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
03/27/1990
FDA Enforcement for the week of March 28, 1990
FDA ENFORCEMENT REPORT
FOR MARCH 28, 1990
March 28, 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.
Product: AJO Natural Garlic-In-Oil, in 8 ounce bottles.
Recall #F-449-0.
Code: Not coded -- 10/2/89, manufacturing date stamped on
outer carton.
Manufacturer: Productos Don Julio, Inc., Ponce, Puerto Rico
Recalled by: Manufacturer, by telephone February 2, 1990 and by
FDA press release February 22, 1990. Firm-initiated
recall ongoing.
-1-
Distribution: Puerto Rico.
Quantity: 50 cases (20 jars/case) were distributed.
Reason: Potential for the development of Clostridium Botulinum
toxin.
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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.
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Epinephrine Mist, 1/2 ounce (15 cc) size, an OTC
inhalation aerosol bronchodilator for the relief of
bronchial asthma under the Barre-National, Eckerd Drug,
Laverdiere's Super Drug, Longs Drug Stores, Peoples
Drug Stores, Perry Distributing Inc., Pic N Save Drugs,
Revco, Rite Aid, Rugby Labs Inc., Thrift Drug Company,
Thrifty Corporation, and Walgreen Co. labels.
Recall #D-172-0.
Code: 82003, 82004, 82060, 82127, 82128, 82175, 82176, 82282,
82284, 82359, 82521, 82622, 82623, 82624, 82625, 92014,
92135, 92136, 92218, 92219, 92220, 92295, 92340, 92341.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letters December 4 and 8, 1989.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,126,392 units were distributed.
Reason: Potency not assured through expiration date.
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-2-
Product: Indomethacin Capsules USP 25 mg and 50 mg., an Rx
non-steroidal anti-inflammatory packaged in bottles of
100, 500 and 1,000 capsules under the Bioline, Goldline,
Schein, and Superpharm labels. Recall #D-173/174-0.
Code: All lots.
Manufacturer: Superpharm Corporation, Bayshore, New York.
Recalled by: Manufacturer, by letter February 1, 1990. Firm-initiated
recall ongoing.
Distribution: New York, California, Connecticut, Florida, Ohio, Texas.
Quantity: 4,200,000/25 ml bottles and 1,700,000/50 ml bottles were
distributed.
Reason: Lack of assurance of bioequivalency and Abbreviated New
Drug Application discrepancies.
----
Product: OTC antacid oral suspension with 200 mg magnesium
hydroxide and 225 mg aluminum hydroxide in 12 ounce
bottles, used for the relief of heart burn, acid
indigestion, sour stomach and upset stomach, under the
Geneva Generics and RIJ Pharmaceutical labels.
Recall #D-176-0.
Code: Lot #90609.
Manufacturer: RIJ Pharmaceutical Corporation, Chester, New York.
Recalled by: Manufacturer, by telephone February 7, 1990. Firm-
initiated recall ongoing.
Distribution: Tennessee, Georgia, Massachusetts, Rhode Island.
Quantity: Firm estimates less than 1 percent remains on market.
Reason: Bacterial contamination.
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Product: Triamterene/Hydrochlorothiazide Tablets, 75 mg/50 mg, in
bottles of 100, 500, and 1,000, an Rx diuretic used for
the treatment of hypertension, under the American
Therapeutics, Best Generics, Bioline Laboratories,
Goldline Laboratories, Harbor Pharmaceutical and
Kaiser Foundation Hospital labels. Recall #D-177-0.
Code: Lot numbers: 805134 EXP. 5/90, 812380 exp. 12/90
810288 10/90 812381 12/90
810289 10/90 812388 12/90
811326 11/90 901031 1/91
812359 12/90 901032 1/91
812360 12/90 903062 3/91
812361 12/90 903063 3/91
812362 12/90 903064 3/91.
Manufacturer: American Therapeutics, Inc., Bohemia, New York.
Recalled by: Manufacturer, by letter February 6-8, 1990. Firm-initiated
recall ongoing.
Distribution: California, Connecticut, Florida, Georgia, Kentucky,
Louisiana, Massachusetts, Maryland, Missouri, Mississippi,
North Carolina, New Jersey, New York, Ohio, Pennsylvania,
Tennessee, Virginia.
