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
09/18/1990
FDA Enforcement for the week of September 19, 1990
FDA ENFORCEMENT REPORT
FOR SEPTEMBER 19, 1990
September 19, 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: Methyclothiazide with Deserpidine (a) 5/0.25 mg Tablets
and (b) 5/0.5 mg Tablets, in 100, 250, 500 and
1,000 tablet bottles, an Rx drug used for hypertension
under the Bolar Pharmaceutical, Goldline Laboratories,
Bioline Laboratories, Parmed Pharmaceutical, Mason
Distributors, Schein Pharmaceutical, H.L. Moore, Best
Generics, Glenlawn, Vita-Rx, Rugby Laboratories, Geneva
Generics labels. Recall #D-360/361-0.
Code: Lot numbers and EXP dates: (a) 027588 7/90, 078531 11/90,
107009 12/90, 804019 2/92, 817029 4/92, 846059 6/92,
900089 10/92;
(b) 028284 6/91, 047716 10/90, 780128 2/92, 885079 10/92.
Manufacturer: Bolar Pharmaceutical Co., Inc., Copiague, New York.
Recalled by: Manufacturer, by letter July 27, 1990. Firm-initiated
recall ongoing.
Distribution: Florida, New York, Connecticut, Indiana, Georgia, Colorado.
Quantity: Firm estimates (a) 640,000 tablets; (b) 1,134,000 tablets
remain on market.
Reason: Products not manufactured in conformity with conditions
approved in the Abbreviated New Drug Application.
----
Product: Ergoloid Mesylates Oral Tablets, 1.0 mg, in 100, 250,
500 and 1000 tablet bottles, an Rx drug used for the
treatment of symptomatic decline in mental capacity of
unknown etiology, under the Bolar Pharmaceutical,
United Research Laboratories, Squibb, Purepac Pharmaceutical,
Bioline Laboratories, Harber Pharmaceutical, Goldline
Laboratories, H.L. Moore, Mason Distributors, Baxter
Healthcare, Glenlawn, Genetco, Best Generics, Arkansas
Cooperative Assoc., Parmed Pharmaceuticals, IDE Interstate,
UDL Laboratories, Dixon-Shane, Vita-Rx, American Preferred
Pharmaceutical, Major Pharmaceutical labels.
Recall #D-362-0.
Code: Lot numbers and EXP dates: 018211 3/91, 018212 4/91,
019893 5/91, 047719 9/90, 048386 7/91, 048387 8/91,
049053 7/92, 067825 9/90, 077892 12/90, 077893 12/90,
079193 7/91, 088624 10/91, 088625 11/91, 099313 11/92,
108707 3/92, 117128 3/91, 128810 1/92, 108706 1/92,
049052 6/92.
Manufacturer: Bolar Pharmaceutical Co., Inc., Copiague, New York.
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Recalled by: Manufacturer, by letter July 26, 1990. Firm-initiated
recall ongoing.
Distribution: Pennsylvania, New Jersey, New York, Florida, Connecticut,
Illinois, Arkansas, Georgia, Tennessee, Virginia.
Quantity: Firm estimates 11,650,000 tablets remain on market.
Reason: Product not manufactured in conformity with conditions
approved in the Abbreviated New Drug Application.
----
Product: Meclofenamate Sodium Capsules (a) 50 mg and (b) 100 mg,
in 100, 250, 500, 1000 tablet bottles, an Rx drug used
for the relief of signs and symptoms of acute and chronic
rheumatoid arthritis and osteoarthritis, under the Best
Generics, Goldline Laboratories, Major Pharmaceutical,
Reno Parmed Pharmaceuticals, Moore, Schein Pharmaceutical,
American Preferred Pharmaceutical, Genetco, Bioline
Laboratories, Harber Pharmaceutical, Dixon-Shane,
IDE Interstate and Bolar Pharmaceutical labels.
Recall #D-363/364-0.
Code: Lot numbers and EXP dates: (a) 691078 11/90, 729078 9/90,
884079 11/91, 941109 11/91, 942109 11/91;
(b) 635058 8/90, 714088 11/90, 755118 4/91, 874069 9/91,
899089 11/91, 945109 10/91, 946109 1/92.
Manufacturer: Bolar Pharmaceutical Co., Inc., Copiague, New York.
