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
12/15/1993
Recalls and Field Corrections: Foods -- Class I -- 12/15/1993
DECEMBER 15, 1993 93-50
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Crabmeat in 1-pound plastic containers:
(a) Jumbo Crabmeat picked 9/29/93
(b) Special Crabmeat picked 9/29/93
(c) Claw Crabmeat picked 9/29/93
(d) Special Crabmeat picked 10/28/93
(e) Backfin Crabmeat picked 10/28/93
(f) Jumbo Crabmeat picked 10/28/93. Recall #F-114/119-4.
CODE None.
MANUFACTURER Gloucester Seafood, Inc., Gloucester, Virginia.
RECALLED BY Manufacturer, by telephone beginning October 13, 1993.
Firm-initiated recall complete.
DISTRIBUTION Maryland, Virginia.
QUANTITY 1,100 pounds were distributed.
REASON Product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Light 'N Fluffy Macaroni Dumplings, in 12 ounce cellophane
packages. Recall #F-122-4.
CODE Lot numbers: 31011SBT and 31011SBU.
MANUFACTURER Hershey Pasta Group, Lebanon, Pennsylvania.
RECALLED BY Hershey Pasta Group, Hershey, Pennsylvania, by press relese
and letter October 21, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, New Jersey, New York, Maryland, Virginia, West
Virginia, Delaware, Washington, D.C.
QUANTITY 480 cases (12 packages per case) were distributed.
REASON Some bags may include egg containing bow-tie noodles. Eggs
are not declared on label.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Ice cream in cardboard cartons: (a) Lemon Meringue Flavored
Ice Cream, in half-gallon containers; (b) Clover Leaf Peach
Flavored Ice Cream, in half-gallon containers.
Recall #F-110/111-4.
CODE Lot numbers: (a) 22392, 18093, 18893, 19393; (b) 21192,
17493.
MANUFACTURER Clover Leaf Dairy, Helena, Montana.
RECALLED BY Manufacturer, by visit October 25, 1993, followed by letter
October 26, 1993. Firm-initiated recall complete.
DISTRIBUTION Montana.
QUANTITY (a) 986 units; (b) 618 units were distributed.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Nursoy Soy Protein, iron fortified infant formula
concentrate, in 13-ounce cans. Recall #F-113-4.
CODE Two line code: AF28A/NOV94 and BG28A/NOV94.
MANUFACTURER Wyeth-Ayerst Laboratories, Inc., Mason, Michigan.
RECALLED BY Wyeth-Ayerst Laboratories, Inc., St. Davids, Pennsylvania,
by letter October 5, 1993. Firm-initiated recall complete.
DISTRIBUTION Ohio, Michigan, Illinois, Pennsylvania, Wisconsin.
QUANTITY 10,250 cases (12 cans per case) were distributed.
REASON Some cans are contaminated with Klebsiella pneumoniae and
Pseudomonas aeruginosa which poses a mild to moderate hazard
to health in the form of gastrointestinal stress to infants
and new borns with developing microbial flora.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Ben & Jerry's Chunky Monkey Banana Ice Cream with Chocolate
Flavored Chunks and Walnuts, in one-pint containers.
Recall #F-112-4.
CODE Lot numbers with expiration dates between 6/28/94 through
10/22/94.
MANUFACTURER Ben & Jerry's, Waterbury, Vermont; and Edy's Grand Ice
Cream, Fort Wayne, Indiana.
RECALLED BY Ben & Jerry's Homemade, Inc., Waterbury, Vermont, by
telephone October 26, 1993, followed by letter dated October
27, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
-2- QUANTITY 182,880 pint containers were distributed; firm estimates
60,960 to 81,280 pint containers remain on the market.
REASON The firm omitted the ingredient "Walnuts" from the label
ingredient declaration, however, the main panel listed
walnuts in the ice cream name.
_______________
PRODUCT Smokey Mountain Mama's brand Barbecue Glaze, packed in 5
ounce bottles. Recall #F-120-4.
CODE None.
MANUFACTURER Riverview Foods, Inc., Glencoe, Kentucky.
RECALLED BY Booneway Farms, Inc., Berea, Kentucky, by visit August 5,
1992. Firm-initiated recall complete.
DISTRIBUTION Tennessee, Georgia, South Carolina, Florida.
