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
10/28/1992
RECALLS AND FIELD CORRECTIONS: October 28, 1992
FOODS -- CLASS I
92-44
PRODUCT Sandwiches and salad products under the Made-Rite, ARA
Services, Canteen, Industrial Vendors, Servomatic Vending,
Southern Vending, and Tri Star Food Services labels:
1. All Beef Burger, 4 ounces;
2. All Beef Burger Lettuce and Tomato, 4.25 ounces;
3. All Beef Cheeseburger, 4 ounces;
4. American Cheese Toast, 2.75 ounces;
5. BBQ Chicken, 4 ounces;
6. BBQ Pork, 4 ounces;
7. BBQ Pork with Slaw, 4 ounces;
8. BBQ Rib, 5 ounces;
9. Bacon Cheeseburger, 4.5 ounces;
10. Baked Ham and Cheese, 5.5 ounces;
11. Bologna and Cheese Triangle, 4 ounces;
12. Cheeseburger Lettuce and Tomato, 4.5 ounces;
13. Chef Salad, 6 ounces;
14. Chicken Filet, 4 ounces;
15. Chicken Salad, 4 ounces;
16. Chicken Salad Multi Grain, 4 ounces;
17. Chicken Salad Toast, 3 ounces;
18. Chicken with Bread, 4.5 ounces;
19. Double Charbroil Cheese, 6 ounces;
20. Double Stacker, 6 ounces;
21. Egg Salad, 4.25 ounces;
22. Egg Salad Multi Grain, 4.25 ounces
23. Fish Sandwich, 3.5 ounces;
24. Fish with Cheese, 4 ounces;
25. Foot Long Hot Dog, 6.25 ounces;
26. Foot Long with Chili Cheese, 7 ounces;
27. Fried Bologna and Cheese, 3.75 ounces;
28. Fried Chicken with Bread, 4.5 ounces;
29. Ham Salad Multi Grain, 3 ounces;
30. Ham Salad Triangle, 3 ounces;
31. Ham and Cheese, 5 ounces;
32. Ham and Cheese Bun, 3.5 ounces;
33. Ham and Cheese Croissant, 4 ounces;
34. Ham and Cheese Mayonnaise, 3.75 ounces;
35. Ham and Cheese Mayonnaise Multi Grain, 3.25 ounces;
36. Ham and Cheese Multi Grain, 4 ounces;
37. Ham and Cheese Toast Lettuce and Tomato, 4 ounces;
38. Ham and Cheese on Toast, 3.5 ounces;
39. Ham and Swiss Multi Grain, 3.25 ounces;
40. Ham on Bun, 3.75 ounces;
41. Hoagie Charbroil, 8 ounces;
42. Hoagie Junior, 5.25 ounces;
43. Hot Dog Plain, 3 ounces;
44. Hot Dog with Chili, 3 ounces;
45. Hot Dog with Slaw, 3 ounces;
46. Hot Frank, 3 ounces;
47. Hot Frank and Cheese, 3 ounces;
48. Jello, 5.0 ounces;
49. Jumbo Barbecue, 5.5 ounces;
50. Large BBQ Beef, 4.25 ounces;
51. Large Charbroil, 4.5 ounces;
52. Large Charbroil Cheese, 5 ounces;
53. Large Charbroil Cheese Lettuce & Tomato, 5.5 ounces;
54. Lettuce and Tomato (salad), 1.5 ounces;
55. Lettuce Tomato Onion (salad), 1.5 ounces;
56. Mini Charbroil, 4 ounces;
57. Mini Charbroil Cheese, 4 ounces;
58. Peanut Butter and Jelly, 2.75 ounces;
59. Philly Steak, 5.5 ounces;
60. Pimento Cheese, 3 ounces;
61. Pimento Cheese Multi Grain, 3 ounces;
62. Polish Sausage, 4 ounces;
63. Poor Boy, 7.5 ounces;
64. Poor Boy Jr., 3 ounces;
65. Quarter Pound Cheese, 5 ounces;
66. Roast Beef Multi Grain, 3 ounces;
67. Roast Beef Triangle, 3 ounces;
68. Roast Beef and Cheddar, 4.75 ounces;
69. Salad, no weight;
70. Sloppy Joe, 3.5 ounces;
71. Small Charbroil, 3.5 ounces;
72. Small Charbroil Cheese, 3.75 ounces;
73. Smoked Sausage, 4.5 ounces;
74. Submarine, 5 ounces;
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75. Tuna Salad Multi Grain, 4 ounces;
