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
09/02/1992
RECALLS AND FIELD CORRECTIONS: Septmber 2, 1992
FOODS -- CLASS I
92-36
PRODUCT: Smoked Herring in vacuum packed, clear plastic packages
with gold, black and red colored paper stickers on labels
on each package of fish. Recall #F-435-2.
CODE: Lot numbers 125-133.
MANUFACTURER: Royal Baltic Ltd., Brooklyn, New York.
RECALLED BY: Manufacturer by telephone and letter on or about June 30,
1992. Firm-initiated recall ongoing.
DISTRIBUTION: Nationwide.
QUANTITY: 200 fish were distributed, firm estimates none remain on
market.
REASON: Product was contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT: Diet Dr. Pepper in 20 fl. oz. plastic bottles, Recall
#F-493-2.
CODE: All of the product and size bearing the code beginning
"2168NS".
MANUFACTURER: Coca Cola Bottling Company, Consolidated, Nashville,
Tennessee.
RECALLED BY: Manufacturer by telephone and electronic mail July 9,
1992. Firm-initiated recall ongoing.
DISTRIBUTION: Tennessee.
QUANITY: 2,915 cases were distributed.
REASON: The product had an excessive amount of caffeine.
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
PRODUCT: Multi Vit Drops, in 50 ml bottles, an OTC product used for
the supplementation of the diet for essential vitamins,
Recall #F-489-2
CODE: Lot #'s 03463, exp. date 7/92; 03890, exp. date 1/93;
l3367, exp. date 7/93.
MANUFACTURER: Barre National, Inc., Baltimore, Maryland.
RECALLED BY: Manufacturer by letter on or about July 27, 1992. Firm
initiated recall ongoing.
DISTRIBUTION: Nationwide.
QUANTITY: 53,341 bottles were distributed. Firm estimates 3,903
bottles remain on market.
REASON: Product fails to meet stability specifications and is
deficient in Vitamin B12.
PRODUCT: Niacin Tablets, 500 mg, 100 per bottle. Recall #F-492-2.
CODE: Lot number 1217-CL-100 or R816.
MANUFACTURER: Custom Label Corporation of America, Mountlake Terrace,
Washington.
RECALLED BY: Manufacturer by telephone September 5, 1991.
Firm-initiated recall complete.
DISTRIBUTION: Nationwide.
QUANTITY: 314 bottles were distributed.
REASON: Product was misbranded as Sustained Release Niacin Tablets.
PRODUCT: (a) Vito's Pizza Sauce; (b) Vito's Spaghetti Sauce in 6
lb. 10 oz. metal cans and 5 gallon buckets. Recall
#F-495/496-2.
CODE: None coded.
MANUFACTURER: Vito's Food Service, Inc., Cincinnati, Ohio.
RECALLED BY: Manufacturer by telephone on or about July 10, 1992.
Firm-initiated recall ongoing.
-2-
DISTRIBUTION: Kentucky, Indiana, Ohio.
QUANTITY: (a) 700 cans; (b) 425 cans were distributed. Firm
estimates none remain on market.
REASON: Product is contaminated with yeast and mold in cans with
defective seams.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT: Xero-Lube Saliva Substitute, an OTC drug for the relief of
dry mouth (xerostomia) in 6 fl. oz. plastic bottles,
Recall #D-470-2
CODE: Lot number 20345, exp. date 4/95.
MANUFACTURER: Colgate Hoyt/Gel-Kam, Dallas, Texas.
RECALLED BY: Colgate Hoyt/Gel-Kam, Canton, Massachusetts by letter May
13, 1992. Firm-initiated recall ongoing.
DISTRIBUTION: California, Ohio, Texas.
QUANTITY: 10,461 bottles were distributed.
REASON: Presence of Pseudomonas aeruginosa.
PRODUCT: Clindamycin Hydrochloride U.S., a Rx drug, used for the
treatment of bacterial infection. Recall #D-472-2.
CODE: Lot number "EC110".
MANUFACTURER: Abbott Laboratories, North Chicago, Illinois.
