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
10/30/1990
FDA Enforcement for the week of OCTOBER 31, 1990.
FDA ENFORCEMENT REPORT
FOR OCT. 31, 1990
October 31, 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.
Product: Hot Smoked Salmon Pieces packaged in plastic seal
package with varying weights and bulk packed hot smoked
salmon in 10 pound cardboard boxes. Recall #F-724-0.
Code: Plastic seal package labels contains date of manufacture,
and bulk package has a handwritten date of production applied
to the box.
Manufacturer: Johnny's Seafood Company Inc., Tacoma, Washington.
Recalled by: Manufacturer, by telephone beginning June 6, 1990.
Firm-initiated recall ongoing.
Distribution: Washington state, California, Minnesota, Arizona,
Florida, Virginia, Arkansas, Oregon, Hawaii, Tennessee.
Quantity: Firm estimates none remains on market.
Reason: Product was contaminated with Listeria monocytogenes.
----
-1-
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. (Class II recalls are listed when received by the
Press Office. Media reporters should contact the companies
involved to obtain the most current information on the
progress of recalls.)
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences. (Class II recalls are listed when
received by the Press Office. Media reporters should
contact the companies involved to obtain the most current
information of the progress of recalls.)
Product: Ground Coffee, packaged in 12 ounce metal cans, labeled
in part, "*** Cafe Molido * Yaucono Cafe Puro ***.
Recall #F-001-1.
Code: Not coded.
Manufacturer: X-Tra Super Food Centers, Pompano Beach, Florida.
Recalled by: Manufacturer, by letter May 29, 1990. Firm-initiated
recall ongoing.
Distribution: Florida.
Quantity: 211 cases were distributed.
Reason: Required label information is not in English.
----
NONE
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: 79 Rx products. Recall #D-001/079-1:
1. Acetazolamide 250 mg Tablets, used in treatment of
convulsive disorders and packaged in bottles containing
100, 250, 500 or 1,000 tablets, under the following
labels: Bolar, Qualitest, Purepac, H.L. Moore Drug Exchange,
Vita-Rx, Dixon-Shane, Baxter Healthcare, Genetco, Parmed,
Glenlawn, Best Generics, IDE-Interstate, Goldline, Harber
Pharmaceutical, Major Pharmaceutical, Rugby, Bioline;
-2-
Allopurinol, used to reduce the production of uric acid,
in bottles containing 100, 250, 500 or 1,000 tablets:
2. Allopurinol 100 mg Tablets under the following labels:
Bolar, Dixon-Shane, American Preferred, Vita-Rx, Parmed,
Genetco, Harber Pharmaceutical, Major Pharmaceutical, Best
Generics, H.L. Moore Drug Exchange, IDE-Interstate, Baxter
Healthcare, J.J. Balan, Lemmon, Rugby, Qualitest;
3. Allopurinol 300 mg Tablets, under the following
labels: Bolar, IDE-Interstate, Dixon-Shane, Harber
Pharmaceutical, Major Pharmaceutical, Best Generics, Parmed,
H.L. Moore Drug Exchange, American Preferred, Lemmon,
Genetco, Baxter Healthcare, Vita-Rx, J.J. Balan, Qualitest,
Squibb-Mark;
Chlorothiazide, a diuretic and antihypertensive,
in bottles containing 100, 250 or 1,000 tablets:
4. Chlorothiazide, 250 mg Tablets, under the following
labels: Bolar, Purepac, Geneva Generic, IDE-Interstate,
Genetco, Major Pharmaceutical, Best Generics, Parmed,
Glenlawn;
5. Chlorothiazide, 500 mg Tablets, under the following
labels: Bolar, Vita-Rx, Purepac, Geneva Generic, Parmed,
IDE-Interstate, Best Generics, Genetco, Major
Pharmaceuticals;
Chloropropamide, an antihyperglycemic, in bottles
containing 100, 250, 500 or 1,000 tablets:
6. Chlorpropamide, 100 mg Tablets, under the following
labels: Bolar Pharmaceutical, Major Pharmaceutical, Baxter
Healthcare, Genetco, IDE-Interstate;
7. Chlorpropamide, 250 mg Tablets, under the following
labels: Bolar Pharmaceutical, American Preferred, Quality
Research, Major Pharmaceutical, Best Generics, Baxter
Healthcare, IDE-Interstate, Genetco;
Chlorthalidone, an antihypertensive/diuretic, in bottles
containing 100, 250, 500 or 1,000 tablets:
8. Chlorthalidone, 25 mg, under the following labels:
Bolar, UDL, Mason Distributors, Harber Pharmaceutical,
Goldline, Major Pharmaceutical, Glenlawn, Bioline, Baxter
Healthcare, Dixon-Shane, H.L. Moore Drug Exchange;
9. Chlorthalidone 50 mg Tablets under the following labels:
Bolar Pharmaceutical, The Arkansas Cooperative Association,
UDL Laboratories, Glenlawn, Harber Pharmaceutical, Bioline,
Baxter Healthcare, Dixon-Shane, H.L. Moore Drug Exchange,
Goldline, Major Pharmaceutical, Mason Distributors;
Clonidine, an antihypertensive, in bottles containing
100, 250, 500 or 1,000 tablets:
10. Clonidine HCl, 0.1 mg Tablets, under the following
labels: Bolar, American Preferred Pharmaceutical, Best
Generics, Squibb-Mark; Major Pharmaceutical;
11. Clonidine HCl, 0.2 mg Tablets, under the following
labels: Bolar, Best Generics, American Preferred
Pharmaceutical, Major Pharmaceutical; Squibb Mark;
12. Clonidine HCl, 0.3 mg Tablets, under the following
labels: Bolar, Best Generics, American Preferred;
Major Pharmaceutical;
-3-
Dicyclomine HCl Capsules and Tablets, used to
treat gastrointestinal muscle spasms, in bottles
containing 100, 250, 500 or 1,000 tablets:
13. Dicyclomine HCl 10 mg Capsules, under the following
labels: Bolar, UDL, Harber Pharmaceutical, United Research
Laboratories, The Arkansas Cooperative Assoc., Genetco, C.S.
