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
04/17/1990
FDA Enforcement for the week of April 18, 1990
FDA ENFORCEMENT REPORT
FOR WEEK OF APRIL 18, 1990
April 18, 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.
Product: Meta brand egg dyes, in 3 gram paper packages, a powder
substance used to color eggs:
(a) Yellow Color; (b) Green Color; (c) Red Color;
(e) Blue Color. Recall #F-469/472-0.
Code: Label shows manufacturer's address in the
capital Greek lettering as META=A.
-1-
Manufacturer: Product of Greece.
Recalled by: Sirob Imports, Lindenhurst, New York (dealer/importer), by
telephone March 30, 1990 followed by letter April 5, 1990.
Firm-initiated recall ongoing.
Distribution: Connecticut, New York, Pennsylvania, Illinois, Wisconsin,
Washington, D.C., Texas, Florida, Massachusetts, New
Jersey, California.
Quantity: 2,047 packages were distributed.
Reason: Product contains nonpermitted colors.
----
Product: Egg Dyes in paper cartons with colored backgrounds,
outer cartons labeled in part, "***Krinos Foods***Egg Dye**
packed from Hassila Bros O.E.***60 sackets:
(a) Gold Dye; (b) Yellow Dye; (c) Green Dye;
(f) Blue Dye. Recall #F-475/478-0.
Code: Not coded - Sackets are color coded.
Manufacturer: X and K Hassila OE, Metamorfosis/Attikis, Greece.
Recalled by: Krinos Foods, Inc., Long Island City, New York, by
telephone beginning March 23, 1990 followed by letter
March 26, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 101,892 units were distributed; firm estimates 50 percent
remains on market.
Reason: Product contains nonpermitted colors.
----
Class III - A situation in which the use of, or exposure to
a violative product is not likely to cause adverse health
consequences.
Product: Old San Francisco Seltzer (except diet), in 10 ounce
non-returnable bottles in the following flavors:
(a) Almond Cream Seltzer; (b) Black Cherry; (c) Root Beer;
(d) Peach; (e) Cran-Raspberry; (f) Red Raspberry.
Recall #F-459/464-0.
Code: All codes prior to 3/13/90 (all prior to COM 313 and
any product which is uncoded).
Manufacturer: Beverage Capital Corporation, Baltimore, Maryland (Red
Raspberry); Beverage Canners International Corporation,
Miami, Florida (all others).
Recalled by: Beverage Canners International Corporation, Miami, Florida,
by visit January and February 1990. Firm-initiated recall
ongoing.
Distribution: Florida.
Quantity: Unknown.
Reason: Product contains mold and/or yeast.
----
-2-
Product: Kraft Velveeta Pasteurized Processed Cheese Spread Slices,
individually wrapped slices in 12 ounce (16 slices) and
(10 slices (extra thick)) and 16 ounce (20 slices)
packages. Recall #F-465-0.
Code: Best when purchased by JUN-20-90/C-*-*, JUN-12-90/C-*-*,
JUN-13-90/C-*-*, JUN-14-90/C-*-*, JUN-15-90/C-*-*,
JUN-16-90/C-*-*, JUN-18-90/C-*-*, JUN-19-90/C-*-*.
Manufacturer: Kraft USA, Champaign, Illinois.
Recalled by: Kraft, USA, Glenview, Illinois, by memorandum March 1 and
28, 1990. Firm-initiated recall ongoing.
Distribution: Eastern United States, Puerto Rico.
Quantity: 65,780 cases of 12 oz., 44,387 cases of 16 oz. packages
and 18,307 cases of extra thick slice 12 ounce packages
were distributed; firm estimates 50 percent remains on
market.
Reason: Product contains lactose crystals which resemble glass.
----
COSMETICS
Class I -
NONE
Class II -
Product: Vitamin E and Lanolin Skin Lotion in 8 ounce plastic
squeeze bottle and in 12 ounce and 18 ounce plastic
bottles with pump, under the Benjamin Ansehl Co.,
Meijer, K Mart, Woolworth, Caldor labels. Recall #F-466-0.
Code: All 1989 production, lot numbers 901031 through 912191.
Manufacturer: The Benjamin Ansehl Company, St. Louis, Missouri.
Recalled by: Manufacturer, by telephone followed by letter March 5, 1990
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 15,282 dozen (12 oz), 1,851 (8 oz.), 1,602 (18 oz) bottles
were distributed.
Reason: Product is contaminated with Paecilomyces molds.
----
Class III -
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: (a) Triamterene with Hydrochlorothiazide Capsules,
in 15, 30, 60 and capsule bottles, for use as a
-3-
diuretic/antihypertensive;
(b) Phenytoin Sodium Extended Release Capsules, 100 mg,
in 30, 50 and 100 capsule bottles, Rx drugs for use as an
anticonvulsant. Recall #D-182/183-0.