RECALLED BY: Spectrum Chemical Manufacture Corporation
(repacker/responsible firm), Gardena, California by
telephone June 8 and letter June 15, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION: North Carolina, Massachusetts.
QUANTITY: 1x1 gram and 1x100 gram bottles were distributed.
REASON: Repacked from bulk material after the expiration date.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT: Ben Aqua 10% Gel, (Benzoyl Peroxide Gel, USP, 10%) in 1.5
oz. tubes, an Rx drug used in the treatment of acne.
Recall #D-466-2.
CODE: Lot number H283, exp. date 12/93.
MANUFACTURER: Syosset Laboratories Company, Inc., Syosset, New York.
RECALLED BY: Manufacturer by telephone June 1992 and letter dated July
2, 1992. Firm initiated recall ongoing.
DISTRIBUTION: Nationwide, Puerto Rico.
QUANTITY: 6,377 tubes were distributed.
REASON: Some tubes have labels stating potency as 5%. The carton
correctly declares 10% potency.
-3-
PRODUCT: Syoxin, Acetone Base Gel (Benzoyl Peroxide Gel, USP 20%)
net wt. 1.5 oz., an Rx drug , Recall #D-467-2
CODE: Lot number H427, exp. date 4/94.
MANUFACTURER; Syosset Laboratories Company, Inc., Syosset, New York.
RECALLED BY: Manufacturer by letter July 31, 1992. Firm initiated
recall ongoing.
DISTRIBUTION: Nationwide, Mexico.
QUANTITY: 9,944 units were distributed.
REASON: Some tubes have leakage at the crimp end.
PRODUCT: Hydrocortisone Cream, USP, 0.5% with Aloe Vera Gel in 1
ounce and 2 oz. tubes, Recall #D-468-2
CODE: Lot numbers G658, G659, G660 exp. date 8/92; H149 exp.
date 8/93; H330 exp. date 2/94.
MANUFACTURER: Syosset Laboratories Company, Inc., Syosset, New York.
RECALLED BY: Manufacturer by telephone during the week of July 27-31,
1992. Firm initiated recall ongoing.
DISTRIBUTION: New York, Florida, Michigan, Illinois.
QUANTITY: 14,377 units were distributed.
REASON: Ingredient statement on label incorrectly indicates 50 mg
hydrocortisone per gram, when product has potency of
0.5%. Preservative listed in ingredient statement is
incorrectly listed as 2-Bromo-2-Nitropropane-1,3 Diol.
The preservative actually used in all these recalled lots
is Imidazolidinyl Urea. Recalled product was also
distributed under another label for lot #G659. This label
has correct amount of active ingredient hydrocortisone (5
mg/gram). Aloe Vera Gel is not listed on label and this
product does contain Aloe Vera Gel.
PRODUCT; "Excel" 0.9% Sodium Chloride Injection U.S.P.in 500 ml
plastic containers, used for treatment of metabolic
alkalosis in the presence of fluid loss, and mild sodium
depletion. Recall #D-469-2
CODE: Lot numbers: J2B600, J2B740, J2C629, J2E552, J2B608,
J2B622 ,J2B627, J2B645, J2B670, J2B673, J2B684, J2B688,
J2B705, J2B736, J2C502, J2C505, J2C549, J2C553, J2C558,
J2C561, J2C591, J2C607, J2C611, J2C626, J2C672, J2C676,
J2C691, J2C694, J2C709, J2C713, J2C726, J2C729, J2C742,
J2C747, J2E597, J2E600, J2E644, J2E649, J2E653, J2E660,
J2E668, J2E671, J2E716.
MANUFACTURER: McGaw, Inc., Irvine, California.
RECALLED BY: Manufacturer by letter July 27, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION: Nationwide, Saudi Arabia, Venezuela, Puerto Rico.
QUANTITY: 29,481 cases were distributed.
REASON: Some units developed leakage under use conditions
involving pressurization.
-4-
PRODUCT: Kenalog Cream, .025% Triamcinolone Acetonide, 15 gram and
80 gram tubes, an Rx drug, used for the relief of the
inflammatory and pruritic manifestations. Recall #D-471-2.
CODE: Lot #1A31752 (15 gram), exp. date 1/1/92, 1A31763 (80
gram), exp. 1/1/93.
