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
02/26/1991
FDA Enforcement for the week of February 27, 1991
FDA ENFORCEMENT REPORT
FOUARY 27, 1991
February 27, 1991
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.
Product: Vineland Syrup brand beverage syrups:
(a) Lemonade Flavor, in 1 gallon and 5 gallon containers;
(b) Orange Flavor, in 1 gallon and 5 gallon containers.
Recall #F-200/201-1.
Code: Not coded.
Manufacturer: Vineland Syrup, Inc., Vineland, New Jersey
Recalled by: Manufacturer, by relabeling products on April 25, 1990.
Firm-initiated field correction ongoing.
-1-
Distribution: New Jersey, Pennsylvania, Delaware, Maryland.
Quantity: (a) 500 five gallon containers and 500 cases
(6 gallons/case); (b) 500 five gallon containers and
100 cases (6 gallons/case) were distributed.
Reason: Products contain undeclared FD&C Yellow No. 5.
----
Product: All packaged circle U kosher-designated shortening in
50 lb. cubes and 380 lb. drums, used in the manufacture of
various bakery products, cake mixes, frostings, etc:
(a) MOA-07234 Cookie Shortening; partially hydrogenated
soybean and cottonseed oils; spec # 11439, product code
11439 (50 lb); Anderson Clayton/Humko Products, Inc.,
Memphis, TN 38101
(b) Pillsbury 18821 Shortening; partially hydrogenated
soybean and cottonseed oils with mono- and diglycerides;
spec #666, product code 84206 (50 lb.) and 86192 (380 lb.)
Anderson Clayton/Humko Products, Inc., Memphis, TN 38101
(c) Pillsbury 18826 Shortening; partially hydrogenated
soybean oil, propylene glycol, mono- and diesters of fats,
mono- and diglycerides and lecithin; spec # 1179, product
code 82091 (380 lb.); Anderson Clayton/Humko Products,
Inc., Memphis, TN 38101
(d) Pillsbury 18897 Shortening; partially hydrogenated
soybean and cottonseed oils, BHA and citric acid added to
preserve freshness; spec #635, product code 11440
(50 lb.); Anderson Clayton/Humko Products, Inc., Memphis,
TN 38101
(e) Pillsbury 18931 Shortening; vegetable oil blend, mono-
and diglycerides, propylene glycol, mono- and diesters of
fats, polysorbate 60 not to exceed 1%, lecithin, BHA, BHT,
and citric acid added to help protect flavor; spec #1086,
product code #10937 (380 lb.); Anderson Clayton/Humko
Products, Inc., Memphis, TN 38101
(f) Pillsbury 18935 Shortening; partially hydrogenated
soybean and cottonseed oils with artificial color; spec
#983, product code 11616 (50 lb.); Anderson Clayton/Humko
Products, Inc., Memphis, TN 38101
(g) GMI Margarine Oil #6; partially hydrogenated soybean
and cottonseed oils with mono- and diglycerides added,
TBHQ and citric acid added to help preserve flavor,
vitamin A palmitate added; spec #1169, product code 82095
(50 lb.); Anderson Clayton/Humko Products, Inc., Memphis,
TN 38101
(h) GMI Margarine Oil #7, code 3-343; partially
hydrogenated soybean and cottonseed oils with mono- and
diglycerides added, TBHQ and citric acid added to help
preserve flavor, vitamin A palmitate added; spec #1352,
product code 11584 (50 lb.); Anderson Clayton/Humko
Products, Inc., Memphis, TN 38101
(i) GMI Margarine Oil #24, code 3-019; partially
hydrogenated soybean and cottonseed oils, mono- and
diglycerides, BHA and BHT added to help protect flavor,
-2-
vitamin A palmitate and vitamin D3 added; spec #1170,
product code 82121 (50 lb.); Anderson Clayton/Humko
Products, Inc., Memphis, TN 38101
(j) GMI #56V Shortening, code 3-926; partially
hydrogenated soybean and cottonseed oils, propylene
glycol mono- and diesters of fats, mono- and
diglycerides; spec #655, product code 81013 (50 lb.);
