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
09/11/1990
FDA Enforcement for the week of September 12, 1990
FDA ENFORCEMENT REPORT
FOR SEPTEMBER 12, 1990
September 12, 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
-1-
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Amoxicillin, labeled in part "Amoxicillin For Oral
Suspension, 125 mg per 5 ml, 150 ml, plastic bottles.
Recall #D-350-0.
Code: Lot numbers: 20120W, 20220W, 20320W, 20420W, EXP FEB 92.
Manufacturer: Clonmel Chemical Company, Ltd., Clonmel, Ireland.
Recalled by: Warner Chilcott Labs, Division of Warner-Lambert Company
Morris Plains, New Jersey by letter July 23, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 47,607 bottles were shipped. Firm estimates 25% remain
on market.
Reason: Labeling mixup. When pharmacist insert is peeled off the
front of some bottles, the consumer bottle label states
250 mg instead of 125 mg. The 125 mg label instructs
reconstitution with 127 ml of water, and the 250 mg
instructs 102 ml of water.
----
Product: Levothroid Tablets (levothyroxine sodium tablets)
200 mcg, an Rx thyroid hormone used in the treatment of
hypothyroidism. Recall #D-353-0.
Code: Lot #01310 EXP 7/91.
Manufacturer: Rorer Pharmaceutical Corporation, Fort Washington,
Pennsylvania.
Recalled by: Manufacturer by telephone August 16, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 2,518 cartons were distributed.
Reason: A portion of this lot of 200 mcg unit dose tablets may
have been packaged in cartons labeled 100 mcg. The unit
dose strips are correctly labeled.
----
-2-
Class III -
Product: Tazicef (Ceftazidime) an Rx sterile, dry powder in bulk
pharmacy vials, 6 grams per vial, used as a broad-spectrum
antibiotic for parenteral administration.
Recall #D-351-0.
Code: Lot #6030T86, EXP 5/31/92.
Manufacturer: Bristol Myers Company, New York, New York.
Recalled by: Smith Kline Beecham Pharmaceutical, Conshohocken,
Pennsylvania by telefax on August 15, 1990.
followed by telephone August 16, 1990 with follow-up
letter August 17, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide.
Quantity: 5,930 vials were distributed.
Reason: Contents of some vials do not dissolve when reconstituted.
----
Product: Swanson Nature-Lax, a herbal laxative in bottles
of 100, 300, 600 tablets, containing 5 gr.
of senna leaves and 1 gr. of senna extract.
Recall #D-352-0.
Code: All lots.
Manufacturer: Freshlabs, Inc., Warren, Michigan.
Recalled by: Swanson Health Products, Fargo, North Dakota (repacker/
responsible firm), by notice printed on the front page of
the August issue of the "Health Shopper", sent
July 20-25, 1990. Firm-initiated recall ongoing.
Distribution Nationwide.
Quantity: 140,000 tablets were distributed.
Reason: Product label lacks Pregnancy-Nursing statement
specified in regulation 201.63(a).
----
Product: Isoetharine Inhalation Solution, USP 0.1% in vials.
Recall D-354-0.
Code: Lot #900457 EXP 10/91.
Manufacturer: Roxane Laboratories, Columbus, Ohio.
Recalled by: Manufacturer by letter August 14, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 311 cartons were distributed. Firm estimates 200
cartons remain on market.
Reason: The shipping cartons were incorrectly labeled as "Each
vial contains: 5 mg., Isoetharine HCl equivalent to
0.5 ml. Isoetharine HCl 1% in Normal Saline", instead of
"Each vial contains 2.5 mg., of Isoetharine HCl
equivalent to 0.25 ml. Isoetharine HCl 1% in Normal
Saline."
----
-3-
Product: Conjugated Estrogen Tablets in 0.3 mg., 0.625 mg.,
1.25 mg. and 2.5 mg. in 100, 1000 tablet bottles,
an Rx used primarily for treating estrogen
deficiencies in post-menopausal women.
Recall #D-355/358-0.
Code: All lots with an expiration date of 1991 under
the following labels: Duramed, Glenlawn, Schein, Geneva,
Rugby, Parmed, Harber, Qualitest, Goldline, Purepac,
Major, URL, Best, Moore, Genetco, Bioline.
