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
06/05/1990
FDA Enforcement for the week of June 6, 1990
FDA ENFORCEMENT REPORT
FOR JUNE 6, 1990
June 6, 1990
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure to
a violative product is not likely to cause adverse health
consequences.
NONE
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: (a-c) Chlordiazepoxide Hydrochloride Capsules, USP 5 mg
10 mg, 25 mg in bottles of 100, 500, 1,000 capsules,
a schedule IV controlled substance used in axiety disorders
and withdrawal sysmptoms of acute alcoholism, under Bioline,
Goldline and Superpharm labels;
(d) Hydroxyzine Pamoate Capsules, USP 25 mg in bottles of
100, 500, 1,000 capsules, an Rx antianxiety agent, under
the Bioline, Goldline, Superpharm and URL labels;
(e) Metronidazole Tablets, USP 250 mg, 500 mg in bottles
of 50, 100, 250, 500 tablets, an Rx oral synthetic
antiprotozoal and antibacterial agent, under the Bioline,
Goldline and Superpharm labels.
(f) Spironolactone and Hydrochlorothiazide Tablets,
25 mg/25 mg, in bottles of 100, 1,000 tablets an Rx diuretic
antihypertensive, under the Bioline, Goldline, and
Superpharm labels. Recall #D-279/285-0.
Code: All lots.
Manufacturer: Superpharm Corporation, Bayshore, New York.
Recalled by : Manufacturer, by letter April 24, 1990. Firm-initiated
recall ongoing.
Distribution: New York, Florida, California, Ohio, Connecticut, Texas,
Illinois.
Quantity: Unknown.
Reason: Lack of assurance of bioequivalency and ANDA discrepancies.
----
Product: Park-Davis brand Benadryl Elixir, (active ingredient 12.5 mg
Diphenhydramine), in 100 unit dose bottles, an OTC product
used for antihistaminic, motion sickness and
antiparkinsonism. Recall #D-286-0.
Code: Lot numbers: 32897L EXP 10/90; 39558L EXP 5/91;
306N8L EXP 10/91.
Manufacturer: Warner-Lambert Company, Lititz, Pennsylvania.
Recalled by: Parke-Davis, Morris Plains, New Jersey by letter April
4, 1990. Firm initiated recall ongoing.
Distribution: California, Illinois, Pennsylvania.
Quantity: 344,700 bottles were distributed, 40% remain on market.
Reason: Product contains glass fragments.
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Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma; (d) Recovered Plasma. Recall #B-139/142-0.
Code: Unit numbers: (a) 1293289, 7318804; (b) 1293289, 7318804,
(c) 1293289; (d) 7318804.
Manufacturer: Lifesource, Glenview, Illinois.
Recalled by: Manufacturer, by letter dated January 26, 1990.
Firm-initiated recall ongoing.
Distribution: Illinois, Switzerland.
Quantity: (a) 2 units; (b) 2 units; (c) 1 unit; (d) 1 unit
were distributed.
Reason: Blood components drawn from donors who either had
a history of cancer or tested repeatably reactive
for the antibody to the hepatitis B surface antigen
(HBsAg) were distributed
----
Class III -
Product: Merck Sharp & Dohme, Decadron Phosphate Injection
(Dexamethasone Sodium Phosphate) 24 mg/ml, in 5 ml vials
used as a steroidal anti-inflammatory in a multi dose
vial. Recall #D-287-0.
Code: Lot #0086S EXP 11/92.
Manufacturer: Merck Sharp & Dohme, West Point, Pennsylvania.
Recalled by: Manufacturer, by telephone May 10, 1990 and follow-up
visit. Firm initiated recall complete.
Distribution: Vermont, Massachusetts, Florida, Tennessee, Illinois,
Texas, Georgia, California, Ohio.
Quantity: 125 units were distributed.
Reason: Mislabeled. 5 ml vials are mislabeled as 10 ml vials.