Ruckstuhl, Vita-Rx, Dixon-Shane, Rugby, Fiver, Schein, Major
Pharmaceutical, Geneva Generics, Goldline, Bioline, H.L.
Moore Drug Exchange, IDE-Interstate, Best Generics, Parmed,
Glenlawn, Qualitest Products, Squibb-Mark;
14. Dicyclomine HCl 20 mg, under the following labels:
Bolar, United Research Laboratories, IDE-Interstate,
Vita-Rx, Schein, Parmed, H.L. Moore Drug Exchange, Best
Generics, Bioline Laboratories, Geneva Generics, Rugby,
Dixon-Shane, UDL, Harber Pharmaceutical, Glenlawn, The
Arkansas Cooperative Assoc., Major Pharmaceutical,
Qualitest, Squibb-Mark;
15. Ergoloid Mesylates Sublingual 1 mg Tablets, used for
treatment of declining mental capacity related to aging,
packaged in bottles containing 100, 250, 500 or 1,000
tablets, under the following labels:
Bolar, Parmed, Major Pharmaceutical, Geneva Generics,
IDE-Interstate, H.L. Moore Drug Exchange, Glenlawn, Bioline,
The Arkansas Cooperative Assoc., UDL Laboratories,
Squibb-Mark;
Fluoxymesterone, used in men as replacement therapy
in conditions associated with a deficiency or absence of
endogenous testosterone and in women, used to treat metastic
mammary cancer, in bottles containing 100 tablets:
16. Fluoxymesterone 5 mg tablets under the Bolar label;
17. Fluoxymesterone, 10 mg Tablets, under the Bolar
and Purepac labels;
Fluphenazine HCl, used to control manifestations of
psychotic disorders, in bottles containing 100, 500 or
1,000 bottles:
18. Fluphenazine HCl 2.5 mg Tablets, under the following
labels: Bolar, Harber, Goldline, Bioline, Parmed, Lemmon,
Best Generics, H.L. Moore Drug Exchange, Genetco, United
Research Laboratories, Baxter Healthcare, Schein, Rugby
Major Pharmaceutical, Warner Chilcott;
19. Fluphenazine HCl, 5.0 mg Tablets under the
following labels: Bolar, Warner Chilcott, Goldline, United
Research Laboratories, Schein, Rugby, Lemmon, Glenlawn, J.J.