Recalled by: Manufacturer, by letter July 27, 1990. Firm-initiated
recall ongoing.
Distribution: New York, Florida, Illinois, Connecticut, Arkansas, New
Jersey, Pennsylvania.
Quantity: Firm estimates (a) 1,956,000 capsules; (b) 2,845,000
capsules remain on market.
Reason: Lack of assurance of bioequivalency.
----
Product: Humco brand 2% Iodine Tincture, in 1 pint bottles,
an OTC product manufactured for hospital use to help prevent
infection in minor cuts, burns, and abrasions.
Recall #D-365-0.
Code: Lot #15205 EXP 3/95.
Manufacturer: Humco Laboratory, Inc., Texarkana, Texas.
Recalled by: Manufacturer, by telephone July 2, 1990, followed by letter
August 1, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,764 bottles were distributed.
Reason: Approximately 115 bottles contain Strong Iodine Tincture
7%.
----
Product: (a) Red Blood Cells; (b) Platelets. Recall #B-178/179-0.
Code: Unit numbers: (a) 41FF57997, 41LG43577, 41LG43576;
(b) 41FC86792.
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Manufacturer: American Red Cross, Alabama Region, Birmingham, Alabama.
Recalled by: Manufacturer, by telephone July 1989 through March 1990.
Firm-initiated recall complete.
Distribution: Alabama.
Quantity: (a) 3 units; (b) 1 unit were distributed.
Reason: Blood products drawn from ineligible donors were
distributed for transfusion.
----
Product: (a) Whole blood; (b) Red blood Cells; (c) Platelets;
(d) Fresh frozen Plasma; (e) Cryoprecipitated AHF;
(f) Recovered Plasma. Recall #B-185/190-0.
Code: Unit numbers: (a) E61277, G09426;
(b) E43023, E52729, E57817, E59300, E71459, KC63855;
(c) E43023, E59300, E61277, E71459, G09426, P01271;
(d) E43023, KC63855;
(e) E52729;
(f) E52729, E57817, E59300, E71459.
Manufacturer: Mid-South Regional Blood Center, Memphis, Tennessee.
Recalled by: Manufacturer, by telephone on or before August 1, 1990,
followed by letter August 2, 1990. Firm-initiated
recall ongoing.
Distribution: Florida, Missouri, Pennsylvania.
Quantity: (a) 2 units; (b) 6 units; (c) 6 units; (d) 2 units;
(e) 1 unit; (f) 4 units were distributed.
Reason: Blood products were distributed which were 1) repeatably
reactive for the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1) or the hepatitis B surface antigen
(HBsAg), or 2) non-reactive for anti-HIV-1 but collected
from a donor who previously tested repeatably reactive for
anti-HIV-1.
----
CORRECTION: Levothroid Tablets, Recall #D-353-0 which appeared in
the September 12, 1990 Enforcement Report should read:
Lot #01319 EXP 7/91.
----
Class III -
Product: Oxygen USP Compressed Gas in D and E size aluminum
cylinders, an Rx product. Recall #D-359-0.
Code: Firm does not code containers.
Manufacturer: Ellis Home Oxygen and Medical Equipment, Marion, Virginia
(repacker/responsible firm).
Recalled by: Manufacturer, by telephone August 21, 1990. Firm-initiated
recall ongoing.
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Distribution: Virginia.
Quantity: 44 cylinders were distributed.
Reason: Current good manufacturing practice deficiencies.
----
Product: (a) Red Blood Cells; (b) Platelets. Recall #B-180/181-0.
Code: Unit numbers: (a) 41GC21559, 41GC21560, 41GC21561,
41GC22592, 41GC22595, 41GC22596, 41GC22597, 41GC22598,
41GC22599, 41GC22600, 41LK07510, 41LK07515, 41LK07516,
41LK07519, 41LK07523, 41LK07524, 41LK07529;
(b) 41GP19576, 41GP19577, 41GP19578, 41GP1957.
Manufacturer: American Red Cross, Alabama Region, Birmingham, Alabama.
Recalled by: Manufacturer, by telephone July 1989 through March 1990.
Firm-initiated recall complete.
Distribution: Alabama.
Quantity: (a) 17 units; (b) 4 units were distributed.
Reason: Blood products were distributed for transfusion
labeled with expiration dates which exceeded approved
dating period.
