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
03/17/1993
Recalls and Field Corrections: Foods -- Class I -- 03/17/1993
MARCH 17, 1993 93-11
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________
PRODUCT Waleeco brand Dainty Filled Candies, in 32 ounce
cardboard cylinders. Recall #F-186-3.
CODE None.
MANUFACTURER F.B Washburn Candy Shop, Brockton, Massachusetts.
RECALLED BY Manufacturer, by telephone December 28, 1992.
Firm-initiated recall complete.
DISTRIBUTION Massachusetts, New York, New Hampshire, Maine,
Maryland, New Jersey, Pennsylvania, Canada.
QUANTITY 7,376 units were distributed in the United States,
6,000 units in Canada.
REASON The product contains peanuts or peanut containing
ingredients which are not declared on the label.
_______________
PRODUCT Dole Salad Mix Classic Blend, consisting of
iceberg lettuce, carrots, and red cabbage packed
in 6 ounce, 10 ounce, 1 pound, 2 pound, 3 pound,
and 5 pound sizes. Recall #F-232-3.
CODE All lots produced November 13, 1992 and before.
MANUFACTURER Dole Fresh Vegetables Company, Marina, California.
RECALLED BY Dole Fresh Vegetables Company, Inc., Salinas,
California, by visit between December 4 and 6,
1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 1,244,888 packages were distributed; firm
estimates none remains on the market.
REASON The product is contaminated with Listeria
monocytogenes.
_______________
PRODUCT Fuego Cheese Sauce, in 16 ounce jars.
Recall #F-260-3.
CODE None.
MANUFACTURER Nina Ltd., Trenton, Missouri.
RECALLED BY Manufacturer, by telephone, from 1/8/93 to
1/16/93. Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 490 units were distributed.
REASON The product has the potential to support the
outgrowth of Clostridium botulinum toxin.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________
PRODUCT Canton Noodles, in 10 pound cartons, 4 cartons per
case. Recall #F-245-3.
CODE All lots.
MANUFACTURER Hanson Foods Mfg. Company, St. Louis, Missouri.
RECALLED BY Manufacturer, by telephone and by letter dated
January 29, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Missouri, Texas, Indiana, Minnesota, Kansas,
Mississippi.
QUANTITY Approximately 1,150 40-pound cases were
distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Children's China Tea Set in Rose Floral or Holly
Hobby Pattern. Recall #F-247/248-3.
CODE None.
MANUFACTURER Pretty Port Ltd., Teun Mun, N.T. China.
RECALLED BY McCrory Corporation/York Distribution Company,
York, Pennsylvania, by electronic mail December
28, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 25,728 units were distributed.
REASON The product contains excessive levels of leachable
lead.
_______________
PRODUCT Various Children's China Tea Sets:
(a) Chilton's China Tea Set, Product #3331-9;
(b) Barbie China Tea Set, 12 pieces,
Product #3334-9;
(c) Barbie China Dinner Set, Product #3335-9;
-2- (d) Holly Hobbie China Tea Set, Product #3339-9;
(e) Holly Hobbie China Dinner Set,
Product #3340-9;
(f) Cabbage Patch Kids China Dinner Set,
Product #3346-9;
(g) Campbell's Soup Time China Set, 9 pieces,
Product #3350-9;
(h) Campbell's Soup Time China Set, 15 pieces,
Product #3351-9. Recall #F-251/258-3.
CODE All lots.
MANUFACTURER Chaozhou Chinaware Factory, Fengxi, Chaozhou,
China.
RECALLED BY Chilton-Globe, Inc., Manitowoc, Wisconsin, by
letters of January 15, 1993 and February 5, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 161,714 sets were distributed.
REASON The product contains excessive levels of leachable
lead.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________
PRODUCT 1. Centrax (Prazepam Capsules, USP), indicated
for the management of anxiety disorders or for
the short-term relief of the symptoms of anxiety:
(a) 5 mg; (b) 10 mg; (c) 20 mg.
Recall #D-147/149-3.
2. Tedral (Theophylline, Ephedrine
Hydrochloride, Phenorbarbital Tablets, USP),
antiasthmatic for temporary relief from the
symptoms of bronchial asthma. Recall #D-151-3.
CODE All codes within their labeled expiration date.
MANUFACTURER Warner Lambert, Inc., Vega Baja, Puerto.