Code: All lots and sizes.
Manufacturer: Bolar Pharmaceutical Company, Inc., Copiague, New York.
Recalled by: Allscrips Pharmaceuticals, Inc., Vernon Hills, Illinois, by
telephone February 15, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 218,690 capsules; (b) 44,780 capsules were distributed;
firm estimates (a) 11,000; (b) 4,000 capsules remain on
market.
Reason: Lack of assurance of bioequivalency and Abbreviated New
Drug Application discrepancies.
----
Product: Herpes Oral Liquid, in 1 ounce amber glass bottle with
dropper screw cap lid, an OTC product. Recall #D-184-0.
Code: Lot #11263 EXP 12/93.
Manufacturer: Apotheca Naturale, Inc., Woodbine, Iowa.
Recalled by: Manufacturer, by letter on or about March 9, 1990.
Firm-initiated recall ongoing.
Distribution: California.
Quantity: 12 bottles were distributed.
Reason: Product lacks an ingredient statement and indications for
use. Also marketed without an approved New Drug
Applicationl.
----
Product: Various Rx drugs:
(a) Ergoloid Mesylates Sublingual 0.5 mg Tablets, used
for treatment of declining mental capacity related to
aging, is packaged in bottles containing 100, 250, 500 or
1,000 tablets, under the following labels: Goldline
Laboratories, Schein Pharmaceutical, Bioline Laboratories
The Arkansas Cooperative Assoc. Inc., H.L. Moore Drug
Exchange, Lederle Laboratories Div., Geneva Generics,
United Research Laboratories, Inc., Parmed Pharmaceuticals,
Inc., Genetco, Inc., Major Pharmaceuticals, Inc., Bolar
Pharmaceutical Co., Inc. (100's);
Bolar Pharmaceutical Co., Inc., (250's);
Parmed Pharmaceuticals, Inc., Bolar Pharmaceutical Co.,
Inc. (500's);
Goldline Laboratories, Lederle Labs Div., Geneva
Generics, Bolar Pharmaceutical Co., Inc. (1000's);
(b) Fluphenazine HCl, 1 mg Tablets, a tranquilizer, in
bottles of 100, 500 or 1,000, under the following labels:
Warner Chilcott Labs, Goldline Laboratories, Schein
Laboratories, Baxter Health Care Corp., Lemmon Company,
Glenlawn, Inc., Harbor Pharmaceutical Co., Best Generics,
Major Pharmaceutical Co., Inc., Rugby Laboratories, Inc.,
United Research Laboratories, Inc., Parmed Pharmaceuticals,
-4-
Inc., H.L. Moore Drug Exchange, Bioline Laboratories,
Genetco, Inc., Bolar Pharmaceutical Co., Inc. (100's);
Harbor Pharmaceutical Co., Bolar Pharmaceutical Co. (500's);
(c) Fluphenazine HCl 10 mg Tablets, a tranquilizer, in
bottles of 100, 500, or 1,000 tablets, under the following
labels: Rugby Laboratories, Warner Chilcott Labs, Goldline
Laboratories, Schein Pharmaceutical, Inc., Baxter Healthcare
Corp., Glenlawn, Inc., Genetco, Inc., Lemmon Company, Bolar
Pharmaceutical Co., Inc., Harbor Pharmaceutical Co., Best
Generics, Inc., Major Pharmaceutical Corp., United Research
Laboratories, Inc., Parmed Pharmaceuticals, Inc., Bioline
Laboratories, Inc., J.J. Balan, Inc., H.L. Moore Drug
Exchange (100's);
Major Pharmaceutical Corp., Baxter Healthcare Corp., H.L.
Moore Drug Exchange, Bolar Pharmaceutical Co., Inc. (500's);
Bolar Pharmaceutical Co., Inc. (1000's);
(d) Hydroflumethiazide w/Reserpine 50 mg/0.125 mg Tablets,
in bottles of 100, 500, or 1,000 tablets, an anti-
hypertensive and diuretic, under the following labels -
(Some labels state Reserpine and Hydroflumethiazide 0.125
mg/50 mg) Geneva Generics, Goldline Laboratories, Purepac
Pharmaceutical Co., Bioline Laboratories, Inc., H.L. Moore
Drug Exchange, Genetco, Inc., Major Pharmaceutical Corp.,
Rugby Laboratories, Inc., Schein Pharmaceutical, Inc., Parmed
Pharmaceuticals, Inc., Best Generics, Inc., Vita-Rx Corp.
