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
11/31/1994
Recalls and Field Corrections: Drugs -- Class III -- 11/31/1994
November 30, 1994 94-48
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Chlorpromazine HCl 10 mg/5 ml Syrup, 4 ounces, Rx oral
tranquilizer/antiemetic. Recall #D-032-5.
CODE 75357 EXP 4/95.
MANUFACTURER Geneva Pharmaceuticals, Inc., Broomfield, Colorado.
RECALLED BY Manufacturer, by letter May 17, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remains on the market.
REASON Product found marginally superpotent.
_______________
PRODUCT Levothyroxine Sodium Tablets, USP 0.1 mg, used in the
treatment of thyroid insufficiency, under the PBI and
Goldline labels, in bottles of 100 and 1000.
Recall #D-033-5.
CODE Lot numbers: T-036-01 (Goldline), T-036-02, T-036-03 (PBI).
MANUFACTURER Rosemont Pharmaceutical Corporation, formerly PBI, Denver,
Colorado.
RECALLED BY Manufacturer, by letter November 11, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,097 bottles of 100 tablets and 5,749 bottles of 1,000
tablets were distributed.
REASON Some individual tablets were found to be superpotent.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Cryoprecipitated AHF. Recall #B-043-5.
CODE 696 units. Contact FDA, Center for Biologics Evaluation and
Research, Recall and Administrative Actions Branch
(301)827-6220* for individual unit numbers recalled.
MANUFACTURER The Blood Center for Southeast Louisiana, New Orleans,
Louisiana.
RECALLED BY Manufacturer, by letters sent from November 15, 1993,
through April 1994. Firm-initiated recall complete.
DISTRIBUTION Louisiana, Massachusetts, Virginia.
QUANTITY 696 units.
REASON Cryoprecipitated AHF, incorrectly processed, was
distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Red Blood Cells,
expired; (d) Platelets; (e) Platelets, Pheresis; (f)
Platelets, Expired; (g) Cryoprecipitated AHF; (h) Fresh
Frozen Plasma; (i) Single Donor Plasma; (j) Recovered
Plasma. Recall #B-046/055-5.
CODE Unit numbers: (a) 15H42373, 15H42626, 15H42921, and
15J35741
(b) 15F71095, 15F73626, 15F75710, 15F84931, 15F85643,
15F88768, 15F89523, 15F93786, 15F95293, 15G03814, 15G06425,
15G07303, 15G10396, 15G11396, 15G15879, 15G16724, 15G18224,
15G20752, 15G22865, 15G23767, 15G27849, 15G28205, 15G28492,
15G30495, 15G32171, 15G32960, 15G37634, 15G39305, 15G40901,
15G41369, 15G42233, 15G43520, 15G46111, 15G46601, 15G48196,
15G52103, 15G54517, 15G60302, 15G63757, 15G65615, 15G66254,
15J31077, 15J31850, 15J32704, 15J33393, 15J34037, 15J35587,
15J36281, 15J37805, 15J38572, 15J39150, 15J39890, 15J40989,
15J41791, 15J42416, 15J43065, 15J43753, 15J44455, 15J45194,
15J45738, 15J46400, 15J47021, 15J47454, 15J48051, 15J48702,
15J51346, 15J52022, 15J52630, 15J53205, 15J53894, 15J54473,
15J55148, 15J55842, 15J56415, 15K15839, 15K20249, 15K20369,
15K23303, 15K23907, 15K24380, 15KG03974, 15KG08635,
15KG12004, 15KG12221, 15KG16615, 15KG20449, 15KH00067,
15KH00709, 15KJ03201, 15KJ04293, 15KJ05512, and 20KK02437
(c) 20KK05079
(d) 15F71095, 15F73626, 15F75710, 15F84931, 15F88768,
15F93786, 15F95293, 15G10396, 15G16724, 15G22865, 15G28492,
15G32171, 15G32960, 15G40901, 15G52103, 15G54517, 15G60302,
15G65615, 15G66254, 15H42035, 15J31850, 15J32704, 15J33393,