-3-
Quantity: 16 lots each consisting of 1,000,000 tablets were
distributed;
firm estimates 1.6 million tablets remain on the market.
Reason: Product failed dissolution testing.
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Product: (a) Platelets; (b) Recovered Plasma. Recall #B-052/053-0.
Code: Unit numbers: 65299, 68163; (b) 63238, 63534, 65200,
65299, 65947, 66163.
Manufacturer: St. Mary's Regional Hospital Blood Bank, Grand Junction,
Colorado.
Recalled by: Manufacturer, by telephone June 29, 1989 followed by
letter June 30, 1989. Firm-initiated recall ongoing.
Distribution: Colorado.
Quantity: (a) 2 units; (b) 6 units were distributed;
Reason: Units which tested repeatably reactive for: 1)
the antibody to the human immunodeficiency virus
(anti-HIV-1); 2) hepatitis B surface antigen (HBsAg); the
antibody to the human immunodeficiency virus (anti-HIV-1)
or were drawn from an ineligible donor based on previous
anti-HIV-1 test results were distributed.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma; (d) Recovered Plasma. Recall #B-089/092-0.
Code: Unit numbers: (a) 80285, 80304, 80316, 80594, 80612, 80693,
80980, 80984, 80994, 82038, 82040, 82150, 82162, 82178,
82184, 82185, 82193, 82194, 92199, 82201, 82209, 82539,
82553, 82554, 82565, 82567, 82573, 82574;
(b) 80612; (c) 80594, 80612; (d) 80285, 80316, 80693, 80725.
Manufacturer: Blood Bank of Alaska, Anchorage, Alaska.
Recalled by: Manufacturer, by telephone October 25, 1989 followed by
letter October 31, 1989. Firm-initiated recall ongoing.
Distribution: Alaska, California, Florida.
Quantity: (a) 28 units; (b) 1 unit; (c) 2 units; (d) 4 units
were distributed.
Reason: Blood products which tested for the antibody to the human
immunodeficiency virus (anti-HIV-1) in a manner inconsistent
with the manufacturer's test kit instructions were
distributed.
----
Class III -
Product: Inulin and Sodium Chloride Injection, USP, in 50 ml vials,
an Rx drug administered intravenously as a sterile, non-
pyrogenic solution and used as a diagnostic agent to
measure kidney glomerular filtration. Recall #D-175-0.
Code: Lot 58803 EXP 3/90.
Manufacturer: Taylor Pharmacal Company, Decatur, Illinois.
Recalled by: Iso-Tex Diagnostics, Inc., Friendswood, Texas, by telephone
February 20-21, 1990. Firm-initiated recall ongoing.
-4-
Distribution: Nationwide, Canada.
Quantity: 2,059 vials were distributed; firm estimates 240 vials
remain on market.
Reason: Free fructose exceeds USP limit.
----
Product: Lariam (Mefloquine Hydrochloride) Tablets, 250 mg, in
unit dose aluminum foil strips in cartons containing 25
tablets, a newly approved Rx antimalarial agent.
Recall #D-178-0.
Code: 0001 EXP 9/1/92.
Manufacturer: F. Hoffmann-LaRoche & Co., Ltd., Basle, Switzerland.
Recalled by: Roche Laboratories, Nutley, New Jersey, by telephone
February 28, 1990 and March 1-2, 1990 followed by letter
March 3 and 6, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,859 (25 unit dose foil packs each) were distributed.
Reason: Packaging defect -- Some unit dose blisters contain two
tablets instead of one tablet.
----
Product: Moisturel Cream, in 4 ounce and 16 ounce jars, an OTC drug
to be applied to the skin for generalized dry skin.
Recall #D-179-0.
Code: Lot numbers 95A011 through 95A056 and 95B001 through
95B046.
Manufacturer: Westwood Pharmaceuticals, Inc., Buffalo, New York.
Recalled by: Manufacturer, by telephone January 30, 1990 followed by
letter. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 549,036 jars were distributed; firm estimates 60,000
jars remain on market.
Reason: Preservative system may not be effective during use
of product.
----
Product: Recovered Plasma. Recall #B-054-0.