Anderson Clayton/Humko Products, Inc., Memphis, TN 38101
(k) PS 12 Shortening; partially hydrogenated soybean oil;
spec #636, product code 11051 (50 lb.); Anderson Clayton/
Humko Products, Inc., Memphis, TN 38101
(l) PS 99 Icing Shortening; partially hydrogenated soybean
and palm oils with monoglycerides and diglycerides,
polysorbate 60 not to exceed 1%, and lecithin added;
spec #648, product code 84216 (50 lb.); Anderson
Clayton/Humko Products, Inc., Memphis, TN 38101
(m) PS 905 Icing Shortening; partially hydrogenated
soybean and palm oils with monoglycerides and
diglycerides, polysorbate 60 not to exceed 1%, lecithin,
TBHQ and citric acid; spec #838, product code 85594
(50 lb.); Anderson Clayton/Humko Products, Inc., Memphis,
TN 38101
(n) Chiffon Pure Vegetable Icing Shortening; partially
hydrogenated soybean and cottonseed oils with
monoglycerides and diglycerides, polysorbate 60 not to
exceed 1%, and lecithin added; spec #642, product codes
81488 and 11403 (50 lb.); Anderson Clayton/Humko
Products, Inc., Memphis, TN 38101
(o) Hazelwood Farms Vegetable Icing Shortening; partially
hydrogenated soybean and cottonseed oils with
monoglycerides and diglycerides, polysorbate 60 not to
exceed 1% and lecithin added; product code 81735
(50 lb.); Distributed by Hazelwood Farms Bakeries, Inc.,
Hazelwood, MO
(p) Karp's All Purpose Shortening; partially hydrogenated
soybean and cottonseed oils; spec #821, product code 84010
(50 lb.); Distributed by Karp's Bakers Supplies,
Minneapolis, MN 55344
(q) Vegetable Shortening with Lecithin #0073; partially
hydrogenated soybean oil with lecithin; spec # 1413,
product code 11903 (50 lb.) and spec #1274, product code
10952 (50 lb.); Anderson Clayton/Humko Products, Inc.,
Memphis, TN 38101;
(r) Partially hydrogenated soybean oil with TBHQ, citric
acid and dimethylpolysiloxane added; spec #632
i) product code #81556 (50 lb.); Kerba Pure Vegetable
Frying Shortening; Anderson Clayton/Humko Products, Inc.,
Dist., Memphis, TN 38101;
ii) product code #83280 (50 lb.); Chiffon Heavy Duty Pure
Vegetable Frying Shortening; Anderson Clayton/Humko
Products, Inc., Dist., Memphis, TN 38101;
iii) product code #82650 (50 lb.); Karp's Vegetable
Frying Shortening; Dist. by Karp's Bakers Supplies,
Milwaukee, WI 53204;
-3-
(s) Partially Hydrogenated soybean and cottonseed oils;
spec #821,
i) product code #11528 (50 lb.); Unifax All Purpose
Vegetable Shortening; Unifax, Inc., Wilkes-Barre, PA 18702;
ii) product code #81986 (50 lb.); Red & White All Purpose
Shortening; Dist. by Red & White International, Park
Ridge, IL 60068;
iii) product code #81984 (50 lb.); Pocahontas Vegetable All
Purpose Shortening; Dist. by Pocahontas Food Brokers,
Richmond, VA 23228;
iv) product code #11406 (50 lb.); PS 857 Shortening;
Anderson Clayton/Humko Products, Inc. Dist., Memphis TN;
v) product code #81705 (50 lb.); Hazlewood Farms Vegetable
all Purpose Shortening; Dist. by Hazlewood Farms Bakeries,
Inc., Hazlewood, MO 63042. Recall #F-202/218-1, F-226/227-1.
Code: All kosher-designated shortening produced between
November 18, 1990 and January 7, 1991. Lot numbers 322JOH
through 365JOH, and 001J1H through 007J1H.
Manufacturer: Kraft Food Ingredients Corp. Jacksonville, Illinois.
Recalled by: Kraft food Ingredients Corporation, formerly known as
Anderson Clayton/Humko Products, Inc., Memphis, Tennessee, by
telephone January 9-10, 1991 followed by letter January
14, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 2,651,610 pounds were distributed; firm estimates 20
percent remains on the market.