15J36281, 15J37805, 15J39150, 15J39890, 15J42416, 15J43065,
15J43753, 15J44455, 15J45194, 15J45738, 15J46400, 15J47454,
15J48051, 15J48702, 15J51346, 15J52022, 15J53205, 15J53894,
15J54473, 15J55148, 15J55842, 15J56415, 15K15839, 15K20249,
15K20369, 15K23303, 15K24380, 15KJ03201, and 20KK02437
(e) 15P01055
(f) 15KG03974 and 15KH00709
-2- (g) 15J33393, 15F84931, 15G23767, 15K21297, 15K23907, and
15KG08635
(h) 15J45738, 15G18224, 15G27849, 15G41369, and 15F75710
(i) 15J44455, 15KJ05512, 15G06425, 15G28492, 15F88768,
15F89523, 15G60302, and 15F95293
(j) 15F71095, 15F73626, 15F84931, 15F93786, 15G03814,
15G07303, 15G10396, 15G11396, 15G15879, 15G16724, 15G20752,
15G22865, 15G23767, 15G24318, 15G28205, 15G30495, 15G32171,
15G32960, 15G37634, 15G39305, 15G40901, 15G42233, 15G43520,
15G46111, 15G46601, 15G48196, 15G52103, 15G54517, 15G60046,
15G63757, 15G65615, 15G66254, 15H42035, 15J31077, 15J31850,
15J32704, 15J33393, 15J34037, 15J35587, 15J36281, 15J37805,
15J38572, 15J39150, 15J39890, 15J40989, 15J41791, 15J42416,
15J43065, 15J43753, 15J45194, 15J46400, 15J47021, 15J47454,
15J48051, 15J48702, 15J51346, 15J52022, 15J52630, 15J53205,
15J53894, 15J54473, 15J55148, 15J55842, 15J56415, 15K15839,
15K20249, 15K20369, 15K21297, 15K23303, 15K23907, 15K24380,
15KG03974, 15KG08635, 15KG12004, 15KG12221, 15KG16615,
15KG20449, 15KH00067, 15KH00709, 15KJ03201, 15KJ04293,
20KK02437, and 20KK05079.
MANUFACTURER The American National Red Cross, Boise, Idaho.
RECALLED BY Manufacturer, by letters issued in March 1994, June 1, 1994,
and August 1994. Firm-initiated recall ongoing.
DISTRIBUTION Montana, New Jersey, Florida, Michigan, California, New
York, The Netherlands.
QUANTITY (a) 4 units; (b) 92 units; (c) 1 unit; (d) 52 units; (e) 1
unit; (f) 2 units; (g) 6 units; (h) 5 units; (i) 8 units;
(j) 83 units.
REASON Blood products that either: tested repeatedly reactive for
the antibody to human immunodeficiency virus type 1 (anti-
HIV-1); tested negative for the anti-HIV-1 but were
collected from donors who previously tested initially or
repeatedly reactive for anti-HIV-1; or were not tested for
anti-HIV-1, were distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Red Blood Cells,
Leukocytes Removed; (d) Platelets; (e) Platelets, Pooled;
(f) Cryoprecipitated AHF; (g) Fresh Frozen Plasma; (h) Red
Blood Cells for Further Manufacture; (i) Recovered Plasma;
(j) Recovered Plasma, Pooled. Recall #B-076/085-5.
CODE 552 unit numbers. Contact FDA, Center for Biologics
Evaluation and Research, Recalls and Administrative Actions
Branch (301) 827-6220* for individual unit numbers recalled.
MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa.
RECALLED BY Manufacturer, by letters of August 15 and 18, 1994, and
September 19, 1994. Firm-initiated recall ongoing.
DISTRIBUTION California, Illinois, Iowa, Louisiana, Michigan, Minnesota,
New York, Pennsylvania, Texas.
QUANTITY (a) 5 units; (b) 196 units; (c) 2 units; (d) 48 units; (e)
51 pools; (f) 1 unit; (g) 21 units; (h) 6 units; (i) 174
units; (j) 48 pools.
-3- REASON Blood products, incorrectly tested for either anti-HIV-1/2;
HBsAg or anti-HTLV-I, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF; (d) Recovered Plasma. Recall #B-056/059-5.
