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
03/12/1991
FDA Enforcement for the week of MARCH 13, 1991
FDA ENFORCEMENT REPORT
FOR MARCH 13, 1991
PART I
March 13, 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.
Product: Cheese and Sour Cream Products, packed in 7 ounce, 13 ounce,
14 ounce, 16 ounce and bulk packages:
1. Queso Panela under Rancho Grande, Vaquero and
El Mexicano labels;
2. Queso Fresco under Rancho Grande, Vaquero, El Mexicano,
and El Centro Americano labels;
3. Crema Mexicana under Rancho Grande, Vaquero,
and El Mexicano labels;
4. Queso Tipo Rancho under Rancho Grande label;
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5. Queso Cotija under Rancho Grande, Vaquero, and
El Mexicano labels;
6. Queso Enchilado under Rancho Grande and El Mexicano
labels;
7. Menonita under Rancho Grande label;
8. Requeson under Rancho Grande, El Mexicano, El
Centro Americano;
9. Monterey Jack under Rancho Grande, El Mexicano labels;
10. Crema Agria Mexicana under El Mexicano label;
11. Queso Anejo under El Mexicano label;
12. Queso Chihuahua under El Mexicano label;
13. Queso Oaxaca under El Mexicano label;
14. Queso Crema under El Mexicano and El Centro Americano
label;
15. Queso Fresco Casero under El Mexicano and Casero
labels;
16. Baby Jack Cheese under El Mexicano label;
17. Caujada under El Mexicano and El Centro Americano
labels;
18. Queso Adobera under El Mexicano label;
19. Queso Duro Blandito under El Centro Americano label;
20. Queso Seco Porso under El Centro Americano label;
21. Queso Chontaleno under El Centro Americano label;
22. Crema Centro Americana, Grade A Sour Cream under El
Centro Americano label;
23. Crema Centro Americana, Grade A Heavy Cream under
El Centro Americano label. Recall #F-228-1.
Code: All weights, all packages types and all codes produced
prior to November 5, 1990.
Manufacturer: Marquez Brothers, Mexican Imports Inc., San Jose,
California.
Recalled by: Manufacturer, by press release November 5, 1990 and by
letter November 6, 1990. Firm-initiated recall ongoing.
Distribution: California, Arizona, Oregon, Washington state, Idaho,
Nevada.
Quantity: Approximately one half million pounds of cheese were
distributed;
Reason: Products are contaminated with Listeria monocytogenes.
----
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: Triguisar, an ethnic cooking seasoning, granular, in
0.7 and 2.47 ounce bottles, used when cooking meats and
chicken. Recall #F-230-1.
Code: Not coded.
Manufacturer: Triguisar de Columbia, Ltda, Medellin, Columbia.
-2-
Recalled by: Cooperativa Latino Americana, Inc., Hialeah, Florida,
(importer), by visits and letter mailing to be
completed by February 15, 1991. Firm-initiated recall
ongoing.
Distribution: Florida, New York.
Quantity: 3,024 .7 ounce units and 1,872 2.47 ounce units
were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Various food colors and flavors:
(a) Imitation Lemon Flavor;
(b) Lemon Flavor Emulsions;
(c) Imitation Butter Flavor;
(d) Butter Flavor Emulsion;
(e) Imitation Pineapple Flavor;
(f) Pineapple Flavor Emulsion;
(g) Imitation Banana Flavor;
(h) Banana Flavor Emulsion;
(i) Imitation Lime Flavor;
(j) Lime Flavor Emulsion;
(k) Imitation Pina Colada Flavor;
(l) Pina Colada Flavor Emulsion;
(m) Leaf Green Color;
(n) Egg Shade Color;
(o) Bright Yellow Color. Recall #F-231/245-1.
Code: Not coded.
Manufacturer: Flayco Products, Inc., Tampa, Florida.
Recalled by: Manufacturer. Firm-initiated recall ongoing.
Distribution: Florida, Puerto Rico.
Quantity: 320 1 gallon and 2,400 1 quart containers were distributed.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Kraft pourable salad dressings in 8 fluid ounce glass
bottles:
1. Kraft French Dressing
2. Kraft Russian Dressing
3. Kraft Creamy Garlic Dressing
4. Kraft Buttermilk Ranch Dressing
5. Kraft Buttermilk Ranch Reduced Calorie Dressing
6. Kraft Rancher's Choice Ranch Dressing
7. Kraft Rancher's Choice Ranch Reduced Calorie Dressing
8. Kraft Chunky Blue Cheese Dressing
9. Kraft Creamy Cucumber Dressing
10. Kraft Thousand Island & Bacon Dressing
11. Kraft Creamy Italian Reduced Calorie Dressing
12. Kraft Creamy Italian Dressing
13. Kraft Red Wine Vinegar & Oil Dressing
14. Kraft Zesty Italian Dressing
15. Kraft Presto Italian Dressing
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16. Kraft Caesar & Golden Caesar Dressing
17. Kraft Bacon & Tomato Reduced Calorie Dressing
18. Kraft Bacon & Tomato Dressing
19. Kraft Catalina French Dressing
20. Kraft Coleslaw Dressing
21. Kraft Thousand Island Dressing
22. Kraft Oil & Vinegar Dressing
23. Kraft Zesty Italian Reduced Calorie Dressing
24. Kraft Roka Blue Cheese Dressing
25. Kraft Roka Blue Cheese Reduced Calorie Dressing
26. Kraft French Reduced Calorie Dressing
27. Kraft Creamy Cucumber Reduced Calorie Dressing
28. Kraft Chunky Blue Cheese Reduced Calorie Dressing
29. Kraft Oil-Free Italian Dressing
30. Kraft House Italian Dressing
31. Kraft House Italian Reduced Calorie Dressing
32. Kraft Caesar Reduced Calorie Dressing
33. Kraft Free Catalina Nonfat Dressing.
Recall #F-246/278-1.
Code: Best when used by dates:
1. AUG 10 91A, AUG 11 91A, OCT 6 91A, OCT 7 91A,
OCT 14 91A, OCT 21 91A
2. OCT 7 91A, OCT 20 91A, OCT 21 91A
3. AUG 2 91A, OCT 6 91A
4. SEP 16 91A, OCT 11 91A
5. JUL 7 91A, AUG 16 91A, AUG 17 91A, SEP 11 91A
6. JUL 23 91A, OCT 4 91A, OCT 11 91A, OCT 12 91A
7. SEP 6 91A, SEP 9 91A
8. JUL 4 91A, JUL 19 91A, AUG 10 91A, SEP 13 91A,
9. JUL 20 91A, AUG 24 91A, SEP 16 91A, OCT 4 91A, OCT 5 91A,
OCT 12 91A
10. AUG 2 91A, SEP 17 91A, OCT 21 91A, OCT 22 91A
11. JUL 25 91A, AUG 16 91A, AUG 17 91A, SEP 19 91A,
SEP 20 91A
12. AUG 24 91A, SEP 15 91A, OCT 6 91A, OCT 12 91A,
OCT 13 91A, OCT 20 91A
13. AUG 9 91A, OCT 5 91A
14. AUG 9 91A, AUG 10 91A, AUG 23 91A, OCT 5 91A,
OCT 19 91A
15. AUG 2 91A
16. AUG 2 91A, AUG 10 91A, AUG 23 91A, SEP 15 91A
OCT 5 91A, OCT 19 91A
17. JUN 21 91A, AUG 18 91A, SEP 22 91A
18. JUL 21 91A, AUG 2 91A, AUG 11 91A, SEP 17 91A, OCT 22 91A
19. AUG 16, 91A, SEP 16 91A, OCT 7 91A, OCT 15 91A
OCT 21 91A
20. JUL 20 91A, AUG 10 91A, OCT 20 91A
21. JUL 20 91A, JUL 21 91A, SEP 16 91A, SEP 17 91A
OCT 7 91A, OCT 8 91A
22. OCT 15 91A
23. JUL 11 91A, JUL 24 91A, JUL 25 91A
24. JUL 19 91A, AUG 10 91A, SEP 13 91A, SEP 23 91A
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25. JUN 3 91A, JUN 4 91A, JUN 19 91A, JUL 11 91A, AUG 14 91A
AUG 23 91A
26. SEP 14 91A, SEP 21 91A
27. JUL 25 91A, AUG 17 91A, SEP 4 91A, SEP 12 91A
28. MAY 20 91A, JUL 15 91A
29. OCT 18 91A, OCT 19 91A
30. SEP 15 91A, OCT 5 91A
31. AUG 16 91A, SEP 15 91A
32. SEP 6 91A
33. AUG 15 91A, AUG 16 91A
Manufacturer: Kraft General Foods, Inc., Decatur, Georgia.
