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
07/03/1990
FDA Enforcement for the week of July 4, 1990
FDA ENFORCEMENT REPORT
FOR JULY 4, 1990
July 4, 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.
Product: Micro-Flora, in 16 ounce bottles, a concentrated liquid
form of viable organisms designed to assist in the
replacement and maintenance of favorable intestinal
bacterial growth. Recall #F-522-0.
Code: Batch #0522.
Manufacturer: Cosmetic Development Systems Inc., Newbury Park,
California.
Recalled by: Micro-Flora Corporation, Camarillo, California, by
letter March 30, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 6,925 bottles were distributed.
Reason: Product contains high Klebsiella pneumoniae counts.
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-1-
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
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Triamterene/Hydrochlorothiazide Tablets 75mg/50mg,
in bottles of 100, 500 and 1,000 tablets, an Rx diuretic
used for the treatment of hypertension under the following
labels: American Therapeutics, Bioline Laboratories,
Goldline Laboratories, Kaiser Foundation Hospitals,
Major Pharmaceutical, Parmed Pharmaceuticals, Best Generics,
Glenlawn, Harber Pharmaceutical, Martec Pharmaceutical,
Moore Drug Exchange, Qualitest Product. Recall #D-296-0.
Code: Lot numbers: 805135 exp. 5/90 906176 exp. 6/91
806152 6/90 906177 6/91
806153 6/90 906186 6/91
807175 7/90 906187 6/91
807176 7/90 906189 6/91
807198 7/90 906190 6/91
807199 7/90 908241 8/91
808239 8/90 908242 8/91
808240 8/90 908243 8/91
808241 8/90 908244 8/91
808242 8/90 909278 9/91
810290 10/90 909279 9/91
810291 10/90 911363 11/91
812387 12/90 911364 11/91
901033 1/91 911365 11/91
901034 1/91 911367 11/91
902053 2/91 911368 11/91
-2-
902054 2/91 911369 11/91
902055 2/91 911370 11/91
904106 4/91 911375 11/91
904107 4/91 911376 11/91
904108 4/91 911377 11/91
904109 4/91.
Manufacturer: American Therapeutics, Inc., Bohemia, New York.
Recalled by: Manufacturer, by telephone May 7, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates 3-1/2 million tablets remain on market.
Reason: Lack of assurance of product meeting dissolution
specifications.
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Product: Humibid L.A. brand Guaifenesin Sustained-Release
Tablets, in 100 tablet bottles, an Rx drug indicated for
the temporary relief of coughs associated with respiratory
tract infections and related conditions. Recall #D-303-0.
Code: Lot #0B1205 EXP 8/92.
Manufacturer: Adams Laboratories, Inc., Fort Worth, Texas.
Recalled by: Manufacturer, by letter May 15, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 3,980 bottles were distributed.
Reason: Some bottles may contain Deconsal II sustained-release
tablets instead of Humibid L.A. sustained-release tablets.
Each Humibid L.A. tablet contains 600 mg guaifenesin, whereas
each Deconsal II tablet contains 60 mg pseudoephedrine and
600 mg guaifenesin.
----
Product: Kapectolin PG Antidarrheal, in 6 ounce and 16 ounce
bottles, an OTC product under the following labels:
Barre, Major, Goldline, Schein, Rugby, Bioline, Ascot,
Qualitest, Baxter, United Research Labs, Moore.
Recall #D-306-0.
Code: Lot #92261 EXP 9/93.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter May 9, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 111,325 bottles were distributed; firm estimates 2,250
bottles remain on market.
Reason: Product was distributed without adequate testing of the
Belladonna Aklaloids component.
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-3-
Product: Doxycycline Hyclate Capsules, 100 mg., an Rx broad
spectrum antibiotic, in bottles of 50 and 500, under the
Bioline, Goldline and Superpharm labels. Recall #D-312-0.
Code: All unexpired lots.
Manufacturer: Superpharm Corporation, Bayshore, New York.
Recalled by: Manufacturer, by letter June 18, 1990. Firm-initiated
recall ongoing.
Distribution: Florida, California, Ohio, Texas, Connecticut, New York.
Quantity: 142,887 bottles of 50 and 19,883 bottles of 500 were
distributed; firm estimates 12,700 bottles of 50 and
1,640 bottles of 500 remains on market.