CODE Unit numbers: (a) 15F71092, 15F71093, 15F71094, 15F73624,
15F73625, 15F73627, 15F73628, 15G08035, 15G15310, 15G18000,
15K21336, 15L06657
(b) 15F71092, 15F71093, 15F71094, 15F73624, 15F73625,
15F73627, 15F73628, 15G15310
(c) 15K21336
(d) 15F71092, 15F71093, 15F71094, 15F73624, 15F73625,
15F73627, 15F73628, 15G08035, 15G15310, 15G18000, 15K21336,
15L06657.
MANUFACTURER The American National Red Cross, Boise, Idaho.
RECALLED BY Manufacturer, by letters issued March 1994, June 1, 1994,
and August 1994. Firm-initiated recall ongoing.
DISTRIBUTION Montana, New Jersey, Florida, Michigan, California, New
York, The Netherlands.
QUANTITY (a) 12 units; (b) 8 units; (c) 1 unit; (d) 12 units.
REASON Blood products were not tested for anti-HIV-1, were
distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Red Blood Cells,
Leukocytes Removed; (d) Red Blood Cells, Washed; (e) Red
Blood Cells, Deglycerolized; (f) Platelets; (g) Platelets,
Pheresis; (h) Platelets, Pooled; (i) Cryoprecipitated AHF;
(j) Fresh Frozen Plasma; (k) Red Blood Cells for Further
Manufacture; (l) Recovered Plasma; (m) Recovered Plasma,
Pooled. Recall #B-086/098-5.
CODE 2006 unit numbers. Contact FDA, Center for Biologics
Evaluation and Research Recalls and Administrative Actions
Branch (301) 827-6220* for individual unit numbers recalled.
MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa.
RECALLED BY Manufacturer, by letter September 19, 1994. Firm-initiated
recall complete.
DISTRIBUTION California, Illinois, Iowa, Louisiana, Michigan, Minnesota,
New York, Pennsylvania, Texas.
QUANTITY (a) 5 units; (b) 823 units; (c) 4 units; (d) 1 unit; (e) 5
units; (f) 181 units; (g) 5 units; (h) 50 pools; (i) 39
units; (j) 93 units; (k) 15 units; (l) 739 units; (m) 46
pools.
-4- REASON Blood products, incorrectly tested for either anti-HIV-1/2;
HBsAg; or anti-HTLV-I, were distributed for transfusion or
further manufacture into injectable products.
RECALLS AND FIELD CORRECTION: DEVICES -- CLASS II
========================
_______________
PRODUCT Gonogen Test Kit, used for the confirmatory identification
of Neisseria gonorrheae. Recall #Z-010-5.
CODE Lot #126.
MANUFACTURER New Horizons Diagnostics Corporation, Columbia, Maryland.
RECALLED BY Manufacturer, by telephone on or about April 1992. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON The kit's sensitivity was decreasing because the strong
binding monoclonal of the antibody pool was losing
stability.
_______________
PRODUCT Coltolux curing light dental devices designed for intra-oral
polymerization of all visible light cured restorative dental
materials: (a) Coltolux 3, Catalog numbers: C7910, C7911,
C7913; (b) Coltolux 4, Catalog numbers: C7915, C7916,
C7918. Recall #Z-098/099-5.
CODE All serial numbers ending in the 4 digit range of 0001 to
2399.
MANUFACTURER Coltene/Whaledent, Inc., Mahwah, New Jersey.
RECALLED BY Manufacturer, by technical bulletin letters dated April
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 2,399 units were distributed; firm estimates none remains on
the market.
REASON Some of the filters used in the curing lights were
defective.
_______________
PRODUCT Safetex Super Sensitive Lubricated Condoms, Product #908.
Recall #Z-104-5.
CODE All lots manufactured and introduced into interstate
commerce from 1/21/94 to 9/28/94 at Safetex, Division of
Aladan, Colonial Heights, Virginia, or Eufaula, Alabama.
MANUFACTURER Safetex, Division of Aladan Corporation,
Eufaula, Alabama.
RECALLED BY Safetex, Division of Aladan Corporation, Colonial Heights,
Virginia, by telephone, and by fax October 14, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION New York, Illinois, New Jersey, North Carolina, Arizona,
California, Ohio, Wisconsin, Texas, Missouri, Nebraska.
QUANTITY 7,232 gross were distributed; firm estimated that 1,000
gross remained on market at time of recall.