Recalled by: Kraft USA Operations Group, Kraft General Foods, Inc.,
Northbrook, Illinois, by letter January 31, 1991.
Firm-initiated recall ongoing.
Distribution: Southeastern United States, including Alabama, Florida,
Georgia, Kentucky, Louisiana, Maryland, Mississippi,
North Carolina, South Carolina, Tennessee, Virginia,
Washington, D.C.
Quantity: 198,567 cases (12 bottles per case) were distributed;
firm estimates 15,774 cases remain on the market.
Reason: Products are contaminated with glass.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Proformane High Energy Carbohydrate Sports Drink, in
16 ounce and 1 liter clear plastic bottles,
(a) Lemon-Lime; (b) Orange; (c) Grape; (d) Fruit Punch
flavors. Recall #F-049/052-1.
Code: Lot numbers: HG90K, HN90M, HH90L.
Manufacturer: Arcadia Dairy Farms, Inc., Arden, North Carolina.
Recalled by: Jim Bags, Inc., doing business as Proformance, Charlotte,
North Carolina, by letter December 14, 1990. Firm-initiated
recall ongoing.
Distribution: North Carolina, South Carolina, Florida.
Quantity: (a) 56,400 bottles; (b) 61,980 bottles; (c) 62,044 bottles;
(d) 72,844 bottles were distributed.
Reason: Product contains mold.
----
Product: Fruit flavored carbonated soft drinks in 10 ounce and
23 ounce glass bottles: (a) Tropical Orange;
(b) Cranberry Orchard; (c) Wild Berry; (d) Golden
Grapefruit. Recall #F-279/282-1.
Code: All lot numbers with the letter "A" (1990 production)
at the end of the code sequence.
Manufacturer: Tropicana Products, Inc., Bradenton, Florida.
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Recalled by: Manufacturer, by press release January 11, 1991
followed by FAX. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: (a) 54,143 cases (23 oz), 67,857 cases (10 oz);
(b) 60,892 cases (23 oz), 85,576 cases (10 oz),
21,091 bulk 10 oz. bottles;
(c) 63,048 cases (23 oz), 91,453 cases (10 oz),
20,794 bulk 10 oz bottles
(d) 42,062 cases (23 oz), 63,408 cases (10 oz)
28,777 bulk 10 oz. bottles were distributed.
Reason: Yeast contamination.
----
Product: Original Hawaiian Punch in 2 liter plastic bottles.
Recall #F-284-1.
Code: Lot #L060D02.
Manufacturer: Pepsi-Cola Metropolitan Co., Inc., McKeesrocks,
Pennsylvania.
Recalled by: Manufacturer, by visit January 11, 1991. Firm-initiated
recall complete.
Distribution: Pennsylvania.
Quantity: 1,600 cases (8 bottles/case) were distributed.
Reason: Product has an off taste.
----
Product: Kellogg's brand Rice Krispies Rice Cereal, in 10 ounce,
13 ounce, 19 ounce and 13/16 ounce boxes and in 5/8 ounce
individual serving vendor bowls. Recall #F-285-1.
Code: Better if used before dates of July 23, 1991,
July 24, 1991; July 25, 1991; July 26, 1991, and
July 27, 1991. The use by date is followed by
"MA---" or "MB---" or "MC---".
Manufacturer: Kellogg Company, Memphis, Tennessee.
Recalled by: Kellogg Company, Battle Creek, Michigan, by telex/
overnight letter August 3, 1990 followed by visit.
Firm-initiated recall ongoing.
Distribution: South Carolina, North Carolina, Georgia, Florida,
Tennessee, Kentucky, Virginia, Alabama, West Virginia,
Missouri, Texas, Louisiana, Arizona, Mississippi,
Puerto Rico.
Quantity: Product code Weight Cases shipped
00512 10 oz. 400 (12 boxes/case)
00514 10 oz. 45 (12 boxes/case)
00522 13 oz 1,153 (12 boxes/case)
00524 13 oz. 446 (24 boxes/case)
00530 19 oz. 490 (12 boxes/case)
00572 13/16 oz. 1,712 (72 boxes/case)
00596 5/8 oz. 353 (96 boxes/case)
5472 13/16 oz. 2,563 (72 packs of assorted
cereals).
Reason: Product has an off-taste.
----
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COSMETICS
NONE
MEDICAL DEVICES AND RADIOLOGY
Class I -
CORRECTION: St. Jude Medical Aortic Expanded Cuff Heart Valve,
Recall #Z-211-1, which appeared in the March 6, 1991
Enforcement Report should read:
Reason: Mitral Heart Valves were labeled as being
Aortic Heart Valves.
----
Class II -
Product: MOX-100 DCM Disposable Organ Preservation Cassette, a
sterile, single use, receptacle for transporting kidneys
to be used as implanted organs. Recall #Z-205-1.
Code: Lot 226 - Used before July 1991; Lot 227 - Used before
September 1991.
Manufacturer: Waters Instruments, Inc., Rochester, Minnesota.
Recalled by: Manufacturer, by telephone and by letter September 18
and 25, 1990. Firm-initiated recall ongoing.
Distribution: Alabama, California, Connecticut, Florida, Illinois,
Indiana, Massachusetts, Missouri, Ohio, Wisconsin.
Quantity: 155 cassettes were distributed; firm estimates 68 unused
cassettes remain on the market.
Reason: Parts of the cassette pump were made from plastic which
did not meet firm's specifications.
----
Product: Anaerosphere - Anaerobic Environmental Device, a completely
self-contained device designed to generate an anaerobic
atmosphere in a 2.5 liter chamber. Recall #Z-257-1.
Code: Catalog #4361204 - Lot numbers and EXP dates:
005045 5/17/91; 004043 2/4/91; 003114 3/28/91; 003037
2/3/91; 003036 2/26/91; 002035 2/16/91; 002034 2/8/91;
001034 1/26/91; 001033 1/11/91; 912024 12/14/90; 911051
11/29/90; 909011 9/28/90; 908912 7/31/90; 908011 8/01/90.
Manufacturer: Becton Dickinson Microbiological Systems, El Paso, Texas.
Recalled by: Becton Dickinson Microbiological Systems, Cockeysville,
Maryland, by letter July 13, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide and international.
Quantity: 6,493 units were distributed.
Reason: The firm has received complaints that ranged from the
catalyst basket melting off to incidents of exploding in
anaerobic jars.
