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
04/10/1996
ENFORCEMENT REPORT FOR 04/10/96
April 10, 1996 96-15
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I =============
_______________
PRODUCT Star Market brand Mini Cupcakes in 10 ounce
clear plastic tray, 12 mini-cupcakes per unit:
(a) Chocolate Mini Cupcakes; (b) Chocolate
Valentine Mini Cupcakes; (c) Gold Mini
Cupcakes; (d) Gold Valentine Mini Cupcakes.
Recall #F-366/369-6.
CODE None.
MANUFACTURER Freed's Bakery, Manchester, New Hampshire.
RECALLED BY Star Markets, Company, Inc., Cambridge,
Massachusetts (distributor), by telephone on
January 31, 1996, and by press release on
February 2, 1996. State-initiated recall
complete.
DISTRIBUTION Massachusetts, New Hampshire.
QUANTITY Undetermined. Approximately 600 packages per
week are distributed.
REASON Product contains undeclared eggs.
_______________
PRODUCT Various ice cream and sherbet products:
(a) Olde Tyme Vanilla Ice Cream, in 1/2 gallon
round containers
(b) Original Vanilla Ice Cream, in 1/2 gallon
round containers
(c) Peanut Butter Fudge Ice Cream, in 1/2
gallon round containers (d) Neapolitan Ice Cream, in 1/2 gallon round
containers
(e) Lemon Lime Sherbet, in 1 quart containers
(f) Tropical Fruit Sherbet, in 1 quart
containers. Recall #F-374/379-6.
CODE Ice cream products: 3185 (embossed);
Sherbet products: 0046 (ink jetted).
MANUFACTURER Velvet Ice cream Company, Inc., Utica, Ohio.
RECALLED BY Manufacturer, by letter and press release on
January 26, 1995. State-initiated recall
ongoing.
DISTRIBUTION Ohio.
QUANTITY (a) 792 gallons; (b) 736 gallons; (c) 484
gallons; (d) 324 gallons; (e) 349 gallons; (f)
179 gallons were distributed.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Owyhee Idaho Spud Candy Bar, 1.5 ounces.
Recall #F-363-6.
CODE All lot numbers ending in "5"; Lot numbers
910016, 909016, 905016, 903016; Any/all loose
bars (the firm codes only cases and boxes, not
the individual bars.)
MANUFACTURER Idaho Candy Company, Boise, Idaho.
RECALLED BY Manufacturer, by telephone on February 16,
1996, followed by letter. FDA-initiated
recall complete.
DISTRIBUTION Washington state, Oregon, Utah, Nevada,
Montana, California, Wyoming, Idaho, North
Dakota, Nebraska, Colorado, Alaska.
QUANTITY Approximately 45,000 bars remained on market
at time of recall initiation.
REASON The product contains an off-odor and an off-
taste.
_______________
PRODUCT Campbell's Home Cookin Country Mushroom Rice
Soup, in 19 ounce cans. Recall #F-380-6.
CODE On can lid: Sept97 9T5/CU CJGK---- (last 4
digits indicates military time and will vary);
on case flat: 20SEP97 P-U (middle digit
varies).
MANUFACTURER Campbell Soup Company, Napoleon, Ohio.
RECALLED BY Campbell Soup Company, Camden, New Jersey, by
letter dated December 19, 1995. Firm-
initiated recall complete.
DISTRIBUTION Connecticut, Kentucky, Illinois, Indiana,
Massachusetts, Michigan, Minnesota, North
Dakota, New Hampshire, New York, Ohio,
Pennsylvania, Wisconsin, West Virginia.
-2- QUANTITY 158,676 cans were distributed; firm estimates
none remains on the market.
REASON Product contained pieces of plastic.
_______________
PRODUCT Rocky Road Ice Cream, in 1/2 gallon round
cardboard containers. Recall #F-381-6.