Manufacturer: Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: Manufacturer, by letter August 20, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 98,000,000 tablets were distributed.
Reason: Some lots fail USP specifications for content uniformity.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Model 3494 X-Ray Control, a part of the Uni-Max II
325 X-Ray Control and Generator. Recall #Z-796-0.
Code: Serial #'s ME0051-0389 thru ME0192-0290.
All units shipped and produced between March 17, 1989
and February 20, 1990.
Manufacturer: Universal X-Ray, Gendex Corporation, Chicago, Illinois
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan June 29, 1990. Firm-initiated field correction
ongoing.
Distribution: Nationwide, Canada.
Quantity: 86 certified and 17 non-certified units were distributed.
Reason: Noncompliance with performance standard for x-ray products
in that the device may fail to comply with the tube current
ranges of the user statement when the line voltage
variations within stated limits are encountered.
----
Product: Modified 225 SIMV Volume Ventilator, MRI compatible
including newly manufactured units, retrofitted units,
and rebuilt units. Recall #Z-853.0
-4-
Code: Newly manufactured units - serial numbers 1001-1089;
Retrofitted units - Serial numbers: 00037, 00040, 00051,
00095, 00106, 00433, 1694, 224-0068, 224-00171, 224-0227,
224-01068, 224-01171, 224-01185, 224-02180, 224-01386,
1275-0003, 0176-0011, 0576-0022, 0576-0048, 0676-0017,
0676-0027, 1076-0024, 1076-0039, 1076-0046, 1176-0021,
1176-0032, 1176-0065, 1176-0070, 0177-0008, 0377-0035,
0037-0040, 0377-0065, 0807-0044, 0928-0927, 0584-0540,
0338-0359, 1457-1458, 1635-1636, 1637-1638, 10252-0253;
Rebuilt units - serial numbers: M5977-1012, M5977-1013,
M5953-1010, M5953-1011, M5914-1009, M5760-1285,
M5748-0007, M5655-0037, M2861-1014, M1161-0112,
M5271-0002.
Manufacturer: Monaghan Medical Corporation, Plattsburgh, New York.
Recalled by: Manufacturer, by letter July 3, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Japan, Italy, Canada.
Quantity: 140 units were distributed.
Reason: The device was marketed from April 1, 1986 to
November 1989 without 510(k) approval.
----
Product: Beckman "Interlink" System, Version 3.2 Software,
an in-vitro diagnostic product used with Beckman
"Synchron" Analyzers for the performance of up to
20 different chemistry panels. Recall Z-856-0.
Code: Not coded. All version 3.2 software diskettes.
Manufacturer: Beckman Instruments, Inc., Brea, California.
Recalled by: Manufacturer by letter March 28, 1990. Firm-initiated
recall complete.
Distribution: Nationwide and international.
Quantity: 110 diskette sets were distributed.
Reason: An error in the device can cause the Sample
Identification (Sample ID) number to be transferred to
another patient in the instrument "Load List". This could
cause an operator who is using only the sample ID
from the instrument load list to select and load
the wrong sample into the tray/sector position of
the analyzer which may result in a patient misdiagnosis.
----
Product: James River Caretouch Latex Examination Gloves
distributed in large, medium, small sizes in boxes
of 100 units. Recall #Z-858/860-0.
Code: The sticker label attached to the bottom of the box
reads "Latex Examination Gloves Cuffed Prepowdered
Distributed by Lifetime International, Inc." Reorder #'s
30401 (small); 30402 (medium); 30403 (large).
Manufacturer: Made in Taiwan and were originally labeled as
distributed by James River Corporation, Health Care
Division, Greenville, South Carolina.
-5-
Recalled by: Lifetime International, Inc., Green Bay, Wisconsin, by
letters July 27, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 225/10 box cases were distributed.
Reason: Product labeled "REJECT-NOT FOR MEDICAL USE" were
relabeled and sold for medical use.
----
Product: Braun Tri-Wheeler, Wheelchair:
(a) Tiller model equipped with a single switch controller,
Model T1100, T1100F, T1200, T1200F;
(b) Joystick model equipped with a double switch or
two-channel controller, Model J1100F, J1200, J1200F.
Recall #Z-861/862-0.