QUANTITY Firm estimates none remains on the market.
REASON Product is contaminated with yeast.
_______________
PRODUCT (a) Food Service of America brand Mayonnaise, in individual
serving packets, 12 grams; (b) Amaricana brand Mayonnaise in
individual serving packets, 9 grams . Recall #F-121-4.
CODE Lot numbers: (a) H02383 H01083, H10403; (b) H03083.
MANUFACTURER Bordens Food Service, Chatsworth, California.
RECALLED BY Manufacturer, by telephone on September 22, 1993, and
October 1993. Firm-initiated recall ongoing.
DISTRIBUTION California, Idaho, Montana, Oregon, Texas, Washington state.
QUANTITY 5,115 cases.
REASON Product is contained in swollen packages.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Transfilled Liquid Oxygen into patient cryogenic vessels.
Recall #D-047-4.
CODE All fill dates.
MANUFACTURER Home Care Concepts, Inc, Farmingdale, New York.
RECALLED BY Manufacturer, by visit beginning November 22, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 17 units were distributed.
REASON Current good manufacturing practice deficiencies.
_______________
PRODUCT Transfilled Compressed Medical Oxygen in C, D, E, and N size
cylinders. Recall #D-048-4.
CODE All fill dates.
MANUFACTURER Home Care Concepts, Inc., Farmingdale, New York.
RECALLED BY Manufacturer, by visit beginning November 22, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 343 cylinders were distributed.
REASON Current good manufacturing practice deficiencies.
-3- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Omniscan (Gadodiamide) 287 mg/ml Injection Solution, used as
a contrasting agent during radiographic processes.
Recall #D-031-4.
CODE B705KB, B840KC, B846KD, B46KA, B776KB.
MANUFACTURER Sterling Pharmaceutical Inc., Barceloneta, Puerto Rico.
RECALLED BY Manufacturer, by Sterling Winthrop, Inc., New York, by
letter November 3, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 21,780 vials were distributed.
REASON Product does not meet specifications for particulate matter.
_______________
PRODUCT Nonprescription drug products:
(a) Chlor-A-Tab, 4 mg antihistamine caplet, in bottles of
100, and Chlor-A-Tab Bulk; (b) Neo-Codion DX, Cough and cold
medicine, in blister packs of 24; (c) Act-A-Met,
antihistamine caplet, in blister packs of 100; (d) Maximum
Strength Amdol, 650 mg, analgesic caplet, blister packed;
(e) Extra Strength Amdol, 500 mg, analgesic caplet, in
blister packs of 100. Recall #D-041/045-4.
CODE All lots.
MANUFACTURER International Pharmaceutical Distribution Company, Ltd.,
doing business as Ampharco USA, Anaheim, California
(repacker).
RECALLED BY Repacker, by letter October 6, 1993. Firm-initiated recall
complete.
DISTRIBUTION California, Texas, Massachusetts, Hawaii, Virginia, New
York, Washington state, Hong Kong.
QUANTITY Undetermined.
REASON Products lack assurance of potency through expiration date.
_______________
PRODUCT Expectorant Cough Syrup containing 100 mg/5 ml guaifenesin,
packaged in 6-fluid ounce amber glass bottles, OTC.
Recall #D-049-4.
CODE Lot numbers: X-1573 EXP 3/97, X-1583 EXP 8/97, X-1593 EXP
8/97.
MANUFACTURER Weeks & Leo Company, Inc., Des Moines, Iowa.
RECALLED BY Manufacturer, by letter October 28, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,079 bottles of lot X-1573, 2,065 bottles of lot X-1583 and
300 bottles of lot X-1593.
REASON Product does not meet potency specifications.
_______________
PRODUCT Natus Patch, pain relief patches containing methyl
salicylate 11%, menthol 2%, and camphor 3.5%, in single-use
packages and boxes of 30. Recall #D-050-4.
CODE Lot numbers: 3225, 3229, 3253.
-4- MANUFACTURER LecTec Corporation, Minetonka, Minnesota.
RECALLED BY Manufacturer, by November 29, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 411,600 units were distributed.
REASON Potency not assured through expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-087/088-4.
