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
08/22/1995
ENFORCEMENT REPORT FOR 08/23/1995
August 23, 1995
_______________
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Tegretol 200 mg (carbamazepine USP), packaged in 100 and
1000 tablet bottles, an Rx drug, used as an anticonvulsant
for patients with epilepsy, and in the treatment of pain
associated with trigeminal neuralgia, Recall #D-236-5.
CODE Lot #s 1T170092 (exp. 6/99), 1T176204 (exp. 7/99) - 100
tablets; Lot #s 1T176199 (exp. 6/99), 1T176205 (exp. 7/99),
1T176213 (exp. 8/99) - 1000 tablets.
MANUFACTURER Ciba Pharmaceuticals Division, Suffern, New York.
RECALLED BY Manufacturer, by letters dated July 21, and August 15, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 86,130 units were distributed.
REASON Product does not meet dissolution specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
=======================
_______________
PRODUCT Lescol (fluvastatin sodium) Capsules, 20 mg bottles/100/30
tablets and 40 mg bottles/100/30 tablets, an Rx drug, Recall
#D-233/234-5.
CODE Lot numbers: 040W8823, 042W8823, 043W8823, 048W7028,
040W7028, 051W7310, 052W7505, 054X7505, 068X7505, 057X7595.
060X7660, 081X7732, 082X7732; 023W6212, 032W6475, 058X7308;
003U6184, 010W6642, 012W6680, 013W6680, 014W6680, 020X7607,
021X7353, 022X7507; D02U5088, D02U5087. 014W6332, 018W6332,
025X7813.
MANUFACTURER Sandoz Pharmaceuticals Corporation, East Hanover, New
Jersey.
RECALLED BY Manufacturer, by letter May 24, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide, Hawaii, Alaska, Puerto Rico.
QUANTITY Firm estimates none remain on market.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Sterile Cefazolin USP, packaged in 100 ml glass vials,
Recall #D-235-5.
CODE Control #4F60532, exp. date 06/96.
MANUFACTURER Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
RECALLED BY Manufacturer, by letter August 1, 1994 and telephone July
29, 1995. Firm-initiated field correction action complete.
DISTRIBUTION Ohio, Tennessee, Kentucky, New Jersey, California, New York,
Massachusetts, Alabama, Oklahoma, Pennsylvania, Illinois,
Minnesota, Wisconsin.
QUANTITY 10,368 vials were distributed.
REASON A small number of vials were mis-packaged in 10-pack trays
labeled 10 grams. The vials are correctly labeled.
_______________
PRODUCT Thorazine Concentrate (brand of Chlorpromazine
Hydrochloride), 100 mg/ml, in 8 fluid ounce bottles, an
tranquilizer, Recall #D-237-5.
CODE Lot #X111T49, Exp. date Oct 31, 1995.
MANUFACTURER SmithKline Beecham Pharmaceuticals, Cidra, Puerto Rico.
RECALLED BY Manufacturer, by letter July 21, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,010 bottles were distributed.
REASON Incorrect dosage information on primary carton. Label
instructions are correct.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
====================
______________
PRODUCT Source Plasma, Recall #B-550-5.
CODE Contact FDA, Center for Biologics Evaluation and Research,
Office of Compliance (301) 594-1070 for individual unit
numbers recalled.
MANUFACTURER Community Bio-Resources, Inc., (in 3 states) Orlando,
Clearwater, Tampa, Florida.
RECALLED BY Community Bio-Resources, Inc., Birmingham, Alabama, by
letter August 11, 1994. Firm-initiated recall complete.
DISTRIBUTION Michigan, New Jersey, Austria.
QUANTITY 582 units were distributed.
REASON Blood products which: 1) tested negative for antibody to the
human immunodeficiency virus type 1 (anti-HIV), but were
collected from donors who previously tested repeatedly
reactive for anti-HIV-1; 2) tested negative for hepatitis B
surface antigen (HBsAg), but were collected from donors who
previously tested repeatedly reactive for HBsAg or had a
history of hepatitis; or 3) were collected from donors with
a history of intravenous (IV) drug use/high risk behavior.