IDE - Interstate, Bolar Pharmaceutical Co., Inc. (100's);
Goldline Laboratories, Bioline Laboratories, Rugby
Laboratories, Inc., Best Generics, Inc. (500's);
Schein Pharmaceutical, Inc., Vita-Rx Corp., Quality Research
Pharmaceutical, Inc., Rugby Laboratories, Inc., IDE -
Interstate, Bolar Laboratories (1,000's);
(e) Maprotiline HCl 25 mg Tablets, in bottles of 100, 500,
or 1,000 tablets, an antidepressant, under the following
labels: Major Pharmaceuticals, Inc., H.L. Moore Drug
Exchange, Geneva Generics, Warner Chilcott Labs, Best
Generics, Inc., Rugby Laboratories, Inc., Lemmon Company,
United Research Labs., Inc., Genetco, Inc., Bolar
Pharmaceutical Co., Inc. (100's);
Rugby Laboratories, Inc., Bolar Pharmaceutical Co., Inc.,
H.L. Moore Drug Exchange (500's);
Bolar Pharmaceutical Co., Inc. (1,000's);
(f) Maprotiline HCl 50 mg Tablets, in bottles of 100, 500,
or 1,000 tablets, an antidepressant, under the following
labels: Major Pharmaceutical Corp, H.L. Moore Drug Exchange,
Warner Chilcott Labs, Genetco, Inc., Geneva Generics,
Rugby Labs, Inc., Lemmon Co., Best Generics, Inc., United
Research Labs, Inc., Bolar Pharmaceutical Co., Inc. (100's);
Rugby Laboratories, Inc., Bolar Pharmaceutical Co., Inc.,
H.L. Moore Drug Exchange (500's);
-5-
Bolar Pharmaceutical Co., Inc. (1,000's);
(g) Maprotiline HCl 75 mg. Tablets, in bottles of 100, 500,
or 1,000 tablets, an antidepressant, under the following
labels: Major Pharmaceutical Corp., Rugby Labs., Inc., Lemmon
Company, Best Generics, Inc., Geneva Generics, United
Research Labs., Inc., Genetco, Inc., Warner Chilcott Labs.,
H.L. Moore Drug Exchange New Britain, Bolar Pharmaceutical
Co., Inc. (100's);
Rugby Laboratories, Inc., Bolar Pharmaceutical Co., Inc.
(500's);
Bolar Pharmaceutical Co., Inc. (1,000's);
Methyldopa Tablets, an antihpertensive, in bottles of 100,
500, or 1,000 tablets.
(h) Methyldopa 125 mg Tablets, under the following labels:
Major Pharmaceutical Corp., Baxter Healthcare Corp., H.L.
Moore Drug Exchange, Bolar Pharmaceutical Co., Inc., Rugby
Labs, Inc., Best Generics, Inc., IDE-Interstate Drug Exchange
(100's);
Best Generics, Inc., Bolar Pharmaceutical Co., Inc. (500's);
Bolar Pharmaceutical Co., Inc. (1,000's);
(i) Methyldopa 250 mg Tablets, under the following labels:
H & H Laboratories, Baxter Healthcare Corp, Genetco, Inc.,
Best Generics, Inc., IDE - Interstate Drug Exchange, Bolar
Pharmaceutical Co., Inc. (100's);
Bolar Pharmaceutical Co., Inc (500's);
H & H Laboratories, IDE - Interstate Drug Exchange,
American Preferred Pharmaceutical Inc., H.L. Moore Drug
Exchange, Genetco, Inc., Baxter Healthcare Corp., Best
Generics, Inc., Bolar Pharmaceutical, Co., Inc. (1,000's);
(j) Methyldopa 500 mg Tablets, under the following labels:
Genetco, Inc., H&H Laboratories, Baxter Healthcare Corp.,
IDE - Interstate, Best Generics, Inc., Bolar Pharmaceutical
Co., Inc. (100's);
American Preferred Pharmaceutical, Inc., Best Generics, Inc.,
IDE - Interstate Drug Exchange, Bolar Pharmaceutical Co.,
Inc., Baxter Healthcare Corp, H&H Laboratories, H.L. Moore
Drug Exchange (500's);
Bolar Pharmaceutical Co., Inc. (1,000's);
Methyldopa w/Hydrochlorothiazide Tablets, in bottles of
100, 500, or 1,000, an antihypertensive and diuretic:
(k) Methyldopa w/Hydrochlorothiazide 250 mg/15 mg Tablets,
under the following labels: Squibb Co., Best Generics, Inc.,
Lederle Labs Div., Rugby Labs, Inc., IDE - Interstate Drug
Exchange, Bolar Pharmaceutical Co., Inc. (100's);
Rugby Labs, Inc., Bolar Pharmaceutical Co., Inc., Best
Generics, Inc. (500's);
Best Generics, Inc., Lederle Lab Div., Bolar Pharmaceutical
Co., Inc. (1,000's);
-6-
(l) Methyldopa w/Hydrochlorothiazide 250 mg/25 mg Tablets,
under the following labels: E.R. Squibb Company, Inc.,
IDE - Interstate Drug Exchange, Best Generics, Inc., Lederle
Labs Div., Rugby Labs, Inc., American Preferred
Pharmaceutical, Inc., Bolar Pharmaceutical Co., Inc. (100's);
Rugby Labs, Inc., Bolar Pharmaceutical Co., Inc., Best
Generics (500's);
E.R. Squibb Company, Bolar Pharmaceutical Co., Inc.,
Best Generics, Inc., Lederle Labs Div (1,000's);
(m) Methyldopa w/Hydrochlorothiazide 500 mg/30 mg Tablets,
under the following labels: Rugby Labs, Inc., H.L. Moore
Drug Exchange, Major Pharmaceutical Corp., Bolar
Pharmaceutical Co., Inc., Goldline Labs, Best Generics,
Bioline Labs, Inc. (100's);
H.L. Moore Drug Exchange, Bolar Pharmaceutical Co., Inc.