----
-7-
Product: Various surgical trays containing Littauer and Sharp
Blunt Scissors:
(a) Product No. 41-311, Suture Removal Set with
Littauer Scissors;
(b) Product No. 41-320, Suture Removal Set with
Sharp/Blunt Scissors;
(c) Product No. 09-9005, Suture Removal Set with
Wetproof Inner Wrap Littauer Scissors and
Forceps;
(d) Product No. 09-9016, Incision and Drainage
Set with Sharp/Blunt Scissors, Forceps #11
Scalpel, Kelly Hemostat;
(e) Product No. 09-9017, Incision and Drainage
Set with Sharp/Blunt Scissors, Forceps and
#11 Scalpel;
(f) Product No. 09-9018, Laceration Set with
Sharp/Blunt Scissors, Tissue Forceps and
Needle Holder. Recall #Z-287/292-1.
Code: Lot numbers: (a) 210121, 208243, 209121;
(b) 21121; (c) 211514, 211543, 209534, 210569;
(d) 211567, 210569; (e) 211505;
(f) 211567, 210569, 211505.
Manufacturer: Professional Medical Products, Inc., Ocala, Florida.
Recalled by: Manufacturer, by letter December 17, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 42,390 trays were distributed.
Reason: Surgical trays were assembled using scissors subject
to Recalls Z-089/092-1. A reddish-brown greasy
residue may form on the surface when the instruments
are ETO sterilized.
----
Product: Software Version 3.1 for Sophy Cameras DS7 and DSX.
Recall #Z-293/294-1.
Code: Software version 3.1 updated to 3.1(2) used in DS7
and DSX model cameras.
Manufacturer: Sopha Medical Systems, Columbia, Maryland.
Recalled by: Manufacturer, by letters to field representatives
June 30, 1990 with subsequent visit to customers.
Firm-initiated field correction ongoing.
Distribution: Nationwide.
Quantity: 322 cameras were distributed.
Reason: A software program problem allows tomographic
comparison images to be displayed for side-by-side
comparison as Stress/Stress images (a comparison with
itself) rather than Stress/Redistribution (a comparison
with resting state) images.
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Product: Weck Electrosurgical Pencils, sterile, a component
of Johnson & Johnson Medical Surgical Packs:
(a) Model No. CMH051F;
(b) Model No. CMH071F;
(c) Model No. CMH11IF;
(d) Model No. CMH031F;
(e) Model No. MI14MA;
(f) Model No. MI16MA;
(g) Model No. MI15MA;
(h) Model No. HHCO1HK;
(i) Model No. CHLA16LAC. Recall #Z-295/303-1.
Code: Defective pencils are coded 809275 and 809276,
but are assembled into Johnson & Johnson sterile surgical
trays Model numbers CMH051F, CMH071F, CMH11IF, CMH031F,
MI14MA, MI16MA, MI15MA, HHC01HK, CHLA16LAC.
Manufacturer: Edward Weck, Inc., Research Triangle Park,
North Carolina (component).
Recalled by: Johnson and Johnson Medical, Inc., Tampa, Florida, by
letter September 25, 1990. Firm-initiated recall complete.
Distribution: Florida, Alabama, Kansas, California.
Quantity: 2,856 packs were distributed with the suspect pencils.
Reason: A post within the switch mechanism of the Weck Electro-
Surgical Pencil may become deformed by the elevated
temperatures of ethylene oxide sterilization. This
deformation may result in the switch not deactivating
(current not cut off) and/or activation of the pencil with
minimal applied force.
----
Product: Various Surgical Kit Trays, made as custom trays for
individual hospital accounts. Recall Z-310-1.
Code: There are 324 catalog numbers which include 544
different out of sequence lot numbers. These numbers
reflect production with the defective pouch from 7/31/90
through 10/10/90.
Manufacturer: Johnson and Johnson Medical Inc., also known as
Sterile Design, Tampa, Florida.
Recalled by: Manufacturer, by letter October 11 and 13, 1990.
Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: 19,800 packs were distributed.
Reason: The pouches may be defective and may not permit ETO
penetration and proper venting. This may result in
non-sterile surgical tray components being packaged in
a container labeled as "sterile".
----
-9-
Product: McGaw/Nutrilipid Mixing Containers, used to mix and
intravenously administer medications to the patient:
(a) Catalog No. S9910-02, 1 liter;
(b) Catalog No. S9911-02, 500 ml;
(c) Catalog No. S9915-02, 2 liters;
(d) Catalog No. S9916-02, 3 liters;
(e) Catalog No. S9940-02, 1 liter;
(f) Catalog No. S9941-02, 500 ml;
(g) Catalog No. S9945-02, 2 liters;
(h) Catalog No. S9946-02, 3 liters. Recall #Z-334/341-1.
Code: All lot numbers with the first three digits reading:
"FOD", "FOE", "FOH", "FOJ" and "FOK". The lot number is
printed on the 4 unit box in blue ink.
Manufacturer: McGaw of Puerto Rico, Inc., Sabana Grande, Puerto Rico.
Recalled by: McGaw, Inc., formerly Kendall McGaw, Irvine, California,
by letter dated September 11, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide, Puerto Rico, Canada, Saudi Arabia.
Quantity: 199,280 units were distributed.
Reason: The plastic clips, packaged with the mixing containers,
may not adequately close off the tubing after solution
transfer and potentially may allow fluid to leak out of
the container.
----
Product: Rate-Mate IV Administration Set, product #6432,
used in conjunction with the Rate-Minder IV Volumetric
Controller. Recall #Z-342-1.
Code: Lot #900926.36.
Manufacturer: Hanggi Manufacturing, Inc., Cupertino, California
(defective component).
Recalled by: Critikon, Inc., Tampa, Florida, by telephone and by
letter November 6, 1990. Firm-initiated recall complete.
Distribution: Connecticut, California, Maryland, Florida, Indiana,
Kansas, Arizona, Virginia, Tennessee, Texas.
Quantity: 167 cases (50 units/case) were distributed.
Reason: Some of the white Rate-Clip regulators, when in the closed
position, do not completely shut off the IV fluid flow.
When the Rate-Minder IV Volumetric controller is on, the
device will alarm "check IV set" but IV fluid may continue
to flow. When the device is off, uncontrolled drops may
flow and no alarm will sound. When the sets are used
outside the device as gravity sets, uncontrolled drops may
also occur.
----
Product: Intrasite Hydrocolloid Wound Dressing, single use,
labeled as sterile, in three different sizes:
(a) Product No. 7427 - 10x10cm;
(b) Product No. 7428 - 15x15cm;
(c) Product No. 7429 -20x20cm. Recall #Z-353/355-1.
-10-
Code: All lots.
Manufacturer: Hospicare, Ltd., County Sligo, Ireland (sterilizer).
Recalled by: Smith & Nephew United, Inc., Largo, Florida, by
telephone December 20, 1990 followed by letter January
15, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 298,448 units were distributed.
Reason: The product is or may be non-sterile, as a Bacillus
organism was isolated in one product lot.
----
CORRECTION: Tomographic Tablet used for all Sopha camera systems,
Recall #Z-284-1 which appeared in the February 27, 1991
Enforcement Report should read:
Quantity: 121 tables were affected.
----
Class III -
NONE
VETERINARY PRODUCTS
Class I -
NONE
Class II -
NONE
Class III -
Product: Pyrantel Pamoate Tablets, Purina dog wormer tablets,
113.5 mg, in 2 tablet and 4 tablet packages, for oral
use for the removal of ascarids and hookworms in dogs
and puppies. Recall #V-056-1.
Code: Lot #900024.
Manufacturer: Purina Mills, Inc., Bridgeton, Missouri.