_______________
PRODUCT Source Plasma, Recall #B-551-5.
CODE Unit #XR50182.
MANUFACTURER Community Bio-Resources, Inc., Fargo, North Dakota.
RECALLED BY Manufacturer, by letters beginning August 11, 1994. Firm-
initiated recall complete.
DISTRIBUTION Austria.
QUANTITY 1 unit was distributed.
REASON Blood product, which tested negative for the hepatitis B
surface antigen (HBsAg) but was collected from a donor who
previously tested repeatedly reactive for HBsAg, was
distributed.
_______________
PRODUCT Platelet Concentrate; Platelets, Pheresis, Recall #B-
544/545-5.
CODE Contact FDA, Center for Biologics Evaluation and Research,
Office of Compliance (301) 594-1070 for individual unit
numbers recalled.
MANUFACTURER American Red Cross Blood Service, Madison, Wisconsin.
RECALLED BY Manufacturer, by letter November 9, 1994. Firm-initiated
recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 29 units were distributed.
REASON Blood products, for which syphillis test results were
misinterpreted as negative, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Fluoricon 300 Generators, Recall #Z-1028/1030-5.
CODE Model numbers 46-164164G1, G2, G3.
MANUFACTURER General Electric Medical Systems, Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by letter February 22, 1995. Firm-initiated
corrective action plan ongoing.
DISTRIBUTION Nationwide.
QUANTITY 140 units were distributed.
REASON The diagnostic x-ray device was found to be in noncompliance
with 21 CFR 1020.32 (d), the Federal Performance Standard
for Diagnostic X-ray Systems and their major components. If
the fuse controlling the +24 VDC supply opens, the radiation
will be continuous rather than pulsed.
_______________
PRODUCT Centrysystem 3 Cartridge Blood Tubing Sets, Recall #Z-
1077/1085-5.
CODE Lot #s 04Axxxxx; 05Axxxxx; 06Axxxxx. All sets manufactured
during April 1, 1995 to June 15, 1995.
MANUFACTURER Cobe Renal Care, Inc., Lakewood, Colorado.
RECALLED BY Cobe Renal Care, Inc., Tijuana, BCN, Mexico, by letter June
16, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, (except Washington, D.C., Vermont, Maine,
Arkansas, and Arizona), Puerto Rico, Taiwan, Canada,
Belgium, Australia, Korea, Hong Kong.
QUANTITY 31,000 units were distributed.
REASON The saline administration line could have an occlusion due
to plastic molding flashing which may not be detected during
the prime or recirculation modes.
_______________
PRODUCT Guardian Sharps Collectors:
(a) Preassembled Side Entry, Catalog #300475, 305425;
(b) Preassembled Horizontal Entry, Catalog #300476, 305428,
305427, 305426;
(c) Nestable Side Entry, Catalog #5449, 300559, 305444,
305443, 300482;
(d) Nestable Horizontal Entry, Catalog #305450, 305452,
305446, 305445, Recall #Z-1091/1094.
CODE Lot numbers beginning with the first two digits of 4F, 4G,
4H, 4J, 4K, 4M.
MANUFACTURER MedSafe, Oceanside, California
RECALLED BY Becton Dickinson, Franklin Lakes, New Jersey by letter July
14 and 17, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Sinapore, Europe, Australia, New
Zealand.
QUANTITY 659,232 units were distributed.
REASON The wall thickness fell below the specification level.
_______________
PRODUCT 3M Administration Sets, Model numbers 4236, 4270, 8C195,
8C201, 8C220, 8C230, 8C230-US, 8C290, 8C390, 8C630, 8C1230,
8C1630, 8C2012, 8C4201, 8C4209, 8C4220, 8C4220-US, 8C4222,
8C4240, 8C4292, AC2029, AC2308, AJ2304, CC1201, CC1301,
CC1501, CC2102, CC2204, CC2308, CC3217, CC4203, CF4203,
CJ1301, CJ3316, CJ3323, CJ4028, CJ4303, CK2304, CK4207, and
CK4303, Recall #Z-1109-5.