----
Product: Go-Clean Toothpaste in 10 gm tubes, under the
Fleur de Lis and Hawthorne-Inn labels.
Recall #D-288-0.
Code: Not coded.
Manufacturer: Ladycare Amenities Manufacturing, Kowloon, Hong Kong.
Recalled by: Marietta Corporation, Cortland, New York, by telephone
April 2 and 30, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 100,000 units were distributed.
Reason: Dual fluoride formulation. Product marketed without new
drug approval.
----
Product: Dipyridamole Tablets, USP, 50 mg, in bottles of 1,000,
an Rx product used as a vasodilator to increase coronary
blood flow, under the following labels: Par Pharmaceutical,
Bioline Laboratories, Goldline Laboratories, Major
Pharmaceuticals. Recall #D-289-0.
Code: Lot #622889 EXP 8/91.
Manufacturer: Par Pharmaceutical, Inc., Spring Valley, New York.
-3-
Recalled by: Manufacturer, by letter May 9, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 5,856 bottles were distributed; firm estimates fewer than
100 bottles remain on market.
Reason: Mold contamination.
----
Product: Navane Intramuscular (Thiothixene HCl) 5 mg/ml, in 2 ml
vials, an Rx neuroleptic product. Recall #D-290-0.
Code: Lot #F948A EXP 9/1/90, A589A EXP 4/1/90.
Manufacturer: The Upjohn Company, Kalamazoo, Michigan.
Recalled by: Pfizer, Inc., New York, New York, by telephone.
Firm-initiated field correction ongoing.
Distribution: Nationwide.
Quantity: 21,831 units were distributed.
Reason: Product was distributed with outdated package inserts.
----
Product: Isosorbide Dinitrate Sublingual Tablets, USP, 5 mg,
in bottles of 100, an Rx vasodilator, under the
Barr Laboratories and Qualitest Products labels.
Recall #D-291-0.
Code: Lot #9B173AR EXP 4/92.
Manufacturer: Barr Laboratories, Inc., Northvale, New Jersey.
Recalled by: Manufacturer, by telephone and by letter April 6, 1990.
Firm-initiated recall ongoing.
Distribution: Alabama.
Quantity: 720 bottles were distributed; firm estimates 32 bottles
remain on market.
Reason: Bottles containing sublingual tablets were mislabeled
as oral tablets.
----
Product: Liquified Carbon Dioxide, in size B cylinders, an Rx
product used in hospitals for medical procedures.
Recall #D-292-0.
Code: Lot #6003C022 EXP 12/94.
Manufacturer: AGA Gas, Inc., Twinsburg, Ohio.
Recalled by: Manufacturer, by telephone May 11-12, 1990 followed
by letter May 15, 1990. Firm-initiated recall complete.
Distribution: Ohio.
Quantity: 3 units were distributed and 1 unit was recovered..
Reason: Product did not meet USP purity specifications.
----
-4-
Product: DuPont Human Immunodeficiency Virus Type 1 (HIV-1)
Elisa, Microplate Test Kits, licensed in-vitro
diagnostic used to test blood/serum for antibodies
to HIV-1 virus. Recall #B-148-0.
Code: Lot #'s 240E0127 EXP 5/7/90; 268E0224 EXP 8/12/90.
Manufacturer: E.I. DuPont De Nemours and Company Inc., Glasgow, Delaware.
Recalled by: E.I. DuPont De Nemours and Company Inc., Wilmington,
Delaware, by letter March 2, 1990. Firm-initiated recall
complete.
Distribution: Nationwide, Venezuela, Italy, Canada.
Quantity: 26,065 kits were distributed.
Reason: A small number of test kits have been found to contain
microplates that are not coated with the HIV-1 antigen.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: Life Design Systems (LDS) Pulmanex Adult Pulmonary
Manual Resuscitator with Oxygen Reservoir -- All model
numbers beginning with LDS-90- and LDS-95-, used to
resuscitate patients in emergency situations.
Recall #Z-574/575-0.
Code: Lot numbers 9172, 9291.