(500's);
Bolar Pharmaceutical Co., Inc. (1,000's);
(n) Methyldopa w/Hydrochlorothiazide 500 mg/50 mg Tablets,
under the following labels: Rubgy Labs, Inc., Goldline Labs,
Best Generics, Inc., Bolar Pharmaceutical Co., Major
Pharmaceutical Corp., H.L. Moore Drug Exchange, Bioline
Labs., Inc., (100's);
H.L. Moore Drug Exchange, Bolar Pharmaeutical Co., Inc
(500's);
Bolar Pharmaceutical Co., Inc. (1,000's);
(o) Orphenadrine Citrate Sustained Release 100 mg Tablets,
a muscle relaxant, in bottles of 100, 500 or 1,000, under the
following labels: Qualitest Products, Inc., Major
Pharmaceuticals, Inc., Best Generics, Dixon-Shane, Inc.,
Genetco, Inc., Glenlawn, Inc., Goldline Labs, Schein
Pharmaceutical, Inc., Bolar Pharmaceutical Co., Inc.,
Parmed Pharmaceuticals, Inc., IDE - Interstate Drug Exchange,
American Preferred Pharmaceutical, Harbor Pharmaceutical Co.,
H.L. Moore Drug Exchange, Rugby Labs, Inc., Geneva Generics,
Bioline Labs (100's);
Major Pharmaceutical Corp., IDE - Interstate Drug Exchange,
Rugby Labs, Inc., Schein Pharmaceutical, Inc., Bolar
Pharmaceutical Co., Inc., Quality Research Pharm., Inc.,
Best Generics, Inc., Goldline Labs, Bioline Labs, Inc.
(500's);
Rugby Labs, Inc., Bolar Pharmaceutical Co., Inc., Geneva
Generics (1,000's);
(p) Procainamide HCl 1000 mg Tablets, an antiarrhythmic and
is packaged in bottles of 100, 500 or 1,000, under the
following labels: Rugby Labs., Inc., Geneva Generics, Harbor
Pharmaceutical Co., Best Generics, Inc., Major Pharmaceutical
Corp., Goldline Labs, Bioline Labs, Inc., H.L. Moore Drug
Exchange, Parmed Pharmaceuticals, Inc., Bolar Pharmaceutical,
Co., Inc. (100's);
Bolar Pharmaceutical Co., Inc. (500's & 1,000's);
-7-
(q) Propoxyphene Napsylate w/Acetaminophen 50 mg/325 mg
Tablets, an analgesic, in bottles of 100, 500 or 1,000,
under the following labels: Geneva Generics, Glenlawn, Inc.,
Rugby Labs, Inc., Bolar Pharmaceutical Co. (100's);
Bolar Pharmaceutical Co., Inc. (500's & 1,000's);
(r) Sulfasalazine Enteric Coated 500 mg Tablets, an anti-
inflammatory in bottles of 100, 500 or 1,000, under the
following labels: Rugby Labs, Inc., Genetco Inc., Best
Generics, Inc., Glenlawn Labs, Harbor Pharmaceutical Co.,
Major Pharmaceutical Co., Inc., Bolar Pharmaceutical Co.,
Inc., Bioline Labs, Inc., Parmed Pharmaceuticals, Inc.,
H.L. Moore Drug Exchange, IDE - Interstate Drug Exchange,
Qualitest Products, Inc., Schein Pharmaceutical, Inc.
(100's)'
H.L. Moore Drug Exchange, Glenlawn Labs, IDE - Interstate
Drug Exchange, Rugby Labs., Harbor Pharmaceutical Co., Best
Generics, Inc., Parmed Pharmaceuticals, Inc., Bolar
Pharmaceutical Co., Inc. (500's);
Bolar Pharmaceutical Co., Inc. (1,000's);
Tolbutamide, a hypoglycemic agent for diabetes, in bottles
of 100, 500, or 1,000.
