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
11/02/1994
Recalls and Field Corrections: Foods -- Class I -- 11/02/1994
November 2, 1994 94-44
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Peony brand Dried Potatoes, in 8 ounce packages.
Recall #F-027-5.
CODE None.
MANUFACTURER Product of the People's Republic of China.
RECALLED BY Tai Wing Hong Importer, Inc., Brooklyn, New York (importer),
by telephone followed by letter September 9, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION New York, Illinois, California, Massachusetts, Virginia.
QUANTITY 500 cartons (100 packages per carton) were distributed.
REASON The product contains undeclared sulfites.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Dudek Foods, Inc. Potato/Cheddar Pierogi's, in 16 ounce
plastic bags and various flavored Nalesniki Crepes, net
weight 16 ounces: (a) Potato/Cheddar Pierogi's; (b)
Nalesniki Cheese Crepes; (c) Nalesniki Strawberry Crepes;
(d) Nalesniki Apple Crepes; (e) Nalesniki Blueberry Crepes.
Recall #F-017/021-5.
CODE All lots.
MANUFACTURER Dudek Foods, Inc., Hamtramck, Michigan.
RECALLED BY Manufacturer, by placing stickers on products beginning
September 29, 1994. Firm-initiated field correction
(relabeling) complete.
DISTRIBUTION Michigan, Ohio, Indiana.
QUANTITY Approximately 600 pounds (100 cases) of Pierogi's and 180
pounds (30 cases) of crepes were distributed.
REASON Product contains undeclared FD&C Yellow no. 5.
_______________
PRODUCT Spice Supreme Candy Sprinkles, in 6 ounce opaque bottles.
Recall #F-025-5.
CODE Lot #IDE20.
MANUFACTURER Gel Spice Company, Inc., Bayonne, New Jersey
(repacker/responsible firm).
RECALLED BY Repacker, by letter September 1, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, British West Indies.
QUANTITY Undetermined.
REASON Product contains undeclared FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Minute Maid Orange Juice, in 16 fluid ounce glass bottles.
Recall #F-022-5.
CODE 04047Y over CT124 and 04110Y over CT124.
MANUFACTURER Knouse Foods, Inc., Gardners, Pennsylvania.
RECALLED BY Coca Cola Foods, Inc., Houston, Texas, by telephone May 20,
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 29,067 cases (24 bottles per case) were distributed.
REASON Product is contaminated with Lactobacillus fermentum.
_______________
PRODUCT ECEE Plus Tablets, a dietary supplement for oral
administration, in 100 tablet bottles. Recall #F-023-5.
CODE Lot ALFM EXP 6/95.
MANUFACTURER Manufacturing Chemists, Inc., Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter September 22, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Mississippi.
QUANTITY 1,122 bottles were distributed.
REASON Product has an off odor and its color is fading.
_______________
PRODUCT Koala Springs Sparkling Fruit Juice Beverages, all flavors,
in 10 ounce and 25.4 ounce bottles. Recall #F-024-5.
CODE All codes beginning with WN followed by Julian date.
MANUFACTURER Hiram Walker British Columbia, Canada (bottling firm).
RECALLED BY Koala Springs International, Inc., Fremont, California, by
press release October 7, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Alaska, Oregon, Washington State.
QUANTITY 20,000 to 25,000 cases were distributed.
REASON Product is contaminated with yeast and Lactobacillus
bacteria.
-2- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT SoloPak Heparin Lock Flush Solution, USP, Preservative,
Free, 10 USP units/ml packaged in 1, 3 and 5 ml pre-filled
syringes; for maintenance of patency of intravenous
injection devices only, not to be used for anticoagulant
therapy; (a) Catalog #06005: 5 ml Hy-Pod Syringe, contained
in the Lok-Pak Heparin Lock Flush Procedure Pack, needle not
included, 200 per case;
(b) Catalog #10671: 1 ml Hy-Pod Syringe and 25G x 5/8"
needle, individually wrapped, 120 per carton;
(c) Catalog #10673: 3 ml Hy-Pod Syringe and 25G x 5/8"
needle, individually wrapped, 120 per carton;
(d) Catalog #10675: 5 ml Hy-Pod Syringe and 25G x 5/8"
needle, individually wrapped, 120 per carton;
(e) Catalog #10681: 1 ml Hy-Pod Syringe (needles not
included), individually wrapped, 120 per carton,
(f) Catalog #10683: 3 ml Hy-Pod Syringe (needles not
included), individually wrapped, 120 per carton;
(g) Catalog #10685: 5 ml Hy-Pod Syringe (needles not
included), individually wrapped, 120 per carton;
(h) Catalog #11771: 1 ml Hy-Pod Syringe, contained in the
Lok-Pak-N Heparin Lock Flush Procedure Pack, 200 per case;
(i) Catalog #11773: 3 ml Hy-Pod Syringe, contained in the
Lok-Pak-N Heparin Lock Flush Procedure Pack, 200 per case;
(j) catalog #11775: 5 ml Hy-Pod Syringe, contained in the
Lok-Pak-N Heparin Lock Flush Procedure Pack, 200 per case.
