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
01/22/1992
Recalls and Field Corrections: January 22, 1992
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
Product: Taro Coconut Cream in 10 ounce plastic cups.
Recall #F-092-2.
Code: All lots.
Manufacturer: Jack Hong Co., Ltd., Bangkok, Thailand.
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Recalled by: Bangkok Market, Inc., Maywood, California, by letter
October 24, 1991 and by telephone. Firm-initiated recall
ongoing.
Distribution: Arizona, California.
Quantity: 65 cases (48 cups per case) were distributed.
Reason: Product is contaminated with Salmonella.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Frozen Whiting from Argentina and Uruguay, in original
50 pound bulk master cartons or in 12 pound repacked
master cartons bearing the Ocean Fresh label.
Recall #F-091-2.
Code: Lot numbers: Bulk - 10069, 10070, 10071;
Tray Packs - 10793, 10373, 10553, 10961, 10955.
Manufacturer: Bivar S.A. (Safe Corp.), Montevideo, Uruguay.
Recalled by: National Fish & Seafood, Inc., Gloucester, Massachusetts,
by telephone November 25-26, 1991, followed by letter
December 6, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 667 50-pound bulk cases and 699 12-pound repacked cases
were distributed; firm estimates 87 bulk cases and 41
repacked cases remain on the market.
Reason: Product is decomposed.
----
COSMETICS
Class I -
NONE
Class II -
Product: Formula 74-1036 Red Shampoo, in 2, 8, 16, 32, 128, and
640 fluid ounce containers. Recall #F-090-2.
Code: All lots.
Manufacturer: Custom Formulations, Inc., Cologne, Minnesota.
Recalled by: Manufacturer, by telephone starting December 10, 1991,
followed by letters December 16, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 12,800 pounds were distributed.
Reason: The product contains banned color D&C Red #19.
----
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Class III -
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Epinephrine Injection USP (1:1000), Rx, packaged in
1 ml tubex sterile cartridge, used to treat severe allergic
(anaphylactic) reactions to such things as bee stings or
to treat severe asthmatic attacks or cardiac arrest.
Hollister-Stier uses the Epinephrine Injection cartridges
in the following products:
(a) Ana-Guard Epinephrine Injection, USP (1:1000),
(b) Ana-Kit Anaphylaxis Emergency Treatment Kit;
(c) Epinephrine Injection, USP, 1:000 Refill.
Recall #D-145/147-2.
Code: Lot numbers: (a) G00017 through G00073 (sequentially);
(b) AK272 through AK279.
(c) S218 through S223.
Manufacturer: Wyeth Laboratories, Inc., Philadelphia, Pennsylvania.
Recalled by: Hollister-Stier, Pharmaceutical Division, Miles, Inc.,
Spokane, Washington, by press release December 16, 1991,
and by letter December 17, 1991. Firm-initiated recall
ongoing.
Distribution: (a & b) Nationwide; (c) International.
Quantity: (a) 27,345 units; (b) 277,890 units; (c) 23,396 units
were distributed.
Reason: Subpotency of Epinephrine Injection component.
----
Product: Antihemophilic Factor (Human) Profilate SD.
Recall #B-049-2.
Code: Lot #AC011A.
Manufacturer: Alpha Therapeutic Corporation, Los Angeles, California.
Recalled by: Manufacturer, by telephone September 13, 1990, followed
by letters dated September 18, 1990. Firm-initiated
recall complete.
Distribution: New York, California.
Quantity: 408 vials were distributed.
Reason: Recipients of the product experienced fever, chills,
nausea and vomiting.
----
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Product: (a) CS-3000 Plus Blood Cells Separators;
(b) CS-3000 Plus Blood Cells Separators with TNX-6,
a self-contained, continuous-flow centrifugal device
which separates whole blood into some of its
components, with the TNX-6 being a platelet separation
container holder used for platelet collection procedures.
Recall #B-050/051-2.
Code: All serial numbers.
Manufacturer: Baxter Healthcare Corporation, Savage, Maryland.
Recalled by: Baxter Healthcare Corporation, Deerfield, Illinois,
by letter August 22, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, Brazil, Mexico, Japan.
Quantity: 295 units were distributed; firm estimates 290 remain
on the market.