Reason: Products are contaminated with metal particles.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Single Serving Size Ketchup under Dixie Crystals, NIFDA,
Vend Rite, Hermitage, Ketchup La Touraine labels.
Recall #F-156-1.
Code: The individual serving size pouches are not coded.
Each case contains an imprint of a code number and
packaging date on the tape used to seal the case:
9/10/90 11365; 9/10/90 11390; 9/10/90 11392;
9/11/90 11350; 9/11/90 11351; 9/11/90 11390;
9/11/90 11355; 9/11/90 11392; 9/12/90 11342;
9/12/90 11355; 9/12/90 11360; 9/12/90 11362;
9/12/90 11392; 9/13/90 11342; 9/13/90 11344;
9/13/90 11357; 9/13/90 11392; 9/14/90 11342;
9/15/90 11356; 9/15/90 11355; 9/14/90 11355;
9/14/90 11357; 9/17/90 11341; 9/17/90 11342;
9/17/90 11354; 9/17/90 11357; 9/17/90 11364;
9/17/90 11365; 9/18/90 11340; 9/18/90 11341;
9/18/90 11342; 9/18/90 11350, 9/18/90 11354;
9/18/90 11392; 9/19/90 11344; 9/19/90 11345;
9/19/90 11355; 9/19/90 11362; 9/19/90 11392;
9/20/90 11340; 9/20/90 11344; 9/20/90 11345;
-4-
9/20/90 11355; 9/20/90 11362; 9/20/90 11364;
9/21/90 11345; 9/21/90 11355; 9/21/90 11362.
Manufacturer: Savannah Foodservice of Florida Inc., Miami, Florida.
Recalled by: Savannah Foods & Industries, Inc., Savannah, Georgia, by
telephone October 25, 1990. Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: 22,757 cases were distributed.
Reason: Product is contaminated with mold.
----
Product: Hinckley & Schmitt brand bottled water in 1 gallon
plastic jugs:
(a) Drinking Water; (b) Distilled Water; (c) Nursery
Water. Recall #F-193/195-1.
Code: Lot numbers: 32390, 32490, 32590.
Manufacturer: Hinckley & Schmitt, Inc., Chicago, Illinois.
Recalled by: Manufacturer, by letter December 4, 1990. Firm-initiated
recall ongoing.
Distribution: Illinois, Wisconsin.
Reason: Product is contaminated with styrene.
----
Product: Franco's brand Frozen Conch Meat, in 5 pound boxes.
Recall #F-219-1.
Code: Not coded.
Manufacturer: B & D Fishing, Ltd., Kingston, Jamaica, W.I.
Recalled by: E & M Seafood Distributors, Inc., Miami, Florida, by
telephone November 15, 1990. Firm-initiated recall
ongoing.
Distribution: Florida, Puerto Rico, Canada.
Quantity: 1,754 fifty pound cases were distributed.
Reason: Product is decomposed.
----
Product: (a) Western Family Reduced Calorie Lite Syrup Product,
in 24 fluid ounce bottles;
(b) Fred Meyer Lite Syrup Product, in 24 fluid ounce
bottles. Recall #F-220/221-1.
Code: All lots.
Manufacturer: Hoody Corporation, Beaverton, Oregon.
Recalled by: Manufacturer, by telephone December 12, 1990 followed
by letter December 13, 1990. Firm-initiated recall
ongoing.
Distribution: Oregon, Washington state, Arizona, Hawaii, Montana, Utah.
Quantity: 3,800 cases (12 bottles/case) were distributed.
Reason: Product is contaminated with yeast.
----
-5-
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
Product: Indocin Ophthalmic Solution, 1%, an Rx product.
Recall #D-190-1.
Code: Not coded.
Manufacturer: Hieber's Drug Store, Pittsburgh, Pennsylvania.
Recalled by: Manufacturer, by telephone November 2, 1990 followed by
letter. Firm-initiated recall complete.
Distribution: Pennsylvania, Ohio, West Virginia.
Quantity: Approximately 1,300 bottles were distributed.
Reason: Bacterial contamination with Pseudomonas aeruginosa.
