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
05/01/1990
FDA Enforcement for the week of MAY 2, 1990
FDA ENFORCEMENT REPORT
FOR MAY 2, 1990
May 2, 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.
Product: Porcelain hand painted China bowls (10", 12" and 14"),
manufactured in China and imported through Hong
Kong and the port of Philadelphia:
-1-
Item Pattern #'s Design
(a) 12" BOWL 087*-575E-BE BLUE FAMILE ROSE
(b) 14" BOWL 087*-575E-BE BLUE FAMILE ROSE
(c) 10" BOWL 087*-575N-GF CHINESE FAMILE ROSE
(d) 12" BOWL 087*-575N-GF CHINESE FAMILE ROSE
(e) 14" BOWL 087*-575N-GF CHINESE FAMILE ROSE
(f) 10" BOWL 087*-588-BK BLACK FLORAL
(g) 12" BOWL 087*-588-BK BLACK FLORAL
(h) 14" BOWL 087*-588-BK BLACK FLORAL
(i) 10" BOWL 087*-627-WT JAPANESE IMARI
(j) 12" BOWL 087*-627-WT JAPANESE IMARI
(k) 14" BOWL 087*-627-WT JAPANESE IMARI
(l) 14" BOWL 087*-625-WT KUTAI FAN
(m) 12" BOWL 087*-TKJ-WT KUTAI GOLD
(n) 14" BOWL 087*-TKJ-WT KUTAI GOLD.
Recall #F-490/503-0.
Code: Not coded.
Manufacturer: Product of China.
Recalled by: Pearl of the East, Inc., Philadelphia, Pennsylvania.
by press release March 2, 1990 and by telephone or
letter. Firm-initiated recall ongoing.
Distribution: Pennsylvania.
Quantity: 25 bowls were distributed.
Reason: Products contain excessive levels of leachable lead and
lack permanent warnings.
----
Class III - A situation in which the use of, or exposure to
a violative product is not likely to cause adverse health
consequences.
Product: Duke's Balsamic Vinegar of Modena, in 16.5 ounce jars.
Recall #F-488-0.
Code: All lots.
Manufacturer: Aceto Balsamico Del Duca, Adriano Grusoli s.r.l.,
S. Vito, Modena, Italy.
Recalled by: Haddon House Food Products Inc., Medford, New Jersey, by
letter to salesmen November 28, 1989. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: 2,553 cases were distributed.
Reason: Product contains undeclared sulfites.
----
COSMETICS
NONE
-2-
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Rugby brand Ergoloid Mesylates Oral Tablets, 1.0 mg,
in bottles of 100, 500 and 1,000 an Rx drug used for
treatment of cerebrovascular insufficiency, especially in
elderly patients. Recall #D-230-0.
Code: Lot No: Exp. Date Lot No. Exp. Date
803PR042 April 90 810PR021 Oct 90
803PR043 April 90 812PR006 Dec 90
803PR044 April 90 812PR007 Dec 90
803PR045 April 90 812PR017 Dec 90
804PR010 May 90 905PR003 May 91
804PR011 May 90 907PR013 Aug 92
804PR012 May 90 908PR010 Aug 92
804PR013 May 90 910PR017 Oct 92
804PR014 May 90 911PR025 Nov 92
804PRO15 May 90 901PR028 Feb 91
809PR002 Sept 90 001PR009 Jan 93
001PR023 Jan 93
Manufacturer: Chelsea Laboratories, Caribe, Inc., Bayamon, Puerto Rico.
Recalled by: Chelsea Laboratories, Inc., West Hempstead, New York,
by letter April 2, 1990. Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 54,474 bottles of 100, 4,629 bottles of 500 and 13,651
bottles of 1,000 were distributed.
Reason: Lack of assurance of bioequivalency and Abbreviated New
Drug Application discrepancies.
----
Product: Rugby brand Doxycycline Hyclate Tablets, 100 mg., in
bottles of 100, 500, and 1000 an Rx tetracycline-type
antibiotic used for treatment of a variety of microbial
conditions including those affecting the genito-urinary
tract. Recall #D-231-0.
Code: Lot No Exp. Date Lot No Exp. Date
803PR047 April 90 905PR028 Jun 91
803PR002 April 90 907PR007 Aug 91
811PR034 Nov 90 911PR019 Nov 91
901PR014 Jan 91 911PR019 Nov 91
903PR001 Mar 91 002PR015 Mar 92
903PR001 Mar 91
Manufacturer: Chelsea Laboratories, Caribe, Inc., Bayamon, Puerto Rico.
Recalled by: Chelsea Laboratories, Inc., West Hempstead, New York, by
letter April 2, 1990. Firm-initiated recall ongoing.
