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
05/28/1991
FDA Enforcement for the week of 5/29/91
FDA ENFORCEMENT REPORT
FOR MAY 29, 1991
May 29, 1991
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: Sulfamethoxazole and Trimethoprim Oral Suspension, USP
Pediatric, an Rx oral suspension antibacterial/anti-
infective in 473 ml (1 pint) bottles under
the following labels: Cotrim, Lemmon Co., Major
Pharmaceutical, Aligen Independent Laboratories, Vedco,
D-M Pharmaceuticals, United Research Laboratories, Schein
Pharmaceutical, Mason Distributors. Recall #D-420-1.
Code: All lots.
Manufacturer: Teva Pharmaceutical Ind., Ltd., Jerusalem, Israel.
Recalled by: Lemmon Company, Sellersville, Pennsylvania, by letter,
April 25, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,069,721 bottles were distributed.
Reason: Crystallization of the sulfamethoxazole ingredient.
----
Product: Sulfamethoxazole and Trimethoprim Oral Suspension, USP,
in 10 ml and 20 ml unit dose cups, 10 cups per tray,
10 trays per carton, an Rx cherry flavored oral
suspension antibacterial/anti-infective. Recall #D-422-1.
Code: Lot numbers: 002617, 005605, 101617 (10 ml cups);
908602, 910608, 001610, 002618, 008611, 011611, 102601
(20 ml cups).
Manufacturer: TEVA Pharmaceutical Ind., Ltd., Jersualem, Israel, for
Lemmon Co., Sellersville, Pennsylvania.
Recalled by: Xactdose, Inc., South Beloit, Illinois (repacker), by
letter May 10, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 491 cases of 10 ml cups and 4,747 cases of 20 ml cups
were distributed; firm estimates 105 cases of 10 ml cups
and 900 cases of 20 ml cups remain on the market.
Reason: Crystallization of the sulfamethoxazole ingredient.
----
Product: Sterile Methylprednisolone Acetate Suspension,
80 mg/ml, an Rx injectable in 5 ml vials, under the
following labels: Hauck Pharmaceuticals,
Durlone-80, Robar, Inc., Depo-Robate-80, American
Pharmaceuticals, Sterile Methylprednisolone Acetate
Suspension, United Research Laboratories, Sterile
Methylprednisolone Acetate
Suspension, Bolan Pharmaceuticals, Predacorten-80, In
Source, Sterile Methylprednisolone Acetate Suspension,
Stewart-Jackson Pharmacal, Inc., Depolone 80.
Recall #D-425-1.
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Code: Lot #19190 EXP 6/92.
Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California.
Recalled by: Walnut Pharmaceuticals, Inc., Anaheim, California, by
telegram March 27, 1991. Firm-initiated recall ongoing.
Distribution: Georgia, Texas, Louisiana, Tennessee, Virginia.
Quantity: 11,197 vials were distributed.
Reason: Product is superpotent for the sodium chloride
ingredient.
----
Product: Film Coated Decongestabs, in 48-count blister packs and
50-count bottles, an OTC product. Recall #D-426-1.
Code: All lots.
Manufacturer: Granutec, Inc., Largo, Florida.
Recalled by: Granutec, Inc., Wilson, North Carolina, by letter May 14,
1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 105,120 48-count blister packs and 34,092 50-count
bottles were distributed.
Reason: The product label does not bear the caution specified
in 21 CFR 369.20 for products containing phenylephrine
hydrochloride.
----
Product: Tetracycline Syrup, in 2 ounce and 16 ounce bottles,
an Rx antibiotic. Recall #D-427-1.
Code: Lot numbers: 82427, 82593, 92112, 92363, 92580,
92806, 03217, 03218, 03374, 03825.
Manufacturer: Barre National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter January 28, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Guam.
Quantity: 175,512 bottles were distributed; firm estimates 18,667
bottles remain on the market.
Reason: Product does not meet stability specifications.
----
Product: Trimethobenzamide HCl 100 mg Suppositories, an Rx drug
for the control of nausea and vomiting, under the GSL and
UDL labels. Recall #D-428-1.
Code: Lot #90690 EXP 10/93.
Manufacturer: Great Southern Laboratories, Houston, Texas.
Recalled by: Manufacturer, by letters of April 26, 1991 and
May 16, 1991. Firm-initiated field correction ongoing.
Distribution: Nationwide.
Quantity: 5,358 boxes, 10 suppositories each were distributed.
Reason: An unknown number of foil packets that contain 100 mg.
suppositories are mislabeled as 200 mg. suppositories.
Paper boxes are correctly labeled as containing 100 mg.
