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
07/10/1990
FDA Enforcement for the week of July 11, 1990
FDA ENFORCEMENT REPORT
FOR JULY 11, 1990
July 11, 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: Circle Sea brand and Scan Fish brand Cold Smoked Salmon
in vacuum packed plastic packages, various sized packages.
Recall #F-521-0.
Code: Various codes including case code 89L14 and uncoded
product. All product packed and shipped between August 1989
and January 23, 1990.
Manufacturer: Circle Sea Seafoods, Ltd., Monroe, Washington.
Recalled by: Manufacturer, by telephone beginning April 18, 1990
followed by letter. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Unknown.
Reason: Product is contaminated with Listeria monocytogenes.
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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: Recovered Plasma. Recall #B-158-0.
Code: Unit numbers: 7773045 (EH5500) and 7782321 (EH 7677).
Manufacturer: City Hospital at Elmhurst, Elmhurst, New York.
Recalled by: Manufacturer, by telephone March 22-23, 1990 followed by
letter March 28, 1990. Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 2 units were distributed.
Reason: Blood products which tested 1) repeatably reactive for
the antibody to the human immunodeficiency virus
(anti-HIV-1) by EIA or 2) non-reactive for anti-HIV-1
by EIA but collected from a donor who had previously
tested repeatably reactive for anti-HIV-1, were
distributed.
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Class III -
Product: Lilly brand Sulfadiazine Tablets, USP, 0.5 gm, an Rx
sulfonamide drug used as a bacteriostatic agent in
bottles of 100. Recall #D-295-0.
-2-
Code: Lot numbers: 9NW33A EXP 9/1/90
OLZ24A 2/1/91
OMR92A 6/1/91
1AX70A 4/1/92
1CY80A 7/1/92
1EJ73A 11/1/92
1EX46A 2/1/93
2PG16A 9/1/93
2RL72A 3/1/94
3AS15A 4/1/94
3CH71A 6/1/94
Manufacturer: Eli Lilly & Company, Indianapolis, Indiana.
Recalled by: Manufacturer, by letter May 16, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Puerto Rico, Barbados.
Quantity: 61,560 bottles were distributed.
Reason: Product may not meet dissolution specifications through
expiration date.
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Product: Dermatopics Prescription Formula Benzoyl Peroxide
10% Gel packaged in 3 ounce plastic tablets, an OTC
topical anti-acne medication. Recall #D-297-0.
Code: Lot #F-094 EXP 11/91.
Manufacturer: Topiderm Inc., also known as Phamagen Inc., Bohemia,
New York.
Recalled by: Manufacturer, by telephone on or about April 24, 1990.
Firm-initiated field correction ongoing.
Distribution: Florida, New York, Massachusetts.
Quantity: 4,623 tubes were distributed; firm estimated 24 mislabeled
units remained on market at time of recall initiation.
Reason: Main label panel correctly declares 10 percent strength
while ingredient statement declares 5 percent.
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Product: Oxygen, USP, Medical Gas, an Rx product in D and E
size cylinders. Recall #D-300-0.
Code: Not coded.
Manufacturer: Home Medical Services, Inc., Parsons, Kansas.
Recalled by: Manufacturer, by visit beginning June 4, 1990.
Firm-initiated recall ongoing.
Distribution: Kansas.
Quantity: Approximately 30 cylinders were distributed.
Reason: Current good manufacturing practice deficiencies.
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Product: Trilafon Concentrate (Perphenazine USP), 16 mg/5 cc, in
4 ounce bottles, an Rx drug indicated for use in the
management of the manifestations of psychotic disorders
and for control of nausea and vomiting in adults.
Recall #D-301-0.
-3-
Code: Lot numbers: 6-ADT-5 (10/91), 7-ADT-1 (2/92), 7-ADT-2
(4/92), 7-ADT-3 (7/92), 7-ADT-4 (10/92), 7-ADT-5 (12/92),
8-ADT-1 (3/93), 8-ADT-2 (6/93), 8-ADT-3 (9/93), 8-ADT-4
(11/93), 9-ADT-1 (2/94), 9-ADT-2 (5/94), 9-ADT-3 (8/94),
9-ADT-4 (11/94), 0-ADT-1 (1/95).
Manufacturer: Schering Laboratories, Division of Schering-Plough Inc.,
Union, New Jersey.
Recalled by: Manufacturer, by letter mailed April 6, 1990. Firm-
initiated recall ongoing.
Distribution: Nationwide.
Quantity: 243,000 bottles were distributed.
Reason: Stability testing indicates potency not assured through
expiration date.