CODE 2 12 96 2 19 96 3 07 96
3 30 96 4 05 96 5 04 96
5 11 96 5 18 96 5 23 96
5 27 96 5 30 96 6 12 96
MANUFACTURER Alta-Dena Certified Dairy, City of Industry,
California.
RECALLED BY Albertson's, Inc., Boise, Idaho, by letter on
February 16, 1996. Firm-initiated recall
complete.
DISTRIBUTION California, Nevada.
QUANTITY 33,820 cartons were distributed.
REASON Product declares walnuts on the label,
however, it actually contains almonds.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Flavorite brand Salad Dressing, in 32 ounce
clear glass jars with white metallic caps.
Recall #F-383-6.
CODE NOV 4 1996KC.
MANUFACTURER Wilsey Foods, Inc., Oakland, California.
RECALLED BY Supervalu Spokane Division, Spokane,
Washington, by memorandum dated February 9,
1996. Firm-initiated recall complete.
DISTRIBUTION Washington state, Idaho, Montana.
QUANTITY 10 cases (12 jars per case) were distributed.
REASON Product is unfit for human consumption due to
product effervescing out of containers.
_______________
UPDATE Recall #F-347/349-6, Minute Maid fruit juice
products containing apple juice which appeared
in the March 27, 1996 Enforcement Report
should read:
REASON: High fructose corn syrup has been
substituted in part for apple juice in these
products.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Sterile Eye Wash Solutions and sterile eye
drops packaged in plastic bottles with plastic
screw on lids:
-3- (a) First Aid Pac-Kit Eye Flush Solution, in 1
ounce bottles; (b) Medco Eye Wash Sterile
Isotonic Buffered Solution, in 4 fluid ounce
and 32 fluid ounce bottles; Respond Eye Wash
First Aid Treatment Ophthalmic Irrigating
Solution, in 4 fluid ounce bottles; Respond
Eye & Skin Flushing Solution, sterile and
isotonic, in 8 fluid ounce bottles; (c)
Masuentm Your First Aid Supply Source Eye &
Body Wash, in 32 fluid ounce bottles; (d) Life
& Safety Eye & Skin Neutralizer for Acid and
Alkali Burns Sterile First Aid Treatment, in 8
fluid ounce bottles. Recall #D-110/113-6.
CODE Lot numbers: (a) 1915; (b) 1635, 1665, 3545;
(c) 1665, 2625; (d) 3545.
MANUFACTURER Medco Pharmaceuticals, Inc., Covington,
Louisiana.
RECALLED BY Manufacturer, by letter March 19, 1996. FDA-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 26,877 units were distributed.
REASON Some units have loose caps resulting in
container leakage.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Dura-Vent/A Capsules packaged in bottles of
100, Rx used for the temporary relief of
symptoms associated with allergic, rhinitis,
sinusitis, and the common cold.
Recall #D-107-6.
CODE Lot KEK EXP 8/97.
MANUFACTURER Central Pharmaceuticals, Inc., Seymour,
Indiana.
RECALLED BY Manufacturer, by telephone on March 1, 1996,
followed by letters on March 4, 1996 and April
1, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,745 bottles were distributed; firm estimated
that little or none of this lot remained on
market at time of recall initiation.
REASON Product does not meet dissolution
specifications for phenylpropanolamine
ingredient.
_______________
PRODUCT Coly-Mycin S Otic with Neomycin and
Hydrocortisone, Rx antibacterial, in 10 ml and
5 ml vials. Recall #D-108-6.
CODE Lot numbers: 03165P EXP 11/96, 02185P EXP
11/96.
-4- MANUFACTURER Warner-Lambert Company, Parke-Davis Sterile
Products Division, Rochester, Michigan.
RECALLED BY The Parke-Davis Division of Warner-Lambert
Company, Morris Plains, New Jersey, by letter
sent on March 25, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 32,178 vials of 03165P and 65,311 vials of lot
02185P were distributed.
REASON Product does not meet potency specifications
for Hydrocortisone.