----
Class II -
Product: Methylprednisolone Tablets, USP 4 mg, in 100 and 500 tablet
bottles, an Rx product used for treating endocrine and
rheumatic disorders, under Aligen, Best, Bioline, Dixon,
Duramed, Genetco, Geneva, Glenlawn, Goldline, Harber,
Major, MedServ, Moore, Par-Med, Qualitest, Rugby, Schein,
and URL labels. Recall #D-179-1.
Code: Lot numbers 80152 to 92535 EXP 1/91-9/93.
Manufacturer: Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: Manufacturer, by letter January 4 and 14, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 73 lots (approximately 69,350,000 tablets) were
distributed.
Reason: The drug was not manufactured in accordance with the
approved Abbreviated New Drug Application specifications.
----
Product: Hydroxyzine Pamoate Capsules, USP, 25, 50 and 100 mg,
in 100, 500 and 1,000 capsule bottles, an Rx product
used to relieve anxiety and tension, under
Aligen, Best, Bioline, Duramed, Genetco, Goldline,
Major, Moore, Par-Med, Qualitest, Rugby, Schein, and
URL labels. Recall #D-180/182-1.
Code: All lots.
Manufacturer: Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: Manufacturer, by letter January 8 and 14, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 169 lots containing approximately 950,000 capsules
per lot were distributed.
-6-
Reason: The product was not manufactured in accordance with
approved Abbreviated New Drug Application specifications.
----
Product: Clonidine Hydrochloride Tablets, USP, 0.1 mg, 0.2 mg,
0.3 mg, in bottles of 100, 500 and 1,000 tablets, an
Rx product used for treating hypertension, under the Best,
Bioline, Duramed, Genetco, Glenlawn, Goldline, Mason,
Parmed, Qualitest, Rugby, and URL labels.
Recall #D-183/185-1.
Code: All lots.
Manufacturer: Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: Manufacturer, by letter January 8 and 14, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 109 lots were distributed.
Reason: The product was not manufactured in accordance with
approved Abbreviated New Drug Application specifications.
----
Product: Trifluoperazine Hydrochloride Tablets, USP,
(a) 1 mg; (b) 2 mg; (c) 5 mg; (d) 10 mg, in 100, 500 and
1,000 tablet bottles, an Rx product used to treat
psychotic disorders, under Aligen, Best, Bioline, Dixon's,
Duramed, Genetco, Goldline, Harber, Major, Moore, Par-Med,
Purepac, Qualitest, Rugby, Schein, URL.
Recall #D-186/189-1.
Code: All lots.
Manufacturer: Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: Manufacturer, by letter January 14, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 37 lots containing approximately 950,000 tablets were
distributed.
Reason: The product was not manufactured in accordance with
approved Abbreviated New Drug Application specification.
----
Product: Lederle brand Albuterol Sulfate Tablets, 4 mg, in
bottles of 100, an Rx bronchodilator. Recall #D-191-1.
Code: Lot #280-227 EXP 2/92.
Manufacturer: Lederle Laboratories, Pearle River, New York.
Recalled by: Manufacturer, by letter January 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 9,694 bottles were distributed.
Reason: Product failed USP dissolution specifications.
----
-7-
Product: Trifluoperazine HC1 Tablets: (a) 2 mg; (b) 5 mg;
(c) 10 mg, in unit dose blister packages of 100 (10 strips
of 10 tablets each), an Rx product used for the management
of the manifestations of psychotic disorders.
Recall #D-192/194-1.
Code: Lot numbers: (a) OJ637 EXP 1/92; (b) OI606 EXP 6/92,
OP063 EXP 4/92; (c) OH521 EXP 5/92, and OJ695 EXP 7/92.
Manufacturer: Duramed Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: UDL Laboratories, Inc., Rockford, Illinois (repacker), by
letter January 23, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 14,930 unit cartons were distributed; firm estimates 40%
of the product remains on the market.
Reason: The product was not manufactured in accordance with
approved Abbreviated New Drug Application specifications.
----
Product: Docusate Sodium Solution, 100 mg, 10 ml unit dose cups,
10 cups per tray, an OTC stool softener. Recall #D-195-1.
Code: Lot number 003006 EXP 3/92.
Manufacturer: UDL Laboratories, Inc., Largo, Florida.
Recalled by: UDL Laboratories, Inc., Rockford, Illinois, by letter
January 22, 1991. Firm-initiated field correction ongoing.
