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
10/11/1995
ENFORCEMENT REPORT FOR 10/11/95
October 11, 1995 95-41
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Savory Foods, Inc Savory Select San'wich brand Ready-to-eat
deli sandwiches:
(a) Egg Salad Sandwiches; (b) Chunky Chicken Sandwiches;
(c) Ham Salad Sandwiches; (d) Ham and Cheese Sandwiches;
(e) Turkey and Cheese Sandwiches; (f) Tuna Sandwiches.
Recall #F-001/006-6.
CODE All sandwiches produced by the firm with an expiration date,
"Enjoy by", up to and including 12 September 1995 with
julian date code of 237 or earlier.
MANUFACTURER Savory Foods, Inc., Grand Rapids, Michigan.
RECALLED BY Manufacturer, by visit on or about September 8, 1995. Firm-
initiated recall complete.
DISTRIBUTION Michigan, Indiana, Ohio, Illinois, Wisconsin.
QUANTITY 20,563 sandwiches were distributed.
REASON The product was contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Classic brand Green Kale in 25 pound cartons.
Recall #F-772-5.
CODE Lot #A9003.
MANUFACTURER Gabilon View Farms, Salinas, California (grower).
RECALLED BY Mills Distributing Company, Salinas, California, by
telephone. Firm-initiated recall complete as of July 31,
1995.
DISTRIBUTION California and Nevada.
QUANTITY 28 cartons were distributed; firm estimates none remains on
the market.
REASON There is no tolerance for permethrin in kale.
_______________
PRODUCT (a) Endive, in 25 cartons, 1 or two dozen per carton; (b)
Kale in 25 pound cartons, one or two dozen per carton.
Recall #F-816/817-5.
CODE Lot numbers: (a) SG-24E3 and Storm 8D+E; (b) Fanoe Home 45.
MANUFACTURER (a) Top Quality, Gonzales, California; John Tamagni,
Salinas, California (growers); (b) Fanoe Brothers, Gonzales,
California (grower).
RECALLED BY Fresh Western Marketing, Inc., Salinas, California, by
telephone. Firm-initiated recall completed as of August 18,
1995.
DISTRIBUTION California, Mississippi, Texas.
QUANTITY Firm estimates none remains on the market.
REASON There is no tolerance for permethrin in kale or acephate in
endive.
_______________
PRODUCT Mor Green Endive in cardboard cartons. Recall #F-818-5.
CODE Lot numbers 4501 and 4114.
MANUFACTURER J.T. Mission, Salinas, California; Top Quality, Salinas,
California (growers).
RECALLED BY Fresh Choice Produce, Salinas, California, by telephone.
Firm-initiated recall completed as of August 9, 1995.
DISTRIBUTION Arizona, California, Florida, Georgia, Illinois, Iowa,
Kansas, Louisiana, Michigan, Missouri, Montana,
Pennsylvania, Tennessee, Texas, Washington state, Wisconsin,
Canada.
QUANTITY 705 cartons were distributed.
REASON There is no tolerance for acephate in endive.
_______________
PRODUCT Orchids of Hawaii Strawberry Daiquiri Cocktail Mix packaged
in 1 gallon (128 fluid ounce) plastic bottles or in 1 pint
9.4 ounce (25.4 ounce) glass bottles. Recall #F-007-6.
CODE None.
MANUFACTURER Three Vee Food and Syrup Products, Inc., Brooklyn, New York.
RECALLED BY Orchids of Hawaii International, Inc., Bronx, New York, by
letter sent on August 9, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION New York, New Jersey, Massachusetts, Maine, Alabama, North
Carolina, Iowa, Virginia, Wisconsin.
QUANTITY 29 4-gallon cases were distributed; firm estimates none
remains on the market.
REASON Product contains undeclared FD&C Yellow No. 5.
-2- RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Calcium and magnesium chelate rice bran chelate, each
capsule contains 180 mg calcium (a rice bran chelate) and
90-mg magnesium (a rice bran chelate), packaged in 100- and
250-capsule bottles. Recall #F-008-6.