CODE Unit #KH32571.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone September 3, 1993, followed by
letter dated September 17, 1993. Firm-initiated recall
complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component.
REASON Blood products, which tested negative for hepatitis B
surface antigen (HBsAg), but were collected from a donor who
previously tested repeatedly reactive for HBsaG and
confirmed positive, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma;
(d) Cryoprecipitated AHF. Recall #B-082/085-4.
CODE Unit numbers: (a) 21Y00511, 21Y01123; (b) 21Y00511; (c)
21Y00511, 21Y01123; (d) 21Y01123.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
RECALLED BY Manufacturer, by letters of March 17, 1993, and April 21 and
27, 1993. Firm-initiated recall complete.
DISTRIBUTION California, Oregon, Washington state, Switzerland.
QUANTITY (a) 2 units; (b) 1 unit; (c) 2 units; (d) 1 unit.
REASON Blood products, which tested non-reactive for the antibody
to the human immunodeficiency virus type 1 (anti-HIV-1), but
were collected from a donor who previously tested repeatedly
reactive to anti-HIV-1, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-086-4.
CODE 04V90416.
MANUFACTURER American Red Cross Blood Services,Dedham, Massachusetts.
RECALLED BY Manufacturer, by letter November 15, 1991. Firm-initiated
recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit.
-5- REASON Blood product, which tested repeatedly reactive for the
antibody to the human T-lymphotropic virus type I (anti-
HTLV-I), was distributed.
_______________
PRODUCT Spacell Leukocyte Removal Filter for Red Blood Cells.
Recall #B-096-4.
CODE Lot numbers: H93G15332R, H93H09424R, H93H16437R,
H93H20314R.
MANUFACTURER Baxter Healthcare Corporation, Mountain Home, Arkansas.
RECALLED BY Baxter Healthcare Corporation, Deerfield, Illinois, by
letter September 30, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Belgium.
QUANTITY 11,821 units were distributed; firm estimates 2,000 units
remain on the market.
REASON Red Blood Cell filters that separate from the tubing while
in use, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT MDE Escort 100 Series Portable Patient Monitors with
Software Versions 1.6, 1.7, or 1.8. Recall #Z-102/104-4.
CODE Serial numbers: 3744 through 11951.
MANUFACTURER Medical Data Electronics (MDE), Arleta, California.
RECALLED BY Manufacturer, by letter June 2, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada, Sweden, Hong Kong, Thailand.
QUANTITY 249 units were distributed.
REASON 160 milliseconds of ECG data is not transmitted to the
Central station.
_______________
PRODUCT Modules used in the Corometrics Model 556 Monitor:
(a) Model 5560AAX ECG/RESP/PRESS;
(b) Model 5561AAX ECG/RESP/TEMP;
(c) Model 5567AAX ECG/RESP/PRESS/TEMP.
Recall #Z-105/107-4.
CODE Units shipped between 12/16/91 through 7/31/92.
MANUFACTURER Corometrics Medical Systems, Inc., Wallingford, Connecticut.
RECALLED BY Manufacturer, by letter August 31, 1993. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 218 modules remain on the market.
REASON The devices fail to emit an audible alarm during an episode
of bradycardia, if preceded by a self-correcting asystolic
event.
_______________
PRODUCT Mammography (X-Ray) Units:
(a) Model ZT005THF, Senographe 500;
(b) Model ZT006THF, Senographe 600T;
-6- (c) Model ZFH000HF, Senix HF Mammography, equipped with
Stereotix biopsy equipment, Model ZRLSTX5T.
Recall #Z-120/122-4.
CODE All serial numbers.
MANUFACTURER GE-CGR Medical System (formerly Thompson CGR), Buc, Paris,
France.
RECALLED BY General Electric Company, Medical Systems Division,
Waukesha, Wisconsin, by Urgent Safety Notice July 19, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 95 units.
REASON The elevator (tube/image receptor carriage) of a unit may
move following release of the up/down motion control, and
this could result in injury to the patient.
_______________
PRODUCT Anago and Abco brand Laparotomy Sponges, used during
surgical procedures to absorb blood, packed in cases
containing 20 pouches, 5 sponges each. Recall #Z-132-4.
