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
09/09/1992
RECALLS AND FIELD CORRECTIONS: September 9, 1992
FOODS -- CLASS I
92-37
PRODUCT: Smoked Black Cod (Sable Fish) in 2 lb. plastic bags.
Recall #F-464-2.
CODE: None.
MANUFACTURER: Inter Ocean Sales, Inc., Kensington, Maryland.
RECALLED BY: Manufacturer, by letter July 13,1992. Firm initiated
recall ongoing.
DISTRIBUTION: Maryland, Washington, D.C.
QUANTITY: 60 pounds were distributed.
REASON: Product was contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT: Sysco brand "IMPERIAL Artichoke Hearts" in 14 ounce cans.
Recall #F-497-2.
CODE: AL640P8 in cartons bearing purchase order numbers SC 4149
and 4165.
MANUFACTURER: Jose Hernandez Perez & Sons, Murcia, Spain.
RECALLED BY: Sysco Corporation (importer), Houston, Texas, by telex May
29, 1992. Firm-initiated recall ongoing.
DISTRIBUTION: Nationwide, international.
QUANITY: 2,831 cases were distributed between October 1, 1991 and
May 28, 1992.
REASON: Swollen cans indicate product may be underprocessed with a
remote probability for the outgrowth of Clostridium
botulinum.
PRODUCT: Licorice Twist, Sour Licorice in 5 pound plastic bags in
the following flavors: Green Apple; Peach; Lemon;
Lemon-lime; Lime, Orange and Spearmint. Recall
#F-524/537-2.
CODE: All codes.
MANUFACTURER: Kenny's Candy Company, Perham, Minnesota.
RECALLED BY: The Sweetery (repacker), Minneapolis, Minnesota, by letter
August 11, 1992. Firm-initiated recall ongoing.
DISTRIBUTION: Minnesota, Wisconsin.
QUANTITY: Approximately 100 pounds of licorice is still in commerce.
REASON: Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT: Shoppers Value Mandarin Orange Segments in Light Syrup in
11 ounce cans. Recall #F-442-2
CODE: Three line code with "601" in the bottom line and "11 2"
in the top line.
MANUFACTURER: Super Valu Inc., Chaska, Minnesota.
RECALLED BY: Manufacturer, by a code clarification dated June 4, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION: Colorado, New Mexico, Wyoming, Kansas, North Dakota,
Minnesota, Wisconsin, South Dakota.
QUANTITY: 3,119 cases were distributed.
REASON: Product is in swollen cans caused by hydrogen formation
due to product reaction with can lining.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT: Fluoracaine (Fluorescein/Proparacaine) a Rx
ophthalmic solution in glass screw-cap bottles. Recall
#D-473-2
CODE: 19148, exp. date 11/92; 19166, exp. date 12/92; 19223,
exp. date 2/93; 19262, exp. date 3/93; 19329, exp. date
5/93; 19349, exp. date 6/93; 19392, exp. date 7/93; 19149
exp. date 11/92; 19167, exp. date 12/92; 19224 exp. date
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2/93; 19263, exp. date 3/93; 19330, exp. date 4/93; 19350,
exp. date 6/93; 19401, exp. date 7/93; 19161, exp. date
12/92; 19183, exp. date 1/93; 19253, exp. date 3/93;
19333, exp. date 4/93; 19359, exp. date 5/93; 19162, exp.
date 12/92; 19184, exp. date 1/93; 19254, exp. date 4/93;
19268, exp. date 3/93; 19336, exp. date 4/93; 19391, exp.
date 7/93.
MANUFACTURER: Walnut Pharmaceuticals, Inc., Los Angeles, California
RECALLED BY: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana
by letter April 16, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION: Louisiana, California, Texas, Oklahoma, Tennessee, Canada.
QUANTITY: 316,605 units were distributed.
REASON: Presence of trace quantities of mercury.
PRODUCT: Dexamethasone Sodium Phosphate Injection, a Rx
corticosteroid. Recall #D-474-2
CODE: Lot Numbers: 18970 exp. date 5/93; 19037, exp. date 7/93,
19299, exp. date 4/94.