Reason: Certain safety features of the separators will be
inoperative after a particular series of events.
----
Product: (a) Red Blood Cells; (b) Frozen Red Blood Cells;
(c) Platelets; (d) Cryoprecipitated AHF;
(e) Fresh Frozen Plasma; (d) Recovered Plasma.
Recall #B-083/088-2.
Code: Unit numbers: (a) 6016772, 6016780, 6016921, 6017001,
6017332, 6017338, 6017621, 6018350, 6018380, 6018430,
6018517, 6018538, 6018689, 6019033, 6019138, 6019672,
6019874, 6021669, 6021794, 6021948, 6021950, 6021964,
6022129, 6022405, 6022418, 6022535, 6022569, 6022687,
6022939, 6023023, 6023054, 6023128, 6023229, 6023432,
6023929, 6024056, 6024103, 6024121, 6024132, 6024298,
6024300, 6024364, 6024368, 6024370, 6024383, 6024402,
6024634, 6024436, 6024770;
(b) 6022067, 6022703;
(c) 6018414, 6018417, 6018689, 6019672, 6019730;
(d) 6021669;
(e) 6019374, 6019869, 6019874, 6021497, 6021981;
(f) 6016772, 6016780, 6017001, 6017332, 6017338, 6017621,
6018200, 6018266, 6018350, 6018380, 6018413, 6018430,
6018500, 6018517, 6018538, 6018689, 6018853, 6019033,
6019138, 6019672, 6019702, 6019730, 6021659, 6021667,
6021669, 6021684, 6021794, 6021948, 6021950, 6021964,
6022405, 6022418, 6022554, 6022569, 6022573, 6022677,
6022687, 6022703, 6022939, 6023023, 6023037, 6023054,
6023128, 6023277, 6023929, 6024056, 6024103, 6024281,
6024298, 6024300, 6024313, 6024345, 6024364, 6024368,
6024370, 6024383, 6024402, 6024436, 6024634, 6024770.
Manufacturer: Department of the Navy, U.S. Naval Hospital, Okinawa, Japan.
Recalled by: Manufacturer, by letters dated between April 25, 1991
and November 1, 1991. Firm-initiated recall ongoing.
Distribution: California, New Jersey, Illinois, The Philippines,
Korea, Japan, Holland.
Quantity: (a) 49 units; (b) 2 units; (c) 5 units; (d) 1 unit;
(e) 5 units; (f) 60 units.
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Reason: Blood products which tested initially reactive for the
hepatitis B surface antigen (HBsAg), were distributed.
----
Product: Red Blood Cells. Recall #B-092-2.
Code: Unit numbers: 6024606, 6024607, 6024608, 6024609,
6024610, 6024611, 6024612, 6024614, 6024615,
6024616, 6024617, 6024618, 6024619, 6024620, 6024621,
6024622, 6024623, 6024624, 6024625, 6024627, 6024628,
6024629, 6024630, 6024631, 6024633, 6024634, 6024635,
6024636, 6024637, 6024638, 6024639, 6024640, 6024641,
6024642, 6024643, 6024644, 6024647, 6024649, 6024650,
6024651, 6024652, 6024654, 6024655, 6024656, 6024657.
Manufacturer: Department of the Navy, U.S. Naval Hospital, Okinawa, Japan.
Recalled by: Manufacturer, by letter November 1, 1991. Firm-
initiated recall ongoing.
Distribution: New Jersey.
Quantity: 45 units.
Reason: Blood products, untested for the antibody of human T
lymphotropic virus type I (anti-HTLV-I), were distributed.
----
Product: Platelets. Recall #B-096-2.
Code: Unit numbers: 5932451, 7215047.
Manufacturer: J.K. & Susie L. Wadley Research Institute and Blood Bank,
Dallas, Texas.
Recalled by: Consignee notified firm by telephone March 26, 1991.
Recall complete.
Distribution: Texas.
Quantity: 2 units.
Reason: Blood products with incorrect expiration dates were
released for transfusion.
----
Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-100/101-2.
Code: Unit #43H88415.
Manufacturer: American Red Cross, Waco, Texas.