RECALLED BY Parke-Davis Division of Warner-Lambert Company,
Morris Plains, New Jersey, by letter dated
January 7, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON 1. Products do not meet dissolution
specifications.
2. Product does not meet dissolution and content
uniformity specifications.
_______________
PRODUCT Dilantin Kapseals, 30 mg, extended Phenytoin
Sodium Capsule USP, in bottles of 100.
Recall #D-170-3.
CODE Lot #39162L EXP 6/94.
MANUFACTURER Warner-Lambert Company, Litiz, Pennsylvania.
-3-
RECALLED BY Parke Davis Division of Warner-Lambert Company,
Morris Plains, New Jersey, by letter dated
February 17, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 26,899 units were distributed.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT (a) Methocarbamol, 750 mg Tablets, in 100 tablet
bottles; (b) Tolbutamide, 500 mg Tablets, in 100
tablet bottles, Rx products under the Rugby
label. Recall #D-171/172-3.
CODE Lot numbers: 206NC061, 209NC022, 210NC025,
211NC025, 212NC022.
MANUFACTURER Chelsea Laboratories, Inc., Monroe, North
Carolina.
RECALLED BY Manufacturer, by letter January 29, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 66,444 bottles were distributed.
REASON Some bottles of Methocarbamol Tablets were
mislabeled as Tolbutamide Tablets.
_______________
PRODUCT Ergostat (Ergotamine Tartrate, USP) Tablets, 2
mg, in vials of 24 tablets. Recall #D-174-3.
CODE All codes within their labeled expiration date.
MANUFACTURER Warner Lambert, Inc., Vega Baja, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner-Lambert Company,
Morris Plain, New Jersey, by letter dated January
28, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 440,389 units were distributed.
REASON Subpotency.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________
PRODUCT 1. Pyridium (Phenazopyridine Hydrochloride
Tablets, USP), 100 mg, in 24 and 100 tablet
bottles, indicated for the symptomatic relief of
pain burning, urgency, frequency, and other
discomforts arising from irritation of the lower
urinary tract mucosa. Recall #D-150-3.
2. Tedral SA (Theophylline, Ephedrine
Hydrochloride, Phenobarbital Sustained Release
Tablets, indicated for the symptomatic relief of
bronchial asthma, asthmatic bronchitis, and other
bronchospastic disorders. Recall #D-152-3.
-4-
3. Estrovis (Quinestrol Tablets, USP), 100 mg,
in 100 tablet bottles, indicated in the treatment
of moderate to severe vasomotor symptoms.
Recall #D-153-3.
4. Norlestrin 21 2.5/50 (5 packages of 21
tablets, oral contraceptive. Recall #D-154-3
5. Norlestrin 21 1/50 (5 packages of 21
tablets), oral contraceptive. Recall #D-155-3.
6. Norlestrin Fe, 1/50, (Norethindrone Acetate
and Ethinyl Estradiol Tablets, USP and Ferrous
Fumarate Tablets, USP), oral contraceptives, 5
packages of 21. Recall #D-156-3.
7. Norlestrin Fe 2.5/50, (Norethindrone Acetate
and Ethinyl Estradiol Tablets, USP and Ferrous
Fumarate Tablets, USP), oral contraceptives, 5
packages of 21. Recall #D-157-3.
8. Norlutate (Norethindrone Acetate Tablets,
USP), 5 mg, in bottles of 50 tablets, indicated
in amenorrhea, in abnormal uterine bleeding .
Recall #D-158-3.
9. Norlutin (Norethindrone Tablets, USP), 5 mg,
in bottles of 50 tablets. Recall #D-159-3.
CODE All codes within their labeled expiration date.
MANUFACTURER Warner Lambert, Inc., Vega Baja, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner-Lambert Company,
Morris Plains, New Jersey, by letter January 7,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Unknown.
REASON (1 and 3-9) Current good manufacturing practice
deficiencies.
(2) Product does not meet sustained release
specifications.
_______________
PRODUCT Choline magnesium Trisalicylate Tablets, 750 mg,
a Rx anti-arthritic, in bottles of 100.
Recall #D-173-3.
CODE Lot #209026 EXP 9/94.
MANUFACTURER Able Laboratories, Inc., Division of A.L.
Laboratories, South Plainfield, New Jersey.