MANUFACTURER: Walnut Pharmaceuticals, Inc., Los Angeles, California.
RECALLED BY: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana
by letter April 21 1992. Firm-initiated recall ongoing.
DISTRIBUTION: Tennessee, Missouri, Louisiana, Virginia, Kansas, Georgia.
QUANTITY: 25,365 units were distributed.
REASON: Lack of assurance of potency through expiration date.
PRODUCT: Folic Acid Injection in 10 ml amber glass vials, an Rx
drug, used for the treatment of megablastic anemias.
Recall #D-475-2.
CODE: Lot number 19096, exp. date 10/92.
MANUFACTURER: Walnut Pharmaceuticals, Inc., Los Angeles, California.
RECALLED BY: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana,
by letter April 21, 1992. Firm-initiated recall ongoing.
DISTRIBUTION: California, Louisiana.
QUANTITY: 10,803 units were distributed.
REASON: Lack of assurance of potency through expriation date.
PRODUCT: Chloramphenicol Solution, 0.5%, a Rx drug used as an
antibiotic. Recall #D-476-2.
CODE: Lot number 19177, exp. date 1/93; 19430, exp. date 7/93.
MANUFACTURER: Walnut Pharmaceuticals, Inc., Los Angeles, California.
RECALLED BY: Walnut Pharmaceuticals, Inc., Abita Springs, Louisiana,
by letter April 21, 1992. Firm-initiated recall ongoing.
DISTRIBUTION: Louisiana, Missouri.
QUANTITY: 29,463 units were distributed.
REASON: Product does not meet stability specifications.
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PRODUCT: Slo-Bid (Theophylline, Extended Release Capsules, USP),
200 mg gyrocaps in bottles of 100 capsules used for
maintenance therapy in the treatment of asthma. Recall
#D-477-2.
CODE: Lot numbers: 07155, exp. date 8/94; 07130, exp. date
8/94; 07152, exp. date 8/94; 07154, exp. date 8/94.
MANUFACTURER: Rhone-Poulenc Rorer, Fort Washington, Pennsylvania.
RECALLED BY: Manufacturer by letter July 17, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION: Nationwide.
QUANTITY: 38,865 units were distributed.
REASON: Lot 07155 does not meet dissolution specifications. Other
lots lack assurance for this specification.
PRODUCT: Naloxone HCI Injection, USP, Neonatal, 0.02 mg/ml a Rx
drug for IV, IM, SC, use as a narcotic antagonist.
Recall #D-478-2.
CODE: Lot number 61-062DK, exp. date 1/94.
MANUFACTURER: Abbott Laboratories, Rocky Mount, North Carolina.
RECALLED BY: Abbott Laboratories, Abbott Park, Illinois, by letter
August 19, 1992. Firm-initiated recall ongoing.
DISTRIBUTION: Nationwide.
QUANTITY: 6,550 vials were distributed.
REASON: Potency not assured through expiration date.
PRODUCT: Bulk Neomycin Sulfate, USP, Powder. Recall #D-479-2.
CODE: Lot numbers: 765FY, 430HR; 073HT; 177FU; 178FU.
MANUFACTURER: UpJohn Company, Kalamazoo, Michigan.
RECALLED BY: Manufacturer by letter August 18, 1992.
DISTRIBUTION: Nationwide and International.
QUANTITY: Approximately 4,035 Kilograms were distributed.
REASON: Elevated levels of sodium fluoride.
PRODUCT: Indomethacin, 75 mg, Extended-release Capsules in bottles of
60 and 100 capsules. Recall #D-480-2.
CODE: Lot number 1K032, exp. date 12/93.
MANUFACTURER: Inwood Laboratories, Inc., Inwood, New York.
RECALLED BY: Manufacturer, by telephone July 24, 1992, and by letter
August 18, 1992. Firm-initiated recall ongoing.