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Product: Theophylline Elixir 80 mg/15 ml, in 1 pint and 1 gallon
bottles, an Rx bronchodilator, under the Barre, Schein,
Bioline, Moore, Major, Haber and Goldline labels.
Recall #D-302-0.
Code: Lot numbers and EXP dates: 82671 01/93, 92063 01/93,
92179 06/93, 92427 07/93, 92443 07/93, 92581 09/93,
92646 10/93, 92647 10/93, 92862 12/93, 92863 01/94.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter May 9, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 228,548 bottles were distributed; firm estimates 12,340
bottles remain on market.
Reason: Incorrect expiration date of 48 months was used instead
of 24 months.
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Product: Conray 400, Iothalamate Sodium Injection, 66.8%, in
25 ml vials, an Rx iodinated contrast imaging media.
Recall #D-304-0.
Code: Lot numbers: D030A, D068A, D115A.
Manufacturer: Mallinckrodt Inc., Raleigh, North Carolina.
Recalled by: Manufacturer, by letter May 31, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Brazil.
Quantity: 439 cases were distributed.
Reason: Labels incorrectly stated 688 mg/ml organically bound
iodine, instead of 400 mg/ml organically bound iodine.
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Product: Selenium Sulfide Lotion USP 2.5%, in 4 fluid ounce bottles,
an Rx antiseborheic and antifungal preparation for
dermatological use, under the Major, United Research
Labs, Inc., Rugby and Barre labels. Recall #D-305-0.
-4-
Code: Lot numbers and EXP dates: 72262 6/90, 72454 10/90,
82014 1/91, 82015 2/91, 82258 5/91, 82473 10/91,
82670 1/92, 92174 4/92, 92420 7/92, 92445 8/92,
92667 10/92, 92668 10/92, 92669 9/92, 92873 1/93.
Manufacturer: Barre-National Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter May 9, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 1,140,312 bottles were distributed; firm estimates
76,417 bottles remain on market.
Reason: Incorrect expiration date of 36 months was used instead
of 24 months.
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Product: (a) Bacteriostatic Water for Injection, USP, in 16 ml
multi-dose vials, for use in reconstituting
methylprednisolone sodium succinate;
(b) Chorionic Gonadotropin for Injection, USP, a gonal
stimulating agent;
(c) Cytarabine USP (sterile), 100 mg, w/Diluent, in
10 ml vials, an anti-neoplastic agent for IV and
subcutaneous use only;
(d) Cytarabine USP (sterile) 500 mg w/Diluent in 15 ml,
vials, an anti-neoplastic agent for IV and subcutaneous
use only;
(e) Glucogan for Injection USP w/Diluent, in 3 ml vials,
an anti-diabetic drug for IM, IV or subcutaneous use only.
Recall #D-307/311-0.
Code: Lot numbers and EXP dates: (a) 051H47B 11/91;
(b) 411J15 10/90, 411J29 01/91, 051J13A 3/92, 051J13A 3/91;
(c) 219H51 6/90, 219J12 9/90, 219J17 10/90, 219J29 1/91,
219J44 5/91, 051H04 1/91, 051G52A 12/90, 051J13B 3/92.
(d) 220J12 9/90, 220J22 12/90, 220J29 1/91,
051H47A 11/91, 051J13A 3/92;
(e) 435H52 5/90, 435H52 6/90, 435J07A 8/90, 435J07B 7/90,
435J18 7/90, 435J19 7/90, 435J22 11/90, 435J24 11/90,
435J25 11/90, 437H45 5/90, 437J02 7/90, 437J11 9/90,
437J02 7/90, 437J18 11/90.
Manufacturer: Quad Pharmaceuticals, Indianapolis, Indiana.
Recalled by: Manufacturer, by letter June 11, 1989. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: (a) 305 vials; (b) 45,584 vials; (c) 79,589 vials;
(d) 50,948 vials; (e) 344,890 vials.
Reason: Unapproved overages of preservatives in diluent.
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-5-
Product: (a) Lidocaine HCl 1% and Epinephrine 1:100,000
Injection, USP;
(b) Lidocaine HCl 2% and Epinephrine 1:100,000
Injection, USP, products are Rx small volume parenterals in
30 ml clear glass vials indicated for production of local
anesthesia by nerve block or infiltration injection.
Recall #D-314/315-0.
Code: (a) 128053 049047 099029
128028 049072 099047
019031 059049 099006
019077 059015 099083
091056 069012 109015
019079 069354 109037
029049 069059 109102
029051 069351 109056
029065 069055 119026
029080 069028 119008
029061 069076 129003
029078 079052 010005
039010 079032 010039
039384 089048 010054
039015 099026 010041
109075 022043;
(b) 029014 079008 029063
089056 039012 019017
109077 039380 129001
049091 010022 059090
020019 069078.