Reason: Lack of assurance of bioequivalency and Abbreviated
New Drug Application discrepancies.
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Product: Organon brand Sterile Corticotrophin Zinc Hydroxide
Suspension, USP, 40 units/ml, injection in 5 ml vials,
an Rx drug used for diagnostic testing of adrenocortical
function. Recall #D-313-0.
Code: Lot #189759 (vial), 2280189759 EXP 3/91 (carton).
Manufacturer: Organon, Inc., West Orange, New Jersey.
Recalled by: Manufacturer, by visit and by telephone beginning
June 4, 1990 followed by letter June 6, 1990. Firm-
initiated recall ongoing.
Distribution: Nationwide.
Quantity: 8,946 vials were distributed.
Reason: Subpotency.
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Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma; (d) Single Donor Plasma; (e) Cryoprecipitated
AHF; (f) Recovered Plasma. Recall #B-152/157-0.
Code: Unit numbers: (a) 56F47996, 56F50644, 56F65538, 56F67603,
56F70012, 56F71522, 56G56020, 56G62630, 56G66724, 56G67753,
56G72515, 56G72551, 56G82050, 56G85772, 56H24065, 56H32534,
56H43445, 56H46471, 56H47520, 56H47936, 56J24076, 56J36293,
56J37674, 56J44073, 56J47949, 56J50119, 56J56270, 56K33376,
56K37982, 56K40289, 56K45489, 56Q15466, 56Q16554, 56Q17359;
(b) 56F65538, 56F71522, 56G66724, 56G85772, 56H32534,
56J36293, 56J37674, 56K37982, 56Q17359;
(c) 56G72515, 56K45489;
(d) 56H43445;
(e) 56K45489;
(f) 56F47996, 56F50644, 56F65538, 56F67603, 56F70012,
56F71522, 56G56020, 56G62630, 56G66724, 56G67753, 56G72551,
56G82050, 56G85772, 56H24065, 56H32534, 56H46471, 56H47520,
56H47936, 56J36293, 56J37674, 56J44073, 56J47949, 56J50119,
56J56270, 56K37982, 56K40289, 56Q15466, 56Q16554, 56Q17359.
Manufacturer: American Red Cross Blood Services, Albany, New York.
Recalled by: Manufacturer, by letter dated February 12 and 22, 1990.
Firm-initiated recall ongoing.
Distribution: New York, Florida, California, Washington, D.C.
-4-
Quantity: (a) 34 units; (b) 9 units; (c) 2 units; (d) 1 unit;
(e) 1 unit; (f) 29 units were distributed.
Reason: Blood components were distributed which tested either:
1) repeatably reactive for the antibody to the human
immunodeficiency virus (anti-HIV-1) by EIA, or
2) nonreactive but were collected from donors who
previously tested repeatably reactive for anti-HIV-1.
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CORRECTION: Benadryl Elixir, Recall #D-286-0 which appeared in the
June 6, 1990 Enforcement Report should read:
Product: Parke-Davis brand Benadryl Elixir, (Active
ingredient 12.5 mg Diphenhydramine), in 5 ml unit dose
bottles, 100 bottles/case, an Rx product used as an
antihistaminic, for motion sickness, and antiparkinsonism.
----
Class III -
Product: Oxygen, USP, Medical Gas, an Rx product, in E and D
size cylinders and home care liquid units of 92 pounds,
under the American Care label. Recall #D-298-0.
Code: Not coded.
Manufacturer: American Care, Inc., Overland Park, Kansas.
Recalled by: Manufacturer, by visit May 14, 1990. Firm-initiated
recall ongoing.
Distribution: Kansas.
Quantity: Firm estimates 18 D or E cylinders and 1 liquid home
unit remain on market.
Reason: Current good manufacturing practice deficiencies.
----
Product: Oxygen, USP, Medical Gas, an Rx product, in D, E,
H, HH and PG45 size cylinders, under Oxygen Service Co.,
and Midwest Gases labels. Recall #D-299-0.
Code: Lot numbers: 040402901, 050411902, 050416902, 050417902,
050417903, 050417904, 050418902, 050423902, 060426902,
060427902, 060427903, 060502902, 060504901, & 060507902.