----
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Class III -
Product: (a) Timed Cold Caps, OTC Strip Foiled, Banded hard gelatin
capsules, 2 X 12 per box contain: Chlorpheniramine Maleate
40 mg & Phenylpropanolamine HCl 750 mg, under the
following labels: Medicine Chest, Arthur, Mutual, Fruth,
Kopp, Edgehill, Peterson, Concord, APC, United, HCA
Reasner, Douglas, Gary, Shelly's, H. Harry, Owl,
Town & Country NH, Arrow, Nelsons, Lincoln, Tarrant,
Quality, Drug Sav., RXD, Richardson, Evans, Freedom,
Sterling, Rix, Denmark, Becker, Fagon, Care, and Export.
(b) Total Allergy Medication, OTC, strip foiled branded
hard gelatin capsules, 1X10 per box contain; Diphenhydramine
HCl, USP, 25 mg. under the following labels:
Medicine Chest, Arthur, Mutual, Fruth, Kopp, Edgehill,
Peterson, Concord, APC, United, Douglas, Gary, Shelly's,
H. Harry, Owl, Town & Country NH, Nelsons,
Lincoln, Tarrant, Drug Sav., RXD, Richardson, Evans,
Freedom, Sterling, Rix, Becker, Fagon, Care, Harco, Pleasant,
Town & Country, Hyde, Thayer, Gateway, Med X.
Recall #D-416/417-1.
Code: (a) Lot #L914104 EXP 1/93
(b) Lot numbers: P5024 EXP 10/91, P5121 EXP 10/91,
P5382 EXP 1/92, P5780 EXP 6/9212
P6012 EXP 8/92, P6077 EXP 9/92
Manufacturer: American Pharmaceutical, Company, Passaic, New Jersey.
Recalled by: Manufacturer, by letter February 5, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: (a) 605,900 capsules in boxes of 10 foil stripped
capsules; (b) 2,062,704 capsules in boxes of 24 foil
stripped capsules were distributed; firm estimates
(a) 3,500 boxes of 10 capsules; (b) 19,000 boxes of
124 capsules remain on the market.
Reason: Product labels do not declare all of the tamper
resistant features of the products.
----
Product: Pulmolite Kit for the preparation of Technetium TC99M
Albumin aggregated, 5 vial kit. Recall #D-418-1.
Code: Lot #7154.
Manufacturer: Dupont Merck, North Billerica, Massachusetts.
Recalled by: Manufacturer, by letter April 12, 1991. Firm-initiated
field correction ongoing.
Distribution: Nationwide.
Quantity: 124 kits/620 vials were distributed.
Reason: Approximately 620 vials with labeling designated for
Australia were mistakenly distributed to the United States.
----
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Product: Barre brand Isoproterenol HCl Aerosol, in 15 ml containers,
an Rx bronchodilator. Recall #D-419-1.
Code: Lot #92069 EXP 3/92.
Manufacturer: Barre National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter January 28, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 47,885 units were distributed; firm estimates none
remains on the market.
Reason: Presence of particulate matter.
----
Product: Nitrous Oxide, in "E" size cylinders. Recall #D-423-1.
Code: Lot #340A010 EXP 1/26/96.
Manufacturer: Potomac Airgas, Inc., Linthicum, Maryland (repacker).
Recalled by: Repacker, by visit. Firm-initiated recall complete.
Distribution: Washington, D.C.
Quantity: 79 cylinders.
Reason: Current good manufacturing practice deficiencies.
----
Product: Calahist Lotion, an 6 ounce bottles, an OTC product.
Recall #D-424-1.
Code: Lot numbers: 92022, 92239, 92520, 92554, 92695, 02007,
03164, 03335, 03484.
Manufacturer: Barre National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter dated January 28, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, The Bahamas, Mexico.
Quantity: 358,144 bottles were distributed; firm estimates
17,672 bottles remain on the market.
Reason: Product does not meet stability specifications.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Model Fascat-360 Fully Automated Scatterometer, used
for measuring scatter that incorporates Class III and IV
visible and infrared laser. Recall #Z-543-1.
Code: Serial number: Undetermined.
Manufacturer: Breault Research Organization, Inc., Tucson, Arizona.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan March 18, 1991. Firm-initiated field correction
ongoing.
Distribution: California.
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Quantity: 1 unit was distributed.
Reason: Noncompliance with performance standards for laser products
in that the microswitch interlocks and labeling are
inadequate.
----
Product: Model SL 10m Biostimulation Laser System, for
investigational use in smoking cessation therapy.
Recall #Z-544-1.
Code: Serial numbers: Undetermined.