(s) Tolbutamide 250 mg Tablets, under the following labels:
H.L. Moore Drug Exchange, Bolar Pharmaceutical Co., Inc.
(100's); Bolar Pharmaceutical Co., Inc. (500's & 1,000's);
(t) Tolbutamide 500 mg Tablets, under the following labels:
Major Pharmaceutical Corp, Bolar Pharmaceutical Co., Inc.
(100's); Bolar Pharmaceutical, Inc. (500's);
American Preferred Pharm., Inc., Bolar Pharmaceutical Co.,
Inc., Major Pharmaceutical Corp (1,000's);
Trazodone HCl Tablets, an antidepressant in bottles of 100,
500 or 1,000.
(u) Trazodone HCl 50 mg Tablets, under the following labels:
Genetco Inc., American Preferred Pharm., Inc., E.R. Squibb &
Sons, Inc., Lemmon Company, Bolar Pharmaceutical Co., Inc.,
Lederle Labs Div (100's);
Bolar Pharmaceutical Co., Inc. (500's & 1,000's);
(v) Trazodone HCl 100 mg Tablets, under the following labels:
E.R. Squibb & Sons, Inc., Genetco Inc., Bolar Pharmaceutical
Co., Inc., American Preferred Pharmaceutical, Inc., Lemmon
Company, Lederle Labs Div (100's);
Bolar Pharmaceutical Co., Inc. (500's & 1,000's).
Recall #D-199/220-0.
Code: All codes.
Manufacturer: Bolar Pharmaceutical Co., Inc., Copiague, New York.
Recalled by: Manufacturer, by letter February 19-20, 1990. Firm-
initiated recall ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: (a) 52,524 (100's), 144 (250's), 3,956 (500's), 5,806
(1,000's);
-8-
(b) 72,200 (100's), 741 (500's), 62 (1,000's)
(c) 113,486 (100's), 6,336 (500's), 85 (1,000's);
(d) 331,810 (100's), 16,134 (500's), 4,085 (1,000's);
(e) 51,731 (100's), 1,766 (500's), 65 (1,000's);
(f) 62,620 (100's), 2,105 (500's), 61 (1,000's);
(g) 17,162 (100's), 6 (500's), 38 (1,000's);
(h) 33,491 (100's), 690 (500's), 120 (1,000's);
(i) 22,015 (100's, 315 (500's), 19,384 (1,000's);
(j) 17,538 (100's), 11,564 (500's), 995 (1,000's);
(k) 89,920 (100's), 6,677 (500's), 2,859 (1,000's);
(l) 199,004 (100's), 23,149 (500's), 13,703 (1,000's);
(m) 23,692 (100's), 222 (500's), 53 (1,000's);
(n) 24,611 (100's), 168 (500's), 62 (1,000's);
(o) 380,946 (100's), 21,907 (500's), 5,471 (1,000's);
(p) 76,545 (100's), 32 (500's), 47 (1,000's);
(q) 16,986 (100's), 12 (500's), 35 (1,000's);
(r) 119,421 (100's), 13,783 (500's), 399 (1,000's);
(s) 862 (100's), 0 (500's), 101 (1,000's);
(t) 11,030 (100's), 880 (500's), 3,182 (1,000's);
(u) 152,320 (100's), 642 (500's), 158 (1,000's);
(v) 67,085 (100's), 132 (500's), 224 (1,000's) bottles
were distributed.
Reason: Products lack assurance that they were manufactured in
conformity with conditions approved in the Abbreviated
New Drug Applications.
----
Product: Various Rx oral drugs, unit dose packaged, 10
capsules/tablets per card, 10 cards per shelf carton,
distributed by UDL Laboratories:
(a) Ergoloid Mesylates Tablets, USP (sublingual), 0.5
mg., an Rx sublingual used in the treatment of patients
with an idiopathic decline in mental capacity;
(b) Fluphenazine Hydrochloride Tablets, USP, 1 mg, 10 mg.,
used in the management of manifestations of psychotic
disorders;
(c) Maprotiline Hydrochloride Tablets, USP, 25 mg., 50 mg.,
75 mg., an Rx tetracyclic antidepressant used in the
treatment of depressive neurosis and manic-depressive
illness;
(d) Trazodone Hydrochloride Tablets, 50 mg., 100 mg., an
Rx antidepressant used in the treatment of depression.
Recall #D-188/195.
Code: All lots.
Manufacturer: Bolar Pharmaceutical Co., Inc., Copiague, New York.
Recalled by: UDL Laboratories, Inc., Rockford, Illinois (repacker), by
letters March 2 and 14, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 1,292 unit cartons; (b) 2,707 units of 1 mg tablets
and 3,102 unit cartons of 10 mg;
(c) 922 unit cartons of 25 mg tablets, 944 unit cartons
of 50 mg tablets, and 401 unit cartons of 75 mg tablets;
(d) 7,377 unit cartons of 50 mg. tablets and 2,873 units were
distributed.