Distribution: Nationwide.
Quantity: 4,022 cases were distributed; firm estimates 30% of the
product remains on the market.
Reason: Some of the trays labeled as Docusate Sodium Solution,
contained some unit dose cups labeled as Guaifenesin DM
Syrup mixed with the Docusate Sodium Solution unit dose
cups.
----
Product: GHB (Gamma Hydroxy Butyrate) Granules, 60 gm and 100 gm
bottles, an OTC product promoted as a growth hormone
stimulant which worked during sleep, under the Biosky
Research Group and Advanced Performance labels.
Recall #D-198-1.
Code: All lots.
Manufacturer: Champion Distributors, Horsham, Pennsylvania.
Recalled by: Manufacturer, by visit and by telephone January 29, 1991
followed by letter. Firm-initiated recall complete.
Distribution: Pennsylvania, Delaware, New Jersey.
Quantity: 253 bottles were distributed.
Reason: Product marketed without new drug approval. See also
FDA press release P90-53, November 8, 1990.
----
Product: Tru-Tar Therapeutic Protein Shampoo, in 8 ounce bottles,
an OTC product used to treat dandruff and psoriasis.
Recall #D-199-1.
Code: Lot #G-266 EXP 9/93.
-8-
Manufacturer: Syosset Laboratories Company, Inc., Syosset, New York.
Recalled by: Manufacturer, by telephone October 18, 1990 and by letter
October 24, 1990. Firm-initiated recall ongoing.
Distribution: Alabama, Arizona, California, Georgia, Illinois, Michigan,
New Jersey, New York, Ohio, Pennsylvania, Texas.
Quantity: 3,862 bottles were distributed; firm estimates less than
750 bottles remain on the market.
Reason: Product is contaminated with Pseudomonas aeruginosa.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered
Plasma. Recall #B-114/116-1.
Code: Unit numbers: (a) 17F03849; (b) 17P77181; (c) 17F03849.
Manufacturer: American Red Cross, St. Paul, Minnesota.
Recalled by: Manufacturer, by telephone January 8, 1990.
Firm-initiated recall complete.
Distribution: (a) Wisconsin; (b&c) Minnesota.
Quantity: 1 unit of each component.
Reason: Blood products collected from donors who engaged in
high risk behavior were distributed.
----
Product: (a) Red Blood Cells; (b) Platelets;
(c) Cryoprecipitated AHF; (d) Recovered Plasma.
Recall #B-117/120-1.
Code: Unit numbers: (a) 04F43781, 04G26669, 04G28860, 04G30611,
04M85796, 04Y70893, 04Y83085, 04LE03380, 04LE04663,
04LE10711, 04LE16431; (b) 04F43781, 04Y70893;
(c) 04G30611; (d) 04F43781, 04G26669, 04G28860, 04G30611,
04M85796, 04Y70893, 04Y83085, 04LE03380, 04LE04663,
04LE10711, 04LEl6431.
Manufacturer: American Red Cross, Dedham, Massachusetts.
Recalled by: Manufacturer, by telephone October 18, 1990 followed by
letter November 1, 1990. Firm-initiated recall ongoing.
Distribution: Maine, Massachusetts, California, Switzerland.
Quantity: (a) 11 units; (b) 2 units; (c) 1 unit; (d) 11 units.
Reason: Blood products which were non-reactive for anti-HIV-1,
but collected from a donor who previously tested
repeatably reactive for anti-HIV-1, were distributed.
----
Class III -
Product: Clorazepate Dipotassium Tablets:
(a) 3.75 mg; (b) 7.5 mg; (c) 15 mg, under the following
labels: American Therapeutics, Best Generics,
Bioline, Dixon Shane, H.L. Moore Drug Exchange, Qualitest
Schein, Goldline, Harber, Major, Martec, Parmed
Rugby. Recall #D-176/178-1.
Code: Lot No. EXP. DATE
(a) 010027 1/92
910313 10/91
-9-
907208 7/91
906195 6/91
901012 1/91
811318 11/90
810273 10/90
(b) 912406 12/91
908270 8/91
908269 8/91
907214 7/91
906191 6/91
904086 4/91
901022 1/91
901020 1/91
812373 12/90
811330 11/90
(c) 010017 1/92
910314 10/91
906192 6/91
901021 1/91
812350 12/90
Manufacturer: American Therapeutics, Inc., Bohemia, New York.
