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
10/19/1994
Recalls and Field Corrections: Foods -- Class I -- 10/19/1994
October 19, 1994 94-42
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT French Vanilla Ice Cream, in 3 gallon containers.
Recall #F-869-4.
CODE All product manufactured between March 6, 1994 and August 6,
1994.
MANUFACTURER Schneider's Dairy, Inc., Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by letter August 26, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY Approximately 500 containers.
REASON Product contains eggs and the label fails to declare the
presence of eggs.
_______________
PRODUCT Omelet Master Microwave Omelets: (a) Cheese Omelet;
(b) Bacon Omelet; (c) Mexican Omelet; (d) Mushroom Omelet;
(e) Western Omelet. Recall #F-001/005-5.
CODE All lots.
MANUFACTURER Land O' Lakes, Inc., Arden Hills, Minnesota (cheese sauce
compound).
RECALLED BY Hormel Foods Corporation, Austin, Minnesota, by visit and by
press release dated August 30, 1994. Firm-initiated recall
complete.
DISTRIBUTION Wisconsin, Colorado.
QUANTITY 12,576 boxes were distributed.
REASON The cheese sauce component has the potential to support the
outgrowth of Clostridium botulinum toxin.
_______________
PRODUCT Montana Big Sky brand Propolis Capsules, 500 mg, in 90 count
bottles, a nutritional supplement. Recall #F-006-5.
CODE M4767.
MANUFACTURER Montana Naturals International, Inc., Arlee, Montana.
RECALLED BY Manufacturer, by letter July 13, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY Approximately 14,000 bottles.
REASON Product is contaminated with lead.
_______________
PRODUCT Magscorbplex 700 Dietary Vitamin Supplement Capsules.
Recall #F-007-5.
CODE Lot #019422.
MANUFACTURER HVL, Inc. - Douglass Laboratories, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by telephone on or before July 18, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY 23,400 capsules were distributed.
REASON Product contains excessive selenium.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Fleischmann's Dry Baker's Yeast, commercial package,
50 pounds. Recall #F-008-5.
CODE 175223M.
MANUFACTURER Fleischmann's Yeast, Inc., Memphis, Tennessee.
RECALLED BY Manufacturer, by letter August 29, 1994. Firm-initiated
recall complete.
DISTRIBUTION Indiana, Kentucky, Mississippi, Wisconsin.
QUANTITY 264 bags were distributed.
REASON Product is contaminated with pieces of metal and plastic.
_______________
PRODUCT Diet with Lemon Nestea contained in 16 ounce glass bottles.
Recall #F-009-5.
CODE JAN2395SFD.
MANUFACTURER Seneca Foods Corporation, Prossor, Washington.
RECALLED BY Coca Cola USA, Atlanta, Georgia, by visits completed
September 24, 1994. Firm-initiated recall complete.
DISTRIBUTION Washington State.
QUANTITY Approximately 2,640 bottles were distributed.
REASON Product labeled Lemon Nestea was actually Diet Lemon Nestea.
_______________
PRODUCT Country Delite brand Purified Drinking Water, in one gallon
translucent rigid plastic jugs with screw-on cap.
Recall #F-010-5.
-2-CODE Lot #2134.
MANUFACTURER Fleming Companies, Inc., Nashville, Tennessee.
RECALLED BY Manufacturer, by telephone beginning August 24, 1994. Firm-
initiated recall complete.
DISTRIBUTION Alabama, Arkansas, Georgia, Kentucky, Mississippi,
Tennessee.
QUANTITY 7,150 gallons were distributed.
REASON Product is contaminated with fecal coliforms.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT SoloPak Heparin Lock Flush Solution, USP, preservative free,
10 USP units/ml packaged in 1 ml single dose vials, for
maintenance of patency of intravenous injection devices
only. Recall #D-006-5.
CODE 940304, 940307, 940327, 940411, 940414, 940811.
MANUFACTURER SoloPak Pharmaceuticals, Inc., Elk Grove Village, Illinois.
RECALLED BY Manufacturer, by letters dated September 21, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 424,825 vials were distributed; firm estimated that 106,206
vials remained on market at time of recall.
REASON Potency not assured through expiration date.
_______________
PRODUCT Minocycline HCl Capsules, USP 50 mg, in 100 capsule bottles,
an antibiotic. Recall #D-007-5.
CODE Lot #41654L EXP 4/96.
MANUFACTURER Warner-Lambert Company, Warner Chilcott Laboratories
Division, Lititz, Pennsylvania.
RECALLED BY Manufacturer, by letter September 19, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 16 bottles were distributed.
REASON Microbial contamination of the capsule shells.