Distribution: New York.
-3-
Quantity: 48,386 bottles of 100; 11,338 bottles of 500;
and 15,709 bottles of 1,000 were distributed.
Reason: Lack of assurance of bioequivalency and Abbreviated
New Drug Application discrepancies.
----
Product: Penicillin G Potassium Tablets, 250,000 units, in 1,000
tablet bottles, an Rx antibiotic product, under the Purepac,
Wesley, and Rugby labels. Recall #D-232-0.
Code: Lot #17594 EXP 06/92.
Manufacturer: Biocraft Laboratories, Elmwood Park, New Jersey.
Recalled by: Biocraft Laboratories, Fairlawn, New Jersey, by telephone
February 22, 1990 followed by letter February 27, 1990.
Firm-initiated recall ongoing.
Distribution: New Jersey, New York, Pennsylvania.
Quantity: 972 bottles were distributed (???)
Reason: Subpotency.
----
Product: Lannett Probalan Tablets, 500 mg., in 100, 500, and
1,000 tablet bottles, an Rx product for treatment of
hyperuricemia associated with gout and gouty arthritis.
Recall #D-233-0.
Code: Lot numbers: 24542 EXP 4/90, 24807 EXP 7/90,
24841 EXP 8/90, 24874 EXP 10/90, 24877 EXP 11/91,
24543 EXP 8/92, 24544 EXP 8/92.
Manufacturer: Lannett Company, Inc., Philadelphia, Pennsylvania.
Recalled by: Manufacturer, by letter March 13, 1990. Firm-initiated
recall ongoing.
Distribution: Alabama, New York, California, Massachusetts, Missouri,
Maryland, Illinois, Ohio, Tennessee, Oklahoma, Arizona,
Florida, Michigan, Utah.
Quantity: 1,004,600 tablets were distributed; firm estimates none
remains on market.
Reason: Product was marketed as a reformulated product without
approval.
----
Product: Propranolol HCl Tablets USP, packaged in bottles of 100,
500, and 1,000 an Rx beta adrenergic receptor blocking
agent indicated in the management of hypertension, may be
used alone or used in combination with other anti-
hypertenssive agents, particulary a thiazide diuretic,
under the Bioline, Goldline, URL, and Superpharm labels:
(a) 10 mg.; (b) 20 mg.; (c) 40 mg.; (d) 80 mg.
Recall #D-238/241-0.
Code: All unexpired lots manufactured by Superpharm Corp.
Manufacturer: Superpharm Corporation, Bayshore, New York.
Recalled by: Manufacturer, by letter March 13, 1990. Firm-initiated
recall ongoing.
-4-
Distribution: Florida, California, Ohio, Texas, Connecticut, New York
Pennsylvania.
Quantity: (a) 2,000 (100's), 2,300 (1,000's);
(b) 2,100 (100's), 2,200 (1,000's);
(c) 2,100 (100's), 2,400 (1,000's);
(d) 1,800 (100's), 200 (500's) bottles were distributed.
Reason: Lack of assurance of bioequivalency and Abbreviated
New Drug Application discrepancies.
----
Product: (a) Red Blood Cells; (b) Cryoprecipitated AHF;
(c) Recovered Plasma. Recall #B-118/120-0.
Code: Unit #17H70064.
Manufacturer: American Red Cross Blood Services, St. Paul, Minnesota.
Recalled by: Manufacturer, by telephone and by telefax March 28, 1989.
Firm-initiated recall complete.
Distribution: Massachusetts, Minnesota and Washington, D.C.
Quantity: 1 unit of each component was distributed.
Reason: Blood products, drawn from a donor who participated in
high-risk behavior, were distributed.
----
Class III-
Product: Platelets. Recall #B-121-0.
Code: Unit #17L84086.
Manufacturer: American Red Cross Blood Services, St. Paul, Minnesota.
Recalled by: Manufacturer, by telephone May 8, 1989. Firm-
initiated recall complete.
Distribution: Minnesota.
Quantity: 1 unit was distributed and destroyed.
Reason: Platelets were improperly tested for the antibody to the
human immunodeficiency virus (anti-HIV-1).
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Model EW100 TOM Laser System, an optical gauging device
used in manufacturing control, machine tool control and
inspection. Recall #Z-462-0.
-5-
Code: Model Nos. Serial Nos.:
EW 100/112, 411 03-085E, 016, 112, 02-063-C,
03-018-C;
EW 100/412, 432/113 00-046-5, 462, 00-067/0039,
00-084/3503;
EW 100/412, 412/113 00-071/3003, 00-051/0113,
00-070/3003.