Recalled by: Manufacturer, by letter on or about October 22, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide and Puerto Rico.
Quantity: Lot number Bottles shipped
100's 500's 1000's
(a) 010027 3,864 3,021 54
910313 11,424 1,611 24
907208 6,588 2,551 48
906195 8,520 2,076 82
901012 7,853 2,148 97
811318 8,616 2,240 0
810273 10,581 1,860 0
(b) 912406 7,111 2,280 108
908270 7,197 2,456 0
908269 10,109 1,728 96
907214 5,069 2,879 24
906191 10,656 1,729 48
904086 4,250 3,048 18
901022 8,020 2,316 0
901020 2,856 3,336 0
812373 7,444 2,485 0
811330 9,689 2,016 0
(c) 010017 144 1,906 0
910314 4,104 144 498
906192 6,486 360 160
901021 2,592 1,462 0
812350 8,256 239 0
Reason: The product is exhibiting crumbling.
----
-10-
Product: Conjugated Estrogens Tablets, (a) 0.3 mg in bottles
of 100, under the Zenith, Major and URL labels;
(b) 2.5 mg. in bottles of 100 and 1,000, under the
Zenith and Major labels, an Rx product used for the
treatment of symptoms of menopause, postmenopausal
osteoporosis and breast swelling after pregnancy.
Recall #D-196/197-1.
Code: Lot numbers: (a) 3636-26 EXP 3/91; (b) 2160-46 EXP 3/91.
Manufacturer: Zenith Laboratories, Inc., Northvale, New Jersey.
Recalled by: Manufacturer, by telephone January 15, 1991 followed
by letter January 17, 1991. Firm-initiated recall
ongoing.
Distribution: Nationwide.
Quantity: (a) 9,365 bottles of 100; (b) 921,100 tablets were
distributed.
Reason: Products do not meet content uniformity specifications.
----
Product: Bulk Ibuprofen, in 70 kg drums, an Rx. Recall #D-200-1.
Code: All lots between LPL 1198 and LPL 1223 inclusive.
Manufacturer: Ethyl Corporation, Oreangeburg, South Carolina.
Recalled by: Ethyl Corporation, Baton Rouge, Louisiana, by telephone
September 14 and 27, 1990 and October 3, 1990.
Firm-initiated recall ongoing.
Distribution: Michigan, New York, New Jersey, Puerto Rico, Belgium.
Quantity: 112,471 kg were distributed; firm estimates 80,000 kg
remain on the market.
Reason: The product was found to have metal/rubber contamination.
----
Product: (a) Red Blood Cells; (b) Plasma. Recall #B-075/076-1.
Code: Unit numbers: (a) 40GN36142, 40GT78632; 40LE00428,
40LE00429; (b) 40LE00428, 40LE00429.
Manufacturer: American Red Cross Blood Services, Peoria, Illinois.
Recalled by: Manufacturer, by telephone May 31, 1990. Firm-initiated
recall complete.
Distribution: (a) Illinois; (b) Missouri.
Quantity: (a) 4 units; (b) 2 units.
Reason: Blood products labeled with incorrect expiration dates
were distributed.
----
Product: Reagent Red Blood Cells Spectrogen-Trio. Recall #B-126-1.
Code: Lot #90440, Cell III EXP 11/16/90.
Manufacturer: Organon Teknika Corporation, West Chester, Pennsylvania.
Recalled by: Manufacturer, by letter October 22, 1990. Firm-initiated
recall ocomplete
Distribution: Nationwide and international.
Quantity: 699 kits were distributed; firm estimates none remains
on the market.
Reason: Lu(a-) Reagent Red Blood Cells labeled as Lu (a+) were
distributed.
----
-11-
Product: Reagent Red Blood Cells; Search-Cyte TCS.
Recall #B-137-1.
Code: Lot #CET-3-85 EXP 9/22/90.
Manufacturer: Baxter Healthcare Corporation, Miami, Florida.
Recalled by: Manufacturer, by letter September 17, 1990. Firm-
initiated recall complete.