CODE 100's - 4087, 8356, 8358, 8441G, and 8553/ 250's- 4087 and
9487.
MANUFACTURER General Therapeutic Company, St. Louis, Missouri.
RECALLED BY The Key Company, St. Louis, Missouri, by letter dated
September 5, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY Approximately 417,900 capsules were distributed.
REASON Product is subpotent in magnesium content.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Multi-Symptom Tylenol Cold Non-Drowsy Gelcaps, packaged in
blister packs, 2 cards of 12 gelcaps each per box, OTC used
for nasal congestion, coughing, sore throat and headache.
Recall #D-001-6.
CODE Lot numbers: PFM 015 EXP 3/97, PFM 016 EXP 6/97,
PFM 072 EXP 6/97, PFM 073 EXP 6/97, PFM 319 EXP 6/97.
MANUFACTURER McNeil Consumer Products Company, Fort Washington,
Pennsylvania.
RECALLED BY Manufacturer, by letter September 7, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 3,906 x 48 cartons remained on market at
time of recall initiation.
REASON The active ingredients are listed as 325 mg acetaminophen,
30 mg Pseudoephedrine HCl 10 mg Dextromethorphan and
Guaifenesin 100 mg. The correct listing should be as
follows: 325 mg Acetaminophen, 30 mg Pseudoephedrine HCl,
and 15 mg Dextromethorphan.
_______________
PRODUCT Rolaids Tablets (calcium rich) Original Flavor, in 75 tablet
bottles, OTC antacid. Recall #D-002-6.
CODE Lot #33694V EXP 8/96.
MANUFACTURER Warner Lambert Company, Vega Baja, Puerto Rico.
RECALLED BY Warner Lambert Company, Morris Plains, New Jersey, by letter
August 8, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 12,500 bottles of 75 tablets were distributed; firm
estimates none remains on the market.
REASON Flavoring inadvertently omitted from the formulation.
-3- _______________
PRODUCT Isuprel Mistometer brand of Isoproterenol Hydrochloride
Inhalation Aerosol, 0.25%, 15 ml/vial, complete units.,
indicated for the relief of bronchospasm.
Recall #D-003-6.
CODE Lot #B425NC EXP 3/97 (imprinted on label -9/97).
MANUFACTURER NYCOMED, Inc., Baraceloneta, Puerto Rico.
RECALLED BY Sanofi Winthrop Pharmaceuticals, Inc., New York, New York,
by telephone between September 18 and 20, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,242 complete units to wholesalers and 108 to NYCOMED for
testing and no refill units were distributed.
REASON Label bears an expiration date not currently in effect.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Red Blood Cells. Recall #B-408-5.
CODE Unit #53FX28584.
MANUFACTURER American National Red Cross, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated April 1 and 4, 1994. Firm-
initiated recall complete.
DISTRIBUTION Maryland and Switzerland.
QUANTITY 1 unit.
REASON Blood products, which were collected from a donor with a
medical history of cancer, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-410-5.
CODE Unit #53M29160.
MANUFACTURER The American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated November 1, 1993. Firm-
initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit.
REASON Blood product, collected from a donor living in a malarial
endemic area, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-411-5.
CODE Unit numbers: V99789, V98989, V98117, V96257.
MANUFACTURER Central California Blood Center, Fresno, California.
RECALLED BY Manufacturer, by letter dated December 15, 1994. Firm-
initiated recall complete.
DISTRIBUTION New Jersey, California.
QUANTITY 4 units.
REASON Blood products, which were collected from a donor with a
medical history of cancer, were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-548-5.
CODE Unit #03X26872.
-4- MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY Manufacturer, by letter January 6, 1992. Firm-initiated
recall complete.
DISTRIBUTION The Netherlands.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for antibody
to the human immunodeficiency virus type 1 (anti-HIV-1), was
distributed.
_______________
PRODUCT Platelets. Recall #B-648-5.
