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
12/06/1995
ENFORCEMENT REPORT FOR 12/06/96
December 6, 1995 95-49
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
========================
_______________
PRODUCT Imported Cerasse Spice. Recall #F-059-6.
CODE None.
MANUFACTURER Eastern Agri Trading Ltd., Portland, Jamaica.
RECALLED BY Angel Brand Company, Springfield, Pennsylvania, by telephone
on September 15, 1995. Firm-initiated recall ongoing.
DISTRIBUTION One foreign consignee.
QUANTITY 7 bags (30-34 pounds) were distributed.
REASON Product is adulterated due to the presence of Salmonella.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
========================
_______________
PRODUCT Caverject Sterile Powder (Alprostadil) for Injection, 20
micrograms, Rx drug for intracavernosal use only.
Recall #D-027-6.
CODE Lot #266MJ EXP 8/96.
MANUFACTURER The Upjohn Company, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter mailed on November 7, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 2,736 cartons of 6 injection systems each were distributed.
REASON Some cartons holding 6 injection systems declare strength as
10 micrograms. Vials and injection system boxes are
correctly labeled as 20 micrograms.
_______________
PRODUCT Pyrazinamide Tablets, USP, 500 mg, Rx drug used to treat
active tuberculosis. Recall #D-028-6.
CODE Lot #S047JL EXP 3/96.
MANUFACTURER Pharmaceutical Corporation of America (PCA), Carmel, Indiana
(repacker).
RECALLED BY Repacker, by letter on June 6, 1995. Firm-initiated recall
complete.
DISTRIBUTION New Jersey.
QUANTITY 603 bottles were distributed.
REASON Part of the lot bore expiration date of 3/96. The correct
date was 3/95.
_______________
PRODUCT Aquaphyllin (Theophylline Anhydrous USP 80 mg/15ml) Syrup,
in 16 ounce plastic bottles, Rx product indicated for the
relief and/or prevention of symptoms from asthma and
reversible bronchospasm. Recall #D-029-6.
CODE Lot numbers: 54-233, EXP MAR 96; 54-062, EXP MAR 96;
53-402, EXP NOV 95; and 53-224, EXP JUL 95.
MANUFACTURER Ferndale Laboratories, Inc., Ferndale, Michigan.
RECALLED BY Manufacturer, by letter dated August 2, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 9,410 units were distributed.
REASON Crystallization of the active ingredient due to shipment
without temperature controls.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Methenamine Mandelate Tablets, USP, 1.0 gram, in bottles of
100, Rx urinary anti-bacterial agent, under the Amide and
Aligen labels. Recall #D-026-6.
CODE Control #4013A1 EXP 1/96.
MANUFACTURER Amide Pharmaceutical, Inc., Little Falls, New Jersey.
RECALLED BY Manufacturer, by telephone on August 10, 1995. Firm-
initiated recall complete.
DISTRIBUTION Maryland, Florida, Texas, Georgia, North Carolina, Texas,
Belarus.
QUANTITY 763 bottles were distributed.
REASON Product packaged with an incorrect package insert.
_______________
PRODUCT Mephyton (Phytonadione) 5 mg Tablets, Rx anticoagulant.
Recall #D-030-6.
CODE Lot numbers: B5713 EXP 5/31/97, B5716 EXP 5/31/97,
B5776 EXP 4/30/97, B5777 EXP 4/30/97, B6127 EXP 2/28/97,
B6128 EXP 2/28/97, B6247 EXP 2/28/97.
-2- MANUFACTURER Merck and Company, West Point, Pennsylvania.
RECALLED BY Manufacturer, by letter dated September 11, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide, Canada, Bermuda, Israel.
QUANTITY Approximately 43,816 market packages were distributed.
REASON Potency not assured through expiration date.
_______________
PRODUCT Neodecadron (Neomycin Sulfate & Dexamethasone Phosphate)
0.1% Cream, Rx antibiotic/corticosteroid, in 30 gram tubes
and 15 gram tubes. Recall #D-031-6.
CODE Lot #A0198 EXP 12/31/96, Lot #V0839 EXP 12/31/95 for 15 gram
tube lot #A0009 EXP 12/31/96, lot #V0837 EXP 12/31/95 for 30
gram tube.
MANUFACTURER Merck and Company, West Point, Pennsylvania.
RECALLED BY Manufacturer, by letter dated September 29, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 60,764 packages were distributed.
REASON Superpotency.
_______________
PRODUCT Edecrin (Ethacrynate Sodium), 50 mg Tablets, Rx diuretic.
Recall #D-032-6.
CODE Lot #B5939 EXP 1/00.
MANUFACTURER Merck and Company, West Point, Pennsylvania.
RECALLED BY Manufacturer, by letter dated October 23, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 6,391 market packages were distributed.
REASON Some tablets were embossed with code "65" instead of "90".
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Red Blood Cells. Recall #B-124-6.
CODE Unit #T78142.
MANUFACTURER Topeka Blood Bank, Inc., Topeka, Kansas.