-9-
Reason: Products lack assurance that they were manufactured in
conformity with the conditions approved in the Abbreviated
New Drug Applications.
----
Product: Baxter brand Prescription oral drugs, unit dose
packaged 10 tablets per card, 10 cards per box:
(a) Fluphenazine Hydrochloride, USP, 10 mg.
tablets, an Rx oral tablet used in the management of
manifestations of psychotic disorders;
Methyldopa Tablets, USP, (b) 250 mg.; (c) 500 mg., an
oral tablet used for the treatment of hypertension.
Recall #D-196/198-0.
Code: All lots.
Manufacturer: Bolar Parmaceuticals Company, Inc., Copiague, New York.
Recalled by: Baxter Healthcare Corporation, Deerfield, Illinois, by
letter February 26, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 40 unit dose cartons; (b) 1,206 unit dose cartons;
(c) 630 unit dose cartons were distributed.
Reason: Products lack assurance that they were manufactured in
conformity with conditions approved in the Abbreviated
New Drug Applications.
----
Product: Triamterene and Hydrochlorothiazide Capsules, 50 mg/25 mg.,
packaged 10 capsules/tablets per card, 10 cards per shelf
carton, an oral diuretic antihypertensive used for the
treatment of hypertension or edema in patients who develop
hypokalemia on hydrochlorothiazide alone. Recall #D-223-0.
Code: All lots.
Manufacturer: Bolar Pharmaceutical Company, Inc., Copiague, New York.
Recalled by: UDL Laboratories, Inc., Rockford, Illinois, by letter
February 9, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 22,657 unit cartons were distributed; firm estimates
40 percent remains on market.
Reason: Lack of assurance of bioequivalency and Abbreviated New
Drug Application discrepancies.
----
Class III --
Product: Fenoprofen Calcium USP 300 mg, in 100 and 500 capsule
bottles, packaged 6 bottles per tray, 18 trays per shipping
box, an Rx non-steroidal, anti-inflammatory, anti-arthritic
drug indicated for pain associated with rheumatoid arthritis
and osteoarthritis, under the Watson, Bioline, Goldline,
Best Generics, Warner Chilcott labels. Recall #D-180-0.
Code: The labels of all bottles under recall bear the lot
number, 36801J8 (exp 8/90), except the Warner Chilcott
Laboratories' label (same production lot), which bears
the lot number, 92588W (exp 8/90).
-10-
Manufacturer: Watson Laboratories, Inc., Corona, California.
Recalled by: Manufacturer, by letter January 19, 1990. Firm-initiated
recall ongoing.
Distribution: California, Connecticut, Florida, Illinois, Nebraska,
New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia.
Quantity: 24 bottles of 500's and 2,384 bottles of 100's were
distributed.
Reason: Product does not meet dissolution specifications.
----
Product: Hook's brand Nite Time Cold Medicine, regular and
cherry flavored, in 14 ounce bottles, an OTC product.
Recall #D-181-0.
Code: Lot numbers: A1479D, A1480D EXP 1/93 (cherry flavor),
A1474D, A1475D EXP 1/93 (regular flavor).
Manufacturer: Pennex Products Company, Inc., Verona, Pennsylvania.
Recalled by: Manufacturer, by telephone February 13, 1990.
Firm-initiated recall ongoing.
Distribution: Indiana.
Quantity: Firm estimates none remains on market.
Reason: Short fill in declared volume.
----
Product: Dipyridamole Tablets, Immediate Action Dipyridamole USP
75 mg., in bottles of 100 and 1,000 tablet bottles, an
Rx product used as a coronary vasodilator to increase
coronary blood flow, under the following labels: Par
Pharmaceutical, H.L. Moore, Goldline Laboratories, Schein
Pharmaceutical, Major Pharmaceutical. Recall #D-185-0.
Code: Lot #327488 EXP 9/91.
Manufacturer: Par Pharmaceutical, Inc., Spring Valley, New York.
Recalled by: Manufacturer, by letter on or about March 16, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 9,560 bottles of 100 and 2,899 bottles of 1,000 tablets
were distributed.
Reason: Product does not meet content uniformity specifications.
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Product: Dipyridamole Tablets, USP, 25 mg., in bottles of 100,
1,000, and 2,500 tablets, an Rx product used as a coronary
vasodilator to increase coronary blood flow under the
following labels: Par Pharmaceutical, H.L.Moore,
Goldline Laboratories, Harbor Pharmaceutical,
Bioline Laboratories, J.J. Balan. Recall #D-186-0.
Code: Lot #127388 EXP 9/91.
Manufacturer: Par Pharmaceutical, Inc., Spring Valley, New York.