76. Tuna Salad Triangle, 4 ounces;
77. Tuna Salad on Rye, 3 ounces;
78. Turkey Club, 3.25 ounces;
79. Turkey Club Multi Grain, 4 ounces;
80. Turkey Club on Wheat, 3.25 ounces;
81. Turkey Salad on Multi Grain, 4 ounces;
82. Turkey Triangle, 3 ounces;
83. Twin Dog, 7 ounces. Recall #F-001/083-3.
CODE All products bearing a use-by date or pull date of OCT 13 or
before.
MANUFACTURER Made-Rite Sandwich Company, Inc., Ooltewah, Tennessee.
RECALLED BY Manufacturer, by press release September 25, 1992, by telephone
beginning September 25, 1992 and by letter dated September 28,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Arkansas, Georgia, Kentucky, Mississipi, North
Carolina, South Carolina, Tennessee, Virginia.
QUANTITY Undetermined.
REASON Products contain Listeria monocytogenes.
PRODUCT Dynasty Szechwan Chili Sauce, in 6.5 ounce glass containers.
Recall #F-090-3.
CODE All codes containing letters H or X and the codes N216 or less.
MANUFACTURER Beaverton Foods, Inc., Beaverton, Oregon.
RECALLED BY JFC International, Inc., S. San Francisco, California, by
letter August 26, 1992. Firm-initiated recall ongoing.
DISTRIBUTION California, Georgia, Illinois, Maryland, New York.
QUANTITY 6,656 cases (12 units/case) were distributed.
REASON Potential for Clostridium botulinum toxin outgrowth.
PRODUCT Air Dried, Salt Cured, Uneviscerated Vobla Fish, packed in
wooden crates each containing 48 pounds. Recall #F-095-3.
CODE None.
MANUFACTURER Vao Sovrybflot, Moscow, Russia.
RECALLED BY Razin International, Inc., Howell, New Jersey, by telephone and
letter August 26, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide, predominately New York City.
QUANTITY 200 wooden crates were distributed.
REASON Potential Clostridium botulinum toxin hazard.
PRODUCT Royal Baltic brand Hot Smoked Mackerel, air packed loose in
cardboard boxes. Recall #F-098-3.
CODE "E" product packed on Aug. 5, 1992.
MANUFACTURER Royal Baltic, Ltd., Brooklyn, New York.
RECALLED BY Manufacturer, by letter on or about September 24, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 12 cartons were distributed; firm estimates none remains on the
market.
REASON Product contains Listeria monocytogenes.
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PRODUCT Garden-fresh Foods brand Mustard Potato Salad, in 8 pound
cartons. Recall #F-099-3.
CODE Product with EXP date of 9/29.
MANUFACTURER Garden-fresh Foods, Inc., Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by letter September 11, 1992, and the Wisconsin
Department of Agriculture issued a press release September 11,
1992. Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY Approximately 270 8-pound cartons (90 cases) were distributed.
REASON Product contains Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
UPDATE Recall #F-089-3, Maybelline 175M-01, Great Lash Mascara Very
Black, which appeared in the October 14, 1992 Enforcement
Report should read:
CODE Lot 2H209 with the letters 2BV on the bottom of the bottle.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Various Rx injectable drug products manufactured by Lyphomed
Div. of Fujisawa USA, Inc:
Dacarbazine for Injection, USP, 10 mg/ml when reconstituted, a
Rx anti-neoplastic: (a) 100 mg single dose vial;
(b) 200 mg single dose vial;
Droperidol Injection, USP, 2.5 mg/ml, a Rx tranquilizer;
(c) Single dose vials, no preservatives, 2 ml and 5 ml;
(d) Multiple dose vials, Preservatives added. 10 ml.