Recalled by: Manufacturer, by telephone July 29, 1991, followed by
letter August 5, 1991; (b) by telephone July 26, 1991,
followed by letter July 29, 1991. Firm-initiated
recall ongoing.
Distribution: Illinois, California.
Quantity: 1 unit of each component.
Reason: Blood components from a donor who previously tested
repeatably reactive for the human immunodeficiency virus
type 1 (anti-HIV-1) were distributed.
----
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Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-102/105-2.
Code: Unit numbers: (a) H71080, H99897, J58469, K43469;
(b) H71080, K04374; (c) K43469; (d) H71080, H99897.
Manufacturer: Aurora Area Blood Bank, Heartland Blood Centers,
Aurora, Illinois.
Recalled by: Manufacturer, by letters dated December 10, 1991.
Firm-initiated recall complete.
Distribution: Illinois, California.
Quantity: (a) 4 units; (b) 2 units; (c) 1 unit; (d) 2 units.
Reason: Blood products, which tested nonreactive for the antibody
to human immunodeficiency virus type 1 (anti-HIV-1), but
were collected from donors who previously tested repeatably
reactive for anti-HIV-1, were distributed.
----
Product: Platelets, pooled. Recall #B-107-2.
Code: Pool numbers: P31591, P31592, P31593, P31594.
Manufacturer: Carter Blood Center, Inc., Fort Worth, Texas.
Recalled by: Consignee notified firm by telephone May 11, 1991.
Recall complete.
Distribution: Texas.
Quantity: 4 units.
Reason: Platelets, pooled, labeled with the incorrect expiration
period, were distributed.
----
Class III -
Product: Colchicine Tablets, USP, 0.6 mg, in 100 and 1,000
tablet bottles, a Rx drug used for the treatment of gout,
under Qualitest and Genetco labels. Recall #D-144-2.
Code: Lot numbers C103B EXP 8/93, H103 EXP 8/93.
Manufacturer: Trinity Technologies Corporation, Roseville, Michigan.
Recalled by: Manufacturer, by telephone October 10, 1991. Firm-initiated
recall complete.
Distribution: New York, Alabama.
Quantity: 76 1,000-tablet bottles with the Genetco label;
1,388 1,000-tablet bottles with the Qualitest label;
and 601 100-tablet bottles were distributed; firm estimates
none remains on the market.
Reason: Product fails dissolution specification.
----
Product: (a) Red Blood Cells; (b) Fresh Frozen Plasma;
(c) Recovered Plasma. Recall #B-089/091-2.
Code: Unit numbers: (a) 6017193, 6017315, 6017330, 6017617,
6018066, 6018660, 6019024, 6019238, 6019267, 6019643,
6021949, 6022258, 6022923, 6023832, 6024276, 6024339,
6024343, 6024351;
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(b) 6018660; (c) 6017193, 6017315, 6017330, 6018066,
6019039, 6019049, 6019238, 6019643, 6022923, 6024276,
6024343, 6024351.
Manufacturer: Department of the Navy, U.S. Naval Hospital, Okinawa, Japan.
Recalled by: Manufacturer, by letters dated between April 25, 1991 and
November 1, 1991. Firm-initiated recall complete.
Distribution: California, New Jersey, Illinois.
Quantity: (a) 18 units; (b) 1 unit; (c) 13 units.
Reason: Blood products which tested initially reactive for
the hepatitis B surface antigen (HBsAg), were distributed.
----
Product: Recovered Plasma. Recall #B-093-2.
Code: Unit numbers: 6024606, 6024607, 6024608, 6024609,
6024610, 6024611, 6024612, 6024614, 6024615,
6024616, 6024617, 6024618, 6024619, 6024620, 6024621,
6024622, 6024623, 6024624, 6024625, 6024627, 6024628,
6024629, 6024630, 6024631, 6024633, 6024634, 6024635,
6024636, 6024637, 6024638, 6024639, 6024640, 6024641,
6024642, 6024643, 6024644, 6024647, 6024649, 6024650,
6024651, 6024652, 6024654, 6024655, 6024656, 6024657.
Manufacturer: Department of the Navy, U.S. Naval Hospital, Okinawa, Japan.
Recalled by: Manufacturer, by letter April 25 and November 1, 1991.
Firm-initiated recall ongoing.