MANUFACTURER: Westwood Squibb Pharmaceuticals, Inc., Buffalo, New York.
RECALLED BY: Bristol-Myers Squibb, Humacoa, Puerto Rico by letter
August 20, 1992. Firm-initiated recall ongoing.
DISTRIBUTION: Naionwide.
QUANTITY: 791 cases of (15 gram), 10,080 cases of (80 gram) were
distributed.
REASON: Subpotency.
UPDATE Tussionex Pennkinetic (Hydrocodone Polistirex and
Chlorpheniramine Polistirex), Extended-Release Suspension,
Recall #D-447, which appeared in the August 12, 1992
Enforcement Report should read:
MANUFACTURER: Fisons Corporation, Rochester New York
instead of American Crystal Sugar, Moorehead, Minnesota.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT: (a) Red Blood Cells, (b) Platelets, (c) Platelets
Pheresis. Recall #B-418/420-2.
CODE: Unit numbers: (a) 19R95611; (b) 19R95611; (c) 19L27032,
19L27033.
MANUFACTURER: American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY: Manufacturer by telephone December 5, 1991 and March 3,
1992 and by letters December 10, 1991 and March 4, 1992.
Firm-initiated recall complete.
DISTRIBUTION: Tennessee
QUANTITY: (a) 1 unit; (b) 1 unit; (c) 2 units.
REASON: Blood product, which were either: 1) labeled with the
incorrect expiration date or 2) collected from an
ineligible donor due to travel in a malarial endemic area,
were distributed.
PRODUCT: Source Plasma, Recall #B-421-2.
CODE: Unit number G18631-126.
MANUFACTURER: Knoxville Plasma Center, Inc., Knoxville, Tennessee.
-5-
RECALLED BY: Manufacturer by facsimile dated July 2, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION: California.
QUANTITY: 1 unit was distributed..
REASON: Product which tested negative for hepatitis B surface
antigen (HBsAg), but was collected from a donor who
previously tested repeatedly reactive for HBsAg, was
distributed.
PRODUCT: (a) Red Blood Cells, (b) Platelets, Recall #B-422/423-2.
CODE: Unit numbers: (a) 0980420, 0983836; (b) 0980420.
MANUFACTURER: Central Kentucky Blood Inc., Lexington, Kentucky..
RECALLED BY: Manufacturer by telephone April 20, 1992. Firm-initiated
recall complete.
DISTRIBUTION: Kentucky.
QUANTITY: 3 units were distributed.
REASON: Blood products, which tested positive for syphilis by the
Visuwell Reagin assay, were distributed.
RECALLS AND FIELD CORRECTION: BIOLOGICS -- CLASS III
PRODUCT: Platelets Pheresis. Recall #B-424-2
CODE: Unit #28P05515.
MANUFACTURER: American Red Cross, Savannah, Georgia.
RECALLED BY: Manufacturer by telephone February 28, 1992.
Firm-initiated recall complete.
DISTRIBUTION: South Carolina.
QUANTITY: 1 unit was distributed.
REASON: A unit of Platelets, Pheresis collected from an ineligible
donor due to immunization which measles, mumps, and
rubella vaccine less than four weeks prior to donation was
distributed.
RECALLS AND FIELD CORRECTION: DEVICES -- CLASS I
PRODUCT: Aequitron Cardiorespiratory Monitors, Recall #Z-1155/1160-2
CODE: Model numbers: 8200; 9200; 9200/70; 9200/50, 9500; 9550.
MANUFACTURER: Aequitron Medical, Inc., Minneapolis, Minnesota.
RECALLED BY: Manufacturer by letter June 29, 1992 and letter June 30,
1992. Firm-initiated recall ongoing.
DISTRIBUTION: Nationwide, Germany, Canada.
QUANTITY: 340 units were distributed.
REASON: An out of specification capacitor was incorporated into
one lot of the audible alarm components resulting in a
potential "No Alarm" condition.
-6-
RECALLS AND FIELD CORRECTION: DEVICES -- CLASS II
PRODUCT: Occucoat Viscoadherent Ophthalmic Surgical Aid, Catalog
No. 101, Recall #Z-948-2.