_______________
PRODUCT Hydromorphone Hydrochloride USP, C-II,
packaged in a 1-kg drum and 1-gm bottles, for
prescription compounding or further
manufacturing, processing, or repacking.
Recall #D-109-6.
CODE Lot numbers: T00252 (1-kg) and T01801 (1-gm).
MANUFACTURER Mallinckrodt Chemical, Inc., St. Louis,
Missouri.
RECALLED BY Manufacturer, by letter dated March 22, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, Oregon, Michigan, Alaska,
Nevada.
QUANTITY 1 1-kg drum and 126 1-gm bottles were
distributed.
REASON Inconsistent assay results.
_______________
PRODUCT Loxitane (Loxapine Succinate) 5 mg and 10 mg
capsules in bottles of 100 and 1000, and
blister packs of 10 (2 X 5) capsules, Rx
antipsychotic drug. Recall #D-114/115-6.
CODE All control numbers of 5 mg and 10 mg doses.
5 mg strength: #431-860 (APR 97), #380-400
(JAN 97), #378-387 (JAN 97),
#362-457 (JULY 98), #362-458 (JAN 96),
#336-365 (JAN 97), #322-351 (OCT 96) and
#308-455 (APR 96).
10 mg strength: #431-862 (APR 97), #431-863
(APR 97), #431-545 (APR 98), #429-867 (APR
98), #426-180 (DEC 97), #429-108 (DEC 97),
#429-109 (DEC 97), #427-202 (DEC 97), #432-249
(JAN 98), #390-410 (AUG 99), #388-453 (JULY
99), #384-418 (JULY 99), #384-417 (JULY 99),
#384-419 (JULY 97), #360-404 (JUNE 98),
#360-336 (APR 96), #360-335 (APR 98), #350-487
(FEB 98), #356-425 (APR 98), #360-358 (APR
98), #344-388 (OCT 97), #344-324 (SEPT 97),
#336-351 (APR 97), #334-362 (APR 97), #360-356
(FEB 97), #328-418 (FEB 97), #326-409 (FEB
-5- 97), #333-302 (FEB 97), #333-303 (FEB 97),
#322-387 (AUG 96), #322-365 (AUG 96), #322-364
(AUG 96), #316-474 (AUG 96), #313-353 (JULY
96), #313-352 (JULY 96), #313-300 (JULY 96)
and #313-321 (JULY 96).
MANUFACTURER Wyeth-Ayerst/Lederle Laboratories, Inc., Pearl
River, New York.
RECALLED BY Whitehall Robins Inc., Division of Wyeth
Ayerst/Lederle Laboratories Inc., Richmond,
Virginia, by letter dated March 29, 1996.
firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 5 mg. strength: 93,585 bottles of 100.
5,997 blister packs of 10 (2 X 5) capsules.
10 mg. strength: 6,059 bottles of 1,000.
144,942 bottles of 100.
9,383 blister packs of 10 (2 X 5) capsules.
REASON Potency not assured through expiration date.
_______________
UPDATE Fujisawa Cytarabine Injection, 20 mg/ml,
Recall #D-062-6, which appeared in the January
10, 1996 Enforcement Report has been extended
to include 50 ml vials with lot numbers:
4011994, 4021994, 4031994, 4041994, 4051994,
4061994.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-358-6.
CODE Unit #11H42081.
MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone on June 30, 1995.
Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit.
REASON Blood product collected from a donor who
traveled to an area designated as endemic for
malaria, was distributed.
_______________
PRODUCT Platelets. Recall #B-360-6.
CODE Unit #11N25838.
MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone on July 19, 1995,
followed by letter. Firm-initiated recall
complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit.
-6- REASON Blood product collected from a donor who had a
history of high risk behavior was distributed.
_______________
PRODUCT Platelets. Recall #B-361-6.
CODE Unit numbers: 11313-0563, 11313-0743,
11313-0744, 11313-1280, 11313-1284,
11313-1300, 11313-1350, 11313-1364,
11313-1389, 11313-1397.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated January 30, 1996. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 10 units.