Recall #D-020/023-3.
CODE All lots within expiration date.
MANUFACTURER Lyphomed, Div. of Fujisawa USA, Inc., Melrose Park, Illinois.
RECALLED BY Manufacturer, by letter September 21, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION (a & b) Nationwide, India, Chile, Peru, Malta, Ecuador, Ireland;
(c & d) Nationwide, Hong Kong, Uruguay, Nicaragua, Peru and the
Bahamas.
QUANTITY Firm estimates: (a & b) 35,347 vials; (c & d) 196,151 vials
remain on the market.
REASON ANDA discrepancies.
PRODUCT Various Rx injectable drug products manufactured by Lyphomed
Div. of Fujisawa USA, Inc.:
(a) Aminophylline Injection, USP, 25 mg/ml, for the relief of
acute bronchial asthma, in 10 ml vials, 20 ml vials;
(b) Atropine Sulfate Injection, USP, 0.4 mg/ml, an
anticholinergic drug, in 20 ml vials;
(c) Atropine Sulfate Injection, USP, 1 mg/ml; an
anticholinergic drug;
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(d) Bacteriostatic Water for Injection, USP; for drug diluent
use only, not for use in newborns; 30 ml vials, with methyl &
propylparabens, and with benzyl alcohol;
(e) Calcium Gluconate Injection, USP, 10%; for treatment of
conditions arising from calcium deficiencies; 10 ml vials;
(f) Lidocaine Hydrochloride Injection, USP, 4% (40 mg/ml), a
local anesthetic for infiltration and nerve block, not for
spinal, epidural or intravenous regional anesthesia, in 50 ml
vials;
(g) Lidocaine Hydrochloride Injection, USP, 2% (20 mg/ml), a
local anesthetic for infiltration and nerve block, not for
spinal, epidural or intravenous regional anesthesia, in 5 ml
vials;
(h) Lidocaine Hydrochloride Injection, USP, 1% (10 mg/ml), a
local anesthetic for infiltration and nerve block, not for
spinal, epidural or intravenous regional anesthesia, 2 ml vials;
(i) Mannitol Injection, USP, 25% (250 mg/ml), for intravenous
use for the promotion of diuresis, and for urologic irrigation
in transurethral prostatic resection, in 50 ml vials, for
irrigation and for injection;
(j) Neostigmine Methylsulfate Injection, USP, 0.5 mg/ml, for
the symptomatic control of myasthenia gravis when oral therapy
is impractical, in 10 ml vials;
(k) Sodium Chloride Injection, USP, Concentrated, 23.4%, an
additive in parenteral fluid therapy for use in patients who
have special problems of sodium electrolyte intake or
excretion, in 30 ml vials;
(l) Sodium Chloride Injection, USP, 0.9%; for diluting or
dissolving drugs for intravenous, intramuscular or subcutaneous
injection, in 100 ml vials;
(m) Sterile Cefazolin Sodium, USP, 1 gram; a semisynthetic
cephalosporin antibiotic for parenteral administration for the
treatment of serious infections due to susceptible organisms;
(n) Sterile Water for Injection, USP; for diluting or
dissolving drugs for intravenous, intramuscular or subcutaneous
injection, in glass vials: 5 ml vials, 50 ml vials, 100 ml
vials; in plastic vials: 10 ml vials, 50 ml vials.
Sold also under the Alpha Therapeutics Corporation label;
(o) Heparin Sodium Injection, USP, 1,000 USP units/ml, for
intravenous or deep subcutaneous administration for
anticoagulant therapy for prevention and treatment of blood
clots, in 10 ml vials;
(p) Heparin Sodium Injection, USP, 10,000 USP units/ml, for
intravenous or deep subcutaneous administration for
anticoagulant therapy for prevention and treatment of blood
clots, in 1 ml vials;
(q) Phenytoin Sodium Injection, USP, 50 mg/ml, for the control
of grand mal seizures and prevention and treatment of seizures
occurring during neurosurgery, in 5 ml vials;
(r) Dextrose Injection, USP, 50%; for treatment of severe
hypoglycemia due to overdosage of insulin, in 50 ml vials.