Manufacturer: Haenni & Company, Ltd., Jegenstorf, Switzerland.
Recalled by: Haenni Instruments, Inc., Gretna, Louisiana. FDA
approved the firm's corrective action plan February 27,
1990. Firm-initiated field correction ongoing.
Distribution: Michigan, Pennsylvania, California, Indiana, Ohio, Virginia.
Quantity: 16 units were distributed.
Reason: Noncompliance with the performance standard for laser
products in that the product lacked adequate required
labeling, beam attenuator, remote control connector and
key switch.
----
Product: (a) Latex and (b) Vinyl Examination Gloves, medium size
only, packaged 100 gloves per box, 20 boxes per case.
Recall #Z-540/541-0.
Code: Not coded.
Manufacturer: Spectrum Brokers, Inc., Twinsburg, Ohio.
Recalled by: Manufacturer, by telephone and visit on or about
February 5, 1990. Firm-initiated recall complete.
Distribution: Ohio, Indiana, Michigan, Wisconsin, Minnesota.
Quantity: (a) 205 cases; (b) 150 cases were distributed.
Reason: Products contain holes in excess of the 20% limit of FDA's
leak test.
----
Product: Cobe BRAT (Baylor Rapid Autologous Transfusion) System
Bowl, a microprocessor controlled and designed for
intraoperative blood recovery and cell washing, and return
of washed cells to the patient Recall #Z-542-0.
Code: Catalog numbers: 007250-000, 007125-000, 007214-000,
lot numbers: F10039A, F10039B, F10039C, F10039D, F10039E,
F11039A, F11039B, F11039C, F12039A, F12039B, F12039C,
F11159A.
Manufacturer: Cobe Laboratories, Arvada, Colorado.
Recalled by: Manufacturer, by letter February 8, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide, Belgium, Australia, Canada, France, Japan.
Quantity: Approximately 3,338 units were distributed.
Reason: The bowls may leak after the wash cycle.
----
Product: Cobe BRAT (Baylor Rapid Autologous Transusion) System,
a microprocessor controlled and designed for intraoperative
blood recovery and cell washing, and return of washed
cells to the patient. Recall #Z-543-0.
-6-
Code: All serial numbers.
Manufacturer: Cobe Laboratories, Arvada, Colorado.
Recalled by: Manufacturer, by letter February 27, 1990.
Firm-initiated field correction ongoing.
Distribution: Nationwide, Belgium, Australia, Canada, France, Japan.
Quantity: Approximately 50 units were distributed.
Reason: Software error in the auto wash function may cause the
wash bag to overfill and burst.
----
Product: Bennett X-Ray System Control Model D-325. Recall #Z-549-0.
Code: Serial #B-12860.
Manufacturer: Bennett X-Ray Corporation, Copiague, New York.
Recalled by: Radco Imaging Technologies, Odessa, Texas (assembler).
FDA approved the firm's corrective action plan April 9,
1990. Firm-initiated field correction complete.
Distribution: Texas.
Quantity: 1 unit was distributed and was corrected.
Reason: Noncompliance with the performance standard for diagnostic
x-ray products in that it did not have a SID indicator.
----
Product: Universal Allied X-Ray System, Model No. 3490, for
chiropractic use. Recall #Z-550-0.
Code: Serial #KF3994-0280.
Manufacturer: Universal Allied Imaging, Inc., Chicago, Illinois.
Recalled by: Alpha X-Ray, Inc., Tulsa, Oklahoma. FDA approved
the firm's corrective action plan March 16, 1990. Firm-
initiated field correction complete.
Distribution: Oklahoma.
Quantity: 1 unit was distributed and was corrected.
Reason: Noncompliance with the performance standard for diagnostic
x-ray products in that a means to align the center of the
x-ray field with respect to the center of the image receptor
to within two percent of the SID was not provided.
----
Product: Raytheon X-Ray System Model RME-325R. Recall #Z-551-0.
Code: Serial #1-12-84-055.
Manufacturer: Fisher Imaging Corporation, Raytheon Medical Systems
Division, Denver, Colorado.
Recalled by: L & W X-Ray Company, Inc., Beaumont, Texas (assembler),
FDA approved the firm's corrective action plan March 19
1990. Firm-initiated field correction complete.
Distribution: Texas.
Quantity: 1 unit was distributed and was corrected.
-7-
Reason: Noncompliance with the performance standard for diagnostic
x-ray products in that the x-ray field size was misaligned
to the undertable image receptor.
---
Product: Bennett Stationary Radiographic X-Ray Unit Model P-325AT.
Recall #Z-554-0.
Code: Serial #B12074.
