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
02/23/1994
Recalls and Field Corrections: Foods -- Class I -- February 23, 1994
February 23, 1994
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Poppy Seed Scones, small light pastry often quadrant
shaped., 12 ounces. Recall #F-290-4.
CODE All product manufactured prior to April 27, 1993.
MANUFACTURER Hazelwood Farms Bakeries, Inc., McMinnville, Oregon.
RECALLED BY Carr Gottstein Foods Company, Anchorage, Alaska, by
electronic mail message sent on April 26, 1993. Firm-
initiated recall complete.
DISTRIBUTION Alaska.
QUANTITY Approximately 31 cases (each containing 120 scones) were
distributed; firm estimates none remains on the market.
REASON Product contains peanuts or peanut containing ingredients
which are not declared on the label. Carr Gottstein Foods
Company is responsible for the incorrect labeling.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Sus-Phrine (Epinephrine) Suspension 1:200 for subcutaneous
injection, packaged in multidose 5-ml vials, and 0.3-ml
ampuls. Recall #D-130/131-4.
CODE Lot No. Exp Date
0.3-ml ampul box of 10's 92A470 02/95
91E790 01/94
91G880 06/94
91G350 06/94
91G351 06/94
91G890 07/94
91H720 08/94
91H710 08/94
91G920 08/94
91H750 09/94
91H740 09/94
91H730 09/94
91J580 11/94
91J540 11/94
91H760 11/94
92D350 03/95
92B270 03/95
92M701 11/95
0.3-ml ampul box of 25's 92C810 03/95
93B920 03/96
5-ml. vial 92C800 12/93
92D400 01/94
92E750 04/94
92H860 07/94
92H850 07/94
92K050 08/94
93A190 10/94
93A890 11/94
MANUFACTURER Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis, Missouri, by
telephone beginning December 4, 1993, followed by letters
dated December 17, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 45,147 0.3-ml ampuls and 39,842
5-ml vials were distributed.
REASON Potential for presence of mold in product containers
resulting from storage conditions at recalling firm.
_______________
PRODUCT Ergoloid Mesylates Tablets (oral), 1 mg, Rx used for the
symptomatic relief of idiopathic decline in mental capacity,
in bottles of 60 and 100. Recall #D-132-4.
CODE All unexpired lots.
MANUFACTURER Danbury Pharmacal, Inc., Carmel, New York.
RECALLED BY Allscrips Phrmaceuticals, Inc., Vernon Hills, Illinois
(repacker), by letters dated January 19, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Ohio, Florida.
QUANTITY 31 bottles of 100 and 22 bottles of 60 tablets were
distributed; firm estimates 25% of product remains on the
market.
-2- REASON Product does not meet USP specifications for content
uniformity.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Loestrin FE (Norethindrone Acetate combined with Ethinyl
Estradiol Tablets, USP and Ferrous Fumarate Tablets, USP)
1.5/30. Recall #D-129-4.
CODE 05832FA EXP 3/95 (sample put-up, 6 x 1's)
07152FA EXP 4/95 (institutional package).
MANUFACTURER Warner Lambert, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner Lambert, Morris Plains, New
Jersey, by letter December 10, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 39,002 units were distributed.
REASON Product does not meet process validation specifications.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Saliva Specimen Collection Kit (OraSure) for the collection
of human mucosal transdudata (saliva component) to be used
in a test for the detection of the antibody to the human
immunodeficiency virus type 1 (anti-HIV-1).
Recall #B-139-4.
CODE All kits.
MANUFACTURER Home Office Reference Laboratory, Lenexa, Kansas.
RECALLED BY Manufacturer, by letter dated July 12, 1991. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 312,197 kits.
REASON An unapproved device.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-157/158-4.
CODE Unit #3A15483.
MANUFACTURER W.E. and Lela I. Stewart Regional Blood Center, Tyler,
Texas.
RECALLED BY Manufacturer, by telephone May 10, 1993, followed by letter
May 17, 1993. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit of each component.
REASON Blood products tested repeatedly reactive for the antibody
to hepatitis B core antigen (anti-HBc).