Manufacturer: Oxygen Service Company, Springfield, Missouri.
Recalled by: Manufacturer, by visit May 17, 1990. Firm-initiated
recall ongoing.
Distribution: Missouri.
Quantity: Approximately 495 cylinders were distributed; firm estimates
5 percent remains on market.
Reason: Current good manufacturing practice deficiencies.
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-5-
Product: Red Blood Cells. Recall #B-150-0.
Code: Unit #5269093.
Manufacturer: Naval Hospital Blood Bank, Millington, Tennessee.
Recalled by: Manufacturer, by letter February 19, 1990. Firm-initiated
recall complete.
Distribution: Tennessee.
Quantity: 1 unit was distributed and destroyed.
Reason: A unit of Red Blood Cells, collected from a donor
who previously tested repeatably reactive for the
antibody to the human immunodeficiency virus (Anti-HIV-1)
was distributed.
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MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Schering Corporation InspirEase delivery system,
mouthpieces and replacement mouthpieces:
(a) InspirEase Delivery System for Metered Dose
Inhalers, an Rx device used in the facilitation of spray
inhaler medications;
(b) InspirEase Mouthpieces, used as part of kit that is
used for the facilitation of spray inhaler medications;
(c) InspirEase Replacement Mouthpieces, a component of an
Rx device used as part of kit that is used for the
facilitation of spray inhaler medications.
Recall #Z-676/678-0.
Code: Control numbers: (a) DDSS followed by 0110, 0731, 0802, 0807,
0808, 0814, 0815, 0821, 0822, 0824, 0825, 0915, 0925, 0927,
1002, 1009, 1020, 1108, 1114, 1117, 1120, 1121, 1204, 1206,
1211, 1214, 1229;
(b) IBMPS 0912, IBMPT 0109;
(c) IEVPS 0918, IEVPS 1012, IRMPS 0905, IRMPS 0907,
IRMPS 1005, IRMPS 1127, IRMPS 1129, IRMPS 1220.
Manufacturer: Custom Plastic Development, Inc., Division of Custom
Injection Molding, Kissimmee, Florida.
Recalled by: Schering Laboratories, Schering-Plough Corporation,
Kenilworth, New Jersey, by letters beginning March 2, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: 149,000 units were distributed.
Reason: Devices may not deliver the complete dosage of the
medicated spray to the patient.
----
Product: Posterior Chamber Intraocular Lenses (IOL), a sterile
Rx device: (a) Model P003UV; (b) Model 685UV;
(c) Model 121UV. Recall #Z-679/681-0.
Code: Lot numbers: (a) V197; (b) V191; (c) U817.
-6-
Manufacturer: Storz Ophthalmics, Inc., Clearwater, Florida.
Recalled by: Manufacturer, by visit beginning January 15, 1990.
Firm-initiated recall complete.
Distribution: Maryland, Florida, Washington state, Ohio, Illinois,
Colorado, California, Tennessee, Michigan, Germany,
Australia, France.
Quantity: 55 were implanted; none remains to be implanted.
Reason: There may be a discrepancy between the labeled refractive
power and the actual correction provided by the lens.
----
Product: Naturalyte 4416-Acid Concentrate for Bicarbonate
Dialysis, in 55 gallon drums and in 4/3.43 liter jugs,
an Rx concentrated liquid used in conjunction
with a basic concentrate in dialysis. Recall #Z-682-0.
Code: Lot numbers: E9E037, E9N168, E9E045, E9H033, E9J001.
Manufacturer: National Medical Care, Medical Products Division,
Turlock, California.
Recalled by: National Medical Care, Rockleigh, New Jersey, by letter
dated December 1, 1989. Firm-initiated recall ongoing.
Distribution: Arizona, California, Massachusetts, Missouri, Montana,
New York, Oregon, Pennsylvania, Texas, Virginia,
Washington state.
Quantity: 332 drums and 187 cases (4 jugs/case) were distributed.
Reason: The sodium chloride constituent of the product may
precipitate out when the product is stored at the lower
end of room temperature.
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Product: Horizon 2000 Pulse Oximetry Monitor, Parts #260-OPT-865,
#260-860-010, and #260-865-010 incorporating an Ohmeda
pulse oximetry printed circuit board assembly (PCBA) and
using Ohmeda light probes. The device determines a
patient's arterial oxygen saturation and pulse rate by
measuring the absorption of selected wavelengths of
light. Recall #Z-683-0.
