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Refrigerated Shredded Monterey Jack Cheese, in sealed 6 ounce
plastic bags. Recall #F-229-3.
CODE Lot #OCT-8-92 C 16.
MANUFACTURER Kraft, Inc., Champaign, Illinois.
RECALLED BY Publix Supermarket, Inc., Lakeland, Florida, by electronic mail
message sent October 7, 1992. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY Approximately 30 cases (12 packs per case) were distributed;
firm estimates none remains on the market.
REASON Product is contaminated with mold.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Dey-Lute Isoetharine Inhalation Solution, USP, 0.08% S/F, 3 ml,
a Rx drug used for the treatment of asthma. Recall #D-165-3.
CODE Lot #2297 EXP 5/94.
MANUFACTURER Dey Laboratories, Inc., Napa, California.
RECALLED BY Manufacturer, by telephone followed by letter, January 20,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
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QUANTITY 3,455 shelf cartons were distributed.
REASON Some shelf cartons are mislabeled as 0.25%. The vials are
correctly labeled.
PRODUCT Nitrous Oxide, USP, a Rx medicinal gas used for anesthesia, in
G cylinders. Recall #D-166-3.
CODE Lot #611A315 (on paper tag), label code MG816C.
MANUFACTURER BOC Group/Airco Medical Specialty Gases, Carol Stream, Illinois.
RECALLED BY BOC Group/Airco Gases, Murray Hill, New Jersey, by telephone
February 18, 1993, followed by letter February 19, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Illinois, Indiana, Iowa, Wisconsin.
QUANTITY 60 cylinders were distributed, with 52 accounted for.
REASON Potential overfilled cylinders.
PRODUCT Simethicone (gas relief) Drops, an anti-flatulent, in 30 ml
amber hard polyethylene bottles, under the following labels:
Liquipharm, Major, WGI, URL, Apothecary Products.
Recall #D-167-3.
CODE Lot numbers: 1H7, 1K3, 1N3 (includes Apothecary's lot number
1964), 2B4, 2F1.
MANUFACTURER Liquipharm, Inc., Los Angeles, California.
RECALLED BY Manufacturer, by letter August 3, 1992. Firm-initiated recall
complete.
DISTRIBUTION Arkansas, California, Florida, Georgia, Hawaii, Illinois,
Kentucky, Massachusetts, Maryland, Michigan, Tennessee, Texas,
Washington state, Puerto Rico.
QUANTITY 221,040 bottles were distributed; firm estimates 211,223
bottles remain on the market.
REASON Presence of Pseudomonas cepacia.
PRODUCT Arthritis Pain Formula, oral, OTC analgesic, in white plastic
bottles of 40, 100, and 175 caplets per bottle.
Recall #D-168-3.
CODE Lot numbers: APF bottle of 40 caplets -- D229 EXP 4/96,
D230 EXP 4/96, E220 EXP 5/96;
APF bottle of 100 caplets -- E213 EXP 5/96, E214 EXP 5/96,
E228 EXP 5/96;
APF bottle of 175 caplets -- E222 EXP 5/96.
MANUFACTURER Whitehall Laboratories Inc., (Whitehall - Robbins Laboratories,
Inc.), Division American Home Products Corporation, Hammonton,
New Jersey.
RECALLED BY Manufacturer, by letters dated December 8, 1992.
Firm-initiated recall complete.
DISTRIBUTION Nationwide, Puerto Rico.
QUANTITY 19,290,180 caplets were distributed.
REASON Possible presence of metal particles.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Oxygen USP in metal cylinders. Recall #D-161-3.
CODE 112392DS01-04, 112492DW01, 112692DS01.
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MANUFACTURER Monitor Medical, Inc., Winston-Salem, North Carolina.
RECALLED BY Manufacturer, by visit December 7, 1992. Firm-initiated recall
complete.
DISTRIBUTION North Carolina.
QUANTITY 30 cylinders were distributed.
REASON Product did not meet USP potency specifications.
PRODUCT Oxygen, USP, in size C, D, and E tanks. Recall #D-162-3.
CODE All tanks.
MANUFACTURER Cardiopulmonary Care, Inc., Logan, Ohio.
RECALLED BY Manufacturer, by visit beginning February 3, 1993, followed by
letter. Firm-initiated recall ongoing.
DISTRIBUTION Ohio.