Recalled by: Purina Mills, Inc., St. Louis, Missouri, by letter
December 19, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 310 cases (12 two tablet boxes/case) and 324 cases
(12 four tablet boxes/case) were distributed.
Reason: Product failed stability testing. Product exceeded
limits for pyrantel pamoate and was below limits for
hardness.
----
-11-
Seizure Actions Filed:
Product: Various Herbs packed in bulk and in gelatin capsules
intended for use in the treatment of a wide range of
diseases, including diabetes, tumors, asthma, impotence,
and arthritis. (89-576-907).
Charge: Products are unapproved new drugs and their labeling lacks
adequate directions for use.
Firm: Soolim Ltd., Chicago, Illinois.
Filed: February 20, 1991 - U.S. District Court for the
Northern District of Illinois, Eastern Division;
Civil #91C0995, FDC 65812.
----
-12-
FDA ENFORCEMENT REPORT PART II - HUMAN DRUGS AND BIOLOGICS
March 13, 1991
Recalls and Field Corrections:
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Fibercin Timed Release Niacin Caplets, an OTC product,
each 4 caplets contains: guar gum 3000 mg, niacin 500 mg,
in bottles of 84 and 360 caplets. Recall #D-213-1.
Code: Lot numbers 03945 and 03943 EXP 10/91.
Manufacturer: Approved Pharmaceutical Corporation, Syracuse, New York
(repacker).
Recalled by: Repacker, by telephone January 15, 1991 followed by
letter on or about February 18, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 2,493 of the 84 caplet bottles and 920 of the 360
caplet bottles were distributed.
Reason: Product marketed without new drug approval.
----
-1-
Product: Rx small volume parenterals, of various strengths and sizes.
Recall #D-215/271-1.
Product Name Potency Product No.
1. Acetylcysteine Solution, USP 10% 935-04
10% 935-30
2. 20% 936-04
20% 936-10
20% 936-30
3. Azathioprine Sodium For Inj., USP 100 mg/vial 227-20
4. Bacitracin, USP (Sterile) 10,000 u/vial 309-20
5. 50,000 u/vial 310-50
6. Biotrace 4C 011-02
012-10
7. Biotrace 4R 010-03
010-10
8. Biotrace 5C 014-02
9. Biotrace 5R 013-10
10. Chorionic Gonadotropin For Inj., USP 10,000 u/vial 411-10
11. Chromic Chloride Inj., USP 4 mcg/mL 007-10
12. Clindamycin Phosphate Inj., USP 150 mg/mL 327-02
150 mg/mL 327-05
150 mg/mL 327-10
150 mg/mL 327-60
13. Cupric Sulfate 0.4 mg/mL 003-10
14. Dacarbazine For Inj., USP 200 mg/vial 205-30
15. Doxycycline Hyclate For Inj., USP 100 mg/vial 301-15
16. Droperidol Inj., USP 2.5 mg/mL 508-02
2.5 mg/mL 510-10
17. Erythromycin Lactobionate (Sterile) 500 mg/vial 306-15
18. 1,000 mg/vial 308-30
19. Floxuridine, USP (Sterile) 500 mg/vial 231-10
20. Fluorouracil Inj., US 50 mg/mL 217-20
50 mg mL 217-50
21. Fluphenazine Decanoate Inj. 25 mg/mL 907-05
22. Glucagon For Inj., USP 1 unit/vial 435-03
23. Glycopyrrolate Inj., USP 0.2 mg/mL 506-01
0.2 mg/mL 506-02
24. Gold Sodium Thiomalate Inj., USP 50 mg/mL 923-02
25. Kanamycin Sulfate Inj., USP 75 mg/2 mL 303-02
26. 500 mg/ 2 ml 304-02
27. 1 g/3 mL 305-05
28. Ketamine Hydrochloride Inj., USP 10 mg/mL 514-30
29. 100 mg/mL 516-05
30. Leucovorin Calcium For Inj. 50 mg/vial 241-10
31. 100 mg/vial 242-20
32. Manganese Sulfate Inj., US 0.1 mg/mL 005-10
33. Methotrexate Sodium Inj., USP 25 mg/mL 207-05
25 mg/mL 207-10
25 mg/mL 207-15
25 mg/mL 207-20
34. Methylprednisol One Sodium 40 mg/vial 401-03
-2-
35. Succinate Inj., USP 125 mg/vial 402-05
36. 500 mg/vial 403-20
37. Metocurine Iodide Inj., USP 2 mg/mL 512-20
38. Nandrolone Decanoate Inj., USP 100 mg/mL 415-02
39. 200 mg/mL 416-02
40. Nitroglycerin Inj., USP 5 mg/mL 608-05
5 mg/mL 608-10
41. Pancuronium Bromide Inj. 1 mg/mL 525-10
42. Pralidoxime Chloride, USP (Sterile) 1 g/vial 944-20
43. Prochlorperazin Edisylate Inj., USP 5 mg/mL 939-10
44. Protamine Sulfate For Inj., USP 50 mg/vial 604-10
45. Protamine Sulfate Inj., USP 10 mg/mL 605-05
10 mg/mL 605-30
46. Sodium Iodide Inj. 1 g/10 mL 828-10
47. Sodium Thiosulfate Inj., USP 10 % 915-10
48. Sulfamethoprim 80mg/mL 16mg/mL 312-05
80mg/mL 16mg/mL 312-10
80mg/mL 16mg/mL 312-30
80mg/mL 16mg/mL 312-50
49. Trifluoperazine Hydrochloride Inj., USP 2 mg/mL 951-10
50. Tubocurarine Chloride Inj., USP 3 mg/mL 511-10
51. Vancomycin Hydrochloride, USP (Sterile) 500 mg/vial 329-10
52. 1,000 mg/vial 330-20
53. Verapamil Hydrochloride Inj. 5 mg/2 mL 603-02
54. 10 mg/mL 603-04
55. Vinblastine Sulfate Inj. 1 mg/mL 202-20
1 mg/mL 202-30
56. Vincristine Sulfate Inj., USP 1 mg/mL 200-05
57. Zinc Sulfate Inj., USP 1 mg/mL 001-10
(Private label distributors: Adria Laboratories, Columbus,
Ohio for Fluorouracil Inj., USP and Methotrexate Sodium
Inj., USP; Rugby Laboratories, Rockville Centre, NY for
Fluphenazine Decanoate Inj.)