CODE JAN95, FEB95, MAR95, APR95, MAY95, JUN95, JUL95.
MANUFACTURER Thai Kawasumi, Bangkok, Thailand.
RECALLED BY 3M Infusion Therapy, Arden Hills, Minnesota by "Safety
Alert" of July 31, 1995 which provided additional safety
instructions and offered customers the addition of a slide
clamp at the customers request. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide
QUANTITY 762,840 sets were distributed.
REASON Some roller clamps of the IV Administration allow leakage of
fluid within the sets.
______________
PRODUCT MicroScan Dried Gram-Negative Urine Combo Type 6 Panels,
Recall #Z-1110-5.
CODE Lot #14APR96; Catalog No. B1017-78.
MANUFACTURER Dade International MicroScan, Inc., West Sacramento,
California.
RECALLED BY Manufacturer, by telephone on or about June 14, 1995. Firm-
initiated recall complete.
DISTRIBUTION Arizona, California, Colorado, Georgia, Idaho, Illinois,
Kentucky, Michigan, New York, South Carolina, Tennessee,
Wisconsin.
QUANTITY 674 boxes were distributed.
REASON "Out-of-range quality control results" had been obtained and
that an "unusual" color had been observed in some of the
wells in the identification part of the panel.
_______________
PRODUCT Innofluor Theophylline Assay System Reagents, Recall #Z-
1111-5, an in-vitro diagnostic for the determination of
theophylline in human serum.
CODE Lot #s 24704A, exp. date 10-01-94; 2470AG, exp. dat 04-01-
95; 24651A, exp. date 01-01-95.
MANUFACTURER Oxis International, Inc., Portland Oregon.
RECALLED BY Manufacturer, by replacement to those customers that
contacted the firm with this problem. Firm initiated recall
complete.
DISTRIBUTION Connecticut, California, New York, Nebraska, Missouri,
Virginia, Oklahoma, North Carolina, Alabama, Belgium,
France, Canada, Hong Kong, Germany, Poland, Australia,
India, Switzerland, United Kingdom.
QUANTITY 591 kits were distributed.
REASON Device was subject to decrease in Net P values, potentially
due to trace instability.
_______________
PRODUCT Abbott Vision Phenytoin, List number 1448-10, an in-vitro
diagnostic test, for the quantititive measurement of
phenytoin in anticoagulated whole blood, plasma or serum,
phenytoin measurements used in the diagnosis and treatment
of phenytoin overdose or in monitoring levels of phenytoin
to ensure appropriate therapy; Recall #Z-1115-5.
CODE Lot number 05417M100.
MANUFACTURER Abbott Laboratories, Diagnostic Division, Abbott Park,
Illinois.
RECALLED BY Manufacturer, by telephone and letter August 4, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION South Dakato, Kansas, Germany.
QUANTITY 497/10 packs were distributed.
REASON Device is subject to calibration and/or control failures.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Claiborne Branded Sunglasses (Plano), Recall #Z-1076-5
CODE Style #76530320.
MANUFACTURER Houkushin Corporation, Osaka, Japan.
RECALLED BY Outlook Eyewear Company, Broomfield, Colorado by letter July
17, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, international.
QUANTITY 15,407 units were distributed.
REASON The products are labelled "Intended for General Use", but
the LT (Luminous Transmittance) value is well below ANSI
standards.
_______________
PRODUCT Innofluor Vancomycin Calibrators, an in-vitro diagnostic
intended for use in the calibration of the INNOFLUOR
Vancomycin Assay System, Recall #Z-1103-5.
CODE Lot #24223A, expiration date 01 Aug 1994.
MANUFACTURER Oxis International, Inc., Portland, Oregon
RECALLED BY Manufacturer, by letter August 19, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, Belgium, Canada, France, Poland, United Kingdom.
QUANTITY 308 sets were distributed.