Recall #D-024/041-3.
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CODE (a) 10 ml: lot #311167, 311198
20 ml: lot #301440
(b) lot #320218, 320126
(c) lot #311331, 320425
(d) lot #311188, 320514, 320521, 320520, 320189, 320190
(e) lot #310987, 311175, 311202, 311203
(f) lot #320234
(g) lot #320228, 320509
(h) lot #320770
(i) lot #320005, 300282
(j) lot #310948
(k) lot #320118
(l) lot #300726, 311125, 311270, 300388, 320778
(m) lot #320593
(n) 5 ml glass: lot #320539
50 ml glass: lot #310291
100 ml glass: lot #300732, 300960, 300961, 300963, 310659
10 ml plastic: lot #311182
50 ml plastic: lot #320573
25 ml. private label: lot #310869
(o) lot #320585
(p) lot #310706
(q) lot #311115, 320489
(r) lot #320833.
MANUFACTURER Lyphomed, Division of Fujisawa USA, Inc., Grand Island, New York
RECALLED BY Fujisawa USA, Inc., also known as Lyphomed, Melrose Park,
Illinois.
DISTRIBUTION Nationwide, United Arab Emirates, The Bahamas, Singapore,
Palau, Nicaragua, Hong Kong, Malta.
QUANTITY Estimated vials to remain on market
(a) 8,270; (b) 3,968; (c) 11,904; (d) 114,867; (e) 10,155;
(f) 3,280 (g) 22,959; (h) 10,204; (i) 1,380; (j) 658;
(k) 4,020; (l) 4,532; (m) 695 (n) 14,918; (o) 7,260;
(p) 23,450; (q) 8,520; (r) 3,200.
REASON Improper vial seal crimp results in a lack of assurance of
sterility of the products.
PRODUCT Omnipaque Injection (Iohexol): (a) 300 mg Iodine/ml, 150 ml;
(b) 240 mg Iodine/ml, 50 ml and 100 ml; (c) 350 mg Iodine/ml,
50 ml, an opaque aqueous solution used for intrathecal
intravascular and oral body cavity contrast enhancement for
computerized tomography. Recall #D-042/044-3.
CODE Lot numbers: (a) B822JJ; (b) B826JJ (50 ml), B823JJ (100 ml);
(c) B832JJ.
MANUFACTURER Sterling Pharmaceuticals, Inc., Barceloneta, Puerto Rico.
RECALLED BY Sterling Winthrop, New York, New York, by memorandum on or
about September 9, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 3,364 boxes (10 units per box) were distributed.
REASON Presence of trace quantities of ethylene glycol due to a
manufacturing equipment failure.
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PRODUCT Erythromycin Estolate Oral Suspension USP, 250 mg, in 16 ounce
bottles, a Rx antibiotic. Recall #D-048-3.
CODE Lot #03582 EXP 11/92.
MANUFACTURER Barre-National, Inc., Baltimore, Maryland.
RECALLED BY Manufacturer, by letter September 29, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates 576 units remain on the market.
REASON Subpotency.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Calmol 4, OTC Hemorrhoidal Suppositories. Recall #D-045-3.
CODE Lot numbers: A511 EXP 1/96, A521 EXP 1/96, B511 EXp 2/96, B521
EXP 2/96, J511 EXP 10/96, J521 EXP 10/96, J531 EXP 10/96.
MANUFACTURER The Mentholatum Company, Inc., Buffalo, New York.
RECALLED BY Manufacturer, by letter on or about October 15, 1992, followed
by telephone. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 55,032 cartons (12 or 24 per carton, 12 cartons per case) were
distributed; FDA estimates 500 cartons remain on the market.
REASON Carton label not in compliance with labeling provisions of
regulation for anorectal products.
PRODUCT Reseau Formula Tii, EDTA for oral chelation therapy, in 60 and
120 capsule bottles. Recall #D-046-3.