RECALLED BY Manufacturer, by letter dated September 28, 1994. Firm-
initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit.
REASON Blood product, collected from a donor taking the drug
Proscar, was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Red Blood Cells. Recall #B-118-6.
CODE Unit #3759614.
MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis,
Indiana.
-3- RECALLED BY Manufacturer, by telephone December 28, 1994. Firm-
initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit.
REASON Blood product, containing anti-e antibodies, but labeled as
negative for the unexpected antibodies, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-119-6.
CODE Unit #068605.
MANUFACTURER Marquette General Hospital, Inc., Marquette, Michigan.
RECALLED BY Manufacturer, by telephone February on February 1, 1994.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASOn Blood product, labeled with an incorrect expiration date,
was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Abbott IMx and AxSYM System Controls, used for the
verification of the calibration of the IMx System and the
AxSYM System when used for the quantitative determination of
Prostate Specific Antigen (PSA) in human serum used as an
aid in the management of prostate cancer patients:
(a) Catalog #2245-10; (b) Catalog 7A49-10.
Recall #Z-166/167-6.
CODE Lot numbers: (a) 06007Q100; (b) 06011Q100.
MANUFACTURER Abbott Health Products, Inc., Barceloneta, Puerto Rico.
RECALLED BY Abbott Laboratories, Abbott Park, Illinois, by telephone
beginning October 24, 1995, followed by letter. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 819 IMx and 323 AxSYM controls were distributed; firm
estimated that 25 percent of the product remained on market
at time of recall initiation.
REASON The controls yield low values which may lead to invalid
runs.
_______________
PRODUCT Software Version 1.2 used with the Ektachem 950 IRC
Analyzer. Recall #Z-168-6.
CODE Software Version 1.2.
MANUFACTURER Johnson & Johnson Clinical Diagnostics, Rochester, New York.
RECALLED BY Manufacturer, by telephone followed by letter July 28, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 85 analyzers were distributed.
REASON A software indexing error can occur following a specific
sequence of operational events during the recovery from a
mechanical shutdown of the sampling module.
-4- _______________
PRODUCT Concha 1500, Sterile Water, 1650 ml Reservoir, used with the
Concha Column Heated Humidification System.
Recall #Z-169-6.
CODE Lot 060995A.
MANUFACTURER Hudson RCI, Arlington Heights, Illinois.
RECALLED BY Hudson RCI, Temecula, California, by telephone August 24,
1995. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 360 bottles were distributed; firm estimates none remains on
the market.
REASON Product's sterility may be compromised.
_______________
PRODUCT SPS 550 Single Patient Dialysis System. Recall #Z-170-6.
CODE All serial numbers.
MANUFACTURER Baxter Healthcare Corporation, Largo, Florida.
RECALLED BY Manufacturer, by overnight letter on October 25, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 155 units were distributed.
REASON The blood pump relay may fail which could disable critical
instrument alarms.
_______________
PRODUCT ECG Monitors with Software Versions 1.42.07, 5.42.07 or
Earlier:
(a) 90332 Biotel 300 Telemetry Receivers (2 ch)
(b) 90334 Biotel 300 Telemetry Receivers (4 ch)
(c) 90335 Biotel 300 Telemetry Receivers (5 ch)
(d) 90336 Biotel 300 Telemetry Receivers (6 ch)
(e) 90338 Biotel 300 Telemetry Receivers (8 ch)
(f) 90407 Alpha PC Dual ECG/ESIS Module
(g) 90408 Alpha PC Dual ECG Module
(h) 90418 PC Dual ECG Adult/Neonatal Module
(i) 90425 Integrated Multiparameter PCMS Module
(Basic)
(j) 90427 PC Multi-Lead ECG/ESIS Module and ST
Seg. Anal.
(k) 90428 Integrated Multiparameter PCMS Module
(Basic + MLRM and VP)
(l) 90432 Integrated Multiparameter PCMS Module
(Basic + CO, HC, Dual Lead ECG).
Recall #Z-171/182-6.
CODE All units with the following defective software versions:
Software Version 5.42.07 and/or prior (Models 90332, 90334,
90335, 90336, 90338, 90407, 90408, 90418, and 90427.
Software Version 1.42.07 and/or prior (Models 90425, 90428,
and 90432).
MANUFACTURER Spacelabs Medical, Inc., Chatsworth, California.
RECALLED BY Spacelabs Medical, Inc., Redmond, Washington, by letter July
20, 1995. Firm-initiated recall ongoing.
-5- DISTRIBUTION Nationwide and international.
QUANTITY 12,601 were distributed.
REASON Devices contain defective software, causing incorrect
waveform display.
_______________
PRODUCT Lambda Photometrics Q-Switched Ruby Laser System, used in
dermatology. Recall #Z-189-6.
CODE None.