Manufacturer: Life Design Systems, Inc., Carrollton, Texas.
Recalled by: Manufacturer, by telephone between December 18 and 22,
1989 followed by letter December 21, 1989. Firm-initiated
recall ongoing. See also FDA press release P90-30,
May 10, 1990.
Distribution: Nationwide.
Quantity: 1,516 units of lot 9172 and 1,624 units of lot 9291
were distributed.
Reason: The device bodies were not properly cured which caused
them to tear or disintegrate and caused the device to
be unusable.
----
Class II -
Product: Dornier Lithotripter used for shock wave kidney stone
treatment Model HM3. Recall #Z-488-0.
Code: Model HM3.
Manufacturer: Dornier Medizintecknik GMBH, Munich, West Germany.
Recalled by: Dornier Medical Systems, Inc., Marietta, Georgia, by
technical bulletin dated April 1989. Firm-initiated
field correction ongoing.
Distribution: Nationwide.
Quantity: 79 units were distributed.
Reason: Possible breakage of the cable which can result in
failure of motion pick-up.
----
-5-
Product: Cobe Spectra Blood Component Separator, a microprocessor
controlled device intended to separate and collect blood
components from both donors and patients. Recall #Z-624-0.
Code: Serial numbers 01S0018 through 01S00190.
Manufacturer: Cobe Laboratories, Inc., Lakewood, Colorado.
Recalled by: Manufacturer, by letter March 20, 1989. Firm-initiated
field correction ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 324 units are involved.
Reason: Software update 2.2 was causing random failure alarms that
resulted in red cell spillovers and difficulties in
operating the procedure. Software change 2.5 also improved
the prime procedure to eliminate the risk of an air
occlulsion in the plasma line, reduced the risk of spillover
by modifying the automatic centrifuge stepdown option,
corrected the causes of failure No. 3, failure No. 41 and
failure No. 40, and corrected the "bug" in the white cell
procedure that previously would set the plasma pump to "0"
occasionally.
----
Product: Intramobile Element (IME), Size 3.3 x 2 mm which is a
component of the Interpore IMZ Integrated Dental Implant
System. Recall #Z-635-0.
Code: Catalog #8270, lot #10362.
Manufacturer: Eberle Medizintechnische, Wurmberg, West Germany.
Recalled by: Interpore International, Irvine, California, by letter
April 20, 1990 followed by telephone. Firm-initiated
recall ongoing.
Distribution: Nationwide, Kuwait, Venezuela.
Quantity: 209 units were distributed.
Reason: Packages labeled as IMZ 3.3 mm IME, catalog #8270,
lot #10362 actually contain 3.3 mm Second Phase Sealing
Screw, catalog #8230.
----
Product: Quick Connect Sutureless Connectors, used for connecting
hydraulic tubing used with a penile prosthesis and
artificial sphincter. Recall #Z-636-0.
Code: Lot numbers: 7581K001 through 7581K050, 7582K001 through
7582K050, 7583K001 through 7483K050, 7584K001 through
7584K050, 7861K001 through 7861K050, 7862K001 through
7862K050, 7863K001 through 7863K050, 7865K003, 7865K005,
7865K006, 7865K010 through 7865K015, 7865K017, 7865K018,
7865K021, 7865K022, 7865K030 through 7865K050.
(The first four numbers and the letter "K" make up the lot
number, and the last three digits (such as 001 or 050) make
up the product serial number.)
Manufacturer: Fred Knapp Engraving Company, Racine, Wisconsin.
Recalled by: American Medical Systems, Inc. (AMS), Minnetonka, Minnesota,
by telephone and by letter April 12, 1990. Firm-initiated
recall ongoing.
-6-
Distribution: Nationwide and international.
Quantity: 384 packages of connectors (three right-angle and four
straight connectors per package) were distributed.
Reason: Some of the right angle connectors are partially or
completely blocked by plastic (flash) left from the
molding process. Obstruction of the right angle may cause
reduction or loss of proper fluid flow.