CODE All lots.
MANUFACTURER North West Marketing Company, Pacoima, California.
RECALLED BY Reseau International, Cincinnati, Ohio (responsible firm), by
letter on or about October 17, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada, Bermuda.
QUANTITY 2,445 120-capsule size bottles, and 147 60-capsule size bottles
were distributed.
REASON Product marketed without new drug approval.
PRODUCT M-End Liquid, in 16 ounce bottles, a Rx product.
Recall #D-047-3.
CODE Lot #13563.
MANUFACTURER Barre-National, Inc., Baltimore, Maryland.
RECALLED BY Manufacturer, by telephone September 17, 1992, followed by
letter September 29, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Tennessee.
QUANTITY 10,128 units were distributed.
REASON Product subpotent for phenindamine tartrate ingredient.
-7-
PRODUCT Pat Duer Diuretic Tablets, an herbal product, in plastic
bottles of 90 and 250 tablets. Recall #D-049-3.
CODE 103792 EXP 12/93.
MANUFACTURER Fibertone/Patten, also known as Naturally Vitamin supplements,
Scottsdale, Arizona.
RECALLED BY Manufacturer, by letter August 14, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION California, Illinois, Oregon, Texas, Utah, Washington state.
QUANTITY 37 bottles of 90 tablets each and 37 bottles of 250 tablets
each were distributed.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Platelets. Recall #B-021-3.
CODE Unit numbers: 19GG28494, 19GG28497, 19GG28499, 19GG28501,
19GG30244, 19GG30246, 19GG30249, 19R98696, 19R98699, 19R98703,
19R98704, 19R98706.
MANUFACTURER American Red Cross, Blood Services, Tennessee Valley Region,
Paducah Location, Paducah, Kentucky.
RECALLED BY Manufacturer, by telephone October 25, 1991 , and April 27,
1992, and by letters of October 29, 1991, and April 30, 1992.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 12 units.
REASON Blood products labeled with incorrect expiration dates were
distributed.
PRODUCT Red Blood Cells. Recall #B-022-3.
CODE Unit #53KM26426.
MANUFACTURER American Red Cross Blood Services, The Greater Chesapeake and
Potomac Region, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter August 29, 1991. Firm-initiated recall
complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit.
REASON Blood product collected from an ineligible donor was
distributed.
PRODUCT Hepatitis B Immune Globulin (Human). Recall #B-023-3.
CODE Lot numbers: 16U01A, 16U01AB, 16U02A, 16U02B, 16U03A.
MANUFACTURER Miles, Inc., Berkeley, California.
RECALLED BY Manufacturer, by letter dated April 11, 1991. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 20,431 vials were distributed; firm estimates none remains on
the market.
REASON Hepatitis B Immune Globulin (Human), exhibiting decreased
potency during the dating period, was distributed.
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PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Platelets;
(d) Cryoprecipitated AHF; (e) Fresh Frozen Plasma;
(f) Recovered Plasma. Recall #B-024/029-3.
CODE (a) 1622664;
(b) 1016116, 1018348, 1018977, 1021893, 1025998, 1026625,
1027544, 1030565, 1031471, 1032471, 1033657, 1033968,
1034695, 1034884, 1188268, 1191135, 1259425, 1266544,
1276657, 1278026, 1319307, 1330260, 1338542, 1347882,
1410689, 1617740, 1635043, 1666995, 1674038, 1698176,
1701775, 1817030, 2019049, 3507270, 3508402, 5005999,
5008016, 7011661, 7147660, 7169206, 7208841, 7213804,
7220549, 7268836, 7314817, 7415004, 7234157, 7420863,
9502931, 9503110, 7168155
(c) 1016116, 1018348, 1018977, 1021893, 1030565, 1031471,
1032471, 1033657, 1033968, 1034695, 1034884, 1188268,
1191135, 1259425, 1266544, 1276657, 1278026, 1330260,
1338542, 1347882, 1410689, 1617740, 1635043, 1666995,
1701775, 1817030, 3507270, 3508402, 7011661, 7147660,
7169206, 7208841, 7213804, 7220549, 7234157, 7268836,
7314817, 7415004, 7420863
(d) 1016116, 1025998, 1027544, 1032471, 1674038, 7208841,
7314817
(e) 1018348, 1033968, 1191135, 1259425, 1276657, 1278026,
1338542, 1347882, 1617740, 1635043, 5005999, 7213804,
7220549, 7268836, 7415004, 7420863
(f) 1018977, 1021893, 1030565, 1031471, 1032471, 1034884,
1188268, 1410689, 1666995, 1674038, 1701775, 1817030,
3507270, 3508402, 7011661, 7147660, 7169206, 7234157,
1016616, 1025998, 1026625, 1266544, 1319307, 1330260,
1698176, 2019049, 5008016, 7314817, 9502931, 9503110
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by letters of April 28, 1992, May 4, 7, 12, 18,
and 27, 1992, June 5 and 10, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Illinois, Iowa, Arizona, Washington, D.C., Florida, California.