Recall #D-018-5.
CODE (a) Catalog #06005: lot #94G008C
(b) Catalog #10671: lot #94E001C
(c) Catalog #10673: lot #94D004C, 94E005C, 94F004C
(d) Catalog #10675: lot #94D007C, 94F008B
(e) Catalog #10681: lot #94G001B
(f) Catalog #10683: lot #94E006B, 94G004B
(g) Catalog #10685: lot #94F008C, 94G008D
(h) Catalog #11771: lot #94D001B, 94E001B
(i) Catalog #11773: lot #94D004B, 94E005B, 94F004B
(j) Catalog #11775: lot #94D007B, 94G008B.
MANUFACTURER SoloPak Medical Products, Inc., Franklin Park, Illinois.
RECALLED BY SoloPak Medical Products, Inc., Elk Grove Village, Illinois,
by letter October 11, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 589,200 were distributed; firm estimated that less than 25
percent of the product remained on market at time of recall.
REASON Potency cannot be assured through expiration date.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Dossitol Stool Softener, 100 mg, in bottles of 1000
softgels. Recall #D-019-5.
CODE Lot numbers 255239 and 297339 EXP 9/96.
-3- MANUFACTURER Chase Laboratories, Inc., Newark, New Jersey.
RECALLED BY Manufacturer, by letter April 20, 1994. Firm-initiated
recall complete.
DISTRIBUTION Undetermined.
QUANTITY 242 bottles were distributed.
REASON Front panel label incorrectly states Docusate Calcium. Left
panel label correctly states Docusate Sodium.
_______________
PRODUCT Levothyroxine Sodium for Injection, (a) 200 microgram (mcg)
and (b) 500 mcg, a thyroid hormone, under the VHA and UDL
labels. Recall #D-020/021-5.
CODE Ben Venue Lot No. Customer Lot No. EXP Date
(a) 328-27-0008 FA559 1/95
328-27-0009 FC575 3/95
328-27-0010 FH597 8/95
328-27-0022 GD686 4/96
GD686A 4/96
(b) 328-27-0010 FL646 12/95
FL646B 12/95.
MANUFACTURER Ben Venue Laboratories, Bedford, Ohio.
RECALLED BY Manufacturer, by letter October 5, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 42,503 vials; (b) 8,420 vials were distributed.
REASON Product does not meet pH specifications on reconstitution.
_______________
PRODUCT Lindane Lotion, USP 1%, an Rx topical, external use only,
ectoparasiticide and ovicide, used for the treatment of
patients infested with scabies under the following labels:
Pennex, in 2 fluid ounce bottles; PBI, in 2 fluid ounce
bottles; Goldline, in 2 fluid ounce and in 1 pint bottles;
GG, distributed by Geneva Pharmaceuticals, Inc., in 2 fluid
ounce bottles, and in 1 pint bottles;
Major, in 1 pint bottles; Qualitest, in 2 fluid ounce
bottles; Rugby, in 2 fluid ounce bottles; Schein, in 2 fluid
ounce bottles, and in 1 pint bottles. Recall #D-022-5.
CODE Lot numbers 19890, 19901, 19944.
MANUFACTURER Pennex Pharmaceuticals, Inc., formerly known as
Pharmaceutical Basics, Inc., Morton Grove, Illinois.
RECALLED BY Pennex Pharmaceuticals, Inc., now known as Morton Grove
Pharmaceuticals, Inc., Morton Grove, Illinois, by letter
October 13, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 50,340 2-fluid ounce and 14,919 pint bottles were
distributed; firm estimated that less than 10 percent of the
product remained on the market at time of recall.
REASON Product does not meet compendial release criteria.
-4- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Red Blood Cells. Recall #B-019-5.
CODE Unit #15KG14596.
MANUFACTURER American National Red Cross, Great Falls, Montana.
RECALLED BY Manufacturer, by telephone March 3, 1993, followed by
letter. Firm-initiated recall complete.