Distribution: Florida.
Quantity: 45 units.
Reason: Blood products, untested for the antibody of human T
lymphotropic virus type I (anti-HTLV-I), were distributed.
----
Product: (a) Red Blood Cells; (b) Platelets. Recall #B-094/095-2.
Code: Unit #R36574.
Manufacturer: Walter L. Shepard Community Blood Center, Inc.,
Augusta, Georgia.
Recalled by: Manufacturer, by telephone April 24, 1991. Firm-initiated
recall complete.
Distribution: Georgia.
Quantity: 1 unit of each component.
Reason: Blood products, untested for viral markers, were distributed.
----
Product: (a) Whole Blood; (b) Red Blood Cells. Recall #B-097/098-2.
Code: Unit numbers: (a) 6048195, 6048655; (b) 4425861, 5595555,
5608677.
Manufacturer: J.K. & Susie L. Wadley Research Institute and Blood Bank,
Dallas, Texas.
Recalled by: Consignee notified firm by telephone on or about
September 3, 1990, March 19 and 25, 1991,
May 22, 1991, and June 25, 1991. Recall complete.
Distribution: Texas.
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Quantity: (a) 2 units; (b) 3 units.
Reason: Blood products with incorrect expiration dates were
released for transfusion.
Product: Whole Blood. Recall #B-106-2.
Code: Unit #151357.
Manufacturer: Blood Bank of Delaware, Inc., Newark, Delaware.
Recalled by: Consignee discovered labeling error and returned the
product to firm August 16, 1991. Recall complete.
Distribution: Delaware.
Quantity: 1 unit.
Reason: Whole Blood, labeled with the incorrect expiration date
was distributed.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Hewlett-Packard Model HP78730A CareVue 5000 HP78730AS
(software). Recall #Z-1088-1.
Code: Serial #78730AS.
Manufacturer: Hewlett-Packard Company, Waltham, Massachusetts.
Recalled by: Manufacturer, by letter June 28, 1991. Firm-initiated
field correction ongoing.
Distribution: Nationwide and international.
Quantity: 571 units.
Reason: Problem with a defect in drug algorithm, in patients
weighing less than 10 kilograms (neonates).
----
Product: IV sets in six different configurations, distributed under
the brand name, Critikon:
(a) Product #6412, IV Administration Set, Universal Spike,
Two Y-Sites;
(b) Product #6422, IV Filter Administration Set, Universal
Spike, Two Y-Sites, .22 micron filter;
(c) Product #6432, IV Piggyback Set, Universal Spike,
Backcheck Valve, Two Y-Sites;
(d) Product #6442, IV Filter Piggyback, Universal Spike,
Backcheck Valve, two Y-Sites, .22 micron filter;
(e) Product #6482, IV Burette Set, Universal Spike, 150
ml chamber, two Y-sites;
(f) Product #6492, Nitroglycerin IV Administration Set,
Universal Spike with Luer Lock. Recall #Z-110/115-2.
Code: Lot numbers: (a-e) All lot numbers except those beginning
with "91"; (f) All lot numbers except numbers 029501 and
116801.
Manufacturer: Critikon, Inc., San Jose, California.
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Recalled by: Critikon, Inc., Tampa, Florida, by telephone August
23, 1991, followed by letter September 13, 1991, and
by telex to foreign consignees September 13, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 12,838.46 cases were distributed.
Reason: Tubing may leak.
----
Product: Cavity Wound Dressings, Allevyn brand (formerly known as
Intrasite brand):
Product #7326 - 5 cm round
#7327 - 10 cm round
#7328 - 9 cm x 2.5 cm
#7329 - 12 cm x 4 cm
Intrasite brand:
Product #7622 - 5 cm round
#7623 - 10 cm round
#7624 - 9 cm x 2.5 cm
#7625 - 12 cm x 4 cm. Recall #Z-120-2.
Code: All lots.
Manufacturer: Smith and Nephew Medical Ltd., Hull, United Kingdom.
Recalled by: Smith and Nephew, Inc., Largo, Florida, by letter
October 21, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and England.
Quantity: 26,885 units were distributed; firm estimates 30 percent
remains on the market.
Reason: Open seals may compromise the sterility of the product.