QUANTITY 460 cylinders were distributed.
REASON Product manufactured using an improperly calibrated analyzer.
PRODUCT Promethazine Syrup Plain, in 1 pint bottles, used for perennial
and seasonal allergic rhinitis. Recall #D-163-3.
CODE Lot #082543 EXP 7/94.
MANUFACTURER H.R. Cenci Laboratories, Inc, Fresno, California, by letter
October 22, 1992. Firm-initiated recall complete.
DISTRIBUTION New York, Oregon, Michigan, New York, Ohio, Puerto Rico.
QUANTITY 500 mislabeled bottles were distributed.
REASON Some bottles were mislabeled as Promethazine VC Syrup Plain
which would contain phenylephrine HCl as an ingredient.
PRODUCT Diphenhydramine HCl, 25 mg tablets, packaged in cartons of 32
tablets and 72 tablets, an OTC antihistamine with sleep aid
indications, under the following labels: Bartell Drugs,
Bi-Mart, Osco. Recall #D-164-3.
CODE Lot numbers on outer cartons: ROG644, MAY 94 (Bartell Drugs),
0G643, MAY 94 (Bi-Mart), OG643, MAY 94 (Osco). OG578 EXP 5/94
is the manufacturing lot number and appears on the immediate
container (blister package).
MANUFACTURER Life-Line Nutritional Products, Inc., Hayward, California.
RECALLED BY Manufacturer, by telephone followed by letter dated January 11,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Washington state, Illinois, Pennsylvania, California, Oregon.
QUANTITY 1,136,256 tablets were distributed; firm estimates none remains
on the market.
REASON Product does not meet content uniformity specifications.
PRODUCT SoloPak Hydralazine HCl Injection U.S.P., 20 mg/ml; 1 ml single
dose vial, 25 vials per case, a Rx intramuscular/intravenous
antihypertensive. Recall #D-169-3.
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CODE Lot numbers: 910826, 910926, 911120, 911251, 920124, 920202,
920242, 920316, 920445, 920455, 920524, 920947, 921130, 921229.
MANUFACTURER SoloPak Pharmaceuticals, Inc., Elk Grove Village, Illinois.
RECALLED BY Manufacturer, by letters dated February 22, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,285,350 vials were distributed; firm estimates that 15% of
the product remains on the market.
REASON Possible presence of particulate matter.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT (a) Red Blood Cells; (b) Plasma. Recall #B-159/160-3.
CODE Unit numbers: (a) 53GL42440, 53K91915, 53M16530, 53X66654;
(b) 53GL42440, 53K91915, 53M16530, 53Y14066.
MANUFACTURER American Red Cross Blood Services, Greater Chesapeake and
Potomac Region, Baltimore, Maryland.
RECALLED BY Manufacturer, by telephone April 28, 1992, followed by letters
dated May 18, 1992. Firm-initiated recall complete.
DISTRIBUTION Washington, D.C., Maryland.
QUANTITY 4 units of each component.
REASON Blood products, corresponding to units of Platelets which were
implicated in a case of post-transfusion septicemia with
coagulase negative Staphylococcus sp., were distributed.
PRODUCT Red Blood Cells. Recall #B-162-3.
CODE Unit numbers: 46M47812, 46M47814, 46M47817, 46M47818,
46M47820, 46M47821.
MANUFACTURER American Red Cross Blood Services, Daytona Beach, Florida.
RECALLED BY Manufacturer, by telephone August 28, 1991, followed by letter
dated August 30, 1991. Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 6 units.
REASON Blood products untested for syphilis were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Bicarbonate Control Monitors (BCM) used in conjunction with the
Gambro AK10 Hemodialysis Machines. Recall #Z-143-3.
CODE Catalog #BCM 10-1, BCM 10-2, BCM 10-3. All serial numbers.
MANUFACTURER Gambro Lundia AB, Lund, Sweden.
RECALLED BY CGH Medical, Inc., Lakewood, Colorado, by letter October 19,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,967 units were distributed.
REASON The monitor system may fail to detect a mix-up in concentrate
combinations which could lead to an incorrect dialysate
administered to the patient.
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PRODUCT Baincide Sterilizing and Disinfection Solution, in 1 gallon
containers. Recall #Z-346-3.
CODE Item #15-100. All codes.
MANUFACTURER Pascal Company, Inc., Bellevue, Washington.