Code: Lot Number EXP Date Vial Size
1. 935J19 5/91 4 cc
935J29 7/91 4 cc
935J43 10/91 4 cc
935J18 5/91 30 cc
2. 936J19 5/91 4 cc
936J43 10/91 4 cc
936J14B 4/91 10 cc
936K01 1/92 10 cc
936J14A 4/91 30 cc
936J47 11/91 30 cc
3. 227J36 9/91 20 cc
4. 309J45 11/91 20 cc
5. 310J09C 3/91 30 cc
310J11A 3/91 30 cc
310J11B 3/91 30 cc
310J12A 3/91 30 cc
310J12B 3/91 30 cc
310J14A 4/91 30 cc
310J14B 4/91 30 cc
-3-
310J14C 4/91 30 cc
310J15A 4/91 30 cc
310J15B 4/91 30 cc
310J16C 4/91 30 cc
310J16D 4/91 30 cc
310J16E 4/91 30 cc
310J18A 4/91 30 cc
310J18B 5/91 30 cc
310J19A 5/91 30 cc
310J19B 5/91 30 cc
310J21A 5/91 30 cc
310J28A 7/91 30 cc
310J28B 7/91 30 cc
310J30A 7/91 30 cc
310J30B 7/91 30 cc
310J31A 8/91 30 cc
310J31B 8/91 30 cc
310J31C 8/91 30 cc
310J32A 8/91 30 cc
310J32B 8/91 30 cc
310J35A 8/91 30 cc
310J35B 8/91 30 cc
310J37A 9/91 30 cc
310J37B 9/91 30 cc
310J41A 10/91 30 cc
310J41B 10/91 30 cc
310J44 11/91 30 cc
6. 011J42 10/92 2 cc
012J42 10/92 10 cc
7. 010H19 5/91 6 cc
010H21 5/91 10 cc
010J43 10/92 10 cc
8. 014J42 10/92 2 cc
9. 013J45 11/92 10 cc
10. 411J42 4/91 10 cc
11. 007J46 11/92 10 cc
12. 327K03 7/91 2 cc
327J50 6/91 5 cc
327J48 5/91 10 cc
327J51 6/9 60 cc
13. 003H19 5/91 10 cc
14. 205J46A 5/91 30 cc
205J46B 5/91 30 cc
15. 301H35 3/91 15 cc
301H38 3/91 15 cc
301J43A 10/91 15 cc
301J43B 10/91 15 cc
16. 508J37 3/91 2 cc
510J36 3/91 10 cc
17. 306J33 8/91 15 cc
-4-
308J33A 8/91 30 cc
308J33B 8/91 30 cc
308J33C 8/91 30 cc
18. 306J42A 10/91 15 cc
306J42B 10/91 15 cc
308J44B 10/91 30 cc
19. 231J20 5/91 10 cc
231K02 1/92 10 cc
20. 217J43B 4/91 10 cc
217J43A 4/91 60 cc
217K03 7/91 60 cc
(N077)
21. 907J41 4/91 10/91 5 cc
22. 435J40A 4/91 3 cc
435J40B 4/91 3 cc
435J45 5/91 3 cc
435J51 6/91 3 cc
23. 506J48 5/91 2 cc
506J47 5/91 2 cc
24. 923J41 4/91 2 cc
25. 303J18 11/91 2 cc
26. 304J02 7/91 2 cc
305H41 4/91 5 cc
27. 305J08 8/91 5 cc
305J22 12/91 5 cc
28. 514J34 8/91 30 cc
29. 516J46 11/91 5 cc
516K04 1/92 5 cc
30. 241J10 3/91 10 cc
241J16A 4/91 10 cc
241J17 4/91 10 cc
241J31 8/91 10 cc
241J36 9/91 10 cc
241J51 12/91 10 cc
31. 242J09 3/91 20 cc
242J10A 3/91 20 cc
242J13B 3/91 20 cc
242J13C 3/91 20 cc
242J14 4/91 20 cc
242J15 4/91 20 cc
242J17A 4/91 20 cc
242J17B 4/91 20 cc
242J19 5/91 20 cc
242J20 5/91 20 cc
242J22A 5/91 20 cc
242J22B 5/91 20 cc
242J23A 6/91 20 cc
242J23B 6/91 20 cc
242J23C 6/91 20 cc
242J25 6/91 20 cc
242J26 6/91 20 cc
242J29A 7/91 20 cc
242J29B 7/91 20 cc
-5-
242J30A 7/91 20 cc
242J30B 7/91 20 cc
242J32 8/91 20 cc
242J34A 8/91 20 cc
242J34B 8/91 20 cc
242J35 8/91 20 cc
242J36A 9/91 20 cc
242J36B 9/91 20 cc
242J36C 9/91 20 cc
242J39 9/91 20 cc
242J39A 9/91 20 cc
242J41 10/91 20 cc
242J43A 10/91 20 cc
242J43B 10/91 20 cc
242J45A 11/91 20 cc
242J45B 11/91 20 cc
242J46 11/91 20 cc
242J49A 12/91 20 cc
242J49B 12/91 20 cc
242J51 12/91 20 cc
32. 005J40 10/92 10 cc
33. 207J24A 6/91 5 cc
(M584)
207J31 8/91 5 cc
207J44A 10/91 5 cc
(M794)
207J33 8/91 10 cc
207J44B 10/91 10 cc
(N068)
207K05A 1/92 15 cc
(N150)
207K05B 7/91 20 cc
(N151)
34. 401J05 8/91 3 cc
401J41 10/91 3 cc
35. 402J41 10/91 5 cc
36. 403J03 7/91 20 cc
37. 512J13 3/91 20 cc
512J42 10/91 20 cc
38. 415J09 3/91 2 cc
39. 416J09 3/91 2 cc
416J17 4/91 2 cc
40. 608J35A 8/91 5 cc
608J35B 8/91 10 cc
608J49 12/91 10 cc
41. 525J50 6/91 10 cc
525K03 7/91 10 cc
42. 944J37 3/91 20 cc
43. 939J48 5/91 10 cc
44. 604J13 3/91 10 cc
604J16 4/91 10 cc
604J22 6/91 10 cc
604J25 6/91 10 cc
-6-
604J30 7/91 10 cc
604J32 8/91 10 cc
604J34 8/91 10 cc
45. 605J20 5/91 5 cc
605J32 8/91 5 cc
605J33 8/91 5 cc
605J11 3/91 30 cc
605J23 6/91 30 cc
605J26 6/91 30 cc
46. 828J33 8/91 10 cc
47. 915J17 4/91 10 cc
915J49 12/91 10 cc
48. 312J13B 3/91 5 cc
312J25B 6/91 5 cc
312J29 7/91 5 cc
312J31A 8/91 5 cc
312J31B 8/91 5 cc
312J44A 10/91 5 cc
312J51A 12/91 5 cc
312J51B 12/91 5 cc
312J13A 3/91 10 cc
312J25A 6/91 10 cc
312J44 10/91 10 cc
312J11 3/91 30 cc
312J28 7/91 30 cc
312J33A 8/91 30 cc
312J33B 8/91 30 cc
312J21 5/91 50 cc
49. 951J39 3/91 10 cc
50. 511J14 4/91 10 cc
511J35 9/91 10 cc
511J50 12/91 10 cc
51. 329J09 3/91 10 cc
329J11 3/91 10 cc
52. 329J13 3/91 10 cc
329J17 4/91 10 cc
329J18 5/91 10 cc
329J19 5/91 10 cc
329J32 8/91 10 cc
329J37 9/91 10 cc
329J44 11/91 10 cc
329K01 1/92 10 cc
329K02 1/92 10 cc
329K03A 1/92 10 cc
329K03B 1/92 10 cc
329K09A 2/92 10 cc
52. 330J18 5/91 20 cc
330J25 6/91 20 cc
330J48 11/91 20 cc
330K04 1/92 20 cc
53. 603J11 3/91 2 cc
603J18 5/91 2 cc
603J34 8/91 2 cc
-7-
54. 603J14 4/91 5 cc
55. 202J35A 3/91 20 cc
202J35B 3/91 30 cc
56. 200JK02 7/91 5 cc
57. 001H14 4/91 10 cc
Manufacturer: Quad Pharmaceuticals, Inc., Indianapolis, Indiana.
Recalled by: Manufacturer, by letter, between February 15, 1991 and
February 22, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 8,141,424 units of injectable drug products were
distributed.
Reason: Lack of assurance that adequate documentation was maintained
on the quality control laboratory test results.
----
Product: (a) Whole Blood; (b) Red Blood Cells; (c) Platelets;
(d) Fresh Frozen Plasma; (e) Cryoprecipitated AHF;
(f) Recovered Plasma. Recall #B-200/205-0.
(Revised, originally published September 26, 1990.)