----
Product: Reagent Red Blood Cells - Tencell Panel . Recall #B-183-0.
Code: Lot #90179 Cell #9, EXP 6/1/90, Lot #90221 Cell #9,
EXP 6/29/90.
Manufacturer: Organon Teknika Corporation, West Chester, Pennsylvania.
Recalled by: Manufacturer, by letter and by FAX May 31, 1990.
Firm-initiated recall complete.
Distribution: Nationwide and international.
Quantity: 1,116 kits were distributed; firm estimates none remains
on market.
Reason: s(+w) Reagent Red Blood Cells labeled as s(-) were
distributed.
----
Product: Reagent Red Blood Cells Data Cyte Plus. Recall #B-184-0.
Code: Lot #DC-7-580, EXP 4/7/90.
Manufacturer: Baxter Healthcare Corporation, Miami, Florida.
Recalled by: Manufacturer, by letter April 3, 1990. Firm-initiated
recall complete.
Distribution: Nationwide and international.
Quantity: 751 packages were distributed.
Reason: Vw(+) Reagent Red Blood Cells labeled as Vw(-) were
distributed.
----
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MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Model LX-20 C02 Surgical Laser. Recall #Z-866-0.
Code: Serial numbers: 000003 through 000008, 000011 through
000019.
Manufacturer: Luxar Corporation, Bothell, Washington.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan August 20, 1990. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 15 units were distributed.
Reason: Noncompliance with performance standard for laser products
in that it was not provided with the required safety
interlocks at both ends of the mast.
----
Product: Time Four Channel Multiprogrammable Implant Model TI-94.
Recall #Z-867-0.
Code: Various serial numbers.
Manufacturer: Neuromed Inc., Ft. Lauderdale, Florida.
Recalled by: Manufacturer, by letter June 25, 1990. Firm-initiated
recall ongoing.
Distribution: Italy, Spain, West Germany.
Quantity: 45 units were distributed.
Reason: The device was marketed without an approved premarket
approval (PMA) supplement after FDA advised the firm of
the withdrawal of the approval of the Investigational Device
Exemption (IDE).
----
Product: U.S.C.I. Disposable Distal Y-Connector and insertion
tool packed in a single unit Tyvec pouch. The Distal
Y-Connector provides a connection for pressure monitoring,
dye delivery, flushing of balloon dilatation catheters
and is used during a transluminal coronary angioplasty
procedure. Recall #Z-868-0.
Code: Catalog #006056, lot numbers: 08EA0040, 08EA0041, 08EA0042,
08EA1371, 08EA1372, 08EA1375.
Manufacturer: U.S.C.I. division, C.R. Bard, Inc., Billerica,
Massachusetts.
Recalled by: Manufacturer, by letter to sales force and catheter
lot managers August 13, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 2,865 units were distributed.
Reason: The Y-Connector gasket can not be punctured as specified
in the instructions.
----
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Product: Ken Sliding Nail, an orthopedic fixation device used in
fracture fixation of the neck of the femur:
(a) Product No. 931-04-36;
(b) Product No. 931-09-36;
(c) Product No. 931-10-36;
(d) Product No. 8505-205-01 (custom device - one piece).
Recall #Z-869/872-0.
Code: Lot numbers: (a) 69838700; (b) 71065600; (c) 71001500;
(d) 32838100.
Manufacturer: Zimmer, Inc., Warsaw, Indiana.
Recalled by: Manufacturer, by letter July 26 and 30, 1990. Firm-
initiated recall ongoing.
Distribution: Alabama, Florida, Georgia, Idaho, Missouri, Ohio,
Tennessee, Washington state, Wyoming.
Quantity: 88 units were distributed.
Reason: The cannulation in the sliding nail may be obstructed
thus prohibiting passage of the guide wire through the
nail.