RECALLED BY Manufacturer, by letter September 4, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 232,854 gallons were distributed.
REASON The usage instructions for the solution diluted 1:4 (0.5%
Glutaraldehyde) for tuberculocidal use have been deleted. The
product should be used full-strength as instructed on the
label. Only the 1:4 dilution claim for tuberculocidal action
has been deleted. All other usage instructions in the labeling
remain unchanged.
PRODUCT Padgett Air Dermatome, Model A, used for cutting of skin
grafts. Recall #Z-348-3.
CODE Serial Numbers: A1001, A1004, A1007, A1009, A1011, A1012,
A1013, A1014, A1015, A1016, A1018 and A1020;
MANUFACTURER Dadson Manufacturing Corporation, Grain Valley, Missouri.
RECALLED BY Padgett Instruments, Inc., Kansas City, Missouri, by telephone,
Fax, and letter on or about December 3, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Florida, Virginia, New York, Texas, Alabama, Connecticut,
Minnesota, and international.
QUANTITY 12 units were distributed.
REASON The device may exhibit an internal air leak associated with the
air motor and nose assembly which could cause the blade to go
out of adjustment.
PRODUCT Direct drive power wheelchairs: (a) Geronimo, also known as
Road Challenger, Model 107RC; (b) Chief, also known as The Road
Stander, Model 107RU. Recall #Z-349-3.
CODE All lots/Serial numbers.
MANUFACTURER Redman, Inc., Tucson, Arizona.
RECALLED BY Manufacturer, by letter December 5, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 89 units were distributed.
REASON The motor shaft may fail resulting in the drive becoming
inoperative and the wheel coming off.
PRODUCT Ultra High Molecular Weight Polyethylene (UHMWP) Uni Tibial
Inserts, Small, Medium, Large, and Extra-large sizes.
Recall #Z-351-3.
CODE Catalog numbers: 1285-3965, 1285-3985, 1285-3911, 1285-4365,
1285-4385, 1285-4311, 1285-4765, 1285-4785, 1285-4711,
1285-5165, 1285-5185, 1285-5111.
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MANUFACTURER BioPro, Inc., Port Huron, Michigan.
RECALLED BY Manufacturer, by telephone on or about January 2, 1991.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 298 units were distributed; firm estimates none
remains on the market.
REASON The device is undersized and fits loosely within the Uni Tibial
Tray of the knee replacement system.
PRODUCT Cidex Activated Dialdehyde Solution for sterilization or
disinfection of medical instruments and equipment, packed in 1
gallon containers. Recall #Z-365-3.
CODE Reorder #2250, Lot #1902AX.
MANUFACTURER Arbrook Manufacturing Corporation, San German, Puerto Rico;
RECALLED BY Johnson & Johnson Medical, Inc., Arlington, Texas (own label
distributor), by letter January 29, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,717 cases (4 gallons per case) were distributed; firm
estimates none remains on the market.
REASON The product may have been inadvertently diluted to below
label-specified levels of active ingredient (glutaraldehyde).
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT In-vitro diagnostic test kits: (a) Cards O.S. HCG-Urine; (b)
Cards O.S. Strep A. Recall #Z-332/333-2.
CODE Catalog Nos. Lot Nos. EXP date
(a) CR7706 500338.1 8/03/93
500412.1 8/03/93
510405.1 8/24/93
CR7709 500225.1 8/03/93
500413.1 8/03/93
510066.1 8/24/93
510067.1 8/24/93
510406.1 8/17/93
(b) CR7740 500029.1 1/27/93
500228.1 1/27/93
500341.1 1/27/93
500341.2 1/27/93
500341.3 1/27/93
500414.1 2/17/92
510068.1 2/17/93
510068.2 2/17/92
510069.1 2/17/93
510069.2 2/17/92
510069.3 2/17/92
510407.1 2/10/93
510408.1 2/17/93
510408.2 2/17/93
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510409.1 2/21/93
CR7441 500031.1 1/27/93
500032.1 1/27/93
500230.1 1/27/93
500230.2 1/27/93
500230.3 1/27/93
500342.1 1/27/93
500415.1 2/17/93
500415.2 2/17/93
510072.1 2/17/93
510075.1 2/24/93
510341.1 2/24/93
510359.1 2/24/93
510359.2 2/24/93
510360.1 2/24/93
510360.2 2/24/93
510360.3 2/24/93
510360.4 2/24/93
CR7742 490496.1 1/20/93
500033.1 1/27/93
500416.1 2/17/93
510077.1 2/24/93
510077.2 2/24/93
510413.1 2/24/93
510413.2 2/24/93.
