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
01/02/1992
Recalls and Field Corrections: January 2, 1992
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 -
Product: Erythromycin Ethylsuccinate and Sulfisosoxazole Acetyl for
oral suspension, 200 mg/600 mg/5 ml (ESP), in bottles of
100 ml; Erythromycin Ethylsuccinate for oral suspension,
200 mg/5 ml, (EES), in bottles of 100 ml. Recall #D-133-2.
Code: Lot 1I445AW numeral 1, letter I, numbers 445, letters AW)
EXP 9/95 for both products.
Manufacturer: Barr Laboratories, Inc., Northvale, New Jersey.
Recalled by: Barr Laboratories, Inc., Pomona, New York, by letters of
November 21 and 26, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 335 mislabeled bottles were distributed.
Reason: The erythromycin/sulfisosoxazole product is mislabeled as
the one ingredient erythromycin product.
----
Class II -
Product: Aspirin USP, bulk, in mesh grades 20, 40, 80, uncut
crystals, and starch granulation, packed in polylined
fiber drums of varying sizes (100 lb, 110.23 lb,
250 lb, 253.5 lb, 1,635.45 lb, and 2,000 lb).
Recall #D-134/138-2.
Code: The following lot numbers with their corresponding mesh
sizes are involved in the recall:
20-Mesh: SA-121 through SA-145, SA-4045 through SA-4049,
SA-4051 through 4058, SA-4060, SA-4065 Through SA-4072
40-Mesh: SA-1201 through SA-1249
80-Mesh: SA-7102 through SA-7147, SA-2033 through SA-2039
SA-5019 through SA-5020
Uncut: SA-8196 through SA-8269
Starch Granulation: SA-10038 through SA-10049
SA-12309 through SA-12311
Manufacturer: Rhone-Poulenc, Inc., St. Louis, Missouri.
Recalled by: Rhone-Poulenc, Inc., Princeton, New Jersey, by letters of
December 10, 12, and 16, 1991. Firm-initiated recall
ongoing.
Distribution: Nationwide, Canada, Argentina, Mexico.
Quantity: Approximately 225 10,000-pound lots were distributed.
Reason: Product was found to contain stainless steel particles.
----
Product: (a) Red Blood Cells; (b) Fresh Frozen Plasma;
(c) Recovered Plasma. Recall #B-055/057-2.
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Code: Unit numbers: (a) FS01525, FS03256, FM47233, FX31487;
(b) FX30096; (c) FM47233, FM48159, FM48118, FM48107,
FM45522, FM48558, FM32044, FX33422, FX35622, FS03881.
Manufacturer: Fairfax Hospital System, Inc., Annandale, Virginia.
Recalled by: Manufacturer, by letter January 16, 1991 and
February 7, 1991. Firm-initiated recall ongoing.
Distribution: Virginia, Washington, D.C.
Quantity: (a) 4 units; (b) 1 unit; (c) 10 units.
Reason: Blood products, improperly tested for the antibody
to the human immunodeficiency virus, type 1
(anti-HIV-1), were distributed.
----
Product: Red Blood Cells. Recall #B-065-2.
Code: Unit #13T37006.
Manufacturer: American Red Cross Blood Services, Detroit, Michigan.
Recalled by: Manufacturer, by telephone April 30, 1991, followed by
letter May 15, 1991. Firm-initiated recall complete.
Distribution: Michigan.
Quantity: 1 unit.
Reason: Red Blood Cells testing repeatably reactive for
hepatitis B surface antigen (HBsAg), were distributed.
----
Product: Recombigen HIV-1 LA Kit. Recall #B-067-2.
Code: Lot #A6706- EXP 7/9/91.
Manufacturer: Cambridge Biotech Corporation, Worcester, Massachusetts.
Recalled by: Manufacturer, by letter April 29, 1991, followed by
telephone on or about April 29, 1991. Firm-initiated
recall complete.
Distribution: Nationwide, Bermuda, Australia, Ankara.
Quantity: 343 kits (100 test per kit) were distributed.
Reason: Test kits, which failed to maintain stability for the
detection of antibodies to the human immunodeficiency virus,
type 1 (anti-HIV-1) throughout the dating period, were
distributed.
----
Class III -
Product: (a) Whole Blood; (b) Red Blood Cells. Recall #B-062/063-2.
Code: Unit numbers: (a) F90254; (b) F90237, F90244, F90245,
F90252, F90258.
Manufacturer: Tacoma-Pierce County Blood Bank. Tacoma, Washington.