DISTRIBUTION: New Jersey, Florida, Pennsylvania, Texas, Nevada, Ohio,
and Washington state.
QUANTITY: 11,257 bottles were distributed.
REASON: Product does not meet dissolution specifications.
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PRODUCT: Acetaminophen, 325 mg tablets, Regular Strength Non-Asprin
Pain Reliever. Recall #D-481-2.
CODE: Lot number OE449, exp. date August1993.
MANUFACTURER: Life-Line Pharmaceuticals, Hayward, California.
RECALLED BY: Manufacturer by letter June 24, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION: Pennsylvania and Tennessee.
QUANTITY: 6,462 units were distributed.
REASON: Presence of metal shavings.
UPDATE: Kenalog Cream, .025% Triamcinolone Acetonide, Recall
#D-471-2, which appeared in the September 2, 1992,
Enforcement Report should read:
MANUFACTURER: Bristol-Myers Squibb, Humacoa, Puerto Rico.
RECALLED BY: Westwood Squibb Pharmaceuticals, Inc.,
Buffalo, New York.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT: Recovered Plasma. Recall #B-425-2.
CODE: Unit number 9119946.
MANUFACTURER: Morristown Memorial Hospital, Morristown, New Jersey.
RECALLED BY: Manufacturer by telephone January 24, 1992. Firm-
initiated recall complete.
DISTRIBUTION: Pennsylvania, California.
QUANTITY: 1 unit was distributed.
REASON: Blood product, which tested negative for the antibody to
human immunodeficiency virus type 1 (anti-HIV-1) but was
colleced from a donor who previously tested repeatedly
reactive for antiHIV-1, was distributed.
PRODUCT: Red Blood Cells. Recall #B-426-2.
CODE: Unit number 12Q73077.
MANUFACTURER: American Red Cross, Charlotte, North Carolina.
RECALLED BY: Manufacturer, by telephone March 16, 1992, and by letter
March 19, 1992. Firm-initiated recall complete.
DISTRIBUTION: Tennessee.
QUANTITY: 1 unit was distributed.
REASON: Blood product, which tested repeatedly reactive for the
antibody to the hepatitis C virus encoded antigen
(anti-HCV), was distributed.
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PRODUCT: (a) Whole Blood, (b) Red Blood Cells, (c) Platelets, (d)
Fresh Frozen Plasma, (e) Recovered Plasma. Recall
#B-427/431-2.
CODE: Unit numbers: (a) 06GM70185; (b) 06GG06760, 06GN85419,
06GN89282; 06GJ21939; 06LP46173; 06GR75014; 06GG60927;
06GH65014; 06GG80692; 06GR12136; 06LQ33415; (c) 06GG06760;
06GN85419; 06GN89282; 06GJ21939; 06LP46173; 06GG60927;
06GG80692, 06GR12136; 06LQ33415; 06GH45017; (d) 06GN85419,
06GN89282; 06GJ21939; 06GG80692; 06LQ33415; (e) 06GG06760;
06LP46173; 06GR75014; 06GG60927; 06GH45017; 06GR12136.
MANUFACTURER: American Red Cross, Los Angeles, California.
RECALLED BY: Manufacturer, by letter April 3, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION: California, Switzerland, The Netherlands.
QUANTITY: (a) 1 unit; (b) ll units; (c) 10 units; (d) 5 units; (e) 6
units were distributed.
REASON: Blood products which were collected from a donor with a
prior history of hepatitis were distributed.
PRODUCT: (a) Red Blood Cells, (b) Platelets, (c) Cryoprecipitated
AHF. Recall #B-432/434-2.
CODE: Unit numbers: (a) 32GQ33311, 32GQ33390; (b) 32GQ33311 (c)
32GQ33390.
MANUFACTURER: American Red Cross Blood Badger Region, Madison, Wisconsin.
RECALLED BY: Manufacturer by letter June 1, 1992. Firm-initiated
recall complete.
DISTRIBUTION: Massachusetts, Wisconsin.
QUANTITY: (a) 2 units; (b) 1 unit; (c) 1 units were distributed.