Recalled by: Manufacturer, by letter on or about March 16, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
-11-
Quantity: 5,322 bottles of 100, 1,027 bottles of 1,000; and
900 bottles of 2,500 tablets were distributed.
Reason: Product does not meet dissolution specifications.
----
Product: Cortifair Hydrocortisone Cream 1.0% packed in 0.5g, 1.0
ounce and 16 ounce sizes, an Rx product used for
corticosteroid responsive dermatoses, under the Pharmafair,
Genetco, and Parmed labels. Recall #D-187-0.
Code: All codes.
Manufacturer: Pharmafair, Inc., Hauppauge, New York.
Recalled by: Manufacturer, by letter on or about March 15, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 2,641,289 units were distributed.
Reason: Product was manufactured using a formula different
from the approved formula.
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Product: Otic (ear) Drops, an Rx product indicated for the treatment
of superficial infections of the external auditory canal
complicated by inflammation caused by organisms
susceptible to the action of the anti-microbial or to
control itching, under the following labels:
Hauck Pharmaceuticals (Otic-HC), Hyrex Pharmaceuticals
(Ear-Eze), Marnei Pharmaceuticals (Otomar-HC),
Ortega Pharmaceutical (Tego-Otic), Blansett Pharmacal
(Cortane-B Otic Ear Drops), Kramer Pharmacal (Oticol),
Ram Laboratories (Otisan). Recall #D-221-0.
Code: Lot numbers: Otic-HC -- C-020 EXP 2/91 (10 ml), C-064 EXP
5/91 (10 ml), C-077 EXP 6/91 (30 ml), C-109 EXP 8/91 (10 ml);
Ear-Eze -- C-020 EXP 2/91 (10 ml), C-109 EXP 8/91 (10 ml);
Otomar-HC -- C-020 EXP 2/91 (10 ml), C-064 5/91 (10 ml),
C-077 EXP 6/91 (30 ml), C-109 EXP 8/91 (10 ml),
C-155 EXP 8/91 (10 & 30 ml);
Tego-Otic -- C-064 EXP 5/91 (10 ml), C-109 EXP 8/91 (10 ml);
Cortane-B -- C-064 EXP 5/91 (10 ml), C-155 EXP 11/91 (10 ml);
Oticol -- C-109 EXP 8/91 (10 ml);
Otisan -- C-155 EXP 11/91 (10 ml).
Manufacturer: Mallard Pharmaceutical, Division of W.A. Hauck, Detroit,
Michigan.
Recalled by: Manufacturer, by letter January 17, 1990. Firm-initiated
recall ongoing.
Distribution: Distribution of all products, except for the Otisan brand
product was directly to Mallard's Inc., parent firm W.E.
Hauck, Inc., Alpharetta, Georgia, who then distributed the
product to the labeled distributors. In the case of the
Oitsan Ear Drops the product was shipped directly to
Ram Laboratories, Miami, Florida from Mallard, Inc.
Quantity: 11,368 (Otic-HC), 2,765 (Ear Eze), 3,857 (Otomar-HC),
4,274 (Tego Otic), 3,995 (Cortane-B), 983 (Oticol),
1,200 (Otisan) units were distributed, firm estimates
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less than 20 percent remains on market.
Reason: Product instability regarding Hydrocortisone content.
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Product: UDL brand Docusate Sodium Liquid, 100 mg., in 10 ml.
unit dose cups, 10 cups per tray, 10 trays per shelf
carton, an OTC oral stool softener. Recall #D-222-0.
Code: Lot #910038 EXP 10/91.
Manufacturer: UDL Laboratories, Inc., Largo, Florida.
Recalled by: UDL Laboratories, Inc., Rockford, Illinois, by letter
February 14, 1990 followed by telephone on or about
April 12, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 613 unit dose cartons were distributed; firm estimates
90 percent remains on market.
Reason: Product labeled as dye free but contains D&C Red #33.
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Product: Cogentin Tablets, Benztropine Mesylate USP (a) 1 mg;
(b) 2 mg., in bottles of 100 and 1,000 as well as unit
dose boxes of 100, an Rx drug used in conjunction with other
medications in the treatment of parkinsonism.
Recall #D-224/225-0.
Code: (a) M1351 EXP 7/91, M1485 EXP 8/91, M1804 EXP 10/91,
N0122 EXP 12/91, P0359 EXP 2/93, P1335 EXP 3/93,
P0114 EXP 1/91, P1336 EXP 4/91, R1221 EXP 4/91;
(b) M1456 EXP 8/91, M1596 EXP 9/91, N1247 EXP 10/90.
Manufacturer: Merck Sharp & Dohme, West Point, Pennsylvania.
Recalled by: Manufacturer, by letter March 26, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Puerto Rico, Virgin Islands.
Quantity: 390,528 units were distributed; firm estimates 6,116
units remain on the market.
Reason: Potency not assured through expiration date.