Balan, Genetco, Parmed, Best Generics, Baxter Healthcare,
Bioline, Harber, Major Pharmaceutical, H.L. Moore Drug
Exchange;
Guanethidine Monosulfate, an antihypertensive, in
bottles containing 100 or 500 tablets:
20. Guanethidine Monosulfate, 10 mg Tablets, under
-4-
the following labels: Bolar, H.L. Moore Drug Exchange,
Harber, Rugby, Schein;
21. Guanethidine Monosulfate, 25 mg Tablets, under the
following labels: Bolar, Goldline, H.L. Moore Drug
Exchange, Schein, Rugby;
Hydralazine HCl/Hydrochlorothiazide, an anti-
hypertensive-diuretic combination, in bottles
containing 100, 250, 500 or 1,000 capsules:
22. Hydralazine HCl/Hydrochlorothiazide, 25/25 mg
capsules under the following labels: Bolar, Qualitest,
IDE-Interstate, Rugby, Major Pharmaceutical, Best
Generics, Parmed, Genetco, H.L. Moore Drug Exchange,
Purepac, Harber;
23. Hydralazine HCl 50 mg/Hydrochlorothiazide 50 mg
Capsules, under the following labels: Bolar, Qualitest,
Harber, Genetco, H.L. Moore Drug Exchange, Purpac, Best
Generics, Rugby, Parmed, Major Pharmaceutical;
24. Hydralazine HCl 25 mg/Hydrochlorothiazide 15 mg
Capsules, under the following labels: Bolar, Qualitest,
H.L. Moore Drug Exchange, Bioline, Major Pharmaceutical,
Goldline, Schein Pharmaceutical, Rugby;
25. Hydrochlorothiazide 15 mg/Reserpine 0.1 mg/Hydralazine
25 mg, an antihypertensive-diuretic combination under
the following labels: Bolar, UDL, The Arkansas Cooperative
Assoc., C.S. Ruckstuhl Co., Geneva Generics, Lemmon,
Genetco, Glenlawn, Best Generics, Major Pharmaceutical,
Purepac;
Hydrochlorothiazide, an antihypertensive, in bottles
containing 100, 250, or 1,000 tablets
26. Hydrochlorothiazide 25 mg Tablets under the following
labels: Bolar, Major Pharmaceutical, Baxter Healthcare,
Best Generics, Glenlawn;
27. Hydrochlorothiazide, 50 mg Tablets, under the
following labels: Bolar, Goldline, Glenlawn, Major
Pharmaceutical, Baxter Healthcare, American Preferred;
28. Hydrochlorothiazide 100 mg Tablets, under the
following labels: Bolar, Geneva Generics, Glenlawn, Harber
Pharmaceutical, Parmed, H.L. Moore Drug Exchange, Schein,
Major Pharmaceutical, Rugby;
29. Hydrochlorothiazide 25 mg/Reserpine 0.125 mg Tablets,
under the following labels: Bolar, Parmed, Purepac, The
Arkansas Cooperative Assoc., H.L. Moore Drug Exchange,
Harber Pharmaceutical, United Research Laboratories,
Glenlawn, IDE-Interstate, Bioline, Wesley Pharmacal,
Qualitest, Vita-Rx, Major Pharmaceutical, Goldline,
Rugby;
Hydroxyzine Pamoate, used to relieve anxiety and tension
associated with pyschoneurosis, in bottles containing 100,
250, 500 or 1,000 capsules:
-5-
30. Hydroxyzine Pamoate 25 mg Tablets, under the following
labels: Bolar, The Arkansas Cooperative Assoc., Best
Generics, Harber Pharmaceutical, Genetco, IDE-Interstate,
American Preferred Pharmaceutical, Qualitest, Baxter
Healthcare, Parmed, Major Pharmaceutical, UDL Laboratories,
Purepac, Schein;
31. Hydroxyzine Pamoate 50 mg Capsules, under the following
labels: Bolar, The Arkansas Cooperative Assoc., Best
Generics, Genetco, IDE-Interstate, American Preferred
Pharmaceutical, Baxter Healthcare, Parmed, UDL Laboratories,
Purepac, Schein;
32. Hydroxyzine Pamoate 100 mg Capsules, under the
following labels: Bolar, Schein, Parmed Pharmaceuticals,
Major Pharmaceutical, Genetco, IDE-Interstate, UDL
Laboratories, Baxter Healthcare;
Imipramine, an antidepressant, in bottles containing
100, 250, or 1,000 tablets:
33. Imipramine HCl 10 mg SC Tablets, under the following
labels: Bolar, Harber Pharmaceutical, Purepac, Qualitest,
Goldline, Bock, Best Generics, Parmed, Glenlawn,
IDE-Interstate, Genetco, Schein, Major Pharmaceutical,
Rugby, H.L. Moore Drug Exchange, Squibb-Mark;
34. Imipramine HCl 25 mg SC Tablets, under the following
labels: Bolar, Glenlawn, Dixon-Shane, Goldline, Bioline,
Genetco, Major Pharmaceutical, Rugby, Harber, H.L. Moore
Drug Exchange, IDE-Interstate, Qualitest, American Preferred
Pharmaceutical, Bock Pharmaceutical, Purepac, Schein,
Parmed, Best Generics, Squibb-Mark, UDL Laboratories, Baxter
Healthcare;
35. Imipramine HCl 50 mg Tablets, under the following
labels: Squibb-Mark, Bolar, Qualitest, American Preferred
Pharmaceutical, Low-Gen Distributors, Bioline, Best
Generics, Glenlawn, Dixon-Shane, Harber Pharmaceutical,
Genetco, IDE-Interstate, H.L. Moore Drug Exchange, Parmed,
Schein, Purepac, Major, Rugby, Goldline;
Isosorbide Dinitrate, used to treat and prevent angina
pectoris, in bottles containing 100, 250 or 1,000 tablets:
36. Isosorbide Dinitrate 20 mg ER Tablets under the
following labels: Bolar, Bioline, Baxter Healthcare,
Parmed, Best Generics, Major Pharmaceutical, Goldline;
37. Isosorbide Dinitrate 40 mg ER Tablets, under the
following labels: Squibb-Mark, Qualitest, Bioline, Mason
Distributors, Baxter Healthcare, Parmed, Dixon-Shane,
Vita-Rx, IDE-Interstate, Genetco, Best Generics, Major
Pharmaceutical, Goldline;
38. Liothyronine Sodium 25 mg Tablets, used as supplemental
or replacement therapy for thyroid disorders, in bottles
containing 100 or 1000 tablets, under the
following labels: Bolar, Qualitest, Schein, Geneva
Generics, Fiver Corporation, Rugby, Major Pharmaceutical,
IDE-Interstate, H.L. Moore Drug Exchange;
-6-
39. Lithium Carbonate 300 mg Capsules, used in the
treatment of manic episodes of manic-depressive illness, in
bottles containing 100, 500 or 1,000 tablets, under the
following labels: Bolar, Lemmon, Schein, Glenlawn, Parmed,
Best Generics, IDE-Interstate, H.L. Moore Drug Exchange,
Genetco, Harber Pharmaceutical, Rugby, Squibb-Mark;
Methylclothiazide Tablets, an antihypertensive, in bottles
containing 100 or 1,000 capsules:
40. Methylclothiazide 2.5 mg Tablets under the following
labels: Bolar, Glenlawn, Parmed, H.L. Moore Drug Exchange,
Major Pharmaceutical, Rugby, Schein;
41. Methylclothiazide 5 mg Tablets, under the following
labels: Bolar, Qualitest, Glenlawn, IDE-Interstate, H.L.