CODE: Lot numbers: 0081 through 0089; part numbers CC196
through CC204.
MANUFACTURER: Ophthalmics Inc., Clearwater, Florida.
RECALLED BY: Storz Instrument Company, St. Louis, Missouri by letter
May 27, 1992. Firm-initiated recall ongoing.
DISTRIBUTION: Nationwide.
QUANTITY: 33,189 syringes were distributed..
REASON: Some of the sterile pouches in which the product is
packaged are not sealed properly.
PRODUCT: Pacing Cathters:
(a) Steerocath Standard Distal/1 Bidirectional Steerable
Pacing Catheter, Model No. 2031;
(b) Steerocath Standard Distal/1 Bidirectional Steerable
Pacing Catheter, Model No. 2000;
(c) Steerocath Standard Distal/1 Bidirectional Steerable
Pacing Catheter, Model No. 2001;
(d) Steerocath Standard Distal/1 Bidirectional Steerable
Pacing Catheter, Model No. 2002;
(e) Steerocath Standard Distal/1 Bidirectional Steerable
Pacing Catheter, Model No. 20031C;
(f) Steerocath Standard Distal/1 Bidirectional Steerable
Pacing Catheter, Model No. 2045;
(g) Steerocath Standard Distal/1 Bidirectional Steerable
Pacing Catheter, Model No. 2031A;
(h) Steerocath Standard Distal/1 Bidirectional Steerable
Pacing Catheter, Model No. 2019;
(i) Steerocath Standard Distal/1 Bidirectional Steerable
Pacing Catheter, Model No. 2032.
(j) Steerocath Extended Distal/1 Bidirectional Steerable
Pacing Catheter, Model No. 2031L;
(k) Steerable Franz MAP/Pacing Catheter, Standard Distal,
Model No. 1675;
(l) Franz MAP/Pacing Catheter, Non-steerable, Model No.
1650; Recall #Z-1224/1235-2.
CODE Model Nos. Lot Nos.
2031 1K145A, 1L026, 1K145B, 1L071
2000 1K142
2001 1K143A
2002 1K144
20031C 1K041A
2045 1K035A
2031A 1L063, 1L057, 1K038A
2019 1K037C
Custom 1L061, 1L002, 1L066
-7-
2032 1K039A
2031L 1L055, 1L059, 1L060, 1L062
1675 1K090, 1K090A
1650 1L025, 1L064.
MANUFACTURER EP Technologies Inc., Mountain View, California.
RECALLED BY Manufacturer, by letter January 10, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Japan, Germany, Canada, England.
QUANTITY 262 units were distributed; firm estimates none remains on
the market.
REASON The bond between the distal and main portion of the outer
plastic tubing may separate and lead to blood leakage.
PRODUCT: Micropressor Ventilator, 7200 Series, Models 7200AE,
7200E, 7200SPE with Software Revision levels "D" through
"G" and "A & B", used to provide a patient with
ventilatory assistance, Recall #Z-1236-2.
CODE: All serial numbers from January 31, 1991 to June 9, 1992.
MANUFACTURER: Puritan-Bennett Corporation, Carlsbad, California.
RECALLED BY: Manufacturer by letter July 14, 1992. Firm initiated
recall ongoing.
DISTRIBUTION: Nationwide, international.
QUNATITY: 5,909 devices were distributed.
REASONS When the ventilator with the affected software is used
with its compressor and the oxygen flow is set at 97%, the
oxygen flow rate drops.
PRODUCT: Seiko Printer Cables used to connect Earscan II Audiometer
to Printer, Recall #Z-1238-2
CODE: Uncoded. However, the serial numbers for Earscan II are:
Serial Numbers: Date
10664 8/23/89
10553 8/23/89
10600 9/25/89
10615 10/2/89
10638 9/26/89
10682 9/12/89
10304 7/19/89
11106 4/12/90
11278 5/21/90
11279 5/15/90
10999 4/3/90
10673 8/16/89
10301 8/16/89
10087 1/13/89
MANUFACTURER: Micro Audiometrics, South Daytona, Florida.