Distribution: Nationwide and international.
Quantity: 495 kits were distributed; firm estimates none remains
on the market.
Reason: Le(a+b+) Reagent Red Blood Cells labeled Le(a-b+)
were distributed.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: Respiration/Heart Rate Monitors, used to monitor patients
who are at risk from central apnea, fast heart rate or slow
heart rate:
(a) Model 9200; (b) Model 9200/50 (International);
(c) Model 9200/70 (CSA); (d) Model 9500;
(e) Model 9550. Recall #Z-155/159-1.
Code: Serial Number Range: (a) 360615-361397;
(b) 450046-450072; (c) 400323-400375
(d) 455002-455056; (e) 429160-429183.
Manufacturer: Aequitron Medical, Inc., Plymouth, Minnesota.
Recalled by: Manufacturer, by letter November 23, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Spain, West Germany, Canada.
Quantity: 867 devices were distributed.
Reason: Mechanical shock may cause the audible alarm to
malfunction. This failure mode can result in a "NO ALARM"
condition.
----
Product: Flexiflo Sacks-Vine Gastrostomy PEG (percutaneous endoscopic
gastrostomy) Kits, used for the feeding of patients
unable to consume food through the mouth:
(a) 14 French Basic Kit, Catalog #226;
(b) 14 French Complete Kit, Catalog #227;
(c) 18 French Basic Kit, Catalog #228;
(d) 18 French Complete Kit, Catalog #238.
Recall #Z-196/199-1.
Code: Lot numbers: (a) 42-347-GZ through 47-479-GZ;
(b) 41-340-GZ through 47-484-GZ;
(c) 41-327-GZ through 46-469-GZ;
(d) 41-334-GZ through 46-464-GZ.
Manufacturer: Ross Laboratories, Division of Abbott Laboratories, Inc.,
Columbus, Ohio.
Recalled by: Manufacturer, by telephone November 21, 1990, followed
by letter. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 18,010 kits were distributed; firm
estimates 5,500 remain on the market.
-12-
Reason: The gastrostomy tube bumper, which is implanted to the
inside of the gastric wall, and serves as the connection for
the feeding tube, may be pulled through the gastric wall,
allowing the stomach to fall away from the anterior
abdominal wall. This separation can go undetected, allowing
the food to enter peritoneal cavity.
----
Class II -
Product: (a & b) Brace Denture Adhesive Cream in 1.4 ounce and 2.4
ounce tubes under Norcliff Thayer, Inc or SmithKline
Beecham Corp. label;
(c - e) Orafix Special Denture Adhesive, in .5 ounce,
1.4 ounce, 2.4 ounce and 3.8 ounce tubes under the Norcliff
Thayer, Inc., SmithKline Beecham Corp. or Beecham Products
U.S.A. labels. Recall #Z-247/251-1.
Code: All lots.
Manufacturer: SmithKline Beecham Consumer Brands, St. Louis, Missouri.
Recalled by: SmithKline Beecham Consumer Brands, Pittsburgh,
Pennsylvania, by mailgram December 27, 1990 and by press
release December 28, 1990. Firm-initiated recall ongoing.
See also FDA press release P90-64, December 27, 1990.
Distribution: Nationwide and international.
Quantity: (a&b) 146,000 units; (c-e) 1,466,000 units were distributed.
Reason: Products contain a unacceptable level of benzene, a known
carcinogen.
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Product: Cushion Grip Denture Adhesive, in .25 ounce, .50 ounce and
1.0 ounce metal tubes. Recall #Z-254-1.
Code: All lots.
Manufacturer: Schering-Plough Healthcare Products, Inc., Memphis,
Tennessee.
Recalled by: Manufacturer, by press release December 28, 1990 and by
letter december 29, 1990. Firm-initiated recall ongoing.
See also FDA press release P90-64, December 27 1990.
Distribution: Nationwide and Canada.
Quantity: Firm estimates 180,000 to 240,000 tubes of each retail
size may remain on the market.
Reason: Product contain an unacceptable level of benzene, a
known carcinogen.
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Product: Posterior, Mod-C Biconvex, UV Absorbing, 6.5 mm Optic,
2-hole Intraocular Lens with Blue PMMA Loops.