MANUFACTURER Pacific Biotech, Inc., San Diego, California.
RECALLED BY Manufacturer, by letter August 14, 1992. Firm-initiated recall
complete.
DISTRIBUTION Nationwide, Puerto Rico, Canada.
QUANTITY Approximately 5,900 kits were distributed; FDA estimates that
little product remains on the market.
REASON The test pouches may not be adequately sealed.
PRODUCT Force 20 Balloon Dilation Catheter, item #032040, used to
dilate arteriosclerotic lesions of the coronary artery.
Recall #Z-350-3.
CODE Lot #11H69245.
MANUFACTURER USCI/Division C.R. Bard, Inc., Haverhill, Massachusetts.
RECALLED BY USCI/Division C.R. Bard, Inc., Billerica, Massachusetts, by
letter dated November 3, 1992. Firm-initiated recall complete.
DISTRIBUTION Alabama, Arizona, Arkansas, California, North Carolina, South
Carolina, Maryland, Louisiana, Wisconsin, Massachusetts,
Indiana, Washington, D.C.
QUANTITY 28 units were distributed.
REASON The outer box is mislabeled in that it has a pre-printed force
30 label and not the required force 20 label.
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PRODUCT Abbott TestPack hCG-Urine, list #6278, an enzyme immunoassay
in-vitro diagnostic pregnancy test for the qualitative
determination of human chorionic gonadotropin (hCG) in urine.
Recall #Z-352-3.
CODE Lot numbers: 57055M300, 57055M301, 57055M302, 57055M303,
57055M304.
MANUFACTURER Abbott Laboratories, North Chicago, Illinois.
RECALLED BY Abbott Laboratories, Abbott Park, Illinois, by telephone
January 13-23, 1992, followed by letters dated January 13,
1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 3,761 40-test kits were distributed; firm estimates none
remains on the market.
REASON The test kits gave false positive results due to a problem with
the reaction discs.
MEDICAL DEVICE SAFETY ALERT:
PRODUCT Nonin Pulse Oximeter, Model 8604-FO, which monitors arterial
hemoglobin oxygen saturation and pulse rate.
Safety Alert #N-032-3.
CODE All serial numbers.
MANUFACTURER Nonin Medical, Inc., Plymouth, Minnesota.
ALERTED BY Manufacturer, by letter November 19, 1992.
DISTRIBUTION Nationwide and international.
QUANTITY 379 units.
REASON If the device is misapplied, the oximeter may exhibit erratic
pulse readings and/or low Sp02 readings under certain
conditions of light and vibration.
INJUNCTION:
PRODUCT PIPA Red Blood Cell Processing Solution (91-637-846).
CHARGE The defendant was charged with causing the product to be
adulterated in that the methods used in, and the facilities
and controls used for, its manufacture, processing, packing,
and storage did not conform with and was not administered in
conformity with current good manufacturing practice
regulations.
DEFENDANT Charles A. Ellis, M.D., doing business as PIPA Laboratories,
Inc., Roslindale, Massachusetts.
FILED January 23, 1993, Complaint for Injunction; February 10,
1993, Consent Decree of Permanent Injunction; U.S. District
Court for the District of Massachusetts; Civil #93-10127WD,
INJ 1284.
DISPOSITION The defendant is preliminarily and permanently restrained
and enjoined from directly or indirectly doing or causing to
be done, the introduction or delivery for introduction into
interstate commerce of any article of drug that is not in
conformity with current good manufacturing practice
regulations.
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SEIZURE:
PRODUCT Potassium chloride extended release tablets (92-579-219).
CHARGE New drug - There is no approved application in effect for
this article since it was produced under conditions
significantly different than those approved in the
application.
FIRM Parmed Pharmaceuticals, Niagara Falls, New York.
FILED February 22, 1993; U.S. District Court for the Western
District of New York; Civil #93-CV-0152A, FDC #66655.
SEIZED March 1, 1993 - goods valued at approximately $18,800.
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END OF ENFORCEMENT REPORT FOR MARCH 10, 1993. BLANK PAGES MAY
FOLLOW.