Moore Drug Exchange, Goldline, Geneva Generics, Bioline,
Best Generics, Parmed, Schein, Major Pharmaceutical;
Oxtriphylline, a bronchodilator, in bottles containing
100, 500 or 1,000 tablets:
42. Oxtriphylline 100 mg Enteric Coated Tablets, under
the following labels: Bolar, IDE-Interstate, Harber, Mason
Distributors, H.L. Moore Drug Exchange, Genetco, Goldline,
Schein, Geneva Generics, Rugby, Bioline, Major
Pharmaceutical;
43. Oxtriphylline 200 mg EC Tablets, under the following
labels: Bolar, Qualitest, Harber, H.L. Moore Drug Exchange,
Genetco, Schein, Geneva Generics, Mason Distributors, Best
Generics, Bioline, IDE-Interstate, Parmed, Major
Pharmaceutical, Goldline, Rugby;
Pentaerythritol Tetranitrate, used in the relief of angina
pectoris, in bottles containing 100 or 1,000 tablets:
44. Pentaerythritol Tetranitrate 10 mg Tablets under
the following labels: Bolar, Qualitest, IDE-Interstate,
Major Pharmaceutical, Rugby, Goldline, H.L. Moore Drug
Exchange, Bioline;
45. Pentaerythritol Tetanitrate 20 mg Tablets, under
the following labels: Bolar, IDE-Interstate, Parmed,
Goldline, Major Pharmaceutical, Bioline, H.L. Moore
Drug Exchange, Rugby, Qualitest;
Perphenazine/Amitriptyline HCl, a psychotherapeutic agent,
in bottles containing 100, 500 or 1,000 tablets:
46. Perphenazine 2 mg/Amitriptyline 10 Tablets under
the following labels: Bolar, Vita-Rx, Parmed, Best Generics
Glenlawn, Genetco, Rugby, American Preferred Pharmaceutical,
Bioline, Goldline, Schein, Major Pharmaceutical, H.L.
Moore Drug Exchange, Squibb-Mark;
47. Perphenazine 2 mg/Amitriptyline 25 mg Tablets, under
the following labels: Bolar Pharmaceutical, Parmed,
Schein, Best Generics, American Preferred Pharmaceutical,
Genetco, Glenlawn, Bioline, Major Pharmaceutical, H.L.
Moore Drug Exchange, Vita-Rx, Rugby, Squibb-Mark;
-7-
48. Perphenazine 4 mg/Amitriptyline 10 mg Tablets, under
the following labels: Bolar, Parmed, Schein, Best
Generics, American Preferred Pharmaceutical, Genetco,
Glenlawn, Bioline, Major Pharmaceutical, H.L. Moore
Drug Exchange, Vita-Rx, Rugby, Goldine;
49. Perphenazine 4 mg/Amitriptyline 25 mg Tablets, under
the following labels: Bolar, Parmed, Schein, Best Generics,
American Preferred Pharmaceutical, Genetco, Glenlawn,
Bioline, Major Pharmaceutical, H.L. Moore Drug Exchange,
Vita-Rx, Rugby, Goldline;
50. Perphenazine 4 mg/Amitriptyline 50 mg Tablets, under
the following labels: Bolar, Major Pharmaceutical, H.L.
Moore Drug Exchange, Schein, Goldline, Best Generics, Parmed;
51. Primidone 250 mg Human Tablets, an anticonvulsant, in
bottles containing 100, 500 or 1,000 tablets, under the
following labels: Bolar, Qualitest, Geneva Generics,
Genetco, Dixon-Shane, UDL Laboratories, Parmed, H.L.