Code: Unit #66709, 66985.
Manufacturer: St. Mary's Regional Hospital Blood Bank, Grand Junction,
Colorado.
Recalled by: Manufacturer, by telephone June 29, 1989 followed by
letter June 30, 1989. Firm-initiated recall ongoing.
Distribution: Colorado.
Quantity: 2 units were distributed.
Reason: Recovered Plasma was distributed which tested repeatably
reactive for the antibody to the human T-lymphotropic
virus (anti-HTLV-I).
----
-5-
Product: (a) Whole Blood; (b) Red Blood Cells; (c) Platelets;
(d) Fresh Frozen Plasma; (e) Recovered Plasma.
Recall #B-093/097-0.
Code: All blood components drawn from July 18, 1989 through
October 24, 1989. Unit numbers 80096 through 83891,
inclusive except those listed in Recall #B-089/092-0.
Manufacturer: Blood Bank of Alaska, Anchorage, Alaska.
Recalled by: Manufacturer, by telephone October 25, 1989 followed by
letter October 31, 1989. Firm-initiated recall ongoing.
Distribution: Alaska, California, Tennessee, Florida, Indiana.
Quantity: (a) 74 units; (b) 3,352 units; (c) 893 units;
(d) 188; (e) 577 units were distributed.
Reason: Blood products were distributed which were not tested in
accordance with the manufacturer's test kit instructions.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: Life Design Systems (LDS) Pulmanex Adult and Pediatric sized
Manual Resuscitators, non-sterile, single-patient use
devices used to resuscitate patients in emergency situations.
Recall #Z-441/442-0.
Code: All model numbers beginning with 90, 91, 95, and 96 and
ending with 0, 1, 2 or 3 after the hyphen. For example
LDS-9000-52, LDS-9102-1 and LDS-9550-473; lot numbers
9321 through 9361, manufactured November 17, 1989
through December 27, 1989.
Manufacturer: Life Design Systems, Inc., Carrollton, Texas.
Recalled by: Manufacturer, by telephone followed by letter January 17
and 22, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 38,000 units were distributed; firm estimates 22,000
units remain on market.
Reason: The rear intake valve may dislodge preventing the
unit from delivering air or oxygen to the patient.
----
Class II -
Product: Model 400 Airway Pressure Monitor (APM), used as a
back-up monitor with infant ventilators. Recall #Z-449-0.
Code: Serial numbers: 1704, 1763, 1776, 1795, 1797, 1804, 1805,
1817, 1819, 1825 through 1842, 1854 through 1868, 1870
through 1899, 1900 through 1903, 1905 through 1945, 1947
through 1953, 1955 through 1995, 1997 through 1999, 2000
through 2003.
Manufacturer: Arium Corporation, Anaheim, California.
-6-
Recalled by: Sechrist Industries, Inc., Anaheim, California, by
letter January 29, 1990. Firm-initiated recall ongoing.
Distribution: Alabama, California, Florida, Iowa, Indiana, Kentucky,
Louisiana, Massachusetts, Minnesota, Missouri, North
Carolina, New Jersey, New York, Ohio, Pennsylvania,
Tennessee, Texas, Utah, Virginia, Canada, Chile, Japan,
Korea, Israel, Malaysia, Singapore.
Quantity: 171 units were distributed.
Reason: The APM's enunciator (alarm buzzer) is defective, and
can fail.
----
Product: Mavig "Overhead Counter Poise System" sold as an option
to Medrad Suspension System. Recall #Z-450-0.
Code: No serial numbers or model numbers on the overhead
ceiling support fixture. All units having a Medrad
injector head on a Mavig suspension system are under recall.
Manufacturer: F. Walter Hanel, Munich, West Germany.
Recalled by: Mavig of America, Torrington, Connecticut, by letter
dated 1/90 and January 1, 1990. Firm-initiated field
correction by hospital or Medrad, Inc using retrofit kit
supplied by Mavig ongoing.
Distribution: Nationwide, Holland.
Quantity: 142 systems were distributed.
Reason: The ceiling support fixture and/or suspension arm mounting
pin may break causing the suspension arm and injector to
fall.
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Product: (a) Fisher & Paykel Model #900MR523 High Frequency
Heater Wire (Infrasonics Part #501280).