QUANTITY (a) 1 unit; (b) 51 units; (c) 39; (d) 7 units; (e) 16 units;
(f) 30 units. Firm estimates none of the products remain on
the market.
REASON Blood products, which tested negative for all viral markers,
but were collected from donors who previously tested repeatedly
reactive for either the antibody to hepatitis C virus encoded
antigen (anti-HCV) or the antibody to human immunodeficiency
virus type 1 (anti-HIV-1), were distributed.
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-030/031-3.
CODE Unit numbers: 2190496, 2190536, 2207478.
MANUFACTURER Department of the Army, Camp Memorial Hospital Blood Center,
Fort Knox, Kentucky.
RECALLED BY Manufacturer, by letters of October 24, 1991, November 4, 1991,
and February 7, 1992, and by telephone August 19, 1992.
Firm-initiated recall ongoing.
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DISTRIBUTION Massachusetts, Kentucky, Florida.
QUANTITY 3 units of each component.
REASON Blood products, which tested repeatedly reactive for the
antibody to hepatitis C virus encoded antigen (anti-HCV) or
tested negative for the antibody to human immunodeficiency
virus type 1 (anti-HIV-1), but were collected from a donor who
previously tested repeatedly reactive for anti-HIV-1, were
distributed.
PRODUCT Platelets. Recall #B-035-3.
CODE Unit #J15043.
MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, Iowa.
RECALLED BY Manufacturer, by telephone August 3, 1992. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON The labeling accompanying the distributed blood product
contained the incorrect expiration date.
PRODUCT Red Blood Cells. Recall #B-036-3.
CODE Unit numbers: 40FE95327, 40GL43783.
MANUFACTURER American Red Cross Blood Services, Heart of America Region,
Peoria, Illinois.
RECALLED BY Manufacturer, by letter June 1, 1992. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 2 units.
REASON Blood component shipped at unacceptable temperatures was
distributed.
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated AHF.
Recall #B-038/040-3.
CODE Unit #KM14767.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter July 22, 1992. Firm-initiated recall
complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component.
REASON Blood products, which tested repeatedly reactive for the
antibodies to the human immunodeficiency virus type-1 and 2
(anti-HIV-1/2), were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT (a) Whole Blood; (b) Red Blood Cells. Recall #B-001/002-3.
CODE Unit numbers: (a) 626500; (b) 609984, 620235.
MANUFACTURER North Colorado Medical Center and Blood Bank, Greeley, Colorado;
Belle Bonfils Memorial Blood Center, Denver, Colorado.
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RECALLED BY Belle Bonfils Memorial Blood Center, Denver, Colorado, by
telephone September 12 and 23, 1991. Firm-initiated recall
complete.
DISTRIBUTION Colorado.
QUANTITY (a) 1 unit; (b) 2 units.
REASON Blood products labeled with incorrect expiration dates, were
distributed.
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-033/034-3.
CODE Unit numbers: (a) 105532, 106894; (b) 105532.
MANUFACTURER Blood Bank of Alaska, Anchorage, Alaska.