Manufacturer: Elkins-Sinn Inc., Cherry Hill, New Jersey.
Recalled by: Manufacturer, by telephone May 2 and 21, 1990 followed by
letter June 18, 1990. Firm-initiated recall ongoing.
Distribution: Virginia, Texas, Illinois, California.
Quantity: Approximately 61 lots in shelf packs of 25/30 ml vials
each were distributed.
Reason: Subpotency of epinephrine ingredient.
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MEDICAL DEVICES AND RADIOLOGY
Class I -
Product: First Medic Model 610 Semi-Automatic Defibrillator.
Recall #Z-446-0.
Code: Serial numbers 600 and higher.
Manufacturer: First Medical Devices Corporation, Kirkland, Washington.
Recalled by: Manufacturer, by letter June 29, 1990. FDA requested
recall ongoing.
Distribution: Nationwide, Canada.
Quantity: Approximately 572 units were distributed.
Reason: A latch-up problem which could render the device unusable.
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Class II -
Product: Scale-Tronix Model 2001 SlingScale Bed Scale, a self-
contained scale for weighing patients in bed.
Recall #Z-564-0.
Code: All units manufactured prior to 1982; serial numbers
00101 through 03299.
Manufacturer: Invacare, Inc., Elyria, Ohio (component).
Recalled by: Scale-Tronix, Inc., Wheaton, Illinois, by letter
March 24, 1990. Firm-initiated field correction ongoing.
Distribution: Nationwide, Canada.
Quantity: Approximately 3,000 units were distributed; firm estimates
all units remain on market.
Reason: The hammock ring assembly of the lift mechanism may
develop cracks or stress fractures near the horizontal
brace which could allow the patient in the hammock/
stretcher to fall while being weighed.
----
Product: Mini Pro Model Beam Machine Laser Projector, used for
laser light shows. Recall #Z-685-0.
Code: Serial #3005.
Manufacturer: Laser Productions, Miami, Florida.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan May 29, 1990. Product was corrected June 21, 1990.
Firm-initiated field correction complete.
Distribution: Florida.
Quantity: 1 unit was distributed.
Reason: Noncompliance with the performance standard for laser
products in that user information was inadequate, labeling
was inadequate, safety interlock was lacking and a gap
between the laser head and the laser projector could
permit unnecessary human access to laser radiation.
----
Product: Protex Contracept Plus Super Thin Latex Condoms
Lubricated with Nonoxynol-9 Anti-Sperm Formula,
individually wrapped for vending distribution.
Recall #Z-698-0.
Code: Lot #30272 162 F, EXP 11 91U.
Manufacturer: Ansell Inc., Dothan, Alabama.
Recalled by: Aller-Care/NSL, Lincolnwood, Illinois, by telephone
June 18, 1990 followed by letter June 19, 1990.
Firm-initiated recall ongoing.
Distribution: North Carolina, Kansas, Ohio, Minnesota.
Quantity: 58.5 gross were distributed; firm estimates very few
if any remains on market.
Reason: The tested condoms have an Acceptable Quality Level (AQL)
in excess of 0.4%.
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Product: Cobe Laboratories CDX Disposable Transducers, physiological
pressure transducers for invasive pressure monitoring:
(a) CDXPress;
(b) CDX-III with Steriflo Continuous Flush Device.
Recall #Z-705/706-0.
Code: Catalog No. Lot No.
041-500-503 02T4637, 04T4604, 02T4611, 02T4613,
07T4606 (and 2 with lots unknown)
041-506-5030 01T4602
041-507-503 10S4653R, 12S4635, 04T4614, 05T4610,
06T4611, 07T4614
041-509-503 Various (none specified)
041-510-503 12S4636
041-512-503 01T4823
041-524-503 11S4688
041-572-504 02T4615
041-574-504 11S4628
041-576-504 Various (none specified)
042-503-406 01S9694
042-519-108 07S9675, 12S6947
042-519-109 03T9670R
042-534-004 Lots not identified
042-607-900 07S6960
042-900-209 07S6966, 08S9603R, 08S9604, 12S9609,
12S9610, 12S9628
042-901-504 02T9676
042-931-601 12S6905
042-942-201 03T9676
042-942-601 02T6921
042-950-901 Various (unidentified)
042-986-106 Various (unidentified.
Note: Catalog numbers beginning with 042 represent custom kits)
Manufacturer: Cobe Laboratories, Inc., Lakewood, Colorado.