RECALLED BY Manufacturer, by letter January 14, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,430 bottles were distributed; firm estimates
675 bottles remain on the market.
REASON Blue colored tablets were labeled as white
tablets. Product is of correct composition.
-5- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________
PRODUCT (a) Recovered Plasma; (b) Source Plasma. Recall
#B-163/164-3.
CODE Unit numbers: (a) 2076573; (b) 9014034.
MANUFACTURER Community Blood Center of Greater Kansas City,
Kansas City, Missouri.
RECALLED BY Manufacturer, by telephone (a) May 5, 1992; (b)
February 19, 1992. Firm-initiated recall
complete.
DISTRIBUTION New York, Kansas.
QUANTITY 1 unit of each component.
REASON Blood products, which: 1) tested repeatedly
reactive for the antibodies to human
immunodeficiency virus type-1 (anti-HIV-1); or 2)
tested repeatedly reactive to Hepatitis B Core
antigen (anti-HBc) and not labeled to reflect the
anti-HBc reactive results, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF.
Recall #B-177/178-3.
CODE Unit #7752754.
MANUFACTURER North Jersey Blood Center, East Orange, New
Jersey.
RECALLED BY Manufacturer, by telephone September 28, 1992.
Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit of each component.
REASON Blood products, which tested repeatedly reactive
for the antibody to hepatitis B core antigen
(anti-HBc), were distributed.
_______________
PRODUCT Source Plasma. Recall #B-179-3.
CODE Unit #842529.
MANUFACTURER Plasma Services, San Antonio, Texas.
RECALLED BY Manufacturer, by telephone December 12, 1991.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit.
REASON Source Plasma, which was untested for all FDA
required or recommended tests, was distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-181-3.
CODE Unit numbers: TM21375, TM21582.
MANUFACTURER Timken Mercy Medical Center, Canton, Ohio.
RECALLED Manufacturer, by telephone February 1 and 3,
1993. Firm-initiated recall complete.
DISTRIBUTION Maryland, California.
QUANTITY 2 units.
-6- REASON Blood products, which either: 1) tested
repeatedly reactive for the antibody to the human
immunodeficiency virus type 1 (anti-HIV-1); or 2)
tested negative for anti-HIV-1, but was collected
from a donor who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________
PRODUCT Allergen Patch Test Kit. Recall #B-165-3.
CODE Lot #13604/1 EXP 4/3/93.
MANUFACTURER Hermal Kurt Herrmann, Reinbeck, Hamburg, Germany.
RECALLED BY Hermal Pharmaceutical Laboratories, Inc., Delmar,
New York, by telephone beginning February 5,
1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 230 kits were distributed.
REASON Allergan Patch Test Kits in which the outer
container was labeled with the wrong lot number
and expiration date were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________
PRODUCT IPI Nasal Oxygen Cannula with 7 foot Over Ear
Tubing, used to administer oxygen to a patient
through both nostrils. Recall #Z-335-3.
CODE Catalog #1200, lot numbers: A242, B015, B041,
B099, B100.
MANUFACTURER IPI Medical Products, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone July 7, 1992, followed
by letter dated September 15 and 21, 1992. Firm-
initiated recall complete.
DISTRIBUTION Maryland, Pennsylvania, Connecticut, Illinois,
Ohio, Austria.
QUANTITY 38,650 units were distributed; firm estimates
none remains on the market.
REASON The cannula may be occluded.
_______________
PRODUCT Cook Tissue Morcellator Rotary Scalpel, used for
morcellation and removal of dissected tissue
under direct vision, open surgical procedures,
and/or endoscopic procedures when used in
conjunction with the LapSac:
(a) Cook Series 1 Power Supply and Motor, Catalog
#410000 and #KCTM-410000;
-7-
(b) Cook Tissue Morcellator Body, Catalog #410010
and KCTM-410010;
(c) Cook Series 1 Power Supply (does not include
motor), Catalog 410100 and KCTM-410100;
(d) Motor only, Catalog #410200 and KCTM-410200
and KCTM-410200. Recall #Z-342/345-3.
CODE All lot numbers.
MANUFACTURER Cook Urological, Inc., Spencer, Indiana.
RECALLED BY Manufacturer, by telephone August 3, 1992,
followed by letter August 3 and 4, 1992. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Switzerland, Australia.
QUANTITY 32 motors, 52 bodies and 29 power supply units
were distributed.