Moore Drug Exchange, Best Generics, Glenlawn, Bioline,
Goldline, Vita-Rx, IDE-Interstate, Rugby;
Procainamide HCl, used to treat ventricular arrhythmias, in
bottles containing 100, 250, 500 or 1,000 tablets:
52. Procainamide HCl 250 mg, under the following labels:
Bolar, Dixon-Shane, Glenlawn, Baxter Healthcare, UDL
Laboratories, IDE-Interstate, Parmed, H.L. Moore Drug
Exchange, Best Generics, Genetco, Harber;
53. Procainamide HCl 500 mg Capsules, under the
following labels: Bolar, Dixon Shane, Glenlawn, Baxter
Healthcare, UDL Laboratories, IDE-Interstate, Parmed,
H.L. Moore Drug Exchange, Best Generics, Genetco,
Harber;
Prochlorperazine Maleate, used to control severe nausea
and vomiting, management of psychotic disorders and
non-psychotic anxiety, in bottles containing 100, 250,
500 or 1,000 tablets:
54. Prochlorperazine Maleate 5 mg Tablets, under the
following labels: Bolar, Qualitest, Genetco, Best
Generics, IDE-Interstate, Glenlawn, Baxter Healthcare,
Dixon-Shane, Harber, Rugby, Major Pharmaceutical,
Bioline, Geneva Generics, Parmed, Schein, UDL Laboratories,
H.L. Moore Drug Exchange, Goldline;
55. Prochlorperazine Maleate 10 mg Tablets, under the
following labels: Bolar, Qualitest, Genetco, Best
Generics, IDE-Interstate, Glenlawn, Baxter Healthcare,
Dixon-Shane, Harber, Rugby, Major Pharmaceutical,
Bioline, Geneva Generics, Parmed, Schein, UDL
Laboratories, H.L. Moore Drug Exchange, Goldline, Vita-Rx;
56. Prochlorperazine Maleate 25 mg Tablets, under the
following labels: Bolar, UDL Laboratories, Harber, Geneva
Generics, Major Pharmaceutical, Rugby, H.L. Moore Drug
Exchange, Parmed;
-8-
57. Propoxyphene Napsylate, 100 mg/Acetaminophen 650 mg
Tablets, an analgesic in bottles containing 100, 500 and
1,000 tablets, under the following labels: Bolar, Major
Pharmaceutical, Warner Chilcott, Genetco, Schein, Parmed,
American Preferred Pharmaceutical, Rugby;
58. Quinidine Gluconate 324 mg ER Tablets, used to
prevent abnormal cardiac rhythms of the atria and
ventricles, in bottles containing 100, 250 and 500 tablets,
under the following labels: Bolar, Parmed, J.J. Balan,
H.L. Moore Drug Exchange, Vita-Rx, Major Pharmaceutical,
Harber, Purepac, Bioline, IDE-Interstate, Baxter Healthcare,
H & H Laboratories, Best Generics, Dixon-Shane, Goldline;
59. Spironolactone 25 mg Tablets, used to manage primary
hyperaldosteronism, congestive heart failure and/or
cirrhosis of the liver, in bottles containing 100, 250,
500 or 1,000 tablets, under the following labels:
Harber, Rugby, Bioline, IDE-Interstate, Baxter Healthcare,
Best Generics, UDL Laboratories, Goldline, C.S. Ruckstuhl,
Schein, Vita-Rx, Genetco, Major Pharmaceutical, American
Preferred Pharmaceutical, Qualitest Products, Bolar,
Parmed, H.L. Moore Drug Exchange, Glenlawn;
60. Spironolactone 25 mg/Hydrochlorothiazide 25 mg
Tablets, used to manage congestive heart failure, cirrhosis
of the liver and/or hypertension, in bottles containing 100,
250, 500 or 1,000 tablets, under the following labels:
Harber, Bioline, IDE-Interstate, Baxter Healthcare, Best
Generics, Goldline, Schein, Vita-Rx, Genetco, Major
Pharmaceutical, American Preferred Pharmaceutical,
Qualitest, Bolar, UDL Laboratories, H.L. Moore Drug
Exchange, Lemmon, Quality Research Pharmaceuticals, Arkansas
Cooperative Assoc., Parmed, Rugby;
Temazepam, used to relieve insomnia, in bottles
containing 100, 500 or 1000 capsules:
61. Temazepam 15 mg capsules, under the following
labels: Bolar, Genetco, American Preferred Pharmaceutical,
62. Temazepam 30 mg Capsules, under the following labels:
Bolar, Genetco, American Preferred Pharmaceutical,
Squibb-Mark;
Thioridazine Hydrochloride, used in management of
psychotic disorders, in bottles containing 100, 500, or
1,000 tablets:
63. Thioridazine HCl 10 mg tablets under the following
labels: Bolar, Goldline, Purepac, Glenlawn, UDL
Laboratories, Parmed, Bioline, Major;
64. Thioridazine HCl 15 mg Tablets, under the following
labels: Bolar, Major, Goldline, Glenlawn, UDL
Laboratories, Parmed, Bioline, Schein, H.L. Moore Drug
Exchange, Genetco, IDE-Interstate;
-9-
65. Thioridazine HCl 25 mg Tablets, under the following
labels: Bolar, Major, Goldline, Glenlawn, UDL, Parmed,
Bioline, Schein, H.L. Moore Drug Exchange, Genetco,
IDE-Interstate;
66. Thioridazine HCL 50 mg, under the following labels:
Bolar, Major, Goldline, Purepac, UDL Laboratories,
Parmed, Bioline, American Preferred Pharmaceutical,
Qualitest Products, Warner Chilcott;
67. Thioridazine HCl 100 mg Tablets, under the following
labels: Bolar Pharmaceutical, Major Pharmaceutical,
Goldline, Purepac, Glenlawn, UDL Laboratories, Parmed,
Bioline, American Preferred Pharmaceutical, Rugby;
68. Thioridazine HCl 150 mg Tablets, under the following
labels: Bolar, Major, Goldline, UDL Laboratories,
Parmed, Bioline, Schein, Genetco, H.L. Moore Drug Exchange,
Best Generics, Rugby;
69. Thioridazine HCl 200 mg Tablets, under the following
labels: Bolar, Major, Goldline, Purepac, UDL Laboratories,
Parmed, Bioline, Genetco, Schein, H.L. Moore Drug,
Exchange, Best Generics, Rugby;
70. Trichloromethiazide 4 mg Tablets, an antihypertensive
diuretic, in bottles containing 100, 500 or 1,000 tablets
under the following labels: Bolar, Qualitest, American
Preferred Pharmaceutical, American Urologicals, Geneva
Generics, Bioline, Goldline, H.L. Moore Drug Exchange;
Trifluoperazine HCl, used to manage manifestations of
psychotic disorders, in bottles containing 100, 500 or
1,000 tablets:
71. Trifluroperazine HCl 1 mg tablets, under the
following labels: Bolar, Baxter Healthcare, H.L. Moore
Drug Exchange, Parmed, Warner Chilcott, Bioline, Goldline;
72. Trifluoperazine HCl 2 mg Tablets, under the
following labels: Bolar, Baxter, H.L. Moore Drug Exchange,
Parmed, Warner Chilcott, Bioline, Goldline, Glenlawn;
73. Trifluoperazine HCl 5 mg Tablets, under the following
labels: Bolar, Baxter Healthcare, H.L. Moore Drug Exchange,
Parmed, Warner Chilcott, Bioline, Goldline, Glenlawn;
74. Trifluoperazine HCl 10 mg Tablets, under the following
labels: Bolar, Baxter Healthcare, H.L. Moore Drug Exchange,
Parmed, Warner Chilcott, Bioline, Goldline, Glenlawn;
Warfarin Sodium, an anticoagulant, in bottles containing
100, 250 or 100 tablets:
75. Warfarin Sodium 2 mg Tablets, under the following
labels: Bolar, Rugby, Best Generics, H.L. Moore Drug
Exchange, Genetco, Glenlawn;
76. Warfarin Sodium 2.5 mg tablets, under the following
labels: Bolar, Rugby, H.L. Moore Drug Exchange,
Best Generics, Genetco, IDE-Interstate, Glenlawn;
77. Warfarin Sodium 5 mg Tablets, under the following
labels: Bolar Pharmaceutical, Rugby, Best Generics,
H.L. Moore Drug Exchange, Genetco, Glenlawn,
Schein, Major, IDE-Interstate, Harber, Goldline, Parmed,
Bioline;
-10-
78. Warfarin 7.5 mg Tablets, under the following labels:
Bolar, Rugby, Best Generics, H.L. Moore Drug Exchange,
Genetco, Glenlawn, Major Pharmaceutical, Best Generics;
79. Warfarin Sodium 10 mg Tablets, under the following
labels: Bolar, Rugby, Best Generics, H.L. Moore Drug
Exchange, Genetco, Glenlawn.
Code: All unexpired lots.
Manufacturer: Bolar Pharmaceutical, Copiague, New York.