Code: (a) T1100-02-0025, T1100-02-0500 thru 0504; T1100F-02-0260
T1100F-02-0500 thru 0508; T1200-02-0501 thru 0503
T1200-02-0531; T1200F-02-0019; T1200-02-0503;
T1200F-02-0513 thru 0547; T1200F-02-0613; T1100F-01-0500
thru 0512;
(b) J1100F-02-0500 and 0501; J1200-02-0500 thru 0502;
J1200F-02-0500 thru 0519.
Manufacturer: Braun Corporation, Clearwater, Florida.
Recalled by: Braun Corporation, Winamac, Indiana by letter April 18,
1990. Firm intiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 76; (b) 25 wheelchairs were distributed.
Reason: A defect may exist in the tiller or joystick control to
the device which causes it to involuntarily accelerate or
chatter.
----
Product: Bard PCA Infusion Pump and Accessories, used for the
controlled rate delivery of parenteral fluids.
Recall #Z-863-0.
Code: All serial numbers for catalog #6464001.
Manufacturer: BardMed Systems, Division of C.R. Bard Inc., North
Reading, Massachusetts.
Recalled by: Manufacturer, letter August 15, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide.
Quantity: 10,404 units were distributed.
Reason: The susceptability of the pump to high levels of
electrostatic discharge (ESD) may cause the pump to reset
from the operating mode to the pre-operation self test
check mode and shut-down pumping operation. The pump may
"freeze" in the operating mode and shut-down pumping
operation with or without activating an alarm.
----
-6-
CORRECTION: Model 7100 Direct 30/30 Blood Glucose Sensor,
Z-751-0 which appeared in the August 29, 1990 Enforcement
Report should read:
Reason: Calibration at or below room temperature followed
by use of these devices (serial numbers below
10000) above 80 degrees F to perform a blood
test may result in slightly lower blood glucose
reading.
----
Class III -
Product: Beckman "RHF CAL" Rheumatoid Factor Calibrator an in-vitro
diagnostic product for use with Beckman specific protein
analyzers in the calibration of immunochemistry.
Recall #Z-854-0.
Code: Lot #M909183, EXP 3/31/91.
Manufacturer: Beckman Instruments, Inc., Carlsbad, California.
Recalled by: Beckman Instruments, Brea, California by letter
March 28, 1990. Firm initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 372 units were distributed.
Reason: Some vials are unstable after reconstitution which may
result in depressed recovery of controlled material
and patient samples.
----
Product: Beckman "CAL I" Protein Calibrator an in-vitro diagnostic
product for use with Beckman specific protein analyzers
and reagents in the calibration of immunochemistry.
Recall #Z-855-0.
Code: Lot #M903115, EXP 10/31/90.
Manufacturer: Beckman Instruments, Inc., Carlsbad, California.
Recalled by: Beckman Instruments, Inc., Brea, California by letter
March 28, 1990. Firm initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 3,341 units were distributed.
Reason: The product exhibits a loss of activity that may
cause an elevated recovery of control materials and
patient samples.
----
Product: Pneumo Check Hand Held Spirometer. Recall #Z-857-0.
Code: Model #61000, serial #'s 600027 to 601965.
Manufacturer: Welch Allyn, Inc., Skaneateles Falls, New York.
Recalled by: Manufacturer, by telephone July 13, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Germany, Japan.
Quantity: 1,068 units were distributed.
-7-
Reason: A defect in the molding of the rear housing can cause
erroneous readings. Squeezing the housing with as little
as five pounds of pressure in a particular location can
interfere with the instrument's transducer.
----
VETERINARY PRODUCTS
NONE
Medical Device Safety Alerts:
Product: Cobe Centrysystem 3 Dialysis Control Unit, a
micro-processor controlled system that provides
ultra-filtration of blood from patients undergoing
dialysis. Safety Alert #M-064-0.
Code: All serial numbers.
Manufacturer: Cobe Laboratories, Inc., Lakewood, Colorado.
Alerted by: Manufacturer by letter June 21, 1990.
Distribution: Nationwide, international.
Quantity: Over 4,000 units were distributed.
Reason: Firm's June 21, 1990 letter alerts users that the
device presents a hazard for over-ultrafiltration which
could lead to unpredictable patient weight fluid problem.