-5- REASON The subject lots failed to meet the airburst test
specification of Aladan's original customer, USAID. They
were subsequently shipped to Safetex where they were packed
and distributed to other customers. Water leak testing of
four of the suspect lots revealed that three lots exceeded
the 0.4 AQL adulteration level.
_______________
PRODUCT McGaw Protected Needle, (Needleless Needle), a sheathed and
recessed safety needle used for accessing I.V. lines during
I.V. therapy, sold individually or in sets:
(a) Catalog #N2319, Protected Needle 19 gauge;
(b) Catalog #V1921-19, Protected Needle 19 gauge packaged
with I.V. administration set;
(c) Catalog #V1922-19, Protected Needle 19 gauge packaged
with a vented I.V. administration set;
(d) Catalog #V6312-22, Protected Needle 22 gauge packaged
with microbore extension set. Recall #Z-113/116-5.
CODE Lot numbers: (a) F4H166, FHJ155, F45156; (b) F4H232,
F4H233, F4J037, F4J038, F4J203; (c) F4J039; (d) F4E165,
F4E276, F4E373, F4H043, F4H372.
MANUFACTURER McGaw of Puerto Rico, Sabana Grande, Puerto Rico.
Inland Technologies, Inc., Fontana, California (plastic
shield).
RECALLED BY McGaw, Inc., Irvine, California, by letter September 2,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 214,100 units were distributed; firm estimated that 20% of
the distributed units remained on the market at the time the
recall was initiated.
REASON The needle sheaths were manufactured with a defective
plastic shield which may break during use and cause I.V.
fluid leakage.
_______________
PRODUCT Apnea Monitors, multiple models with unprotected (exposed
pin style) lead wires and unprotected patient cables.
Recall #Z-117-5.
CODE None.
MANUFACTURER Air-Shields Vickers Medical, Hatboro, Pennsylvania.
RECALLED BY Manufacturer, by letter January 17, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON Product labeling fails to provide adequate directions for
use and the devices pose an unwarranted risk of injury to
patients, because the product is not labeled to warn against
the hazards of unprotected electrode lead wires being
connected to electrical power sources.
-6- _______________
PRODUCT Electrode Lead Wires, multiple models, used with
electroencephalograph, electromyograph and electrophysiology
monitors, and other similar devices. Recall #Z-118-5.
CODE All models with unprotected exposed metal pins, marketed in
the past 3 years.
MANUFACTURER Staodyn, Inc., Longmont, Colorado.
RECALLED BY Manufacturer, by letters August 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON Product labeling fails to provide adequate directions for
use and the devices pose an unwarranted risk of injury to
patients, because the products are not labeled to
contraindicate use with apnea monitors.
_______________
PRODUCT 5/0 Blue TI.Cron with Teflon Pledget, polyester
nonabsorbable surgical suture, Catalog #3297-71.
Recall #Z-123-5.
CODE Lot numbers: 927726 EXP 7/99, 923251 EXP 6/99, 926563 EXP
6/99, 924586 EXP 6/99.
MANUFACTURER Davis & Geck, Inc., Manati, Puerto Rico.
RECALLED BY Davis & Geck, Division of American Cyanamid Company,
Danbury, Connecticut, by letter September 6, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Finland, Israel, France, Austria, Poland, Italy
United Kingdom.
QUANTITY 5,724 units were distributed.
REASON The teflon pledge attachment strength may be affected due to
incorrect radiation sterilization processing.
_______________
PRODUCT Triad DuaLine Dual-Cure Reline Material used for the
relining of dentures usually after gums have receded in the
following products:
(a) DuaLine Introductory Kit (Catalog No. 89825);
(b) DuaLine Refill Kit (Catalog No. 89820);
(c) Triad VLC Material Sample Kit (Catalog No. 90130).
Recall #Z-124/126-5.
CODE Lot numbers: (a) 940119, 940120A-D; 940203A,B; 940204A;
940511A; 940405A,B; 940503A,B; 940505A,B; 940517A.
(b) 931217b; 931220A; 931221A; 940105A; 940110A;
940120A,B; 940221A; 940307A; 940331A,B; 940401A,B;
940401C; 940404A.
