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
06/11/1990
FDA Enforcement for the week of June 13, 1990
FDA ENFORCEMENT REPORT
FOR JUNE 13, 1990
June 13, 1990
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure to
a violative product is not likely to cause adverse health
consequences.
NONE
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: LyphoMed Multi-Vitamin Concentrate, in 5 ml single dose
vials, 25 vials per shelf carton, an Rx injectable
multivitamin (9 vitamins) for I.V. infusion.
Recall #D-293-0.
Code: Lot numbers: 190428 EXP 5/90, 190811 EXP 9/90, 100022
EXP 1/91, 100128 EXP 2/91. (Also 190496 and 100042
distributed only in Canada).
Manufacturer: LyphoMed, Inc., Melrose Park, Illinois.
Recalled by: LyphoMed, Inc., Rosemont, Illinois, by letter April 20,
1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Puerto Rico, Hong Kong, Israel, Canada.
Quantity: 575,825 vials were distributed in the United States.
Reason: Some units were found to have leakage around the metal
closure which secures the metal stopper.
----
Product: UDL brand Amoxicillin (Amoxicillin Trihydrate) Capsules,
500 mg., in unit dose cards of 10 in cartons containing 10
cards, an Rx semisynthetic penicillin. Recall #D-294-0.
Code: Lot #21584 EX 8/1/91.
Manufacturer: Biocraft Laboratories, Elmwood Park, New Jersey.
Recalled by: Manufacturer, by letter May 14, 1990. Firm-initiated
recall ongoing.
Distribution: Distributed through one own-label distributor nationwide.
Quantity: 4,480 unit dose capsules were distributed.
Reason: Mislabeling - A package of 100 unit dose capsules of
Amoxicillin 500 mg was found mislabeled as Oxacillin
capsules 500 mg. The individual capsules were correctly
labeled.
----
Class III -
CORRECTION: Isosorbide Dinitrate Sublingual Tablets, USP, 5 mg,
Lot #9B173AR EXP 4/92 which appeared in the June 6, 1990
Enforcement Report: The recall applies only to product
distributed under the Qualitest label.
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MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: Infant and adult apnea/respiration monitors, designed for
continuous respiratory surveillance to guard against
undetected apnea and automatically alarm after a preselected
delay following the onset of apnea:
(a) Model RE-134B, 115 volts and 220 volts for patient
over four years of age;
(b) Mon-A-Therm Respirate, 115 volts for patients over
four years of age, RE-134B manufactured for own-label
distributor;
(c) Model RE-134D, 115 volts and 220 volts for infants.
Same as Model RE-134C but equipped with a breaths-per
minute meter;
(d) Model RE-134C, 115 volts and 220 volts for infants.
Recall #Z-617/620-0.
Code: Serial number range: A0152 through A0192 (RE-134B, 115V);
9036 through 9191 (RE-134C and 134D, 115V);
1141 through 1800 (Mon-A-Therm Respirate, 115V);
B0100, B0101, 10668 11084, 11085 (RE-134B 220V);
10318 through 11119 and B0102 through B0305 (RE-13C
and RE-134D, 220V).
Manufacturer: Electronic Monitors, Inc., Euless, Texas.
Recalled by: Manufacturer, by letter April 23, 1990 and by facsimile
May 3, 1990 to foreign consignees. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 1,583 units were distributed.
Reason: Each device contains audible alarm systems that may fail
to alarm as intended due to a defective time delay switch.
----
Class II -
Product: Laser Projection System. Recall #Z-585-0.
Code: Serial number 10004.
Manufacturer: Laser Fantasy, Redmond, Washington.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan April 24, 1990. Firm-initiated field correction
ongoing.
Distribution: Illinois.
Quantity: 1 unit was distributed.
Reason: Noncompliance with the performance standards for lasers
in that labeling, performance features and user
information were inadequate.
----
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Product: Software Revision LVP36F-Intelligent (infusion) Pump
Model No. 521, intended for use with Kendall McGaw
Intelligent Pump I.V. set to regulate the flow of I.V.
fluids when positive pressure is required.
Recall #Z-648-0.
Code: All model 521 Intelligent Infusion Pumps within the
serial number range P0895 through P7724.
Manufacturer: Kendall McGaw Laboratories, Inc., Carrollton, Texas.
Recalled by: Manufacturer, by letter March 19, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide.
Quantity: 2,027 pumps with software version LVP36V were distributed.
Reason: Under certain conditions the device may stop delivering
or continue delivery at the set rate without displaying
complete delivery information.
----
Product: Lifepak 10 Defibrillator/Monitor for emergency medical
care. Recall #Z-649-0.
Code: Lot numbers: 101, 104, 105, 107, 109, 111, 114, 115,
116, 117, 119, 121, 124, 128, 129, 133 through 146, 259.
Manufacturer: Physio Control Corporation, Redmond, Washington.
Recalled by: Manufacturer, by Technical Service Update 142 in
September 1989. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 30 units were distributed.
Reason: Removal of a battery causes an overvoltage condition
that leads to the display of incorrect information
on the status display.
----
Product: SiMed Model S-100 Pulse Oximeter, designed for non-invasive
monitoring of arterial oxygen saturation and pulse rate.
Recall #Z-647-0.
Code: Various. Units with software version 1.41 or earlier.
Manufacturer: SiMed Corporation, Bothell, Washington.
Recalled by: Manufacturer, by letter May 29, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, international.
Quantity: 83 units remain on market.
Reason: There is a lack of an alarm if the sensor becomes detached
from either the patient or the unit.
----
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Class III -
Product: Nova Stat Control - Clinical Chemistry Control, Level 1, 2,
3 and Multipak (24 vials/pack):
(a) Level 1 - Catalog No. 04627;
(b) Level 2 - Catalog No. 04628;
(c) Level 3 - Catalog No. 04629;
(d) Multipak - Catalog No. 06391. Recall #Z-629/632-0.
Code: Lot numbers: (a) 060890, 102790, 032891;
(b) 061590, 102790, 031491, 060791;
(c) 051190, 092190, 121490, 011191;
(d) 102790/102790/051190, 032891/031491/092190,
062891/060791/121490, 062891/060791/011191.
Manufacturer: Nova Biomedical, Waltham, Massachusetts.
Recalled by: Manufacturer, by letter April 3, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 2,676 packs were distributed.
Reason: Controls were found to be out-of-range for low
ionized calcium values and high pH values as compared
to the assigned values.