Manufacturer: Edmenton Laser Therapy Center, Hesperia, California.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan March 22, 1991. Firm-initiated field
correction ongoing.
Distribution: Both units are at the manufacturer.
Quantity: 2 units were distributed.
Reason: Noncompliance with performance standards for laser
products in that the product labeling and operating
instructions are inadequate.
----
Product: Model Prolink 500 Optical Communication Link, used
for optical data communication. Recall #Z-545-1.
Code: Serial numbers: Undetermined.
Manufacturer: Graycor Laser Systems, Inc., Glendale, Arizona.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan April 5, 1991. Firm-initiated field
correction ongoing.
Distribution: Unit returned to manufacturer.
Quantity: 1 unit was distributed.
Reason: Noncompliance with performance standards for laser
products in that the labeling and user information
are inadequate.
----
Product: Model YCM-OOA-AZH Medical Biostimulation Lasers, for
investigational use in pain control. Recall #Z-546-1.
Code: Serial numbers: Undetermined.
Manufacturer: Laser Photonics, Orlando, Florida.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan March 22, 1991. Firm-initiated field
correction ongoing.
Distribution: Texas.
Quantity: 4 units were distributed.
Reason: Noncompliance with performance standards for laser devices
in that the labeling and user information was inadequate.
----
Product: X-Ray Control Model 46-275910 and 46-275911, used for
general purpose fluoroscopy. Recall #Z-547/548-1.
Code: Serial #U1D009893.
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Manufacturer: General Electric Company, Milwaukee, Wisconsin.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan April 1, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: 144 units were distributed.
Reason: Noncompliance with the diagnostic x-ray standard in
that the control does not indicate the pre-selected
technique factors.
----
Product: Coherent 920 Argon/dye Photodynamic Laser, used for
delivery of laser radiation to treatment sites for
investigational use in photodynamic therapy.
Recall #Z-549-1.
Code: Serial numbers: Undetermined.
Manufacturer: Coherent, Palo Alto, California.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan April 11, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide and Canada.
Quantity: 12 units were distributed.
Reason: Noncompliance with performance standards for light
emitting products in that they were not provided with
safety interlocks at the fiber connector port.
----
Product: Extension and Treatment Optical Fibers, used for
delivery of laser radiation to treatment sites for
investigational use in photodynamic therapy.
Recall #Z-550-1.
Code: Serial numbers: Undetermined.
Manufacturer: American Cyanamid, Inc., Lederle Laboratories,
Pearl River, New York.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan April 11, 1991. Firm-initiated recall
field correction ongoing.
Distribution: Nationwide.
Quantity: 64 units were distributed.
Reason: Noncompliance with performance standards for light
emitting products in that safety interlocks were not
provided to prevent human access to laser radiation
when disconnected during normal operational procedures.
----
Product: Sagittaire Radiation Therapy System, an electron linear
accelerator which produces electron beam impulses to kill
cancer cells. Recall #Z-673-1.
Code: All units.
Manufacturer: GE-CGR (formerly Thomson CGR), Buc (Paris), France.
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Recalled by: General Electric Company, Waukesha, Wisconsin, by
letter February 27, 1991 and April 3, 1991. Firm-
initiated field correction ongoing.
Distribution: Connecticut, Kansas, Indiana, Canada.
Quantity: 5 units were distributed.
Reason: An initial breakdown of the accelerator, followed by an
incorrect repair which may lead to patients receiving
potentially improper doses of radiation.
----
Product: Abbott Spectrum System Bicarbonate Reagent for
quantitative determination of bicarbonate in serum
or plasma. Recall #Z-676-1.
Code: Lot numbers: 50-764-HW, 51-916-HE, 51-919-HW.
Manufacturer: Abbott Laboratories, South Pasadena, California.
Recalled by: Abbott Laboratories, Abbott Park, Illinois, by
telephone beginning April 16, 1991 followed by letter.
Firm-initiated recall ongoing.
Distribution: Nationwide, Singapore, Canada, The Bahamas, Panama.
Quantity: 2,465 kits were distributed; firm estimates that
25 percent of the product remains on the market.
Reason: There is a potential for reduced on-board stability
(less than 24 hours).
----
Product: Electrocardiograph (ECG) Electrodes,
(a) Catalog #SF110, ECG Electrodes - STRESS FOAM;
(b) Catalog #TT113, TRAUMA TRODE Electrodes.
Recall #Z-682/683-1.
Code: Lot numbers: (a) JJ9A12; (b) JJ9A21.
Manufacturer: Labeltape Meditect, Inc., Grand Rapids, Michigan.