CODE Lot numbers: AC294, AC337, AD005, AD007, AD019.
MANUFACTURER Anago, Inc., Del Rio, Texas and Ciudad Acuna, Mexico.
RECALLED BY Anago, Inc., Fort Worth, Texas, by letters of September 10
and 15, 1993, and October 7, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 857 cases.
REASON The laparotomy sponges were found to be nonsterile.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Awareness Technology EPROM Computer Firmware Version 1.04,
used in photometric diagnostice devices. Recall #Z-084-4.
CODE None.
MANUFACTURER Awareness Technology, Inc., Palm City, Florida.
RECALLED BY Manufacturer, by telephone of October 5, 1992, and letter of
October 8, 1992. Firm-initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 130 chips were distributed; firm estimates none remains on
the market.
REASON A manufacturing defect caused the software in the EPROM to
misinterpret light transmission through reaction wells,
providing erroneous results.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
_______________
PRODUCT Metofane (methoxyflurane) Inhalation Anesthetic for
Veterinary Use, in 118 ml glass bottles, Rx used for the
induction and maintenance of general anesthesia for all
types of surgery in a wide variety of animal species.
Recall #V-003-4.
CODE All lots.
-7- MANUFACTURER Pitman-Moore Pharmaceuticals, Ltd., Bray, County Wicklow,
Ireland (since 2/90); Pitman-Moore, Inc., Washington
Crossing, New Jersey (prior to 2/90).
RECALLED BY Pitman-Moore, Inc., Kansas City, Kansas, by letter September
29, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 248,836 units were distributed.
REASON Product leaking around the caps.
MEDICAL DEVICE SAFETY ALERTS:
============================================
_______________
PRODUCT Eagle Patient Monitor, designed to monitor a fixed set of
parameters including ECG, two invasive blood pressures, non-
invasive blood pressure, impedance respiration, Sp02, and
temperature. Safety Alert #N-001-4.
CODE All serial numbers.
MANUFACTURER Marquette Electronics, Inc., Milwaukee, Wisconsin.
ALERTED BY Manufacturer, by letter May 3, 1993.
DISTRIBUTION Nationwide and international.
QUANTITY 1,379 units were distributed.
REASON The display of inaccurate pulse oximetry values by the
device has been linked to the presence of low signal
strength or artifacts due to patient motion during signal
analysis. This has resulted in the display of erroneously
low or unstable values.
_______________
PRODUCT Pacemaker Models 1230, 1204, 8220, and 8222.
Safety Alert #N-031/034-4.
CODE Various individually serial numbered units.
MANUFACTURER Telectronics Pacing Systems, Englewood, Colorado.
ALERTED BY Manufacturer, by letter September 30, 1993, and by safety
alert issued October 1, 1993.
DISTRIBUTION Nationwide and international.
QUANTITY 3,324 units were implanted of these 2,825 remain implanted.
REASON The pacers may fail without warning, and exhibit a sudden no
output condition due to loss of hermeticity as a result of
cracked ceramic feedthrough assemblies.
SEIZURES:
=================================================================
_______________
PRODUCT Canned mushrooms (93-690-604, et al).
CHARGES Adulterated - The articles have been prepared and packed
under conditions whereby they may have been rendered
injurious to health. Misbranded - The articles' labeling is
false and misleading because it represents and suggests that
the articles were packed and grown in Taiwan, which is
contrary to fact.
FIRM New Orleans Cold Storage, New Orleans, Louisiana.
-8- FILED November 3, 1993; U.S. District Court for the Eastern
District of Louisiana; Civil #93-3623 SECT. NMAG.2;
FDC #66771.
SEIZED November 10, 1993 - goods valued at approximately $68,500.
_______________
PRODUCT UV absorbing posterior chamber intraocular lenses (IOL)
(93-676-676/80.
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture, packing, and
storage are not in conformity with current good
manufacturing practice regulations.
FIRM Optical Radiation Corporation, Azusa, California.
FILED November 16, 1993; U.S. District Court for the Central
District of California; Civil #93 6928 WDK(SHX); FDC #66754.
SEIZED November 23, 1993 - goods valued at approximately
$30 million.
_______________
PRODUCT Frozen concentrated orange juice (94-697-527).