Code: Unit numbers (all unit numbers actually begin with the
designated prefix "06":
(a) FC07179, FC90515, GF38378, GG39895, GG64446, GH24723, GH26820, GK25545,
GL11875, GL12931, GN92017, GN92976, LN00447, LS88845;
(b) FC06999, FC07795, FC08615, FC12311, FC85394, FF14704, FF15556, FF99061,
FG00429, FG75839, FG79444, FG81752, FG89745, FG95274, FG95441, FG97497,
FG98720, FH01390, FH04346, FH05297, FH08654, FH10608, FH11542, FH12160,
FH13720, FH13801, FH14731, FH16135, FH16343, FH16352, FH16725, FH18702,
FH18849, FH19012, FH20901, FH21018, FH21743, FH22214, FH22999, FH23010,
FH23939, FH25172, FH25527, FH25561, FH26408, FH26514, FH97493, FH99737,
FJ33314, FJ38373, FJ47056, FJ51464, FJ56332, FK51862, FK53088, FK54227,
FK55571, FK58476, FK59781, FK61649, FK65890, FL34414, FL34836, FL36513,
FL38193, FL39073, FL40476, FL42550, FL44093, FL44444, FL45978, FL47685,
FL48746, FL49928, FL50673, FL51223, FL52390, FL52459, FL53831, FN01684,
FN03919, FN04068, FN05101, FN06041, FN08609, FN08944, FN10947, FN23370,
FP37937, FP38165, FR18884, FR18910, FR22675, FR28816, FR31083, FR32150,
FR32745, FR33108, FR33577, FR33684, FR34112, FR35415, FR36744, FR36875,
FS02573, GC47407, GC53915, GC76337, GE14663, GE14878, GE25056, GE29729,
GE35374, GE39951, GE40405, GF18380, GF28905, GF30020, GF30522, GF31954,
GF35995, GF37029, GG24997, GG29020, GG34968, GG42860, GG49210, GG55203,
GG59585, GG61978, GG64053, GG70085, GG72244, GG72486, GG73904, GG73986,
GG74948, GG78207, GG80632, GH31480, GH38767, GH39530, GH45626, GH46469,
GH49301, GH50499, GH51228, GJ22211, GJ26783, GJ30378, GJ32622, GJ34324,
GJ40076, GK23631, GK37956, GK39609, GK46780, GK51741, GK51874, GL13926,
GL14393, GL25309, GL30221, GL31225, GL33386, GN08061, GN08243, GN08746,
GN14532, GN14978, GN17415, GP02439, GP86081, GP87428, GQ60669, GQ64782,
GR64713, GR80052, GR81392, GR87958, GR94093, GS23913, LC72905, LF47494,
LF58156, LF65745, LF67360, LH30392, LK00102, LP64803, LP70065, LP73476,
LP75890, LQ07602, LQ07980, LQ10349, LQ11807, LQ91148, LQ92426, LQ96629,
LR88150, LR88810, LR91840, LS77421, LS78121, LS80526, LS85544, LS91793,
LT69902, LV66806, LV70271, LV75646, LV80324, LV83878, LW58629, LW60155,
LW61094, LW62155, LW63180, LW63335, LW63855, LW64991, LW66155, LW67339,
-8-
LX72781, LX79002, LY79918, LY80832, LY81307, LY83639, LY88211;
(c) FC06999, FC12311, FF14704, FF15556, FF99061, FH01390, FH04346, FH05297,
FH08654, FH10608, FH11542, FH13160, FH13801, FH14731, FH16343, FH16352,
FH18702, FH18849, FH19012, FH20901, FH21018, FH21743, FH22214, FH22999,
FH23010, FH23939, FH25527, FH26514, FH97493, FJ47056, FK51862, FK55571,
FK58476, FK59781, FK61649, FK65890, FL34414, FL34836, FL36513, FL39073,
FL40476, FL42550, FL44093, FL44444, FL45978, FL47685, FL49928, FL50673,
FL51223, FL52390, FL52459, FL53831, FN03919, FN08944, FN23370, FP37937,
FP38165, FR22675, FR28816, FR31083, FR32150, FR32745, FR33108, FR33577,
FR33684, FR34112, FR35415, FR36875, FS02573, GC47407, GC53915, GE14878,
GE25056, GE35374, GE39951, GE40405, GF18380, GF28905, GF30020, GF30522,
GF31954, GF35995, GF37029, GG29020, GG34968, GG42860, GG59585, GG61978,
GG70085, GG72244, GG72486, GG74948, GG78207, GG80632, GH31480, GH38767,
GH39530, GH45626, GH46469, GH49301, GH50499, GH51228, GJ22211, GJ26783,
GJ30378, GJ32622, GJ34324, GJ40076, GK23631, GK37956, GK39609, GK46780,
GK51741, GK51874, GL13926, GL14393, GL25309, GL31225, GL33386, GN08061,
GN08243, GN08746, GN14978, GN17415, GP86081, GQ60699, GQ64782, GR64713,
GR80052, GR94093, GS23913, KL02222, KL02558, KL02929, KL03137, KL03372,
KL03919, KL04078, KL04336, KL04811, KL04971, KL05152, LC72905, LF47494,
LF58156, LF67360, LH30392, LP64803, LP70065, LQ07602, LQ07980, LQ10349,
LQ91148, LQ92426, LQ96629, LR88810, LS77421, LS78121, LS80526, LS85544,
LS91793, LV83878, LW60155, LW61094, LW62155, LW63335, LW63855, LW64991,
LW66155, LW67339, LX72781, LY79918, LY81307, LY83639, LY88211;
(d) FC06999, FC12311, FC85394, FF15556, FH05297, FH11542, FH18702, FH23939,
FH25527, FL34414, FP37937, FR28816, FR32150, FR33577, FR34112, FR35415,
GE35374, GF30020, GG29020, GG42860, GG61978, GH31480, GH45626, GH46469,
GJ34324, GJ40076, GK37956, GK51741, GL13926, GL14393, GN08061, GN08243,
GN08746, GN17415, GR64713, GS23913, LP70065, LQ07980, LQ10349, LS85544,
LS91793, LV93295, LW63335, LW66155;
(e) FH13720, FJ56332, FN04068, GG64053;
(f) FC07795, FC08615, FF14704, FF99061, FG00429, FG75839, FG79444, FG81752,
FG89745, FG95274, FG95441, FG97497, FG98720, FH01390, FH04346, FH08654,
FH10608, FH13160, FH13720, FH13801, FH14731, FH16135, FH16343, FH16352,
FH16725, FH18849, FH19012, FH20901, FH21018, FH21743, FH22214, FH22999,
FH23010, FH25172, FH25561, FH26408, FH26514, FH97493, FH99737, FJ33314,
FJ38373, FJ47056, FJ51464, FJ56332, FK51862, FK53088, FK54227, FK55571,
FK58476, FK59781, FK61649, FK65890, FL34836, FL36513, FL38193, FL39073,
FL40476, FL42550, FL44093, FL44444, FL45978, FL47685, FL48746, FL49928,
FL50673, FL51223, FL52390, FL52459, FL53831, FN01684, FN03919, FN04068,
FN05101, FN06041, FN08609, FN08944, FN10947, FN23370, FP38165, FR18884,
FR18910, FR22675, FR31083, FR32745, FR33108, FR33684, FR36744, FR36875,
FS02573, GC47407, GC53915, GC76337, GE14663, GE14878, GE25056, GE29729,
GE30909, GE39951, GE40405, GF18380, GF28905, GF30522, GF31954, GF35995,
GF37029, GG24997, GG34968, GG49210, GG55203, GG59585, GG64053, GG68419,
GG70085, GG72244, GG72486, GG73904, GG73986, GG74948, GG78207, GG80632,
GH38767, GH39530, GH49301, GH50499, GH51228, GJ22211, GJ26783, GJ30378,
GJ32622, GK23631, GK39609, GK46780, GK51874, GL25309, GL30221, GL31225,
GL33386, GN14532, GN14978, GP02439, GP86081, GP87428, GQ60669, GQ64782,
GR80052, GR81392, GR87958, GR94093, LC72905, LF47494, LF65745, LF67360,
LH30392, LK00102, LP64803, LP73476, LP75890, LQ07602, LQ11807, LQ91148,
LQ92426, LQ96629, LR88150, LR88810, LR91840, LS77421, LS78121, LS80526,
LT69902, LV66806, LV70271, LV75646, LV80324, LV83878, LW58629, LW60155,
LW61094, LW62155, LW63180, LW63855, LW64991, LW67339, LX72781, LX79002,
LY79918, LY80832, LY81307, LY83639, LY88211.