(c) 940111A; 940211A,B; 940302A-E; 940303A-I;
940317A,B; 940318A,B; 940321A; 940322A; 940323A-E;
940330A-C; 940331A-B; 940428A; 940429A-C;
940520A-D.
MANUFACTURER Dentsply Trubyte Division (formerly York Division), York,
Pennsylvania.
-7- RECALLED BY Dentsply International, Inc., York, Pennsylvania, by letter
July 6, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,707 kits were distributed.
REASON Some of the denture reline material was not curing properly.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Stratus Ultra-Sensitive Human Thyroid Stimulating Hormone
(hTSH) Fluorometric Enzyme Immunoassay, an automated
procedure for the quantitative determination of hTSH in
serum and plasma samples. Recall #Z-088-5.
CODE Catalog #B5700-44, Lot # KXTS-516M.
MANUFACTURER Baxter Diagnostic of Puerto Rico, Inc., Aguada, Puerto Rico.
RECALLED BY Baxter Diagnostic, Inc., Miami, Florida, by letter August
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 491 kits were distributed.
REASON An incorrect checksum was calculated by using the wrong
expiration date in the original calculation provided to the
customers in the product label.
_______________
PRODUCT Dade brand TDM (Therapeutic Drug Monitoring) Control, Level
I-Low, Level II-Intermediate and Level III-High:
(a) Catalog #B5700-1; (b) Catalog # B5700-2; (c) Catalog
#B5700-3; (d) Catalog #B5700-4; (e) Catalog #B5700-S.
Recall #Z-093/097-5.
CODE Lot numbers: (a) TDMK-24; (b) TDM1-124; (c) TDM2-224;
(d) TDM3-324; (e) TDMK-24. All reagent expire 8/28/96.
MANUFACTURER Baxter Diagnostics, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter July 20, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 20,907 units were distributed.
REASON There has been a change in the published expected range of
the mean for the TDM control.
___________
PRODUCT Captia Rubella-G, enzyme immunoassay for the detection of
IgG antibodies to Rubella Virus in human serum, under the
following labels: (a) Centocor; (b) Syva; (c) Fresenius;
(d) Dako. Recall #Z-119/122-5.
CODE Lot numbers: (a) 4161053, 4164053, 4165053, 35K0054; (b)
4162053, 35K0054; (c) 4163053, 35K0054; (d) 35K0054.
MANUFACTURER Centocor, Inc., Malvern, Pennsylvania.
RECALLED BY Manufacturer, by letter dated May 20, 1994. Firm-initiated
recall complete.
DISTRIBUTION California, Massachusetts, international.
-8- QUANTITY The firm estimated that 300 kits of lot 35K0054 remained on
market at time of recall. The other lots have passed their
expiration date and therefore should not be in the
commercial channel.
REASON The high and low titer positive controls supplied with the
device tested positive to antibodies to Hepatitis C.
_______________
PRODUCT Frozen Shrimp (94-595-108/9).
CHARGE Adulterated - The articles consist in part of a filthy
substance by reason of the presence therein of insects,
rodent hair, and cat or dog hair.
LOCATION Northwestern Meat, Inc., Miami, Florida.
FILED September 21, 1994; U.S. District Court for the Southern
District of Florida; Civil #94-1970-CIV-MOORE; FDC #66961.
SEIZED October 16, 1994 - goods valued at approximately $18,045.
_______________
PRODUCT Acu-Stop 2000 (plastic ear piece that is promoted for weight
loss) (94-682-497).
CHARGES Adulterated - The article is a class III device for which no
approved premarket approval application is in effect.
Misbranded - The article was manufactured in an establish-
ment not duly registered as required, and the article was
not included in a required list.
LOCATION Original Marketing, Inc., Coral Springs, Florida.
FILED October 21, 1994; U.S. District Court for the Southern
District of Florida; Civil #94 7021 CIV-RYSKAMP; FDC #66976.
SEIZED November 1, 1994 - goods valued at approximately $568,431.
-9-
END OF ENFORCEMENT REPORT FOR NOVEMBER 30, 1994. BLANK PAGES MAY
FOLLOW.
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*Telephone number changed April 16, 1999
(Hypertext updated by jch 1999-APR-29)