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.
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