RECALLED BY Manufacturer, by telephone March 24, 1992, and by memorandum
dated March 27, 1992. Firm initiated recall complete.
DISTRIBUTION California, Alaska.
QUANTITY (a) 2 units; (b) 1 unit.
REASON Blood products collected from a donor who took antimalarial
prophylaxis were distributed.
PRODUCT Red Blood Cells. Recall #B-037-3.
CODE Unit numbers: 40LH00458, 40LH00459, 40LH00460, 40LH00463,
40LH00464, 40LH00465.
MANUFACTURER American Red Cross Blood Services, Heart of America Region,
Peoria, Illinois.
RECALLED BY Manufacturer, by letters of May 19, 27, and 28, 1992.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 6 units.
REASON Blood component labeled with incorrect expiration dates was
distributed.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
PRODUCT Organic Iodine '20' (EDDI), in 25 pound pails. Recall #V-004-3.
CODE Lot #50-1422.
MANUFACTURER Forage Research, Inc., Clarksdale, Missouri.
RECALLED BY Manufacturer, by letter June 17, 1992. Firm-initiated recall
complete.
DISTRIBUTION Texas.
QUANTITY 40 pails were distributed.
REASON Unapproved new animal drug.
INJUNCTION:
PRODUCT Liquid injectable silicone (also known as polydimethyl-
siloxane and PDS) (92-663-574).
CHARGE: The product is a class III medical device which does not
have in effect the required approved premarket approval
application or investigational device exemption.
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DEFENDANTS Richard B. Aronsohn, M.D., an individual and a corporation,
Los Angeles, California.
FILED May 7, 1992, Complaint; September 21, 1992, Consent Decree
of Permanent Injunction; U.S. District Court for the Central
District of California; Civil #CV 92 2780 WJR (LEX);
INJ 1279.
SEIZURES:
PRODUCT NEOVET Neomycin Sulfate for oral or topical use
(92-598-217).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the product's manufacture, processing,
packing, and holding do not conform to and are not operated
and administered in conformity with current good
manufacturing practice regulations.
FIRM Rx Veterinary Products, Kansas City, Missouri.
FILED October 5, 1992; U.S. District Court for the Western
District of Missouri, Western Division; Civ. #92-0891-CV-
W-6; FDC #66604.
SEIZED October 16, 1992 - goods valued at approximately $5,940.
PRODUCT Nolatrim-75 Phenylpropanolamine Hydrochloride Timed Release
Capsules (92-630-655).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the product's manufacture, processing,
and holding do not conform to and are not operated and
administered in conformity with current good manufacturing
practice regulations.
Misbranded - The product's label fails to contain the
correct place of business of the distributor.
FIRM Wesley Pharmacal Company, Ivyland, Pennsylvania.
FILED September 22, 1992; U.S. District Court for the Eastern
District of Pennsylvania; Civil #92CV5491; FDC #66601.
SEIZED September 28, 1992 - 93 bottles, valued at approximately
$2,697.
PRODUCT Calcium pangamate tablets (92-607-526).
CHARGE Adulterated - The product contains the food additive,
N,N-dimethylglycine, which is unsafe because there is no
regulation in effect prescribing the conditions under which
the additive may be safely used.
FIRM General Nutrition Corporation, Inc., Leetsdale,
Pennsylvania.
FILED June 5, 1992 - U.S. District Court for the Western
District of Pennsylvania; Civil #92-1388; FDC #66377.
SEIZED June 29, 1992 - goods valued at approximately $3,775.
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PRODUCT Sterile Latex Surgical Gloves (92-610-446).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the product's manufacture, packing, and
storage are not in conformity with current good
manufacturing practice regulations.
FIRM American Pro Latex, Inc., Monmouth, Illinois.
FILED October 14, 1992; U.S. District Court for the Central
District of Illinois; Civil #92-1453; FDC #66461.
SEIZED October 15, 1992 - goods valued at approximately $80,155.
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END OF ENFORCEMENT REPORT FOR OCTOBER 28, 1992. BLANK PAGES MAY
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