CODE Unit #33LS21946.
MANUFACTURER American National Red Cross Blood Services, Farmington,
Connecticut.
RECALLED BY Manufacturer, by telephone on June 28, 1995, followed by
letter dated June 29, 1995. Firm-initiated recall complete.
DISTRIBUTION Connecticut.
QUANTITY 1 unit.
REASON Blood product, which tested positive for anti-Yta but was
labeled as negative for unexpected antibodies, was
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-002/004-6.
CODE Unit #22LV18945.
MANUFACTURER American Red Cross, Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by letters dated May 15, 1995. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania, New Jersey, California.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor with a
medical history of hepatitis, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-005/007-6.
CODE Unit #2N-4262.
MANUFACTURER Puget Sound Blood Center, Seattle, Washington.
RECALLED BY Manufacturer, (a) by telephone on June 20, 1995; (b) by
letter dated July 6, 1995; (c) by letter dated June 21,
1995. Firm-initiated recall complete.
DISTRIBUTION Washington, California.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor with a
medical history of jaundice, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
===================
_______________
PRODUCT Recovered Plasma. Recall #B-409-5.
CODE Unit #53FX28584.
MANUFACTURER American National Red Cross, Baltimore, Maryland.
-5- RECALLED BY Manufacturer, by letters dated April 1 and 4, 1994. Firm-
initiated recall complete.
DISTRIBUTION Switzerland.
QUANTITY 1 unit.
REASON Blood products, which were collected from a donor with a
medical history of cancer, were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-412-5.
CODE Unit numbers: V99789, V98989, V96257.
MANUFACTURER Central California Blood Center, Fresno, California.
RECALLED BY Manufacturer, by letters dated December 15, 1994. Firm-
initiated recall complete.
DISTRIBUTION New Jersey, California.
QUANTITY 3 units.
REASON Blood products, which were collected from a donor with a
medical history of cancer, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-646/647-5.
CODE Unit numbers: 47G91341, 47C47079.
MANUFACTURER American Red Cross Blood Services, Galesburg, Illinois.
RECALLED BY American Red Cross Blood Services, Peoria, Illinois, by
letters dated May 3 and 31, 1995. Firm-initiated recall
complete.
DISTRIBUTION Illinois, Iowa, California.
QUANTITY 2 units of each component.
REASON Blood products, which tested initially reactive for the
hepatitis B surface antigen (HbsAg), with only a single
repeat test, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-001-6.
CODE Unit #66294.
MANUFACTURER Blood Bank of Hawaii, Honolulu, Hawaii.
RECALLED BY Manufacturer, by telephone on July 28, 1992. Firm-initiated
recall complete.
DISTRIBUTION Hawaii.
QUANTITY 1 unit.
REASON Blood product, which was labeled with an incorrect
expiration date, was distributed.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-008-6.
CODE 22GG66052, 22GG66191, 22GG66245, 22GG74288, 22GG74668.
MANUFACTURER American Red Cross, Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by telephone on October 20, 1994, and by
letter dated October 24, 1994. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania, New Jersey.
QUANTITY 5 units.
-6- REASON Fresh Frozen Plasma which was not frozen within six hours of
whole blood collection, was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Denver Ascites Shunt System Percutaneous Access Kit, Model
42-5000.Recall #Z-1108-5.
CODE Lot numbers: BM907, BM911, CM913, CM914.
MANUFACTURER Denver Biomaterials, Inc., Evergreen, Colorado.
RECALLED BY Manufacturer, by letter August 8, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Germany, Australia, Netherlands, Sweden.
QUANTITY 83 kits were distributed.
REASON The barium stripe in the venous catheter may not be
sufficiently radiopaque which could lead to difficulty or
inability to visualize the catheter during fluoroscopy.
_______________
PRODUCT Infant Radiant Warmers. Recall #Z-1175/1183-5.