-9-
Manufacturer: American Red Cross, Los Angeles, California.
Recalled by: Manufacturer, by telephone or visit starting October
20, 1988 followed by letter and press release.
Firm-initiated recall ongoing.
Distribution: California, New York, Tennessee, Pennsylvania, Minnesota,
Switzerland.
Quantity: (a) 14; (b) 231; (c) 175; (d) 44; (e) 4; (f) 189 units.
Reason: Units which tested repeatably reactive for 1)
the antibody to the human immunodeficiency virus type 1
(anti-HIV-1); 2) hepatitis B surface antigen (HbsAg); or
were drawn from ineligible donors based on previous
anti-HIV-1 or HBsAg test results, were distributed.
----
Product: Platelets. Recall #B-127-1.
Code: Unit #17H12518.
Manufacturer: American Red Cross, St. Paul, Minnesota.
Recalled by: Manufacturer, by telephone October 5, 1990. Firm-initiated
recall complete.
Distribution: Wisconsin.
Quantity: 1 unit.
Reason: Blood product collected from a donor potentially exposed
to rabies was distributed.
----
Product: (a) Red Blood Cells; (b) Platelets. Recall #B-128/129-1.
Code: Unit #17F10397.
Manufacturer: American Red Cross, St. Paul, Minnesota.
Recalled by: Manufacturer, by letter September 19 and 20, 1990. Firm-
initiated recall complete.
Distribution: Minnesota, California.
Quantity: 1 unit of each component.
Reason: Blood products collected from a donor who visited an
endemic area for malaria two months prior to donation,
were distributed.
----
Product: (a) Red Blood Cells; (b) Platelets. Recall #B-142/143-1.
Code: Unit numbers: (a) 41FF59270; (b) 41FF59270, 41GT98160.
Manufacturer: American red Cross Blood Services, Birmingham, Alabama.
Recalled by: Manufacturer, by telephone July 13, 1990. Firm-
initiated recall complete.
Distribution: Alabama.
Quantity: (a) 1 unit; (b) 2 units.
Reason: Blood components, drawn from donors who were
1) diagnosed with cancer; 2) diagnosed with mononucleosis,
were distributed for transfusion.
----
-10-
Product: Recovered Plasma. Recall #B-145-1.
Code: Unit numbers: 2416840, 2416879
Manufacturer: Noble Army Community Hospital, Ft. McClellan, Alabama.
Recalled by: Manufacturer, by telephone August 8, 10, and 17, 1990,
followed by letter August 24, 1990. Firm-initiated
recall ongoing.
Distribution: Florida.
Quantity: 2 units.
Reason: Units which tested initially reactive for the antibody
to the human immunodeficiency virus (anti-HIV-1) by
EIA, were distributed.
----
Class III -
Product: (a) Whole Blood; (b) Red Blood Cells; (c) Platelets;
(d) Fresh Frozen Plasma; (e) Cryoprecipitated AHF;
(f) Recovered Plasma. Recall #B-206/211-0.
(Revised, originally published September 26, 1990.)
Codes: Unit numbers: (a) GE26523, GF27370, GF36789, GF40760,
GK24893, GN91958, GR81993, LT67326, LV86286.
(b) FC03477, FC10068, FC24870, FC30676, FC37259, FC42257, FC51373, FC54716,
FC99514, FF04514, FF06430, FF06622, FF08628, FF10030, FF12241, FF14666,
FF15045, FF16314, FF20123, FG66771, FG68252, FG71682, FG74691, FG76577,
FG79949, FG80160, FG82380, FG82679, FG83887, FG85826, FG87580, FG87843,
FG89946, FG90210, FG91402, FG92641, FG93698, FG94505, FG95018, FG96383,
FG96421, FG97279, FG97301, FG98957, FG99395, FH23362, FH26696, FH42573,
FJ54642, FJ59539, FJ66633, FK52016, FK52253, FK53418, FK54055, FK54816,
FK58869, FK60170, FK60819, FK62232, FK63520, FK63924, FK64733, FL45210,
FL45217, FL50755, FL53099, FN00137, FN00144, FN00147, FN00148, FN12085,
FN13579, FN13758, FN16304, FN16305, FN16839, FN20867, FN23938, FN25374,
FN25420, FN27249, FN28050, FN29143, FN30961, FN31741, FP28158, FP29509,
FP30573, FP30806, FP31017, FP31625, FP31839, FP32160, FP32947, FP33115,
FP33328, FP33967, FP34456, FP35969, FP36011, FP36363, FP36449, FP36780,
FP37488, FP37825, FP38269, FP38601, FP39534, FP40224, FR38799, FR35974,
FS02742, FS03387, GC76044, GE21240, GE30037, GE30072, GE30909, GE39398,
GE39563, GF19894, GF26813, GF31976, GF33928, GF35166, GF38142, GF38701,
GF39309, GF40177, GF41067, GG34579, GG51568, GG52780, GG57340, GG61517,
GG62084, GG64392, GG65199, GG65761, GG68419, GG71310, GG71313, GG71997,
GG74046, GG77585, GH25197, GH27050, GH31578, GH35636, GH39384, GH39452,
GH41380, GH45663, GJ29071, GJ31490, GJ32655, GJ37656, GJ38990, GK38862,
GK38869, GK41939, GK44353, GK50051, GK53912, GL10259, GL24424, GL31526,
GL32520, GL33378, GL34345, GM95284, GM95489, GM96250, GN03810, GN08635,
GN12173, GN13507, GN16780, GN17336, GN17704, GN18683, GP02449, GP02451,
GP02458, GP84641, GP90964, GR75476, GR83292, GR83462, GR87764, GR88650,
GR91992, GR94520, LC79153, LC80875, LC82314, LC89148, LF47901, LF51793,
LF59141, LF65141, LF65146, LF65148, LF65256, LF68464, LF68732, LF69494,
LF70680, LH28625, LH28890, LH34441, LH35817, LH35828, LH35835, LP42428,
LP62797, LP67678, LP71587, LP72583, LP73484, LQ02746, LQ07972, LQ08425,
LQ11189, LQ12635, LQ14169, LQ15198, LQ96382, LQ99903, LR87900, LR90374,
LR91845, LR95208, LR95377, LR95487, LR97326, LR99537, LS92517, LS95065,
LS97018, LS98035, LS98822, LS99737, LS99771, LS99775, LT61777, LT68950,
-11-
LT69700, LT69769, LV82039, LV82772, LV84036, LV85341, LV90498, LV90801,
LV93295, LW56954, LW66269, LW66680, LW66681, LX696258 LX77165, LX77247,
LX78490, LX81107, LY76007, LY78836, LY81828, LY86895, LY87463.