_______________
PRODUCT Dexamethasone Sodium, in 5 ml bottles, a topical ocular
solution, under the following labels: Akron, Aligen,
Butler, Equipharm, Goldline, IDE, Infinity, Major, Moore,
Ocusoft, Phoenix, Pro-Vet, Rugby, Qualitest, Schein, URL,
Vedco, and Webster. Recall #D-009-5.
CODE 0552, 0634, 0658, 0731, 0765, 0770, 0816, 0886, 0953, 1058,
1060, 1086, 1231, 1263, 1369, 1418, 1460, 1484, 1530.
MANUFACTURER Pharmfair, Inc., Hauppauge, New York.
RECALLED BY Bausch & Lomb Pharmaceutical Division, Tampa, Florida, by
letter July 28, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
-3-QUANTITY 528,423 units were distributed; firm estimated that 270,905
units remained on market at time of recall.
REASON Product does not meet preservative efficacy test.
_______________
PRODUCT Hyoscyamine Sulfate, USP Timed-Release Capsules, 0.375 mg,
in 100 capsule bottles, Rx drug indicated for various uses
including, control of gastric secretion, visceral spasm and
hypermotility. Recall #D-011-5.
CODE Lot numbers: 27001 EXP 7/95, 27002 EXP 11/95,
HS403 EXP 2/96.
MANUFACTURER Eros Pharma PVT., Ltd., Bangalore, India.
RECALLED BY Econolab, Inc., Westland, Michigan, by letter October 7,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,487 bottles of lot 27001, 5,298 bottles of lot 27002, and
3,439 bottles of lot HS403 were distributed.
REASON Product fails dissolution specification.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Medical Center brand of Boric Acid Solution, in 48 fluid
ounce bottles. Recall #D-008-5.
CODE Lot #0011.
MANUFACTURER Diamond Products, Seffner, Florida.
RECALLED BY Manufacturer, by letter September 8, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Oklahoma, Oregon, California.
QUANTITY 25 cases of 48 bottles each were distributed.
REASON Product failed microbial limit test.
_______________
PRODUCT Amiloride HCl and Hydrochlorothiazide 5 mg/50 mg Tablets,
used for hypertension. Recall #D-010-5.
CODE Lot numbers: 3516-006 and 3516-007.
MANUFACTURER Biocraft Laboratories, Inc., Elmwood Park, New Jersey.
RECALLED BY Vangard Labs, Inc., Glasgow, Kentucky, by letter August 30,
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 440 packages of 100 unit dose boxes were distributed.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Source Plasma. Recall #B-466-4.
CODE Unit numbers: H3852, T2810, T2836, T2857, T2890, T2909,
T2949.
MANUFACTURER HemaBiologics, Inc., Torrance, California;
HemaBiologics, Inc., West Hollywood, California.
-4-RECALLED BY HemaCare, Inc., (formerly MD Laboratories), Sherman Oaks,
California, by telephone May 7, 1993, followed by letter
dated May 13, 1993. Firm-initiated recall complete.
DISTRIBUTION Florida, California.
QUANTITY 7 units.
REASON Blood products which were untested for the antibody to the
human immunodeficiency virus Type 2 (anti-HIV-2), or tested
negative, but collected from a donor who previously tested
repeatedly reactive for anti-HIV-1/2, were distributed.
_______________
PRODUCT Immune Globulin Intravenous (Human), "Venoglobulin-I"
indicated for the maintenance treatment of patients with
primary immunodeficiency syndromes. Recall #B-467-4.
CODE Lot numbers: GT2301A, GT2305A, GT2310A, GT2312A, GT2313A,
GT2313AB, GT2315A, GT2316A, GT3301A, GT3302A, GT3303AB,
GT3303AC, GT3304A, GT3306AB, GT3307B, GT3308A, GT3308AB,
GT3309A, GT3311A, GT3312A, GT3312AB, GT3313A, GT3314A,
GT3315A.
MANUFACTURER Alpha Therapeutics Corporation, Los Angeles, California.
RECALLED BY Manufacturer, by letter January 13, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 19,494 units were distributed; firm estimates none remains
on the market.
REASON Immune Globulin Intravenous (IGIV) (Human), which exhibited
turbidity upon reconstitution, was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Unprotected Electrode Lead Wires and ECG Cables used with
Kontron Apnea Models as follows: Minimon 7134000, 7134200,
7134300, 7136000, 7136200, 7136300, Supermon 7271000,
Kolormon 7271100. (Kontron Instruments discontinued sales
of Apnea monitors, March 1992.) Recall #Z-1097-4.
CODE All serial numbers.
MANUFACTURER Kontron Instruments, Inc., Everett, Massachusetts (currently
known as Arrow Kontron Instruments).