Recalled by: Manufacturer, by letter August 28, 1990. Firm-initiated
Recall ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: (1) 41,035,300; (2) 53,802,800; (3) 78,878,200;
(4) 5,912,000; (5) 12,788,600; (6) 5,815,500;
(7) 43,576,100; (8) 11,587,200; (9) 15,667,600;
(10) 9,227,000; (11) 6,140,400; (12) 1,445,300;
(13) 141,464,100; (14) 134,421,300; (15) 5,758,200;
(16) 241,400; (17) 1,127,200; (18) 3,971,200;
(19) 9,775,300; (20) 709,600; (21) 962,400;
(22) 13,678,200; (23) 3,912,200; (24) 3,833,500;
(25) 34,404,020; (26) 86,781,200; (27) 37,234,300;
(28) 2,935,600; (29) 9,490,800; (30) 16,672,000;
(31) 16,680,200; (32) 2,740,000; (33) 21,685,300;
(34) 106,647,500; (35) 97,058,600; (36) 41,093,100;
(37) 105,237,800; (38) 10,383,200; (39) 36,105,900;
(40) 3,857,100; (41) 29,073,100; (42) 1,839,600;
(43) 19,176,300; (44) 3,896,100; (45) 12,647,900;
(46) 9,895,000; (47) 20,027,900; (48) 3,448,500;
(49) 11,436,500; (50) 982,800; (51) 75,582,300;
(52) 11,717,700; (53) 9,731,800; (54) 17,604,000;
(55) 35,085,100; (56) 2,369,600; (57) 24,589,800;
(58) 126,185,000; (59) 117,366,100; (60) 78,153,100;
(61) 489,800; (62) 490,000; (63) 11,705,100;
(64) 4,911,900; (65) 19,199,100; (66) 12,330,000;
(67) 7,200,600; (68) 1,944,500; (69) 5,841,100;
(70) 13,859,700; (71) 955,400; (72) 1,938,600;
(73) 2,027,400; (74) 1,964,600; (75) 2,139,900;
(76) 1,939,300; (77) 14,816,200; (78) 949,200;
(79) 898,600 tablets/capsules were distributed.
Reason: Lack of assurance that the products were manufactured
in conformity with the conditions approved in the
Abbreviated New Drug Applications.
----
Product: Abbott Pentothal 1 g/2.5% Transfer Kit, (25 mg/ml)
Thiopental Sodium for Injection, USP, an Rx I.V.
anesthetic. Recall #D-081-1.
Code: Kit: 37-321-DK EXP 8/1/91,
Diluent: 37-345-DM EXP 2/1/92,
Pentothal: 39-261-DK EXP 4/1/92.
Manufacturer: Abbott Laboratories, Rocky Mount, North Carolina.
Recalled by: Abbott Laboratories, Abbott Park, Illinois, by
telephone and by letter September 23, 1990.
Firm-initiated recall ongoing.
-11-
Distribution: Nationwide, Puerto Rico.
Quantity: 70 cases were distributed; firm estimates 17 cases remain
on the market.
Reason: The kits contain a 200 ml size diluent instead of the
correct 40 ml size.
----
Product: URL brand Chlordiazepoxide Hydrochloride Capsules,
USP 10 mg, in 100 capsule bottles, an Rx drug used
for the management of anxiety disorders. Recall #D-084-1.
Code: Lot #4012-5 EXP 4/91.
Manufacturer: Pioneer Pharmaceuticals, Irvington, New Jersey.
Recalled by: Manufacturer, by telephone July 9, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 3,066 bottles were distributed; firm
estimates none remains on market.
Reason: A bottle labeled to contain 10 mg capsules contained
25 mg capsules.
----
Product: Lederle Laboratories brand Folic Acid Tablets, 1 mg,
in bottles of 100 and 1,000 tablets, and in unit dose
blister packs, an Rx drug indicated for the treatment of
megaloblastic anemias. Recall #D-085-1.
Code: All lots.
Manufacturer: Lederle Laboratories, Pearl River, New York.
Recalled by: Manufacturer, by letter on or about August 20, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide, Puerto Rico, Switzerland, Saudi Arabia.
Quantity: 78,343 bottles of 100 tablets, 2,494 bottles of 1,000
tablets, 31,038 unit dose packages containing 10 strips
of blister-packs were distributed; firm estimates only
small quantities may remain on market.
Reason: Potency not assured through expiration date.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered
Plasma. Recall #B-222/224-0.
Code: Unit numbers: (a) 9393566, (b) 9393566; (c) 1098736,
1099281, 1099290, 1099312, 5595555, 6091600.
Manufacturer: Oklahoma Blood Institute, Oklahoma City, Oklahoma.
Recalled by: Manufacturer, by telephone followed by letter
February 22, 1990. Firm-initiated recall ongoing.
Distribution: Oklahoma, California.
Quantity: (a) 1 unit; (b) 1 unit; (c) 6 units.
Reason: Blood components, collected from donors: 1) who
tested confirmed positive for syphillis or 2) with
a history of cancer or 3) with a previous hepatitis
exposure were distributed.
----
-12-
Product: (a) Whole Blood; (b) Red Blood Cells; (c) Platelets;
(d) Fresh Frozen Plasma; (e) Recovered Plasma.
Recall #B-018/022-1.
Code: Unit numbers: (a) 290596160; (b) 290766552, 290700124,
290813266, 290824840, 290876118;
(c) 290766552, 290700124, 290813266, 290824840, 290876118,
290855309; (d) 290700124; (e) 290766552.
Manufacturer United Blood Services, Chicago, Illinois.
Recalled by: Manufacturer, by letter August 1, 1990. Firm-initiated
recall ongoing.
Distribution: Blood and blood products were shipped to Illinois.
Recovered Plasma was shipped to North Carolina for
further processing.
Quantity: (a) 1; (b) 5; (c) 6; (d) 1; (e) 1 units.