CHARGES Adulterated - Pineapple concentrate has been substituted in
part for orange juice concentrate. Misbranded - The label
represents and suggests that the product is frozen
concentrated orange juice, which representation and
suggestion is false and misleading because the product
consists in part of pineapple juice concentrate. The label
represents and suggests that the product is frozen
concentrated orange juice, a food for which a definition and
standard of identity has been prescribed, and the article
fails to conform to that standard because it contains
pineapple concentrate, an ingredient not permitted by the
standard.
FIRM Walker Meats, Inc., Carrollton, Georgia.
FILED December 1, 1993; U.S. District Court for the Northern
District of Georgia, Civil #93-CV-116-JTC; FDC #66909.
SEIZED December 2, 1993 - 19 cases of frozen concentrated orange
juice, valued at approximately $375.
_______________
PRODUCT 100% Pure Orange Juice from Concentrate (93-719-884).
CHARGES Adulterated - Pineapple juice has been substituted in part
for orange juice. Misbranded - The label represents and
suggests that the product is 100 percent pure orange juice
from concentrate, which representation and suggestion is
false and misleading because the product consists in part of
pineapple juice solids. The label represents and suggests
that the product is orange juice from concentrate, a food
for which a definition and standard of identity has been
prescribed, and the article fails to conform to such
definition and standard because it contains pineapple juice
solids, an ingredient not permitted by the definition and
standard.
-9- FIRM Gracewood State School and Hospital, Gracewood, Georgia.
FILED November 30, 1993; U.S. District Court for the Southern
District of Georgia; Civil #CV-193-193; FDC #66910.
SEIZED December 3, 1993 - 150 cases of 48 4-ounce containers of
orange juice from concentrate, valued at approximately $870.
_______________
PRODUCT Various articles of food and porcelain ware (93-449-929).
CHARGES Adulterated - One lot of lemon juice ginger and two lots of
preserved plum contain cyclamate, a food additive which is
unsafe because its presence in the foods is not in
conformity with any regulation or exemption. One lot of
sweetened wintermelon contains filth, namely live and dead
insects. Two lots of red beans have been held under
insanitary conditions whereby they may have become
contaminated with rodent filth. Articles of porcelain ware
contain food additives, lead (spoons and bowl) and cadmium
(bowl), which are unsafe because their use or intended use
are not in conformity with a regulation. Misbranded - The
labeling of the lot of sweetened wintermelon is false and
misleading since it fails to reveal that the product
contains sulfites. The labeling of two lots of red beans
and the lot of sweetened wintermelon fails to declare
(1) the place of business of the manufacturer, packer, or
distributor; (2) an accurate statement of the quantity of
contents in terms of weight, measure or numerical count; and
(3) the common or usual name of the food. The lot of lemon
juice ginger, two lots of preserved plum, and the lot of
sweetened wintermelon are fabricated from two or more
ingredients and their labels fail to bear the common or
usual name of each such ingredient. The lot of lemon juice
ginger and two lots of preserved plum contain saccharin and
their labels fail to bear the required warning statement.
FIRM Lop Sing Trading Company, South San Francisco, California.
FILED September 2, 1993; U.S. District Court for the Northern
District of California; Civil #C 93-3245-SBA; FDC #66759.
SEIZED September 10, 1993 - goods valued at approximately $20,300.
_______________
PRODUCT Ear candles, components, and brochures (93-671-958).
CHARGES Adulterated - The article is a class III medical device for
which no approved premarket approval application is in
effect; and, the methods used in, and the facilities and
controls used for, its manufacture, packing, and storage are
not in conformity with current good manufacturing practice.
Misbranded - The article's labeling represents and suggests
that it is adequate and effective for reducing ear wax,
fever, and infections associated with a ruptured ear drum,
and that it may be used as a replacement for surgical tubes
inserted in the ear, which representations and suggestions
-10- are contrary to fact. The article's labeling fails to bear
adequate directions for use for the purposes for which it is
intended. The article is dangerous to health when used in
the manner recommended and suggested in the labeling
Attachment too large to be entirely displayed.
-11-
END OF ENFORCEMENT REPORT FOR DECEMBER 15, 1993. BLANK PAGES MAY
FOLLOW.
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