REASON Platelets manufactured from whole blood units
with excessive bleed times.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT AS-1 Red Blood Cells. Recall #B-356-6.
CODE Unit #11FF18503.
MANUFACTURER American Red Cross, St. Louis, Missouri.
RECALLED BY Manufacturer, by telephone on September 22,
1994, followed by letter September 26, 1994.
Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit.
REASON Blood product mislabeled with the incorrect
expiration date was distributed.
_______________
PRODUCT Red Blood Cells, Irradiated. Recall #B-359-6.
CODE Unit 11F12842, 11W19558, 11M41733, 11G03114,
11G03085.
MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone February 20, 1995.
Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 5 units.
REASON Blood products irradiated and labeled with an
extended expiration date were distributed.
_______________
PRODUCT Red Blood Cells, Leukocytes Removed by
Filtration. Recall #B-362-6.
CODE Unit #11M44300.
MANUFACTURER American Red Cross Blood Services, St.Louis,
Missouri.
-7- RECALLED BY Manufacturer, by telephone on April 15, 1995.
Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit.
REASON Blood product, which was leukodepleted greater
than five days after collection, was
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Olympus brand Lubricated Condoms.
Recall #Z-564-6.
CODE Lot #950201.
MANUFACTURER Custom Services International, Inc., doing
business as Olympus Condoms, Las Vegas,
Nevada.
RECALLED BY Manufacturer, by letter dated November 8,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON Product failed the FDA water leak test.
_______________
PRODUCT LifeStyles Lubricated Condoms with Nonoxynol-
9, in boxes of 1,000. Recall #Z-565-6.
CODE Lot #401003100 EX 12/96.
MANUFACTURER Ansell, Inc., Troy, Alabama.
RECALLED BY Ansell, Inc., Dothan, Alabama, by letter on
February 2, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION California, Georgia, Texas, Wyoming.
QUANTITY 43 boxes were distributed.
REASON Product failed the firm's water leak test
apparently due to deterioration of the latex.
The device may also be misbranded because it
deteriorated prior to the expiration date
present on the product labeling.
_______________
PRODUCT Datascope System 97 Intra-Aortic Balloon Pump,
for use as a patient aid during pre- intra- or
post-operative open heart surgery; use within
patients demonstrating unstable angina; use
within patients with left main artery
occlusion or poor left ventricle function.
Recall #Z-567-6.
CODE Part #0998-00-0104-XX, multiple serial
numbers: 1085 through 1198 inclusive.
MANUFACTURER Bimba Manufacturing Company, Monee, Illinois
(cylinder).
-8- RECALLED BY Datascope Corporation, Paramus, New Jersey, by
letter delivered beginning March 22, 1994.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 114 units were distributed; firm estimates
none remains on the market.
REASON The device's volume cylinder was found to
malfunction during the autofill process mode
at the self test stage.
_______________
PRODUCT Triad XLT-20 Nuclear Imaging Systems, used by
technologists for diagnostic and research
purposes. Recall #Z-570-6.
CODE Serial numbers 126 - 225.
MANUFACTURER Trionix Research Laboratory, Twinsburg, Ohio.
RECALLED BY Manufacturer, by telephone November 1994.
Firm-initiated field correction ongoing.
DISTRIBUTION Connecticut, Tennessee, New York, Maryland,
Texas.
QUANTITY 6 units were distributed.
REASON The detector head may drop on a patient or
healthcare provider because of metal fatigue
at the device's ball screw assembly.
_______________
PRODUCT Bear Ventilator, Model 1000, indicated for
ventilation of adult and pediatric patients.
Recall #Z-571-6.
CODE 1,868 unique, non-sequential serial numbers.
MANUFACTURER Precision Dynamics, Inc., New Britain,
Connecticut (solenoid).
RECALLED BY Allied Healthcare Systems, Inc., Riverside,
California, by letter sent on October 30,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,868 units were distributed.