Recall #Z-262-1.
Code: All six digit Alpha-numeric serial numbers beginning with
"EU" and all eight digit Alpha-numeric catalog numbers
beginning with "48-25".
Manufacturer: 3M Vision Care, Goleta, California.
Recalled by: Manufacturer, by telephone followed by letter
August 10, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Singapore, Australia.
-13-
Quantity: 404 lenses were distributed.
Reason: The inner package is labeled as the lens having an optic
diameter of 6.0 mm, while the optic diameter is actually
6.5 mm. The outer package/box is correctly labeled.
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Product: Chemstrip bG Test Strips, Catalog #00502, used with
Accu-Chek II and IIm Monitors for self-testing of blood
sugar (glucose) by diabetics. Recall #Z-278-1.
Code: Lot #252146 EXP 10/1/91.
Manufacturer: Boehringer Mannheim America Ltd., Ponce, Puerto Rico.
Recalled by: Boehringer Mannheim Corporation, Indianapolis, Indiana,
by letters sent between September 27, 1989 to October 5,
1989. Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: 96,002 vials of 50 test strips were distributed; firm
estimates none remains on the market.
Reason: This lot was exposed to high temperature during
transportation which caused shrinkage of the container cap
resulting in a loose-seal which led to absorption of
moisture affecting the product performance.
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Product: Tomographic Tables used for all Sopha camera systems.
Recall #Z-284-1.
Code: All tables not manufactured with the new process which is
currently being determined by the firm.
Manufacturer: Stratline, Paris, France.
Recalled by: Sopha Medical Systems Columbia, Maryland, by visit
not yet initiated.
Distribution: Nationwide.
Quantity: 322 tables were distributed.
Reason: The tables may break during use exposing patients to injury
from the fall to the floor.
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Product: (a) All Purpose Instrument Tray, Catalog #24008-020;
(b) Suture Removal Tray, Catalog #24000-005.
Recall #Z-285/286-1.
Code: Lot numbers: (a) DOK809 EXP 5/92; (b) DOK811.
Manufacturer: Baxter Healthcare Corporation, Johnson City, Tennessee.
Recalled by: Baxter Healthcare Corporation, Deerfield, Illinois, by
letter December 20, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 5,000; (b) 39,000 units were distributed.
Reason: The trays were assembled using thumb forceps subject to
recalls Z-089/092-1. A reddish-brown greasy residue may form
on the surface when the instruments are ETO sterilized.
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Class III -
Product: Contact lenses:
(a) Bi-Soft; (b) Cibasoft; (c) Cibasoft (Visitent);
(d) Focus; (e) Newvues; (f) Softcolors, STD Cibasoft;
(g) Cibathin; (h) Softcon Daily Wear; (i) Softcon EW;
(j) Spectrum Bifocal; (k) Spectrum Toric;
(l) Spectrum Visitint; (m) STD (Cibasoft);
(n) STD (Visitint); (o) Torisoft. Recall #Z-263/277-1.
Code: Lot numbers: (a) 104363;
(b) 983619, 101313, 104363, 107221, 871202;
(c) 105156, 983619; (d) 115069;
(e) 961920, 992826, 991422, 100118, 100402, 100237,
100364, 104467, 104165, 105269, 105147;
(f) 105156, 107221, 102347, 105156;
(g) 107221, 871202; (h) 972745; (i) 110490;
(j) 106330, 111485; (k) 110414, 990853, 102277, 106317;
(l) 961904, 981118, 105077, 105457; (m) 107221;
(n) 102347, 871202, 105156; (o) 046482.
Manufacturer: Ciba Vision Corporation, Atlanta, Georgia.
Recalled by: Manufacturer, by letter November 30, 1990. Firm-initiated
recall complete.
Distribution: Nationwide and international.
Quantity: Amounts distributed: (a) 356; (b) 13,857; (c) 9,067;
(d) 1,275; (e) 61,581; (f) 4,828; (g) 1,493;
(h) 235; (i) 283; (j) 1,492; (k) 1,863; (l) 12,416;
(m) 653; (n) 5,028; (o) 1,267.
Reason: The lenses are labeled to the wrong power.
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VETERINARY PRODUCTS
NONE