Reason: Units, drawn from ineligible donors based on
repeatably reactive results for the antibody to the
human immunodeficiency virus (anti-HIV-1) or the antibody
to the human T-lymphotropic virus (anti-HTLV-I), were
distributed.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma; (d) Recovered Plasma. Recall #B-025/028-1.
Code: Unit numbers: (a) 02M77205-0, 02-86969-5;
(b) 02M61878-9, 02M77205-0, 02-86969-5;
(c) 02M61878-9; (d) 02M77205-0, 02-86969-5.
Manufacturer: Civitan Regional Blood Center, Inc., Gainesville, Florida.
Recalled by: Manufacturer, by telephone followed by letter
May 24, 1990. Firm-initiated recall ongoing.
Distribution: Florida, Illinois.
Quantity: (a) 2; (b) 3; (c) 1; (d) 2 units were distributed.
Reason: Blood components collected from an unsuitable donor
were distributed.
----
Product: Source Plasma. Recall #B-029-1.
Code: Unit #900918.
Manufacturer: Plasma Services, Division of Blood Systems, Inc.,
Denver, Colorado.
Recalled by: Manufacturer, by telephone July 10, 1989. Firm-
initiated recall complete.
Distribution: Austria.
Quantity: 1 unit was distributed and destroyed.
Reason: Unit testing repeatably reactive for hepatitis B
Surface antigen (HBsAg) was distributed.
----
-13-
Class III -
Product: (a) Fresh Frozen Plasma; (b) Recovered Plasma.
Recall #B-023/024-1.
Code: Unit numbers: (a) 290813266; (b) 290824840, 290876118,
290800932.
Manufacturer: United Blood Services, Division of Blood Systems, Inc.,
Chicago, Illinois.
Recalled by: Manufacturer, by letter August 27, 1990. Firm-initiated
recall complete.
Distribution: Illinois. The Recovered Plasma was shipped to North
Carolina for further processing.
Quantity: (a) 1 unit; (b) 3 units.
Reason: Units, drawn from ineligible donors based on
repeatably reactive results for the antibody to
the human T-lymphotropic virus (anti-HTLV-1) were
distributed.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Model ME 220 Electrical Neuromuscular Stimulator,
indicated for the treatment of pain, muscle spasm, and
other conditions. Recall #Z-883-0.
Code: Serial numbers: "59 PM 1" - "20": (20 devices),
"59 PP 2" - "14" & "16" - "23" (21 devices),
"69 IF "3" - "8", "10" - "13", "14" - "24", "26" - "44",
"46", "47", "49" - "67", "69" - "74", "76" - "93",
"95" - "98" & "100" (90 devices).
There are some gaps in the serial numbers, because they
were preissued and some were never used.
Manufacturer: Mettler Electronics Corporation, Anaheim, California.
Recalled by: Manufacturer, by telephone August 29, 1989 and by letter
August 30, 1989. Firm-initiated recall ongoing.
Distribution: California, Florida, Georgia, Illinois, Indiana,
Massachusetts, Maryland, Michigan, New Mexico, Missouri,
North Carolina, New York, Ohio, Pennsylvania, South
-14-
Carolina, Tennessee, Texas, Virginia, Washington state.
Quantity: 131 units were distributed.
Reason: An unintended intermittent transient output (surge) can
occur if a particular component tolerance condition
exists in the unit.
----
Product: Latex Condoms in retail and bulk packages as follows:
(a) Saxon Ultra-Thin Condoms (contoured);
(b) Saxon Wet-Lubricated condoms (uncontoured);
(c) Saxon Spermicidal with Nonoxynol (uncontoured);
(d) Gold Circle Coin Condoms (non-lubricated)
(uncontoured);
(e) Embrace Condoms, (colored, contoured).
Recall #Z-911/915-0.
Code: All product manufactured prior to 7/1/90.
Manufacturer: Safetex Corporation, Colonial Heights, Virginia.
Recalled by: Manufacturer, by letter the week of June 18, 1990.
FDA requested recall ongoing.
Distribution: Nationwide, Mexico, Canada.
Quantity: Approximately 80,000 to 100,000 gross were distributed.
Reason: Products failed FDA leak test.
----
Product: Replacement Temperature Probe, for Air-Shields C-100
Incubators, P78-1 Infant Warmers, or intensive care
bassinet. Recall #Z-019-1.
Code: Catalog #K20970.
Manufacturer: Dale Electronics Inc., El Paso, Texas.
Recalled by: L-Med Inc., Danbury, Connecticut, by telephone
February 1, 1990. Firm-initiated recall ongoing.
Distribution: Pennsylvania, California.
Quantity: 50 units were distributed.
Reason: The device may react with the probe cover and gel
to cause a chemical reaction which may irritate the
patient's skin.
----
CORRECTION: Recall #Z-909/910-0 which appeared in the October 3, 1990
Enforcement Report should read:
Product: (a) Angiographic P5.0B, DP5.0B Catheters 5.0
French; (b) Pert-5.0B Bulk Tubing.
----
Class III -
NONE
VETERINARY PRODUCTS
NONE