REASON Device is constructed with a defective
solenoid valve with may cause patient
breathing difficulties.
_______________
PRODUCT New Star Model 600 Ho:YAG Laser, used in
cardiovascular surgery. Recall #Z-573-6.
CODE Model 600.
MANUFACTURER New Star Lasers, Inc., Auburn, California.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan March 27, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 6 units.
-9- REASON The device failed to comply with 21 CFR
1040.10(f)(5)(ii) in that under certain
circumstances the emission indicator would not
be illuminated although the laser could emit a
beam if the footswitch were depressed.
_______________
PRODUCT Sysmex Automated Coagulation Analyzers, for
in-vitro diagnostic use:
(a) Model CA-1000; (b) Model CA-5000.
Recall Z-574/575-6.
CODE All serial numbers.
MANUFACTURER TOA Medical Electronics Company, Ltd., Kobe,
Japan.
RECALLED BY Sysmex Corporation of America, Long Grove,
Illinois, by letter dated November 20, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 592 units; (b) 59 units were distributed.
REASON The analyzers may report incorrect coagulation
times due to flat coagulation curves without
the presence of appropriate error code
messages or flagging. This could result in
incorrect patient results being reported.
_______________
PRODUCT Novametric Handheld Pulse Oximeter, used to
measure and display, on an ongoing continuous
basis, the respiration (heart beat) and
saturation (oxygen level in a patient's
blood) of a patient: (a) Model 510 domestic,
Part numbers 5950-00 and 6350-00; (b) Model
511 international, Part #6116-00.
Recall #Z-577/578-6.
CODE All serial numbers.
MANUFACTURER Novametrix Medical Systems, Inc., Wallingford,
Connecticut.
RECALLED BY Manufacturer, by letter dated January 16,
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 2,193 units of part #5950-00; 572 units of
part #6350-00; 2,387 units of part #6116-00
were distributed.
REASON There is a potential of a system lock-up,
holding the last saturation and pulse display,
but not alarming when an alarm condition
occurs. The incidence of system lockup has
been found to happen when the unit battery
voltage drops below the power necessary to
operate the internal circuitry.
-10- _______________
PRODUCT Titanium CP Obutment Antirotational Implant,
non-coated with 2mm collars:
(a) Catalog #3516TE; (b) Catalog #4012TE.
Recall #Z-579/580-6.
CODE Lot numbers: (a) 1900; (b) 1901.
MANUFACTURER The O'Company, Albuquerque, New Mexico.
RECALLED BY Manufacturer, by letter on February 1, 1996.
FDA-initiated recall complete.
DISTRIBUTION New Mexico, West Virginia.
QUANTITY 5 implants were distributed; all have been
returned.
REASON The product has not undergone the
sterilization process.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======
_______________
PRODUCT 3M Sarns Turbo Membrane Oxygenator, used in
blood profusion procedures. Recall #Z-572-6.
CODE Serial numbers 155208 - 155244.
MANUFACTURER Sarns/3M Health, Ann Arbor, Michigan.
RECALLED BY Manufacturer, by letter telephone and by visit
October 4, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 37 units were distributed.
REASON The oxygenators contain blocked fibers that
resulted in reduced gas transfer between
fibers and the blood.
_______________
PRODUCT Disposable Mouthpiece, 7/8" outside diameter,
a single use device used with pulmonary
function equipment. Recall #Z-576-6.
CODE Catalog #1622. Products manufactured prior to
1976.
MANUFACTURER A-M Systems, Inc., Everett, Washington.
RECALLED BY Manufacturer, by telephone on March 20, 1995.
Firm-initiated recall complete.
DISTRIBUTION Georgia, Michigan, Wyoming, California,
Minnesota, Massachusetts.
QUANTITY 10 cases of 500 mouthpieces were distributed.
REASON The product was contaminated with a red
substance.
-11-
END OF ENFORCEMENT REPORT FOR APRIL 10, 1996. BLANK PAGES MAY
FOLLOW.
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