Recalled by: Manufacturer, by telephone May 29, 1991, May 31, 1991,
and June 7, 1991. Firm-initiated recall complete.
Distribution: Washington state.
Quantity: (a) 1 unit; (b) 5 units.
Reason: Blood products, labeled with incorrect expiration dates,
were distributed.
----
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Product: Red Blood Cells. Recall #B-064-2.
Code: Unit #8138711.
Manufacturer: The Blood Center for Southeast Louisiana, New Orleans,
Louisiana.
Recalled by: Manufacturer, by telephone July 29, 1991. Firm-initiated
recall complete.
Distribution: Louisiana.
Quantity: 1 unit.
Reason: Blood product, labeled with incorrect expiration date
due to the addition of AS-1 additive after the 72 hour
limit, was distributed.
----
Product: Platelets. Recall #B-066-2.
Code: Unit #10099.
Manufacturer: Lane Memorial Blood Bank, Eugene, Oregon.
Recalled by: Manufacturer, by telephone August 8, 1991. Firm-
initiated recall complete.
Distribution: Oregon.
Quantity: 1 unit.
Reason: Blood product, untested for the antibody to hepatitis
C virus (anti-HCV), was distributed.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Ohmeda 7810 Anesthesia Ventilators, stock #1500-8000-000
(all 7810 Ventilators are an integral part of Ohmeda
Modulus II Plus Anesthesia Machines, stock #0236-5320-910).
Recall #Z-149-2.
Code: All Ohmeda 7810 Anesthesia Ventilators that begin with
letters CAHR, CAHS, CAHT, and CAHU 00100 through CAHU 01050
including those serial numbers that end with letter "R".
Manufacturer: Ohmeda, Madison, Wisconsin.
Recalled by: Manufacturer, by letter dated November 1, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 4,200 units.
Reason: The device exhibits a sensitivity to electromagnetic
interference (EMI) and power line disturbances, which could
cause the ventilator to stop ventilating and the
ventilator's monitoring functions, including alarms,
to become inoperative. In addition, the display may
exhibit one or more ventilator failure messages or display
unintelligible messages.
----
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Product: Astra T Single Chamber Pulse Generator:
(a) Models 437/438/439 Low Profile, In-Line Bipolar
Pulse Generators;
(b) Models 537/538/539 Unipolar Pulse Generators.
Recall #Z-147/148-2.
Code: All serial numbers.
Manufacturer: Cardiac Pacemakers, Inc., St. Paul, Minnesota.
Recalled by: Manufacturer, by letter dated November 26, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 59 units were distributed.
Reason: The generators contain capacitors from a specific vendor lot
that may not perform to specification. Some devices
have exhibited lack of sensing resulting in asynchronous
pacing at the programmed rate.
----
Product: GE Computers for Magnetic Resonance (MR) System Models
46-301394G4, 46-301394G14, 46-301394G24.
Recall #Z-154-2.
Code: All serial numbers.
Manufacturer: GE Medical Systems, Waukesha, Wisconsin.
Recalled by: Manufacturer, by letters dated September 27, 1991 and
October 25, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 180 units were distributed.
Reason: The imaging, patient, and other hospital information for
one patient exam may be mismatched by the MR with the images
from different MR exams.
----
Product: MR Adjustable Stool, Catalog #E8806AA, for use with
magnetic resonance systems in the examination room.
Recall #Z-155-2.
Code: All units.
Manufacturer: EF Brewer Company, Menomonee Falls, Wisconsin.
Recalled by: GE Medical Systems, Waukesha, Wisconsin, by letter
September 1, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, England, Canada, Japan, Portugal.
Quantity: 161 units were distributed.
Reason: Over time, the ferrous nails which attach the mounting
brackets to the backrest may pull out of the backrest
and be attracted by the MR magnet, presenting a
potential for injury.
----
Product: Companion Airway and Delivery Management (ADAM) Circuit
with pressure tap for obstructive sleep apnea patients.
Recall #Z-202-2.
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Code: Lot #AAX manufactured on 4/18/91.
Manufacturer: COF Training Services, Inc., Ottawa, Kansas.
Recalled by: Puritan Bennett Corporation, Lenexa, Kansas, by letter
August 2, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 150 units were distributed.
Reason: The devices were manufactured without a tap hole and the
pressure top was incorrectly placed in the vent hole.
----
Product: Ivion Intellijet Multi-Channel Infusion Pump.
Recall #Z-212-2.