REASON Post release quality control real time testing of vancomycin
calibrators at four weeks refrigerated storage indicated the
device was subject to degradation which is noted by an
upward shift in control values.
_______________
PRODUCT Innofluor Theophylline Assay System Reagents, an in-vitro
diagnostic for the determination of theophylline in human
serum, Recall #Z-1112-5.
CODE Lot #s 24179A, exp. date 07-01-94; 24179A, exp. date 07-01-
94; 2417AGQ, exp. date 07-01-94; 24536, exp. date 01-01-95.
MANUFACTURER Oxis International, Inc., Portland, Oregon.
RECALLED BY Manufacturer, by telephone January 4, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, international.
QUANTITY 980 kits were distributed.
REASON Device is subject to stability problems.
_______________
PRODUCT (a) Abbott Vision Cholesterol Test Pack, List No. 1415-10;
for the quantitative determination of cholesterol in
anticoagulated whole blood, plasma or serum, cholesterol
measurements are used in the diagnosis and treatment of
disorders involving excess cholesterol in the blood and
lipid and lipoprotein metabolism disorders;
(b) Abbott Vision HDL Cholesterol Test Pack, List No. 1446-
16, for the quantitative determination of HDL cholesterol in
plasma or serum, HDL cholesterol measurements are used in
the diagnosis and treatment of disorders involving excess
cholesterol in the blood and lipid and lipoprotein
metabolism disorders; Recall #Z-1113/1114-5.
CODE (a) Lot #s 0609M200, 06070M200, 06071M200, 06075M200,
06076M200; (b) 0682M100, 06073M200, 06610M300.
MANUFACTURER Abbott Laboratories Diagnostic Division, Abbott Park,
Illinois.
RECALLED BY Manufacturer, by letter July 31, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Italy, japan, Hong Kong, Taiwan, Germany,
Brazil, Dominican Republic, Singapore.
QUANTITY 10,923 packs were distributed.
REASON Test results have not been able to be obtained with some
test packs and an error code "Endpoint Not Reached" provided
instead.
_______________
CORRECTION: Recall #Z-1096-5, which appeared in the August 16, 1995,
Enforcement Report. 91 additional serial numbers were
inadvertently omitted from this list. They are as follows:
PRODUCT Digital Ultrasound Systems, Model EUB-515 Plus:
CODE SE15018109 SE15018105 SE15018106 SE15018107 SE15018108
SE15018114 SE15018110 SE15018111 SE15018112 SE15018113
SE15115101 SE15018115 SE15018116 SE15018117 SE15018118
SE15117101 SE15115102 SE15115103 SE15115104 SE15115105
SE15193101 SE15117102 SE15117103 SE15117104 SE15117105
SE15193106 SE15193102 SE15193103 SE15193104 SE15193105
SE15310101 SE15193107 SE15193108 SE15193109 SE15193110
SE15310106 SE15310102 SE15310103 SE15310104 SE15310105
SE15373101 SE15310107 SE15310108 SE15310109 SE15310110
SE15485101 SE15373102 SE15373103 SE15373104 SE15373105
SE15485106 SE15485102 SE15485103 SE15485104 SE15485105
SE15551102 SE15485107 SE15485108 SE15485109 SE15551101
SE15551107 SE15551103 SE15551104 SE15551105 SE15551106
SE15574102 SE15551108 SE15551109 SE15551110 SE15574101
SE15652102 SE15574103 SE15574104 SE15574105 SE15652101
SE15655102 SE15652103 SE15652104 SE15652105 SE15655101
SE15752102 SE15655103 SE15655104 SE15655105 SE15752101
SE15752102 SE15655103 SE15655104 SE15655105 SE15752101
SE15752107 SE15752103 SE15752104 SE15752105 SE15752106
SE15752108
MANUFACTURER Hitachi Medical Corporation, Tokyo, Japan
RECALLED BY Hitachi Medical Corporation of America, Tarrytown, New York.
####
END OF ENFORCEMENT REPORT FOR AUGUST 23, 1995. BLANK PAGES MAY
FOLLOW.