Manufacturer: Bennett X-Ray Corporation, Copiague, New York.
Recalled by: Radco Imaging Technologies, Odessa, Texas. FDA approved
the firm's corrective action plan April 9, 1990.
Firm-initiated field correction complete.
Distribution: Texas.
Quantity: 1 unit was distributed and was corrected.
Reason: Noncompliance with the performance standard for diagnostic
x-ray products in that the x-ray field size was misaligned
to the undertable image receptor.
----
Class III -
Product: Beckman Digoxin Reagent Kit, used for the quantitative
determination of digoxin consentration in serum using the
Beckman Synchron CX4 and CX5 Analyzer Systems.
Recall #Z-487-0.
Code: Part #442887 -- All lots.
Manufacturer: Beckman Instruments, Inc., San Diego, California.
Recalled by: Beckman Instruments, Inc., Brea, California, by
letters of December 11, 1989 and January 22, 1990.
Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 340 units were distributed.
Reason: Loss of recovery of quality control materials before the
36 hour calibration interval.
----
Product: 550 Express Analyzer, a chemistry analyzer for
in-vitro diagnostic use. Recall #Z-539-0.
Code: Various serial numbers starting with 101 and going
through 1745. Serial numbers are not all consecutive and
many were not released for distribution.
Manufacturer: Ciba Corning Diagnostics Corporation, Oberlin, Ohio.
Recalled by: Manufacturer, by letter dated February 9,1990.
Firm-initiated field correction ongoing.
Distribution: Nationwide.
Quantity: 1,302 units were distributed.
-8-
Reason: If a position sensor in the sample transport were to fail,
this would result in the device failing to home the
sample transport correctly.
----
Product: Air Shields Remote Alarm Module (RAM), Model AM68-1
Compatible with Air-Shields Vickers Model C100, C200,
C100QT and C200QT Isolette Infant Incubators. This
optional accessory provides the unit with enhanced
audible and visual alarm capabilities. Recall #Z-544-0.
Code: All serial numbers.
Manufacturer: Air-Shield Vickers, Hatboro, Pennsylvania.
Recalled by: Manufacturer, by letter the week of April 8, 1990.
Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 631 units were distributed.
Reason: Failure to fully insert the 1/4 diameter phono jack
connector on the incubator can disable the audible and
visual alarms on the remote alarm module and the audible
alarms on the incubator.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Life Cycle 30% Lamb Grower-Finisher-LS-100 Medicated
Feed containing Lasalocid Sodium 100 gm/ton, in 50
pound bags, used for the prevention of coccidiosis.
Recall #V-040-0.
Code: Lot numbers: 11319X, 111324X, 111317, 111325, 111326.
Manufacturer: Indiana Farm Bureau Cooperative Association, Inc.,
Indianapolis, Indiana and Rochester, Indiana.
Recalled by: Manufacturer, by telephone February 22, 1990. Firm-
initiated recall complete.
Distribution: Indiana.
Quantity: 362 bags were distributed; firm estimates none remains on
market.
Reason: The product is superpotent in Lasalocid sodium.
----
Class III -
NONE
-9-
Medical Device Safety Alert:
Product: Clip-on Spray Tube Assembly, an air water spray accessory
used with the Midwest Shorty Low Speed Handpiece Air Motor
Dental units:
(a) Catalog #710012; (b) Catalog #710013; (c) Catalog
#710022;
(d) Catalog 230601. Safety Alert #M-035/038-0.
Code: All lots.
Manufacturer: Midwest Dental Products Corporation, Des Plaines, Illinois.
Alerted by: Manufacturer, by letter dated April 3, 1990.
Distribution: Nationwide.
Quantity: Unknown.
Reason: The devices present a possible risk of air embolism or acute
emphysema with a risk for infection in an oral cavity when
a soft tissue wound is present.
----
Product: Star Exhalation Isolation System, Siemens Version, a
ventilator circuit heating device used with the Siemens
900B, 900C and 900D Servo Ventilators to improve the
stability of the flow sensor by keeping the components of
the ventilator both clean and dry. Safety Alert #M-039-0.
Code: Product #45 40 50 -- All serial numbers.
Manufacturer: Infrasonics, Inc., San Diego, California.
Alerted by: Siemens Life Support Systems, Division of
Elema-Schonander, Inc., Schaumburg, Illinois, by
letter November 17, 1989.
Distribution: Nationwide.
Quantity: 1,836 units were distributed.
Reason: There is no indicator on the front panel of the Exhalation
Isolation System to indicate internal component failure,
which could result in an inability of the unit to heat
expired respiratory gases, which in turn could result in a
partial or complete blockage of the bacterial filter
cartridge.