Code: All serial numbers.
Manufacturer: Mennen Medical Inc., Clarence, New York.
Recalled by: Manufacturer, by letter on or about March 14, 1990 followed
by telephone and a second letter May 14, 1990. Firm-
initiated recall ongoing.
Distribution: Nationwide, India, Israel, Canada.
Quantity: 249 units were distributed.
Reason: The oximeter circuitry may not shut off the current
by itself and may result in an overheated LED and probe.
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-7-
Product: Model STR-270 Rotating Static Balancing Machine, utilizing
a standard Spectra Physics Model 810 600 watt CO2
HeNe laser, used for balance correction in job shop
applications. Recall #Z-684-0.
Code: Serial #2989.
Manufacturer: Balance Engineering Corporation, Troy, Michigan.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan September 12, 1989. Firm-initiated field
correction complete.
Distribution: Ohio.
Quantity: 1 unit was distributed.
Reason: Noncompliance with the performance standard for laser
products due to inadequate labeling, inadequate user
information, lack of safety interlock, inadequate
protective housing, lack of laser radiation emission
indicator and inadequate beam attenuator.
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Product: (a) Sigma 6000; (b) Sigma 6000+ Volumetric Infusion pump,
a critical device for Rx use. Recall #Z-686/687-0.
Code: Numerous serial numbers are involved. Products affected
are those with batteries bearing code numbers G10/88
through G16/89.
Manufacturer: Sonnenschein Batteries Inc., Cheshire, Connecticut (battery)
Recalled by: Smith & Nephew Sigma Inc., Medina, New York, by letter
March 12, 1990. Firm-initiated field correction ongoing.
Distribution: Nationwide, Canada.
Quantity: Approximately 5,500 units were distributed.
Reason: These devices contain batteries with a defective vent
diaphragm, which causes the battery to fail, resulting in
the pump stopping.
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Product: Kerr Unidose Composite Gun, a gun delivery system for
unidose prefilled tips containing composite material for
dental restorations. Recall #Z-693-0.
Code: Catalog #21782 -- All product on the market as of 5/3/90.
Manufacturer: Tenax Corporation, Danbury, Connecticut (contract
injection molder).
Recalled by: Kerr Manufacturing Company, Romulus, Michigan, by letters
of May 3 and 17, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 7,851 units were distributed.
Reason: The dental tip may fracture.
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Product: Braasch Bulb Ureteral Catheters, catalog numbers:
(a) 3326-06; (b) 3326-08; (c) 3326-10 (the last two
numbers are the French sizes of the product).
Recall #Z-694/696.
-8-
Code: Lot numbers: (a) G990104, G990638;
(b) G086290, G086291, G086292, G086294 through G086298,
G983308, G984215, G984409, G984410, G984901, G984902,
G985003, G990408, G990818, G990819, G990820, G990821,
G990822, G990825, G990826;
(c) G088438, G086515, G086516, G086763, G087214,
G087215, G087216, G087346, G990105, G990114, G990115,
G990117, G990412, G990501, G990827.
Manufacturer: TFX Medical/Rusch, Inc., Duluth, Georgia.
Recalled by: Manufacturer, by letter January 3, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada.
Quantity: (a) 140 pieces; (b) 7,330 pieces; (c) 5,320 pieces were
distributed.
Reason: The catheters may separate due to sterilization having
caused the shaft to weaken in the area below the bulb.
The device tips may break off.
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Class III -
NONE
VETERINARY PRODUCTS
NONE
Medical Device Safety Alerts:
Product: Barium Enema Kits and all components, used for diagnosis
of lower G.I. ailments, sold in complete kits ready to
use, kits without barium sulfate in individual pieces, and
bulk barium sulfate. Safety Alert #M-055-0.
Code: All lots.
Manufacturer: E-Z-EM Inc., Westbury, New York.
Alerted by: Manufacturer, by letter and by telegram May 17, 1990.
Distribution: Nationwide and international.
Quantity: Unknown.
Reason: Potential adverse (allergic vasovagal or anaphylactoid)
reactions associated with the use of the product.