REASON: Blood products, incorrectly tested for the antibody to the
hepatitis C virus encoded antigen (anti-HCV), were
distributed.
PRODUCT: Source Plasma. Recall #B-435-2.
CODE: Unit number: N-18663-126.
MANUFACTURER: Knoxville Plasma Center, Inc., Knoxville, Tennessee.
RECALLED BY: Manufacturer, by letter April 24, 1990, and by telephone
April 2, 1990. Firm-initiated recall complete.
DISTRIBUTION: California.
QUANTITY: 1 unit was distributed.
REASON: Source Plasma, which tested repeatedly reactive for the
antibody to human immunodeficiency virus type 1
(anti-HIV-1), was distributed.
PRODUCT: Recovered Plasma. Recall #B-437-2.
CODE: Unit number 7285892.
MANUFACTURER: LifeSource, Glenview, Illinois.
RECALLED BY: Manufacturer by telephone and letter May 19, 1992.
Firm-initiated recall ongoing.
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DISTRIBUTION: California.
QUANTITY: 1 unit was distributed.
REASON: Recovered Plasma which tested repeatedly reactive for
hepatitis B surface antigen (HBsAg) was distributed.
PRODUCT: Platelets. Recall #B-438-2.
CODE: Unit number EO5356.
MANUFACTURER: San Diego Blood Bank, San Diego, California .
RECALLED BY: Manufacturer, by telephone September 4, 1991 and by letter
September 20, 1991. Firm-initiated recall complete
DISTRIBUTION: California.
QUANTITY: 1 unit was distributed.
REASON: Platelets, collected from an ineligible donor due to a
previous history of hepatitis, were distributed.
PRODUCT: Source Plasma. Recall #B-442-2.
CODE: Unit numbers: 5290, 5305, 5313, 5362.
MANUFACTURER: Allegheny Biologicals, Inc., Pittsburgh, Pennsylvania.
RECALLED BY: Manufacturer, by letters January 14, 1992, and June 23,
1992. Firm-initiated recall complete.
DISTRIBUTION: Georgia, Montana, Switzerland, France.
QUANTITY: 4 units were distributed.
REASON: Blood products, which tested repeatedly reactive for the
antibody to the human immunodeficiency virus type 1
(anti-HIV-1), or which tested non-reactive for anti-HIV-1,
but were collected from a donor who previously tested
repeatedly reactive, were distributed.
PRODUCT: (a) Red Blood Cells, (b) Recovered Plasma. Recall
#B-443/444-2.
CODE: Unit numbers: (a) TM14170; (b) TM14170.
MANUFACTURER: Timken Mercy Medical Center, Canton, Ohio.
RECALLED BY: Firm notified the consignee by letter July 20, 1992. Firm.
initiated recall ongoing.
DISTRIBUTION: Maryland, Ohio.
QUANTITY: 2 units were distributed.
REASON: Blood products, which 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.
RECALLS AND FIELD CORRECTION: BIOLOGICS -- CLASS III
PRODUCT: Red Blood Cells. Recall #B-436-2.
CODE: Units E20344, E20345.
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MANUFACTURER: Regional Health Resource Center, Champaign County Blood Bank,
Urbana, Illinois.
RECALLED BY: Manufacturer, by telephone March 20,1992. Firm-initiated
recall complete.
DISTRIBUTION: Illinois.
QUANTITY: 2 units were distributed.
REASON: Red Blood Cells, untested for the antibody to hepatitis C
virus encoded antigen (antigen (anti-HCV), were
distributed.
RECALLS AND FIELD CORRECTION: DEVICES -- CLASS II
PRODUCT: "Causse Piston"-Inner Ear Implant. Recall #Z-1246-2
CODE: Catalog No. 11-56314, Lot Nos. 81831-00, 84428-00.
MANUFACTURER: Xomed-Treace, Jacksonville, Florida.
RECALLED BY: Manufacturer by letter March 19, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION: Nationwide and International.
QUANTITY: 450 units were distributed.