(b) High Frequency Breathing Circuit with a Fisher &
Paykel Model No. 900MR523 Heating Wire included
(Infrasonics part #501023). Products are intended to
heat gases flowing to the patient. Recall #Z-451/452-0.
Code: All lots.
Manufacturer: Fisher & Paykel, Healthcare Division, Fisher & Paykel
Electronics, Ltd., Auckland, New Zealand.
Recalled by: Infrasonics, Inc., San Diego, California, by letter
August 21-22, 1989 and September 13, 1989. Firm-initiated
recall ongoing.
Distribution: Alabama, California, Florida, Georgia, Illinois, Kansas,
Kentucky, Louisiana, Massachusetts, Maryland, New York,
Ohio, Oklahoma, Pennsylvania, Texas, Utah and
international.
Quantity: 390 heater wire assemblies were distributed.
Reason: The devices contain defective wiring which may short
circuit and cause a fire and possible injury to the
patient.
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-7-
Product: Industrial X-Ray Systems (Diffractometers). Recall #Z-453-0.
Code: Shutter unit 20, catalog #D461, D/MAX Controller catalog
#D5072 or remote shutter switch catalog #D4610RI.
Manufacturer: Rigaku/USA, Inc., Danvers, Massachusetts.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan February 13, 1990. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 44 units were distributed.
Reason: Noncompliance with the Radiation Control for Health and
Safety Act in that the device may emit electronic product
radiation unnecessary to the accomplishment of its primary
purpose.
----
Product: Duocon I Collimator (for Veterinary use only reinstalled on
an X-Ray System for human use). Recall #Z-445-0.
Code: Serial #01-9-4 4215.
Manufacturer: Delta X-Ray, Oklahoma City, Oklahoma.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan February 5, 1990. Firm-initiated field correction
complete.
Distribution: Oklahoma.
Quantity: 1 unit was distributed.
Reason: Noncompliance with the Radiation Control for Health and
Safety Act in that the firm installed the collimator
intended for veterinary use in a mixed certified and
non-certified x-ray system for human use.
----
Product: 60 Well Reaction Trays, commodity #93-8566, an
accessory item used with Abbott's EIA Bead Assay In-vitro
Diagnostic Kits. Recall #Z-456-0.
Code: Products marked with mold #93-0981 with lot numbers:
911C, 057D, 065D.
Manufacturer: Courtesy Med Tech, Wheeling, Illinois.
Recalled by: Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois, by telephone February 14, 1990 and by letters
February 14-15, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, Japan, Korea.
Quantity: 49,120 trays were distributed; FDA estimates 50 percent
remains on market.
Reason: Some wells of this tray mold number have been found to
cause increased absorbency values with Abbott Corzyme
EIA (LN 9977), Auszyme Monoclonal (LN 1980), and
Auszyme IV (LN 3198) assays. This creates a potential
for false negative test results on Corzyme, and increased
reactive rates on Auszyme Monoclonal and Auszyme IV.
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-8-
Class III -
Product: Hydron (Polymacon) Echelon Bifocal Hydrophilic Contact
Lenses for Daily Wear. Recall #Z-454-0.
Code: Lot #904905B.
Manufacturer: Allergan Optical, Santa Isabel, Puerto Rico.
Recalled by: Allergan Optical, Inc., Woodbury, New York, by
telephone on or about November 20, 1989 followed
by letter February 1, 1990 to French consignee.
Firm-initiated recall ongoing.
Distribution: California, New York, Canada, The Netherlands, France,
Australia.
Quantity: 302 contact lenses were distributed.
Reason: The device label indicates a sphere power of + 3.00
Diopters but the actual measurement of sphere power is
- 3.00 Diopters.
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Product: 600 CT and 1200 CT Scanner. Recall #Z-447/448-0.
Code: 600 CT and 1200 CT Scanners.
Manufacturer: Picker International, Inc., Highland Heights, Ohio.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan January 9, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 690 units were distributed.
Reason: Noncompliance with performance standard for laser products
in that the test data indicated that CTDI values published
by the firm were noncompliant with the measured values also
the normalization values for changes in the slice thickness
were noncompliant.
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VETERINARY PRODUCTS
NONE