----
Product: Zenith II Hylo Chiropractic Adjusting Tables Equipped
with a Tuck-A-Way Footboard: Model numbers 210, 220, 230,
320 and 440. Recall #Z-637/641-0.
Code: Serial numbers 56000 through 60800, which represents all
serial numbers distributed between October 1985 and August
31, 1988.
Manufacturer: Williams Manufacturing Company, Elgin, Illinois.
Recalled by: Manufacturer, by letters of August 21, 1989, December
12, 1989 and February 7, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 700 tables were distributed; firm estimates
635 tables remain on market.
Reason: The hydraulic cylinder front mounting bolts may break
allowing the table to fall.
----
Product: Computer Interface Cables and Connector Plug for Gambro
AK-10 Monitoring System for Hemodialysis. Product is
packaged as a component piece with the AK-10 System or
as a spare part in a plastic bag. Recall #Z-643-0.
Code: Product numbers: IFC06, IFC00, IFC05 -- All serial
numbers.
Manufacturer: Gambro Instruments AB, Lund, Sweden.
Recalled by: Gambro-Hospal, Inc., Newport News, Virginia, by letter
April 18, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 2,000 cables were distributed.
Reason: There may be a potential for a short circuit of a
capacitator in the interface cables and connector plug
which could affect the machine alarm systems.
----
Product: Care Bedside ECG Module Model No. EG5014 a component
of the Care MB5000 Computer Bedside Monitor.
Recall #Z-644-0.
Code: All serial numbers of Care part #CPRD-0005-00.
Manufacturer: Care Systems, Inc., Huntsville, Alabama.
-7-
Recalled by: Manufacturer, by letter March 29, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Singapore, Hong kong.
Quantity: 153 units were distributed.
Reason: Some ECG modules may have been assembled improperly. If
stress is applied to the ECG cable connector, the ECG
waveform display could be distorted resulting in possible
misinterpretation and misdiagnosis.
----
Product: Autobac Interpretive Susceptibility Antimicrobial Disk
for in-vitro diagnostic use (erythromycin E), 0.25 mcg.
Recall #Z-645-0.
Code: Catalog #33335, lot #110284 EXP 5/90.
Manufacturer: Organon Teknika, Durham, North Carolina.
Recalled by: Manufacturer, by letter on or about April 6, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide, France, Canada.
Quantity: 1,464 unit packs (100 disks to a cartridge and 6
cartridges to a unit pack) were distributed.
Reason: Some of the disks no longer meet full performance
specifications.
----
Product: Adel brand Infant Warmer Model No. 986W. Recall #Z-646-0.
Code: Serial numbers between 100 and 263.
Manufacturer: Adel Medical, Clackamas, Oregon.
Recalled by: Stryker Corporation, Medical Division, Kalamazoo,
Michigan, by letter February 21, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide, Canada.
Quantity: 148 units were distributed.
Reason: If a large quantity (greater than 200 ml) of water is
poured into the plenum (reservoir) of the unit, it could
cover the transformer and present a potential shock
hazard.
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Class III -
Product: 3M Red Dot T002X Holter Monitor Cable Leadwire Assembly,
Part #12-2376-9864-7 or Part #T002, for use with
various Holter (ambulatory ECG) monitors and with 3M
electrodes. Recall #Z-642-0.
Code: Lot numbers: R19677 and R19678.
Manufacturer: Medical Device Division, 3M Health Care Group, 3M Company,
St. Paul, Minnesota.
Recalled by: Manufacturer, by memorandum March 23, 1990 followed by
telephone or visit and by letter March 26, 1990.
Firm-initiated recall ongoing.
-8-
Distribution: Nationwide.
Quantity: 367 assemblies were distributed.
Reason: The leadwire of some leadwire assemblies cannot be connected
to the snap-on skin contact electrode due to the fact that
the female snap-on connector of leadwire is misformed.
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VETERINARY PRODUCTS
NONE