_______________
PRODUCT Red Blood Cells. Recall #B-159-4.
CODE Unit #MU31019.
MANUFACTURER East Texas Blood Center, Inc., Nacogdoches, Texas.
-3- RECALLED BY Manufacturer, by telephone May 18, 1993. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product tested repeatedly reactive for the antibody to
human T-lymphotropic virus type I (anti-HTLV-I).
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Red Blood Cells. Recall #B-138-4.
CODE Unit #10187-6147.
MANUFACTURER United Blood Services Blood Systems, Inc., Scottsdale,
Arizona.
RECALLED BY Manufacturer, on August 26, 1991. Firm-initiated recall
complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit.
REASON Autologous blood product tested positive for syphilis but
was not labeled with a biohazard label.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Model LP10 Ventilator. Recall #Z-736-3.
CODE All units prior to serial number 101132.
MANUFACTURER Aequitron Medical, Inc., Minneapolis, Minnesota.
RECALLED BY Manufacturer, by letter dated August 25, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 915 units.
REASON The pressure limit control valve may stick in some
ventilators, which may allow patient pressure to increase
above the control setting.
_______________
PRODUCT Bird Adult/Pediatric Volume Ventilators, product #15020,
electrically powered, microprocessor controlled volume
cycled, pressure limited critical care ventilator:
(a) Model 8400ST; (b) Model 8400STi. Recall #Z-225/226-4.
CODE All serially numbered units.
MANUFACTURER Bird Products Corporation, Palm Springs, California.
RECALLED BY Manufacturer, by letter September 15, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,112 units.
REASON The products' exhalation valve is malfunctioning due to the
premature failure of the component flex circuit which
provides electrical energy to the voice coil.
-4- _______________
PRODUCT Baxter Flo-Gard Volumetric Infusion Pumps, used to deliver a
wide variety of fluids:
(a) Flo-Gard 6201 Volumetric Infusion Pump Model 2M8063;
(b) Flo-Gard 6301 Dual Channel Volumetric Infusion Pump,
Model No. 2M8064 (two channels allow the delivery of two
fluids simultaneously). Recall #Z-253/254-4.
CODE All serial numbers of both models.
MANUFACTURER Sharp Corporation, Nara, Japan.
RECALLED BY Baxter Healthcare Corporation, Round Lake, Illinois, by
letters dated December 9, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 16,300 units; (b) 4,400 units were distributed.
REASON Reported failure of the devices to detect air in the IV
tubing. The devices have ultrasonic air-in-line-sensors on
the pumps that may not detect the presence of air in IV
tubing and not trigger their alarms.
_______________
PRODUCT Laser Illuminator Model-ALP-1, used to illuminate object in
low light level with infrared radiation for viewing through
a night vision scope. Recall #Z-258-4.
CODE Model ALP-1.
MANUFACTURER Life Plus Management, Inc., New York, New York.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan January 27, 1994. Firm-initiated recall ongoing.
DISTRIBUTION International.
QUANTITY 15 units.
REASON Product lacked a certification label; lacked an
identification label; failed to incorporate a remote
interlock connector; failed to incorporate a key control;
failed to incorporate an emission indicator; failed to
incorporate a beam attenuator; failed to have a Class IIIb
warning logotype affixed to the product; failed to have an
aperture label affixed to the product; user information
failed to include the required caution statement and a
reproduction of all required warning labels.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Matrx Centurion Mixer, Rx medical device used in dental
analgesia which electronically mixes nitrous oxide and
oxygen. Recall #Z-770-3.
CODE All serial numbers lack a prescription device label; and
domestic serial numbers 13314 and higher and international
serial numbers 2819 and higher, contain a typographical
error on page 8 of the operations manual.
MANUFACTURER Matrx Medical, Inc., Orchard park, New York.
RECALLED BY Manufacturer, by letters beginning on or about September 10,
1993. Firm-initiated recall complete.
-5- DISTRIBUTION Nationwide, Japan, Australia, Finland, Colombia, Sweden,
Italy, Brazil, Israel.
QUANTITY 342 units were distributed.