Code: All new and serviced devices built between May 23, 1990
and May 3, 1991. Serial numbers are as follows:
P210, P245, P259, P282, P355, P386, P396, P403, P430, P461,
P467, P481, P487, P508, P562, P570, P573, P625, P626,
P648, P649, P682, P696, P771, P774, P784, P829, P840,
P853, P873, P884, P888, P915, P932, P935, P936, P937, P942,
P947, P958, P961, P974, P981, P988, P992, P995, P997,
P1007, P1009, P1018, P1021, P1046, P1053, P1057,
P1060-P1064, P1066, P1068, P1070-P1083, P1085-P1090,
P1092-P1104, P1107, P1109-P11l1, P1113-P1119, P1121-P1129,
P1131-P1133, P1135-P1139, P1141, P1143-P1144, P1146-P1147,
P1149, P1152-P1161, P1163, P1165-P1167, P1169-P1170, P1210,
P1212, P1214, P1218, P1220, P1223-1224, P1227-11232,
P1235-P1241, P1244, P1248, P1254, P1256-P1258, P1260-P1266,
P1268-P1275, P1277, P1279, P1282-P1285, P1287-P1293, P1295,
P1297-P1302, P1304-P1311, P1313-P1317, P1319, P1320,
P1326-P1327, P1330, P1339-P1343, P1345-P1347, P1349-P1350,
P1352, P1371, P1373-P1375, P1377.
Manufacturer: Ivion Corporation, Broomfield, Colorado.
Recalled by: Manufacturer, by letter November 30, 1991. Firm-initiated
field correction ongoing.
Distribution: Nationwide, France.
Quantity: 263 pumps subject to field correction.
Reason: Excessive adhesive was migrating down the shaft and onto
the outside of the motor gear. This caused the motor pawl
to bond to the motor gear when the adhesive cured.
----
Product: Propaq Monitors with Software versions 6.01 and 6.10:
(a) Model 102; (b) Model 104; (c) Model 106.
Recall #Z-213/215-2.
Code: Various serial numbers.
Manufacturer: Protocol Systems, Inc., Beaverton, Oregon.
Recalled by: Manufacturer, by letter September 27 and 28, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 992 units were distributed.
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Reason: There is a software error in the computation of the
diastolic pressure in those monitors with software versions
6.01 and 6.10, which could cause falsely elevated diastolic
readings from non-invasive blood pressure measurements taken
by the monitor.
----
Class III -
Product: Operational Program Software, Version 05 (M235) for
the AU5000. Recall #Z-203-2.
Code: All units of Version 05.
Manufacturer: Olympus Optical Company, Ltd., Tokyo, Japan.
Recalled by: Olympus Corporation, Lake Success, New York, by
telephone June 18, 1991, followed by letter June 21,
1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 100 copies of software (M235).
Reason: Utilization of the BATCH mode for either online accession
input or online data output may compromise the reported
patient results, due to the inappropriate inclusion of
previous sample ID numbers and patient results.
----
CORRECTION: This a correction to Recall #Z-131/135-2 which appeared in
the December 11, 1991 Enforcement Report. Recall numbers
Z-133/135-2 will be re-issued.
Product: Urostomy Pouches (two styles) designed to collect urine
exiting from a stoma from people having a Urostomy.
Recall #Z-131/132-2.
Code: ConvaTec Accuseal Urostomy Pouches
21926 OEX2811, OGX2814, ODX2830
21927 9BX2844, OGX2811, 9MX2814, OGX2825, OEX2805
21928 OEX2804, OGX2815, OEX2815, OBX2824
21936 OBX2800, ODX2829, OFX2826, OFX2813, OFX2826,
OEX2813
21937 OEX2816, OGX2804, OBX2821, ODX2828
21956 OEX2806, OBX2833, 9LX2810
21957 OEX2817, 9MX2833, OBX2811, 9MX2823
21958 OCX2814, 9CX2815
21938 OCX2812, OFX2830, OEX2822, 9MX2810.
ConvaTec Standard Sytle Urostomy Pouch
List number Control number
24231 OEX2809, OFX2834, OFX2804, OGX2810
24232 OFX2802
24233 OEX2803, OFX2836, OFX2803, OFX2805, OGX2809
24235 ODX2832, OFX2838, ODX2804, OFX2807
24236 ODX2837, ODX2805
24237 OAX2824.
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Manufacturer: ConvaTec, Ltd., Whales, UK (pouches), and Medispo APS,
Denmark (flanges).