Recalled by: Manufacturer, by telephone and by letter February 8,
1989. Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: (a) 9,200 units; (b) 12,300 units were distributed.
Reason: The stud and eyelet were not properly seated, allowing the
conductive gel to leak from the eyelet to the stud
causing corrosion and possible electrical failures.
----
Product: USCI Teflon Coated Steerable Guidewire, .016", 180 cm
length, J-Tip, packed in a single unit Tyvek pouch,
5 pouches per box, sterile, non-pyrogenic. Recall #Z-675-1.
Code: Catalog #006678, lot #08LA2334.
Manufacturer: USCI Division C.R. Bard, Inc., Billerica, Massachusetts.
Recalled by: Manufacturer, by letter April 2, 1991 followed by
telephone and visit April 5, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
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Quantity: 135 units were distributed; firm estimates none
remains on the market.
Reason: If the tip movement is restricted and the device is
manipulated, the device could fail.
----
Product: Clear plastic flexible tubes and connectors used in
breathing circuits:
(a) Product No. 1001, Humid-Vent Mini (Sterile);
(b) Product No. 1771, Humid-Vent 2S Flex (Sterile);
(c) Product No. 2001, Flex-Tube (Sterile);
(d) Product No. 2221, Flex-Tube (Clean);
(e) Product No. 171032-571, 360 Kits which include
No. 1771 Humid-Vent 2S Flex. Recall #Z-677/681-1.
Code: (a) 90 Feb. Lot #38, 90 MAR Lot #69, 90 Mar. Lot #78,
90 APR. Lot #99, 90 May Lot #25, 90 June Lot #52,
90 Jul. Lot #73, 90 Aug. Lot #96, 90 Sep. Lot #15,
90 Oct. Lot #56, 90 Oct. Lot #65, 90 Oct. Lot #82;
(b) 90 Jan. Lot #30, 90 Feb. Lot #47, 90 Feb. Lot 48,
90 Mar. Lot #72, 90 Mar. Lot #73, 90 Mar. Lot #80,
90 Apr. Lot #01, 90 Apr. Lot #04, 90 Apr. Lot 09,
90 May Lot #29, 90 May Lot #31, 90 Jun. Lot #51,
90 Aug. Lot #86, 90 Aug. Lot #87, 90 Sep. Lot #18,
90 Sep. Lot #23, 90 Oct. Lot #61, 90 Nov. Lot #90,
90 Nov. Lot #94;
(c)90 Feb. Lot #51, 90 May Lot #10, 90 Aug. Lot #05,
90 Oct. Lot #69, 90 Oct. Lot 70A;
(d) 90 Mar. Lot #83, 90 Jun. Lot #59, 90 Aug. Lot #88,
90 Oct. Lot #86, 90 Nov. Lot #96;
(e) 003348, 008028, 008328, 011028, 012160.
Manufacturer: Gibeck Respiration AB, Vasby, Sweden.
Recalled by: Gibeck-Dryden Corporation, Indianapolis, Indiana, by
letter dated March 25, 1991. Firm-initiated recall
ongoing.
Distribution: Nationwide and Canada.
Quantity: 140,940 units were distributed; firm estimates that
10-15 percent of the product remains on the market.
Reason: The clear plastic connector was blocked by a thin
membrane of plastic.
----
CLARIFICATION: Baxter Interlink Cannulas, Recall #Z-600/601-1 which
appeared in the May 8, 1991 Enforcement Report does
not mean that the Interlink products are being
physically removed from the market, nor does it mean
that such a removal is necessary. The Interlink system
should not be used for the infusion of lipids.
----
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RETRACTION: Brown Milled Rubber Surgeon's Gloves, Recall #Z-599-1
which appeared in the May 8, 1991 Enforcement Report.
After further review, it has been determined that the
firm's, North Hand Protection, Clover, South Carolina,
action should be considered a stock recovery instead of
a recall.
----
Class III -
NONE
VETERINARY PRODUCTS
NONE
Seizure Actions Filed:
Product: Fujinon Yag Laser Stimulator (91-617-489).
Charge: Adulterated - Product is classified as a class III
device under 21 USC 360c(f) and under 21 USC 360j
may not be distributed without the approval of an
application for premarket approval, and is not
exempt from such approval under 21 USC 360j(g);
and 21 USC 351(i) in that an exemption has been
granted under 21 USCj(g) and the person having custody
of the device is not the person named in the exemption.
Firm: Jaime Davidson, M.D., Hummana Hospital Medical Center,
Dallas, Texas.
Filed: May 13, 1991 - U.S. District Court for the Northern
District of Texas, Dallas Division; Civil #CA3-91-0910-D,
FDC #66098.