REASON The devices lack a prescription device label and the user
manual contains a typographical error which resulted in
column headings being switched on page 8 of the operations
manual dealing with performance and accuracy specifications.
_______________
PRODUCT Hypoguard Supreme Blood Glucose Test Strips, 50 test strips
per bottle, used with Supreme Blood Glucose Meters by
diabetic patients to monitor their blood glucose levels.
Recall #Z-208-4.
CODE Lot numbers beginning with 978A___, EXP APR 94.
MANUFACTURER Chronimed, Inc., Minnetonka, Minnesota.
RECALLED BY Manufacturer, by letter November 15, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 314 bottles of 50 test strips per bottle were distributed.
REASON Incorrect meter codes on the test strips resulted in glucose
readings which were as much as 17.5 percent low.
_______________
PRODUCT Apex Hole Eliminator, product #1246-01, a metal plug that is
screwed into a threaded hole in the bottom of acetabular cup
shells. Recall #Z-223-4.
CODE Lot numbers: 526150, 526160, 526170.
MANUFACTURER Thortex, Inc., Clackamas, Oregon.
RECALLED BY DePuy Division, Boehringer Mannheim Corporation, Warsaw,
Indiana, by fax October 27, 1992. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 144 pieces were distributed.
REASON The minor dimension on the plug, which is screwed into a
threaded hole in the bottom of acetabular cup shells, was
oversized and would not mate properly.
MASS SEIZURE:
=============================================================
_______________
PRODUCTS Various foods in rodent susceptible containers (94-710-099).
CHARGE Adulterated - The articles have been held under insanitary
conditions whereby they may have become contaminated with
filth.
LOCATION La Hacienda Brands, Inc., Chicago, Illinois.
FILED February 14, 1994; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #94C 00900;
FDC #66929.
SEIZED February 14, 1994 - goods valued at approximately
$1 million.
-6-
SEIZURES:
=================================================================
_______________
PRODUCT Canned Mushroom Pieces and Stems (93-681-640).
CHARGES Adulterated - The article contains an added poisonous and
deleterious substance, staphylococcal enterotoxin, which may
render it injurious to your health; and, it was prepared and
packed under conditions whereby it may have been rendered
injurious to health. Misbranded - The article's labeling is
false and misleading because it represents and suggests that
the article was grown and packed in Taiwan, which is
contrary to fact.
LOCATION Winn-Dixie Warehouse #301, Tampa, Florida.
FILED January 11, 1994; U.S. District Court for the Middle
District of Florida, Tampa Division; Civil #94-51-CIV-T-25B;
FDC #66793.
SEIZED February 1, 1994 - goods valued at approximately $57,300.
_______________
PRODUCT Albacore Solid White Tuna (93-724-783).
CHARGE Misbranded - The article purports to be and is represented
as canned tuna, a food for which a standard of fill of
container has been prescribed by regulation, and it falls
below such standard and its label does not bear a statement
that it falls below standard.
LOCATION Caribe Tuna, Inc., Ponce, Puerto Rico.
FILED January 19, 1994; U.S. District Court for the District
of Puerto Rico; CIV 94-1109(RLA); FDC #66921.
SEIZED February 15, 1994 - goods valued at approximately $5,385.
_______________
PRODUCT Chinese Iron Balls (93-634-0611).
CHARGES Adulterated - The article is a class III medical device for
which no approved premarket approval application is in
effect. Misbranded - The article's labeling is false,
misleading, and contrary to fact; the article's labeling
fails to bear adequate directions for use for the purpose
for which it is intended; and, the article was manufactured,
prepared, and processed in an establishment not duly
registered, it was not included in a required list, and a
notice or other information respecting the device was not
provided as required.
LOCATION Hanover Direct, Inc., Hanover, Pennsylvania.
FILED November 26, 1993; U.S. District Court for the Middle
District of Pennsylvania; Civil #1:CV-93-1842; FDC #66797.
SEIZED December 9, 1993 - goods valued at approximately $7,350.
-7-
END OF ENFORCEMENT REPORT FOR FEBRUARY 23, 1994. BLANK PAGES MAY
FOLLOW.
####