RECALLED BY Arrow Kontron Instruments, Everett, Massachusetts, by letter
September 14, 1994. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 355 units.
REASON Device labeling fails to provide adequate directions for use
and the devices pose an unwarranted risk of injury to
patients, because the product is not labeled to warn against
the hazards of unprotected electrode lead wires being
connected to electrical power sources.
-5-_______________
PRODUCT Electrode Lead Wires and Patient Cables, multiple models:
(a) All models of unprotected electrode lead wires as
follows: (a) Medi-Trace Neonatal ECG Electrode, Reorder
#4903, with pre-attached standard pin lead wire, a single
use, disposable electrode in sets of three with a
preattached lead, 24" long. NOTE: This product was
withdrawn from the marketplace 12/31/93.
(b) All models of unprotected patient cables. There are
290 unprotected patient cables and lead wires with various
designs, styles, sizes and wire colors.
Recall #Z-1103/1104-4.
CODE All codes.
MANUFACTURER Graphic Controls Corporation, Methuen, Massachusetts (Medi-
Trace 4903 Neonatal ECG Electrode).
(b) Tronomed Inc., San Juan Capsitrano, California (all
other patient cables and lead wires).
RECALLED BY Graphic Controls Corporation, Buffalo, New York, by letter
November 1, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Cables and Lead wires:
101,319 cables and lead wires were distributed in 1992;
102,457 cables and lead wires were distributed in 1993;
4903 Medi-Trace Neonatal Monitoring Electrodes:
603,300 electrodes produced in 1992;
393,000 electrodes produced in 1993.
REASON Device labeling fails to provide adequate directions for use
and the devices pose an unwarranted risk of injury to
patients, because the products are not labeled to
contraindicate use with apnea monitors.
_______________
PRODUCT Model 2014 FLO-LAB Peripheral Doppler Ultrasound Vascular
Testing System equipped with vascular information program
(VIP) Software Version 4.2. Recall #Z-006-5.
CODE All software versions prior to 4.30.
MANUFACTURER Parks Medical Electronics, Inc., Aloha, Oregon.
RECALLED BY Manufacturer, by letter December 7, 1993. Firm-initiated
field correction ongoing.
DISTRIBUTION Illinois, New York, Vermont, Ohio, Missouri, Texas, Indiana,
Wisconsin, Pennsylvania, Michigan, California, Canada.
QUANTITY 21 units were distributed.
REASON Batch printing of multiple patients' full spectrum waveforms
will result in erroneous output (same waveform for each
patient).
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Farm Tech XLP-30 Sow Conditioner and Swine Wormer Medicated,
medicated feed. Recall #V-001-5.
CODE DOXX634.
-6-MANUFACTURER Farmland Industries, Inc., Protein and Premix Plant, Eagle
Grove, Iowa.
RECALLED BY Manufacturer, by telephone August 17, 1994. Firm-initiated
recall complete.
DISTRIBUTION Kansas, Nebraska, Iowa.
QUANTITY 32 50-pound bags were distributed.
REASON Product is subpotent in dichlorvos ingredient.
MASS SEIZURE:
=============================================================
_______________
PRODUCTS Falafel Vegetarian Mix and Other Various Food (94-171-152).
CHARGE Adulterated - The articles have been held under insanitary
conditions whereby they may have become contaminated with
filth.
LOCATION International Golden Foods, Inc., Niles, Illinois.
FILED October 7, 1994; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #94C 6013;
FDC #67026.
SEIZED October 11, 1994 - goods seized valued at approximately
$250,000.
SEIZURE:
==================================================================
_______________
PRODUCTS Soft Cheeses and Yogurt (94-710-490).
CHARGES Adulterated - Two lots of the articles contain a poisonous
and deleterious substance, Listeria monocytogenes, which may
render them injurious to health. Misbranded - All lots of
the articles bear nutrition information, but fail to meet
the regulatory requirements. The labels lack prominently
and conspicuously placed information on the labels in the
English language. The ingredient declaration, and name and
place of business of the manufacturer, packer or
distributor, appear on the labels in a smaller type size
than that required. Three lots of the articles fail to meet
the requirements of the Fair Packaging and Labeling Act
because the net quantity of contents statement fails to
appear on the principal display panel, the lid of the
container.
LOCATION Midwest Vending Supplies, Inc., trading and doing business
as Lily Food Products, Chicago, Illinois.
FILED September 27, 1994; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #94C 5880;
FDC #67013.
SEIZED September 28, 1994 - goods valued at approximately $12,210.
-7-
END OF ENFORCEMENT REPORT FOR OCTOBER 19, 1994. BLANK PAGES MAY
FOLLOW.
####