MANUFACTURER Polytec PI, Inc., Auburn, Massachusetts.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan November 17, 1995. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 79 units
REASON Noncompliance with performance for laser products in that
the operator's manual lacked adequate calibration
procedures.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Stratus II Prolactin Fluorometric Enzyme Immunoassay:
(a) Catalog #B5700-53; (b) Catalog #B5700-53S.
Recall #Z-161/162-6.
CODE Lot numbers: (a) KXPL-212/215; (b) KXPL-34S.
MANUFACTURER Dade International, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter sent on or about August 29, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 270 kits were distributed.
REASON The labeling contains an incorrect Code 09 for the metric
Assay Parameters, the correct code is 0.014.
_______________
PRODUCT Abbott AxSYM System CK-MB Standard Calibrators, Master
Calibrators and Controls used for calibration and
verification of calibration of the AxSYM System when used
for the microparticle enzyme immunoassay quantitative
measurement of the MB isoenzyme of creatine kinase (CK-MB)
in human serum or plasma to assist in the diagnosis of acute
myocardial infarction: (a) Catalog #7A57-01;
(b) Catalog #7A57-30; (c) Catalog #7A57-10.
Recall #Z-163/165-6.
CODE Lot numbers: (a) 09242M100; (b) 08375M400, 09245M100;
(c) 08366M400.
MANUFACTURER Abbott Laboratories, Abbott Park, Illinois.
RECALLED BY Manufacturer, by telephone beginning October 6, 1995,
followed by letters dated October 6, 1995. Firm-initiated
recall ongoing
DISTRIBUTION Nationwide and international.
-6- QUANTITY 194 standard calibrators, 104 master calibrators and 496
controls were distributed; firm estimated that 50 percent of
the product remained on the market at time of recall
initiation.
REASON The calibrators and controls were shipped under ambient
temperature conditions instead of on dry ice, possibly
resulting in a decrease in potency and an increase in the
reported CK-MB value.
_______________
PRODUCT Amplatz "Goose Neck" Snare Kit, including catheter:
(a) Catalog #GN500; (b) GN1000; (c) GN1500; (d) GN2500;
(e) GN3500. Recall #Z-183/187-6.
CODE Lot numbers: A2241 through A3923 and 1202 through 1361.
MANUFACTURER Angion Corporation (now B. Braun), Plymouth, Minnesota
(catheter)
RECALLED BY Microvena Corporation, White Bear Lake, Minnesota, by letter
October 2, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 3,869 units/kits were distributed.
REASON The catheters within these snare kits degrade over time,
becoming brittle.
_______________
PRODUCT Alko Type 1 Buffer for AVL pH/Blood Gas Analyzers, serves as
a calibrator for pH. Recall #Z-190-6.
CODE Catalog #A007-7, Lot #40816 EXP 8/96.
MANUFACTURER Alko Diagnostic Corporation, Holliston, Massachusetts.
RECALLED BY Manufacturer, by letter on January 26, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 846 units were distributed.
REASON The pH value of the lot is outside the label declared value,
which may cause measured pH values to be falsely depressed.
_______________
PRODUCT Alko 7.382 Buffer for Corning 100 Series, used for
calibrating pH/Blood Gas. Recall #Z-191-6.
CODE Catalog #A477-073, Lot #30615 EXP 6/97.
MANUFACTURER Alko Diagnostic Corporation, Holliston, Massachusetts.
RECALLED BY Manufacturer, by letter on December 2, 1993, followed by
letter. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 686 units were distributed.
REASON The pH value of the lot is outside the label declared value,
which may cause measured pH values to be falsely depressed.
_______________
PRODUCT Alko 7.3 Buffer for Corning 200 Series Analyzers, provides
calibration points for the Na+,K+,C1-,Ca++, and pH Electrode
as for Corning 200 Series Analyzers.
Recall #Z-193-6.
-7- CODE Product #A478-855, Lot numbers: 40940 EXP 9/98, 41131 EXP
11/98, 50119 EXP 1/99, 50244 EXP 2/99, 50314 EXP 3/99.
MANUFACTURER Alko Diagnostic Corporation, Holliston, Massachusetts.
RECALLED BY Manufacturer, by letter on February 24, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,706 units were distributed.
REASON Bacteria caused the pH value to be outside the label
declared value, which may cause measured pH values to be
raised.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Radix Labs Milk Fever S, in 500 ml bottles, a sterile
injectable calcium, phosphorus, magnesium and dextrose
product for intravenous, intramuscular, subcutaneous or
intraperitoneal administration as a treatment of milk fever
in cattle. Recall #V-001-6.
CODE Lot R4E012 EXP 5/96.
MANUFACTURER Radix Laboratories, Inc., Eau Claire, Wisconsin.
RECALLED BY Manufacturer, by letter dated November 14, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Illinois, Iowa, Minnesota, New York, New Jersey, Wisconsin.
QUANTITY 5,958 bottles were distributed.
REASON Precipitates found in injectable parenteral product.
-8-
END OF ENFORCEMENT REPORT FOR DECEMBER 6, 1995. BLANK PAGES MAY
FOLLOW.
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