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Product: Xactdose Lactulose Syrup, 20g/30 ml, in 30 ml unit
dose cups, 10 cups per tray, 10 trays per carton, an
oral Rx gastroenteric used for the prevention and
treatment of portal-systemic encephalopathy.
Recall #D-226-0.
Code: Lot numbers: 805723, 808740, 811758, 812769, 901775,
902784.
Manufacturer: Merrell Dow Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: Xactdose, Inc., Roscoe, Illinois, by letter April 3, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,742 unit cartons were distributed; firm estimates less
than 10 percent of product remains on market.
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Reason: Product may be adulterated with penicillium mold.
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Product: Cytosar-U Sterile Powder (brand of sterile Cytarabine), USP,
100 mg., lyophilized powder, in 5 ml vials, an Rx anti-
neoplastic drug. Recall #D-227-0.
Code: Lot #620DX.
Manufacturer: The Upjohn Company, Kalamazoo, Michigan.
Recalled by: Manufacturer, by letter February 28, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Egypt.
Quantity: 13,978 vials were distributed.
Reason: Portion of labeling has incorrect reconstitution
instructions.
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MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Hewlett-Packard Pressure Module Model M1006A, Option C01,
a plug-in module used in the HP M1175A or 1176A component
monitoring systems. Recall #Z-464-0.
Code: Serial numbers: A12992-A12999, A13000-A13123,
A13455-A13534, A13921-A13945, A14307-A14309, A14321-A14350,
A14715-A14767, A15080-A15102, A15544-A15574, A15673-A15716,
A15906-A15952, A16236, A16237, A16239, A16240-A16242,
A16245, A16247, A16248, A16251, A16252, A16253, A16254,
A16502, A16507, A16512, A16514, A16536, A16539.
Manufacturer: Hewlett-Packard Company, Clinical Systems Business Unit,
Waltham, Massachusetts.
Recalled by: Manufacturer, by letter February 5, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada, Netherlands, Japan, Australia.
Quantity: 487 units were distributed.
Reason: A hardware defect causes a shift in analog output that
synchronizes the balloon pump and in the numeric
display or recording the pressure waves.
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Product: USCI Sprint Balloon Dilatation Catheters, used in
angioplasty, packaged in plastic trays in Tyvek pouches
in cardboard cartons, 1 unit per carton:
(a) Catalog No. 004927 - 2.00 mm, 20 mm length;
(b) Catalog No. 004928 - 2.25 mm, 20 mm length;
(c) Catalog No. 004929 - 2.50 mm, 20 mm length;
(d) Catalog No. 004930 - 2.75 mm, 20 mm length;
(e) Catalog No. 004931 - 3.00 mm, 20 mm length;
(f) Catalog No. 004932 - 3.25 mm, 20 mm length;
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(g) Catalog No. 094933 - 3.50 mm, 20 mm length;
(h) Catalog No. 094934 - 3.75 mm, 20 mm length;
(i) Catalog No. 004935 - 4.00 mm, 20 mm length.
Recall #Z-465/473-0.
Code: All lot numbers.
Manufacturer: USCI Division, C.R. Bard, Inc., Haverhill, Massachusetts.
Recalled by: USCI Division, C.R. Bard, Inc., Billerica, Massachusetts,
by letter March 9, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 21,309 units were distributed; firm estimates 7,000
remain on market.
Reason: The catheters, lacking introducer sheaths and appropriate
labeling instructions, were distributed without an
approved PMA supplement.
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Product: USCI Solo Balloon Dilatation Catheters, used in
angioplasty, packaged in plastic trays in Tyvek pouches
in cardboard cartons, 1 unit per carton:
(a) Catalog No. 004830 - 2.00 mm, 20 mm length;
(b) Catalog No. 004831 - 2.25 mm, 20 mm length;
(c) Catalog No. 004832 - 2.50 mm, 20 mm length;
(d) Catalog No. 004833 - 2.75 mm, 20 mm length;
(e) Catalog No. 004834 - 3.00 mm, 20 mm length;
(f) Catalog No. 004835 - 3.25 mm, 20 mm length;
(g) Catalog No. 004836 - 3.50 mm, 20 mm length;
(h) Catalog No. 004837 - 3.75 mm, 20 mm length;
(i) Catalog No. 004938 - 4.00 mm, 20 mm length.
Recall #Z-474/482-0.
Code: All lot numbers.
Manufacturer: USCI Division, C.R. Bard, Inc., Haverhill, Massachusetts.
Recalled by: USCI Division, C.R. Bard, Inc., Billerica, Massachusetts,
by letter March 9, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,280 units were distributed; firm estimates 400 units
remain on market.
Reason: The catheters, lacking introducer sheaths and appropriate
labeling instructions, were distributed without an
approved PMA supplement.
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Class III -
NONE
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VETERINARY PRODUCTS
NONE