(c) FC30676, FC37259, FC42257, FC51373, FC99514, FF04514, FF06430, FF06622,
FF08628, FF10030, FF12241, FF14666, FF15045, FF16314, FF20123, FG66771,
FG71682, FG76577, FG79949, FG82380, FG82679, FG83887, FG87843, FG89946,
FG90210, FG91402, FG93698, FG94505, FG95018, FG96383, FG96421, FG98957,
FH24573, FJ59539, FJ66633, FK54055, FK58869, FK60819, FK62232, FK63520,
FK63924, FK64733, FL45210, FL45217, FN23938, FN25374, FN25420, FN27249,
FN28050, FP28158, FP29509, FP30573, FP30806, FP31017, FP31839, FP32160,
FP32947, FP33115, FP33328, FP33697, FP34456, FP35969, FP36011, FP36449,
FP36780, FP37488, FP37825, FP38269, FP38601, FP39534, FP40224, FR35799,
FR35974, FS02742, GC76044, GE21240, GE30037, GE39563, GF26813, GF31976,
GF35166, GF38701, GF39309, GF41067, GG51568, GG52780, GG57340, GG62084,
GG65199, GG65761, GG71997, GG74046, GG77585, GH25197, GH27050, GH31578,
GH35636, GH39384, GH39452, GH41380, GJ29071, GJ31490, GJ32655, GJ38990,
GK38862, GK38869, GK44353, GK53912, GL10259, GL24424, GL31526, GL32520,
GL33378, GL34345, GN03810, GN08635, GN12173, GN16780, GN17704, GN18683,
GP90964, GR75476, GR83292, GR83462, GR87764, GR88650, GR91992, KC00799,
KC02195, KC02705, KC03802, LF47901, LF51793, LF59141, LF65141, LF65146,
LF65148, LF65256, LF68464, LF69494, LF70680, LH28890, LH35817, LP42428,
LP62797, LP67678, LP71587, LP72583, LQ02746, LQ07972, LQ08425, LQ11189,
LQ14169, LQ15198, LQ96382, LQ99903, LR87900, LR90374, LR95208, LR95377,
LR95487, LR97326, LR99537, LS95065. LS97018, LS98035, LS98822, LS99737,
LS99771, LS99775, LT61777, LT68950, LT69700, LV82039, LV82772, LV84036,
LV85341, LV93295, LW66269, LW66680, LW66681, LX69628, LX77247, LY76007,
LY78836, LY81826, LY87463.
(d) FC03477, FC10068, FC30676, FC42257, FF08628, FF10030, FF15045, FF16314,
FF20123, FK60819, FK62232, FK63520, FK64733, FN28050, FP29509, FP30573,
FP30806, FP31839, FP34456, FP35969, FP38269, FP38601, FP40224, FR35974,
GF26813, GF39309, GG51568, GG65761, GH35636, GH39452, GJ29071, GJ31490,
GJ38990, GK38869, GK44353, GL34345, GN03810, GN13507, GN18683, GR83292,
GR91992, LF58156, LF68464, LF69494, LF70680, LQ02746, LQ08425, LQ14169,
LQ96382, LR95377, LS98822, LT61777, LT68950, LV85341, LV93295, LX69628,
LX77165, LY76007, LY81828, LY87463.
(e) FJ54642, FN12805, FN13579, FN13758, FN16304, FN16839, FN20867, FN29143,
FN30961, GE30072, LC79153, LC82314, LH28625, LH34441, LH35828, LH35835.
(f) FC24870, FC37259, FC51373, FC54716, FC99514, FF04514, FF06430, FF06622,
FF12241, FF14666, FG66771, FG68252, FG71682, FG74691, FG76577, FG79949,
FG80160, FG82380, FG82679, FG83887, FG85826, FG87343, FG87580, FG89946,
FG90210, FG91402, FG92641, FG93498, FG94505, FG95018, FG96383, FG96421,
FG97279, FG97301, FG98957, FG99395, FH23362, FH24573, FH26696, FJ54642,
FJ59539, FJ66633, FK52016, FK52253, FK53418, FK54055, FK54816, FK58869,
FK60170, FK63924, FL45210, FL45217, FL50755, FL53099, FN00137, FN00144,
FN00147, FN00148, FN12805, FN13579, FN13758, FN16304, FN16305, FN16839,
FN20867, FN23938, FN25374, FN25420, FN27249, FN29143, FN30961, FN31741,
FP28158, FP31017, FP31625, FP32160, FP32947, FP33115, FP33328, FP33967,
FP36011, FP36363, FP36449, FP36780, FP37488, FP37825, FP39534, FR35799,
FS02742, FS03387, GC76044, GE21240, GE30037, GE30072, GE39398, GE39563,
GF19894, GF31976, GF33928, GF35166, GF38142, GF38701, GF40177, GF41067,
GG34579, GG52780, GG57340, GG61517, GG62084, GG64392, GG65199, GG71310,
GG71313, GG71997, GG74046, GG77585, GH25197, GH27050, GH31578, GH39384,
GH41380, GH45663, GJ32666, GK38862, GK41939, GK50051, GK53912, GL24424,
-12-
GL31526, GL32520, GL33378, GM95284, GM95489, GM96250, GN08635, GN12173,
GN16780, GN17336, GN17704, GP02449, GP02451, GP02458, GP84641, GP90964,
GR75476, GR83462, GR87764, GR88650, GR94520, LC79153, LC80875, LC82314,
LC89148, LF47901, LF51793, LF59141, LF65141, LF65146, LF65148, LF65256,
LF68732, LH28625, LH28625, LH28890, LH34441, LH35817, LH35828, LH35835,
LP42428, LP62797, LP67578, LP71587, LP72583, LP73484, LQ07972, LQ11189,
LQ12635, LQ15198, LQ99903, LR87900, LR90374, LR91845, LR95208, LR95487,
LR97326, LR99537, LS92517, LS95065, LS97018, LS98035, LS99737, LS99771,
LS99775, LT69700, LT69769, LV82039, LV82772, LV84036, LV90498, LV90801,
LW56954, LW66269, LW66680, LW66681, LX77247, LX78490, LX81107, LY78836,
LY86895.
Manufacturer: American Red Cross, Los Angeles, California.
Recalled by: Manufacturer, by telephone or visit starting October
20, 1988 followed by letter and press release.
Firm-initiated recall ongoing.
Distribution: California, New York, Tennessee, Pennsylvania, Minnesota,
Switzerland.
Quantity: (a) 9; (b) 271 (c) 187; (d) 60; 16; (e) 209 units.
Reason: Units which tested repeatably reactive for 1) the
antibody to the human immunodeficiency virus type 1
(anti-HIV-1); 2) hepatitis B surface antigen (HBsAg)
or were drawn from ineligible donors based on previous
anti-HIV-1 or HBsAg) test results, were distributed.
----
Product: Whole Blood. Recall #B-144-1.
Code: Unit #41GS31247.
Manufacturer: American Red Cross Blood Services, Birmingham, Alabama.
Recalled by: Manufacturer, by telephone on or about September 19, 1990.
Firm-initiated recall complete.
Distribution: Alabama.
Quantity: 1 unit.
Reason: Blood product labeled with an incorrect expiration date
was distributed for transfusion.
----
Product: Recovered Plasma. Recall #B-146-1.
Code: Unit #2416906.
Manufacturer: Noble Army Community Hospital, Ft. McClellan, Alabama.
Recalled by: Manufacturer, by telephone August 8, 10, and 17, 1990
followed by letter August 24, 1990. Firm-initiated
recall complete.
Distribution: Florida.
Reason: Blood product which tested repeatably reactive for
the hepatitis B surface antigen (HBsAg), was distributed.