----
Product: Becton Dickinson Subclavian Jugular Catheter Sets,
Rx, nonpyrogenic sterile, and for single use only
devices used for central venous catheterization during
cardiac surgical procedures:
(a) Subclavian Jugular Catheter Set, Catalog #39-755-1,
contains single lumen 16 gauge, 12 inch catheter and
14 gauge 2 3/4 inch needle;
(b) Subclavian Jugular Catheter Set, Catalog #39-757-1,
contains single lumen 16 gauge, 8 inch catheter and 14
gauge 2-3/4 inch needle;
(c) Subclavian Start Pak, Catalog No. 39-758-1,
contains 1 subclavian jugular catheter set; 16 ga.,
12 in.; 2 - 5 cc syringes,; 1 prep, Povidone-Iodine
Topical Solution; 6 gauze sponges; 1-3-0 silk suture with
straight needle; 1-25 ga. needle; 1-22 ga needle;
1-fenestrated drape; 1-CSR wrap; 1-Ensure-it dressing, 4
inch; and 1-ointment containing Povidone-Iodine USP.
Recall #Z-873/875-0.
Code: Lot numbers: (a) NOAB240, NOBA560, NOBA830, NOCA160,
NOCA860, NOCB280, NOCB560, NODA380, NODB400;
(b) N9NB310;
(c) NOAB250, NOCB290.
Manufacturer: Deseret Medical, Inc., Nogales, Mexico (owned by Becton
Dickinson).
Recalled by: Becton Dickinson, Critical Care Monitoring, Sandy, Utah,
by letter August 3, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 54,000 units were distributed.
Reason: The catheters may have a split at the edge of the
external blunt endthat is connected to the snap-on adapter.
----
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Product: Russell Gastronomy Kit with Foley Catheter. Recall #Z-876-0.
Code: Product code GASTY-19-RSS, lot numbers: 91215, 91216, 91217,
91218, S92935 (S - designates special custom kit);
Product code GASTY-21-RSS, lot numbers: 92241, S91199
(S - designates special custom kit), Product code
GASTY-17-RSS, lot #91544.
Manufacturer: Wilson Cook Medical Inc., Winston-Salem, North Carolina.
Recalled by: Manufacturer, by telephone June 28, 1990 followed by
letter June 29, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Italy Australia, France.
Quantity: 116 kits were distributed.
Reason: The balloon on the end of the catheter may deflate during
use.
----
RETRACTION NOTICE: The U.S. Food and Drug Administration is retracting
recall numbers Z-705/706, published in the July 11, 1990
issue of the FDA Enforcement Report. It has been
determined and confirmed that the Cobe Laboratories
CDX Disposable Transducers, CDX Press and CDXIII with
continuous Flush Device were never replaced or
corrected in the field as initially reported.
----
Class III -
Product: Beckman Cholesterol Reference Serum, in 10 ml. bottles,
Part #683977, used for calibrating manual and automated
in-vitro diagnostic assays for total cholesterol by
enzymatic procedures. Recall #Z-877-0.
Code: Lot #M906157 EXP 9/91.
Manufacturer: Beckman Instruments, Inc., Carlsbad, California.
Recalled by: Beckman Instruments, Inc., Brea, California, by
letter May 4, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 492 units were distributed.
Reason: The labeled assay recovery value of 43 mg/dl should be
labeled as 47 mg/dl.
----
Product: Beckman "I.D.-Zone" CK Isoenzyme Control, an in-vitro
diagnostic product, intended for use in monitoring the
overall reliability of CK isoenzyme procedures in the
clinical laboratory. Recall #Z-878-0.
Code: Lot numbers: M909034 EXP 1/31/91, M903160 EXP 7/31/90.
Manufacturer: Beckman Instruments, Inc., Carlsbad, California.
Recalled by: Beckman Instruments, Inc., Brea, California, by letter
May 14, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 898 units were distributed.
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Reason: Product fails to meet labeled performance specifications
due to raw material decay.
----
Product: Beckman "AST" Enzyme Reagent Kits, an in-vitro diagnostic
intended for use on Beckman "ASTRA" or "Sychron" Systems
Analyzers, for the assay of aspartate amino transferase.
Recall #Z-879-0.
Code: Part number Lot Number
660680 M9120265 EXP 4/20/91
661960 M9120266 EXP 4/20/91.
Manufacturer: Beckman Instruments, Inc., Carlsbad, California.
Recalled by: Beckman Instruments, Inc., Brea, California, by
letter April 30, 1990. Firm-initiated recall complete.
Distribution: Nationwide and international.
Quantity: 3, 520 units were distributed.
Reason: Product may not perform to labeled specifications
due to an excessive moisture content problem.
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VETERINARY PRODUCTS
NONE