Recalled by: ConvaTec, (a Bristol-Myers Company) Skillman, New Jersey,
by memorandum dated August 24, 1990, and September 4, 1990.
Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: Approximately 51,000 market units (10's) units were
distributed; firm estimates none remains on the market.
Reason: The flange's binding strength was compromised on some
Urostomy Pouches as a result of an increase in channel width.
----
VETERINARY PRODUCTS
NONE
Medical Device Safety Alerts:
Product: Ohmeda Biox 3740 Pulse Oximeter, a microprocessor-controlled
device used to determine oxygen saturation in the tissue
vascular bed. Safety Alert #M-019-2.
Code: All serial numbers.
Manufacturer: Ohmeda, Division of the BOC Group, Inc., Louisville,
Colorado.
Alerted by: Manufacturer, by letter December 18, 1991.
Distribution: Nationwide, Taiwan, Brazil, Holland, El Salvador, Colombia,
Jamaica, Canada.
Quantity: 26,700 units were distributed.
Reason: Firm is informing users that the pulse oximeter should not
be used as an apnea monitor.
----
Product: Edwards-Duromedics Bileaflet Valves, also previously known
as the Hemex Scientific Bileaflet Valve:
(a) Bileaflet Valve Model 3160 (Aortic);
(b) Bileaflet Valve Model 9120 (Mitral).
Safety Alert #M-020/021-2.
Code: All sizes and serial numbers.
Manufacturer: Edwards CVS Division, Baxter Healthcare Corporation
(formerly Hemex Scientific), Austin, Texas.
Alerted by: Baxter Health Corporation, Irvine, California, by
initiating a patient notification program November 15, 1991
containing letter dated November 4, 1991.
Distribution: Nationwide.
Quantity: No unimplanted valves are known to remain in commerce.
Approximately 1,707 valves were distributed and implanted
in the United States between 1982 and 1988.
Reason: One of the two leaflets of the valve may fracture and
break loose from the valve housing.
----
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Injunction Actions Filed:
Against: West-ward Pharmaceutical Corporation, Eatontown, New Jersey.
Product: Prescription Drugs (91-524-393).
Charge: Adulterated - The articles were manufactured under
conditions not in conformity with current good manufacturing
practice regulations.
Filed: November 6, 1991 - U.S. District Court for the District of
New Jersey; Civil #91-5-54CSF; INJ #1259.
Consent Decree: A consent decree was signed on December 19, 1991,
providing for shut-down of the firm.
----
Seizure Actions Filed:
Product: Caldex CMPK Injection, an article of drug for veterinary
use (91-625-203).
Charge: Misbranded - Product is a veterinary drug that does not
bear the required prescription legend, "Caution: Federal law
restricts this drug to use by or on order of a licensed
veterinarian." The product was manufactured in Canada for
Agri Laboratories, Ltd., St. Joseph, Missouri.
Firm: Veterinary Pharmaceuticals, Inc., Hanford, California.
Filed: December 19, 1991 - U.S. District Court for the Eastern
District of California; FDC #66267.
----
Product: Le Tan Canthaxanthin tanning tablets (91-627-663).
Charge: Adulterated - Product contains an unsafe color additive.
Shipper: Le Tan, Montrose, Colorado;
Firm: Northbest Natural Products, Seattle, Washington.
Filed: December 6, 1991 - U.S. District Court for the Western
District of Washington; Civil #91-1685; FDC #66321.
Seized: December 13, 1991; 53 80-tablet bottles and 300 leaflets.
----
Product: Betel Nut and Betel Nut Leaves (91-556-866).
Charge: Adulterated - Products contain a poisonous and
deleterious substance.
Distributor: United Asian Foods, Ltd., Vernon, California.
Firm: Asian Specialty Food Company, Ltd., Chippewa Falls,
Wisconsin.
Filed: November 4, 1991 - U.S. District Court for the Western
District of Wisconsin; Civil #91 C 0943 S; FDC #66299.
----
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Product: Oxygen, USP (91-610-137/8).
Charge: Adulterated - Product was repacked under conditions
not in conformity with current good manufacturing practice
regulations.
Misbranded - The product labels fail to contain a statement
of the quantity of contents.
Firm: Apache Oxy-Med, Inc., Mesa, Arizona.
Filed: September 27, 1991 - U.S. District Court for the
District of Arizona; Civil #91-1547-PHX-EHC; FDC #66228.
Seized: October 8, 1991; stand tank, cylinders, etc., valued at
$99,000.
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