REASON There is a potential for microshock hazard to the
patient.
_______________
PRODUCT Mitek GII Drills, used in Mitek GII Kits. The
kits are used in the installation of Mitek GII
bone anchors. Recall #Z-354-3.
CODE Catalog #218093 (kit), lot #920419.
MANUFACTURER Mitek Surgical Products, Inc., Norwood,
Massachusetts.
RECALLED BY Manufacturer, by letter October 14, 1992. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Japan, United Kingdom.
QUANTITY 50 kits (2 drills per kit) were distributed.
REASON The drills were distributed without depth marking
and drill identification.
_______________
PRODUCT Racz Neurological Catheters, used in the
treatment of acute and chronic pain control:
(a) Racz Lec-Tro-Kath, Mono-Polar Catheter;
(b) Racz Tun-L-Kath Catheter;
(c) Racz Caud-A-Kath Catheter;
(d) Racz Epidural Catheter. Recall #Z-355/358-3.
CODE All 4 digit lot numbers ending with the numeral 2
followed by either C, T, R, L or RG.
MANUFACTURER Medical Evaluation Devices & Instruments
Corporation, also known as MEDIC Corp.,
Gloversville, New York.
RECALLED BY Manufacturer, by letter January 4, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Germany, Italy, Netherlands,
Australia, United Kingdom.
QUANTITY (a) 917 units; (b) 3,142 units; (c) 1,901 units;
(c) 2,700 units were distributed.
-8-
REASON Foreign particulate matter and hair-like
materials were found inside the inner packaging
of the finished packaged sterile devices.
_______________
PRODUCT Debakey Tunneler, used for vascular
reconstruction, to insert a vein bypass graft in
the leg. Recall #Z-372-3.
CODE Catalog #80-8000, lot #9106N.
MANUFACTURER Codman & Shurtleff, Inc., New Bedford,
Massachusetts.
RECALLED BY Codman & Shurtleff, Inc., Randolph,
Massachusetts, by telephone January 25 & 26,
1993, followed by letter January 29, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Florida, New Hampshire, New Jersey, New Mexico,
Rhode Island, Texas, Puerto Rico, Germany,
England.
QUANTITY 8 units.
REASON The Olive tip may come off.
_______________
PRODUCT Medic-4 Defibrillator, a portable emergency
system designed to serve the hospital, clinic or
physician's office. Recall #Z-381-3.
CODE Serial numbers from 23001 through 26255.
MANUFACTURER Burdick, Inc. (previously known as Siemens-
Burdick, Inc.), Milton, Wisconsin.
RECALLED BY Manufacturer, by letter September 25, 1992.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,255 units are subject to field correction.
REASON Under certain conditions of use, the device may
deliver more energy than was selected.
_______________
UPDATE Tomoscan SR Computed Tomography (CT) System,
Recall #Z-202-3, recalled by Philips Medical
Systems, which appeared in the February 17, 1993
Enforcement Report should read:
REASON: The device defects cause intermittent
loss of acquired data during data processing.
The loss of data necessitates retakes, therefore,
patient is subjected to additional radiation.
----
-9- ________________
UPDATE I.V. Catheter Extension and Y-Type Extension
Sets, Recall #Z-231/244-3, recalled by Baxter
Healthcare Corporation, which appeared in the
March 3, 1993 Enforcement Report should read:
Baxter brand Catheters: Catalog numbers:
(b) 2N1191;
Medex brand Catheters: Catalog numbers:
(j) MX458L.
CODE: Lot numbers: (e) 21L17126 through
22A23112.
MANUFACTURER: Medex, Inc., Hillard, Ohio.
RECALLED BY: Manufacturer, by letter October 8,
1992. Firm-initiated recall ongoing.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS I
______________
PRODUCT Premium Swine 60 MA, in 60 pound bags, non-grain
based, nutritional animal feed supplement.
Recall #V-019-3.
CODE Lot #323761-10312-308A.
MANUFACTURER Carl S. Akey, Inc., Lewisburg, Ohio, by
instructing consignees to stop using the feed on
December 28, 1992. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 39 bags were distributed.
REASON The product is contaminated with high
concentrations of Selenium.
-10-
END OF ENFORCEMENT REPORT FOR MARCH 17, 1993. BLANK PAGES MAY
FOLLOW.
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