----
Class III -
Product: EPROM Software Chips used in certain serial numbers of
the firm's Stat-Fax Photometer device, used to verify
calibration parameters of diagnostic lab test equipment:
(a) Model 303; (b) Model 309. Recall #Z-235/236-2.
Code: Serial numbers: (a) 1010, 1076, 1084-1095, 1099-1106, 1109;
(b) 1001-1022, 1333-1335.
Manufacturer: Awareness Technology, Palm City, Florida.
Recalled by: Manufacturer, by letters of September 27, 1991 and
October 8, 1991. Firm-initiated field correction ongoing.
Distribution: Nationwide, Poland, Bombay, Italy, France,
Spain, Rio de Janeiro, Australia.
Quantity: 44 units.
Reason: Device is capable of reporting erratic results if
attempts were made to recall stored curves.
----
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Product: The EPROM Software Chip used in certain serial numbers
of the firm's Stat-Fax Photometer device:
(a) Model 1904; (b) Model 1908; (c) Model 1914;
(d) Model 1915. Recall #Z-239/242-2.
Code: Serial numbers: (a) 1081, 1089; (b) 1034;
(c) 1001 to 1010; (d) 1002 to 1011.
Manufacturer: Awareness Technology, Inc., Palm City, Florida.
Recalled by: Manufacturer, by telephone or FAX February 8, 1991, and
by letter February 12, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide, Bombay, Venezuela, India.
Quantity: 23 units.
Reason: Erratic test results. In the batch mode, inaccurate
calculations were being made by the device and an
overrange message was displayed at times when absorbency
should not have been overrange.
----
VETERINARY PRODUCTS
NONE
Medical Device Safety Alerts:
Product: (a) Tram Multiparameter Modules-Series 7200 and 7200AR;
(b) Tram Module 100; (c) Tram Module 200;
(d) Tram Module 300; (e) Tram Module 400;
(f) Tram Module 500; (g) Tram Module 600 when used in
conjunction with Camino Model 420 Intracranial Pressure
Module. Safety Alert #M-026/032-2.
Code: All serial numbers.
Manufacturer: Marquette Electronics, Inc., Milwaukee, Wisconsin.
Alerted by: Manufacturer, by letter September 19, 1991.
Distribution: Nationwide and international.
Quantity: 9,000 units were distributed.
Reason: Leakage current as high as 900 micro amps may occur
when the devices are connected with a Camino Model 420
Intracranial Pressure Monitor. This is due to an
incompatible grounding system between the devices.
----
Injunction Actions Filed:
Against: Marlon "John" Bruce Whittemore, Modesto, California.
Product: Veal Calves (91-034-863).
Charge: Sale of veal for slaughter intended for food containing
illegal antibiotic drug residues.
Filed: December 13, 1991 - U.S. District Court for the
Eastern District of California; Civil #CV-F-91-682REC,
INJ #1266.
----
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Seizure Actions Filed:
Product: Eye Shadow (91-594-101).
Charge: Misbranded - The package form and the label fail to
bear a statement of the quantity of contents; also
the product consists of two or more ingredients and the
label fails to bear the common or usual name of each
such ingredient listed in the order of decreasing
predominance.
Firm: Imported by Iota Cosmetics, Inc., Miami Beach, Florida
from Spain; located at Lemott Cosmetics, Inc., Miami,
Florida.
Filed: November 22, 1991 - U.S. District Court for the
Southern District of Florida; Civil #91-2744-CIV-
NESBITT; FDC #66294.
Seized: December 26, 1991 - 52,000 units valued at $7,830.
----
Product: Sensor Pad, a round latex rubber bladder that contains
silicone, a medical grade lubricant, and is sold
over-the-counter for use as an aid in performing
breast self-examination (92-503-638).
Charge: The sensor pad is a class III medical device which
does not have in effect the required approved
premarket application.
Firm: Located at St. James Hospital, Chicago Heights, Illinois;
Manufacturer - Inventive Products, Inc., Decatur, Illinois.
Filed: January 14, 1992 - U.S. District Court for the Northern
District of Illinois; Eastern Division; Civil #92C0281;
FDC #66339.
Seized: January 14, 1992 - sensor pads valued at $5,000.
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