DISTRIBUTION Montana.
QUANTITY 1 unit.
REASON A unit of Red Blood Cells, which tested repeatedly reactive
for antibody to the hepatitis C virus encoded antigen(anti-
HCV), was distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-021-5.
CODE Unit #MU36132.
MANUFACTURER East Texas Blood Center, Nacogdoches, Texas.
RECALLED BY Manufacturer, by telephone January 25, 1994. Firm-initiated
recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit.
REASON Blood product, that tested repeatedly reactive for the
antibody to hepatitis C virus encoded antigen (anti-HCV),
was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Recovered Plasma. Recall #B-015-5.
CODE Unit #587097.
MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky.
RECALLED BY Manufacturer, by letter April 8, 1994. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
REASON Blood product, which tested reactive for syphilis, was
distributed.
_______________
PRODUCT Whole Blood. Recall #B-020-5.
CODE Unit #18Q31209.
MANUFACTURER The American National Red Cross, Lansing, Michigan.
RECALLED BY Manufacturer, by telephone May 30, 1993, followed by letter
June 4, 1993. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASON Blood product, labeled with the incorrect expiration date,
was distributed.
-5- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Apnea Monitors, multiple models. Recall #Z-891-4.
CODE All models with unprotected (exposed pins style) lead wires
and unprotected patient cables.
MANUFACTURER Arvee Medical, Austin, Texas.
RECALLED BY Manufacturer, by letter May 5, 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
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.
_______________
PRODUCT Electrode lead wires and patient cables, multiple models,
used with apnea monitors. Recall #Z-1084/1085-4.
CODE All models of unprotected (exposed pin style), lead wires
and unprotected patient cables.
MANUFACTURER Del Mar Avionics, Irvine, California.
RECALLED BY Manufacturer, by letter June 9, 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Undetermined.
REASON Undetermined.
REASON 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 Marquette male-connector lead wires and cables. The
respiration monitors are in the following monitoring systems
and modules: Marquette 7000 Series Monitoring System,
Marquette ECG/Respiration Modules, Tram AR Modules, Tram III
Modules, Tram A Modules, Tram SL Modules, Eagle (w/Resp)
Monitors, and IVY Monitors. Recall #Z-1106-4.
CODE All serial numbers of the Marquette Modules and monitoring
systems, capable of monitoring respiration, and all lots of
Marquette male-connector leadwires and cables.
MANUFACTURER Marquette Electronics, Inc., Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by letters of September 14, 1994, and October
3, 1994. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 13,000 monitors.
REASON 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.
-6- _______________
PRODUCT Electrode Lead Wires and Patient Cables, multiple models,
used with apnea monitors. Recall #Z-1318/1319-4.
CODE All models of unprotected (exposed pin style) lead wires and
unprotected patient cables.
MANUFACTURER Pace Tech Medical Monitors, Inc., Clearwater, Florida.
RECALLED BY Manufacturer, by letter March 15, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON 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 Electrode Lead Wires, used with Holter monitor recorders.
Recall #Z-1320-4.
CODE All marketed in the past three years.
MANUFACTURER Scole Engineering Company, Inc., Culver City, California.
RECALLED BY Manufacturer by letter February 28, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON 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 their
use with apnea monitors.
_______________
PRODUCT Electrode Lead Wires, used with muscle stimulators and TENS
devices. Recall #Z-1321-4.
CODE All marketed in the past 3 years.
MANUFACTURER Jace Systems, Inc., Moorestown, New Jersey.
RECALLED BY Manufacturer, by letter April 7, 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON 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 Apnea Monitors, multiple models. Recall #Z-1383-4.
CODE All models with unprotected (exposed pin style) lead wires
and unprotected patient cables.
MANUFACTURER Siemens Medical Systems, Inc., Danvers, Massachusetts.
RECALLED BY Manufacturer, by letters of May 25 & 27, 1994. Firm-
initiated field correction ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
-7- REASON 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.
_______________
PRODUCT Electrode Lead Wires, used with apnea monitors.
Recall Z-1384-4.
CODE All units marketed in the past 3 years.
MANUFACTURER Contour Medical Technology, Inc., LaVergne, Tennessee.
RECALLED BY Manufacturer, by letter July 19, 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON 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 Electrode Lead Wires, multiple models, used with
electrocardiograph monitors, and other similar devices.
Recall #Z-1411-4.
CODE All models with unprotected exposed metal pins.
MANUFACTURER Sentry Medical Products, Irvine, California.