CODE (a) Infant Radiant Warmer, Code/Lot Number /7810
(b) Infant Radiant Warmer, Code/Lot Number /7820
(c) Infant Radiant Warmer, Code/Lot Number /7821
(d) Infant Radiant Warmer, Code/Lot Number /7830
(e) Infant Radiant Warmer, Code/Lot Number /7840
(f) Infant Radiant Warmer, Code/Lot Number /7860
(g) Infant Radiant Warmer, Code/Lot Number /7861
(h) Infant Radiant Warmer, Code/Lot Number /7865
(i) Infant Radiant Warmer, Code/Lot Number /7880.
Recall #Z-1175/1183-5.
MANUFACTURER Air Shields, Inc., Hatboro, Pennsylvania.
RECALLED BY Manufacturer, by letter/memorandum August 1, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 24,000 units.
REASON The design does not provide enough strain relief for the AC
Power Cord which may result in heat damage to itself and
connector.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT 12 mm Femoral Stem Template, used to aid physicians in the
alignment of the femoral head and neck prior to hip
replacement surgery. Recall #Z-933-5.
CODE Part #1101-0400-01-12.
MANUFACTURER Endotec, Inc., Bloomfield, New Jersey.
RECALLED BY Endotec, Inc., South Orange, New Jersey, by telephone
beginning April 12, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 13 units were distributed.
-7- REASON The 1/8" hole diameter in the shaft of the temporal stem
plate was too small to fit the locator pin.
_______________
PRODUCT Software version 1.2, used with the Ektachem 950IRC
Analyzer. Recall #Z-1203-5.
CODE None.
MANUFACTURER Johnson & Johnson Clinical Diagnostics, Rochester, New York.
RECALLED BY Manufacturer, by telephone July 28, 1995, followed by
letter. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 85 analyzers were distributed.
REASON Loss of slide rotor control could be accompanied by
misidentification of electrolyte results if a certain
sequence of events occur, due to software indexing error.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Nature's Recipe Pet Food (dry) in 5, 20, and 40 pound paper
bags (canine) and 4, 8, and 20 paper bags (feline), in the
following varieties:
(a) Maintenance Lamb Meal and Rice Canine Diet
(b) Puppy/Performance Lactation Lamb Meal and Rice
Canine Diet
(c) Senior/Pension Lamb and Rice Canine Diet
(d) Maintenance Lamb Meal Rice and Barley Canine Diet
(e) Chicken Meal Rice and Barley Canine Diet
(f) Maintenance Feline Diet
(g) Lite/Senior Feline Diet. Recall #V-043/049-5.
CODE "170595" through "200795" 17(day)05 (month)95(year) through
20(day)07(month)95(year).
MANUFACTURER Southwest Pet Products Inc., Phoenix, Arizona.
RECALLED BY Nature's Recipe Pet Foods, Corona, California, letters of
July 10 and 27, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,557,493 lbs. of dry dog food and 921,035 lbs. of dry cat
food were distributed.
REASON Products are adulterated with the micotoxin vomitoxin, which
may cause dogs and cats to become ill (vomiting and/or
diarrhea).
MEDICAL DEVICE SAFETY ALERTS
==============================================
_______________
PRODUCT Air Shield Neonatal Incubators:
TI100 Transport Incubators; (b) C300 Neonatal Transport
Incubators. Safety Alert #N-047/048-5.
CODE All serial numbers.
MANUFACTURER Air Shields, Inc., Hatboro, Pennsylvania.
ALERTED BY Manufacturer, by letter dated September 4, 1995.
DISTRIBUTION Nationwide and international.
-8- QUANTITY Firm estimated that 3,270 units remained in commerce at time
the alert was initiated.
REASON A potential for heat related failure of the battery charger
connector, when batteries other than those specifically sold
by Air-Shields, or batteries that have been supplied by Air-
Shields and exceeded their useful life expectancy are used
in the battery tray of the incubators.
-9-
END OF ENFORCEMENT REPORT FOR OCTOBER 11, 1995. BLANK PAGES MAY
FOLLOW.
####