REASON: The device has incorrect dimensions. The label of the
product denotes the size to be 0.4 mm x 6.0 mm when the
actual size of the product was 0.4 x 6.4 mm.
PRODUCT: Halogen Light Products, (a) Outpatient Light with Fleximount,
Single Ceiling Mount Kit; (b) Cool Spot Light with Fleximount
Single Ceiling Mount; (c) Fleximount Single Ceiling Mount
Kit; (d) Single Ceiling Trolley. Recall #Z-1247/1250-2.
CODE Model numbers: (a) 0114122; (b) 0134122; (c) 0100140; (d)
0100180.
MANUFACTURER: Burton Medical Products Corp., Van Nuys, California.
RECALLED BY: Manufacturer by letter on or around May 12, 1989.
Firm-initiated recall ongoing.
DISTRIBUTION: Nationwide and International.
QUANTITY: (a) 1,297; (b) 940; (c) 2834; (d) 408 kits were distributed.
REASON: The devices contain a component called a clam shell (also
called a switch housing) that is separating, causing the
connected light and extension arm to fall during
examinations and surgery.
PRODUCT: Shiley Blood Cardioplegia Delivery (BCD) Sets Heat
Exchanger used to mix, cool and deliver oxygenated
blood/cardioplegic solutions during bypass surgery.
Recall #Z-1252-2.
-8-
CODE: Product designation (catalog #) Lots Numbers
BCD'S
BCD Plus 1 9210182000 and Below
BCD Plus 2 9200009400 and below
BCD Plus 4 9101294400 and below
BCD HE 9101210800 and below
BCD ADV 1 9101225900 and below
BCD ADV 2 9200099100 and below
BCD ADV 4 9200117800 and below
Shiley Cardiopulmonary Profusion Systems (SCPS)
SCPS 2186 9101234100 and below
SCPS 3048 9210262600 and below
SCPS 3340 9101281900 and below
SCPS 3511 9001484400 and below
SCPS 3528 9210261800 and below
SCPS 5072 9210243300 and below
PTS Sets
PTS 3192 9001453600 and below
PTS 3256 9100368100 and below
PTS 3548 9200070100 and below
PTS 3665 9210220700 and below
PTS 5001 9100910600 and below
PTS 5007 9216244200 and below
PTS 5014 8800168400 and below
PTS 5015 9200003700 and below
PTS 5017 9210243800 and below
PTS 5020 9200131400 and below
PTS 5037 8900390200 and below
PTS 5049 9101182000 and below
PTS 5087 9200133600 and below
PTS 5088 9210260100 and below
PTS 5092 9001207500 and below
PTS 5098 9200028700 and below
PTS 5101 9200080800 and below
PTS 5105 9000920900 and below
PTS 5108 9001032400 and below
PTS 5109 9101161400 and below
PTS 5113 9101006300 and below
PTS 5115 9200028300 and below
PTS 5137 9101227100 and below
PTS 5139 9200121400 and below
PTS 5141 9101265900 and below
PTS 5149 9210174700 and below
PTS 5150 9200166200 and below
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MANUFACTURER: Shiley, Inc. and Sorin Biomedical Inc., Irvine California.
RECALLED BY: Sorin Biomedical, Inc., Irvine, California, by letters
June 2-4, 1992. Firm-initiated recall ongoing.
DISTRIBUTION: Nationwide and international.
QUANTITY: 314,910 units were distributed between January 1, 1987, and
May 28, 1992.
REASON: The pressure monitoring ports on the heat exchanger
housing may break.
UPDATE: COBE CentrySystem 2 Dialysis Control Units, Recall
#Z-992/1000-2, which appeared in the Enforcement Report
August 12, 1992 should read:
Serial numbers: (1-7) 2C51092 through 2C51184, 2C51231
through 2C51420. The "5" was left out of the last two
serial numbers in both series.
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END OF ENFORCEMENT REPORT FOR SEPTEMBER 9, 1992. BLANK PAGES MAY
FOLLOW.
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