RECALLED BY Manufacturer, by letter September 24, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON 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 IVAC Model 2863A Infusion Pump. Recall #Z-008-5.
CODE 510 individual serial numbers.
MANUFACTURER IVAC Corporation, San Diego, California.
RECALLED BY Manufacturer, by letter July 19, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 433 units were distributed.
REASON Unintended changes in the device's settings may occur due to
a capacitor rubbing on the keyboard, which may result in
erroneous infusion rates.
_______________
PRODUCT Angiographic contrast media injectors, used to inject
contrast media directly into the circulatory system:
(a) Medrad Mark IV; (b) Mark IV CT 202 Injectors.
Recall #Z-032/033-5.
-8- CODE All serial numbers.
MANUFACTURER Medrad, Inc., Indianola, Pennsylvania.
RECALLED BY Manufacturer, by instructions sent on October 24, 1991.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Product is no longer being manufactured, but firm estimated
that approximately 4,000 units might still possibly be in
commerce.
REASON Grease in the push button switches congealed causing the
devices to deliver contrast media at higher rates or volumes
than desired.
_______________
PRODUCT Ophthalmic surgical packs:
(a) Deluxe Posterior Vitrectomy Pack with Reflux, Catalog
No. DP4800;
(b) Deluxe Phaco Pack without Reflux, Catalog No. DP4310;
(c) Deluxe Phaco Pack, Catalog No. DP4330.
Recall #Z-046/048-5.
CODES (a) 1742A 1742B 1882B 1912B 2102B 2522A
2552A 2612A 2792B 2822B 2882B 3222B
3452A 3492A 3512A 0113A 0183A 0433B
0503B 0533A 0633A 0743A 1063B 1173B
1413A 1463B 1663AF 1723AF 1753AF 2093AF
2093BF 2103AF 2103BF 2143AF 2143BF 2443AF
2573BF 2653AF 2773BF 2993BF 3063AF 3093AF
3143AF 3363AF 1113B 2752B 3222A.
(b) 0893B 1672A 1672B 1692B 1702B 1972B
2032A 2202A 2232A 2252A 2252B 2262A
2262B 2302B 2312A 2312B 2322A 2322B
2332A 2332B 2342A 2352A 2392A 2392B
2402A 2402B 2452B 2472B 2482B 2542B
2592B 2612B 2652B 2662B 2672A 2682A
2692B 2732A 2752A 2792A 2812A 2932A
2932B 2952A 2952B 2962B 3002B 3012B
3062A 3062B 3102A 3102B 3152A 3292B
3422B 3452B 3462B 3502B 3522B 3562B
3632B 3642B 3662B
0073A 0073B 0113B 0143B 0153B 0193B
2022B 0213B 0223B 0273B 0293B 0323A
0343B 0363B 0393A 0403B 0413A 0423A
0483A 0493A 0633B 0673B 0713B 0783B
0823B 0843B 0923A 0953B 1023B 1043A
1043B 1093A 1123A 1163A 1313A 1313B
1333A 1333B 1373A 1383B 1403B 1543A
1543B 1583A 1613A 1663B 1693B 1743B
1793B 1833A 1833B 1893B 1903A 1943B
1953A 1963B 1973A 2233B 2253A 2283B
2303B 2313A 2353A 2353B 2373A 2503A
2523B 2533A 2603B 3013B 3063B 3083B
3123B 3153B 3203B 3223B 3373A 3373B
3423A 3443A 3483A 0114A
(c) 2943B 2953B 3273B 3343B 3623A.
-9- MANUFACTURER Storz Instrument Company, St. Louis, Missouri.
RECALLED BY Manufacturer, by letter May 12, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 60,528 packs; (b) 202,005 packs; (c) 6,210 packs were
distributed.
REASON The sterility of the devices may be compromised due to
packaging defects.
MEDICAL DEVICE SAFETY ALERTS:
============================================
_______________
PRODUCT Electrode lead wires, used with Dynography Physiological
Recorder. Safety Alert #N-055-4.
CODE All marketed since 1983 with unprotected (exposed pin style)
lead wires.
MANUFACTURER Sensormedics Corporation, Yorba Linda, California.
ALERTED BY Manufacturer, by letter November 22, 1994.
DISTRIBUTION Undetermined.
QUANTITY Approximately 1,500 units.
REASON Electrocution hazard associated with unprotected (exposed
pin style) lead wires.
-10-
END OF ENFORCEMENT REPORT FOR NOVEMBER 2, 1994. BLANK PAGES MAY
FOLLOW.
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