Recalled by: Manufacturer. Redesigned product was made available
June 1989. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: Unknown.
Reason: The devices are subject to fluid leakage at the linden
seal.
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Product: Davol/Bard Hickman 9.0 French Round Dual Lumen Vascular
Access Catheter (Adult Length) with VitaCuff Antimicrobial
Cuff and Percutaneous Introducer Kit with Tunneler, a
single-use, sterile device intended for multi-purpose
long-term vascular access. Recall #Z-707-0.
Code: Catalog #60060-4, lot #36EA4307.
Manufacturer: Davol, Inc., Salt Lake City, Utah.
Recalled by: Manufacturer, by telephone and by letter June 5, 1990.
Firm-initiated recall ongoing.
Distribution: Missouri, Indiana, Oregon, New York, Virginia, Mississippi,
Florida.
Quantity: 28 units were distributed.
-8-
Reason: The trays contain a 12 French Catheter instead of the
9.0 French Catheter specified in the labeling.
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Product: Medicomp Alpha Analyzer, (a) Model PM 220;
(b) Model PM 240. Products are Holter monitors which
are used for monitoring heart function on a 24 hour basis.
Recall #Z-708/709-0.
Code: Serial numbers: (a) 6 through 32, 34 through 39,
41 through 46, 48 through 52, 54, 55, 57 through 61, 64;
(b) 40 and 56.
Manufacturer: Medicomp, Inc., Melbourne, Florida.
Recalled by: Manufacturer, by letter May 17, 1990. Firm-initiated
recall ongoing.
Distribution: (a) West Germany, Italy, Austria, United Kingdom, France;
(b) Australia.
Quantity: (a) 52 units; (b) 2 units were distributed.
Reason: Devices may or may not detect pacemaker firing spikes.
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CORRECTION: Stryker Fold Down Siderails, Recall #Z-661/662 which
appeared in the June 20, 1990 Enforcement Report should
read:
Reason: The Hex-head bolts which serve as siderail stops
on Stryker stretchers, with fold-down siderails,
manufactured before January 1985 may bend and
loosen over time allowing siderails which are being
put into the down position to collapse completely.
A pinched or injured finger may result.
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Class III -
Product: Kodak Ektachem Calibrator and Diluent Set (Isoenzyme),
an in-vitro diagnostic product used for the calibration
of Kodak Ektachem clinical chemistry slides on Kodak
Ektachem Analyzers. Recall #Z-704-0.
Code: Catalog #135-2004, kit lot #16 (calibrator and diluent set),
bottles within the kit have calibrator lot numbers 0133709,
0135710, 0137711; and diluent lot numbers: 0134709,
0136710, 0138711.
Manufacturer: Aalto Scientific, Vista, California.
Recalled by: Eastman Kodak Company, Rochester, New York, by letters
of May 17 and 18, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 2,298 boxes (4 calibrator sets/box) were distributed;
firm estimated 1,070 boxes remained on market when
recall was initiated.
-9-
Reason: Possible misinterpretation of CKMB results due to loss of
some enzyme activity.
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VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Diethylcarbamazine Citrate (DEC) Tablets, 50 mg, 200 mg
and 400 mg, in 500, 200, and 100 tablet bottles, an
Rx veterinary drug for the prevention of heartworm in
dogs. Recall #V-048-0.
Code: Lot numbers: 280-001 (50 mg), 282-002 (200 mg), 284-001
(400 mg).
Manufacturer: Sanofi Animal Health, Fort Dodge, Iowa.
Recalled by: Manufacturer, by letter May 29, 1990. Firm-initiated
recall ongoing.
Distribution: Massachusetts, Missouri.
Quantity: 4,452 bottles were distributed.
Reason: Three lots were not manufactured in compliance with NADA
107-506. Tablets were film coated the wrong color (green).
Film coat used for these lots is approved for 300 mg
Diethylcarbamazine Citrate Tablet formulation.
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Class III -
NONE
Medical Device Safety Alerts:
Product: Ohmeda Model 3700, 3710 and 3740 Pulse Oximeters, a
microprocessor controlled device used to determine
oxygen saturation in the tissue vascular bed.
Safety Alert #M-056/058-0.
Code: All serial numbers.
Manufacturer: Ohmeda, Division of BOC Group, Inc., Louisville, Colorado.
Alerted by: Manufacturer, by letter April 30, 1990.
Distribution: Nationwide and international.
Quantity: Unknown.
Reason: When a Physio-Control sensor is used with Ohmeda 3700,
3710, and 3740 Pulse Oximeters, patient burns may occur
at the sensor site.