RECALLED BY: Manufacturer by letter July 25, 1990. Firm-initiated
recall complete.
DISTRIBUTION: Ohio, Indiana.
QUANTITY: 14 devices were distributed Firm estimate none remain on
market.
REASON: The cables are causing excessive heat accumulation near
the on/off switch and the hookup to the printer.
-8-
PRODUCT: Monitrol Tilting X-Ray Tables (a) Monitrol 90/90 Table
Catalog No. R4303JA; Monitrol 90/15 Table, Catalog No.
R4303JB; RFX or SFX Tables, Catalog No. R4303JC. Recall
#Z-1239/1241-2.
CODE: All serial numbers.
MANUFACTURER: General Electric Company, Inc., Waukesha, Wisconsin.
RECALLED BY: Manufacturer by letter July 8, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION: Nationwide.
QUANTITY: 8,000 to 9,000 units were distributed.
REASON: The tables have angulated both with and without operator
activation.
PRODUCT: Hemotherm Nodel 400M Dual Cooling/Heating System
Reservoir, used in open heart surgery to maintain, raise,
or lower, blood temperature, Recall #Z-1245-2.
CODE: Serial numbers ranging from 914-9834M to 914-9843M,
914-9844M to 914-9853M.
MANUFACTURER: Plastech, Atwood, Indiana.
RECALLED BY Cincinnati Sub-Zero Products, Inc., Cincinnati, Ohio by
letter April 6, 1992. Firm-initiated recall ongoing.
DISTRIBITON: Nationwide, The Netherlands, Japan, India.
QUANTITY: 20 units were distributed, 8 units remain in distribution.
REASON: Cracks were found in a number of the water reservoirs.
PRODUCT: Shiley Brand Plexus Integral Reservoir Hollow Fiber
Oxygenator (Plexin V), Recall #Z-1251-2.
CODE: Lot numbers 177072000, 9100438500, 910049900, 9100522800,
9100523400, 9100537400, 9100682500, 9100684100,
9100696500, 9100717700, 9100720800, 9100756500,
9100756700, 9100801300.
MANUFACTURER: Shiley Inc., Irvine, California.
RECALLED BY: Sorin Biomedical, Inc., Irvine, California by letter June
2, 1992. Firm-initiated recall ongoing.
DISTRIBUTION: Nationwide, Japan, Spain, Canada.
QUANTITY: 937 units were distributed.
REASON: Cracking and breaking of the recirculation line at the
junction to the venous reservoir.
-9-
RECALLS AND FIELD CORRECTION: DEVICES -- CLASS III
PRODUCT: Accumeter Cholesterol Test Cassettes, used for providing
quantitative determination of total cholesterol in whole
blood. Recall #Z-1212-2.
CODE: Lot numbers: K1537-A; K1543-A; K1543-XA; K1650-A, K1556-A,
K1597-A, K1647-A, K1553-A, K1619-A, K1638-A, K1550-A,
K1616-A, K1663-A, K1672-A, K1606-A, K1653-A, K1600-A,
K1678-A;
MANUFACTURER: ChemTrak, Inc., Sunnyvale, California.
RECALLED BY: Manufacturer by telephone and letter May 18, 1992. Firm
initiated recall ongoing.
DISTRIBUTION: New Jersey, Italy.
QUANTITY: 174,035 kits were distributed between March 31 and May 22,
1992. FDA estimates 15% remains on market.
REASON: Product may give false, low readings which may be
difficult and fuzzy to read because of microbial
contamination.
PRODUCT: Minimum Inhibitory Concentration (MIC) Gram Positive
Panels used to determine the minium inhibitory
concentration (MIC) of antimicrobial at which no growth
occurs for a given bacterial strain. Recall #Z-1237-2
CODE: 794277, exp. date 12/9/91.
MANUFACTURER: Pasco Laboratories, Inc., Wheat Ridge, Colorado.
RECALLED BY: Difco Laboratories, Inc., Livonia, Michigan by facsmile on
September 26, 1991. Firm-initiated recall complete.
DISTRIBUTION: Spain.
QUANTITY: 8,840 panels were distributed. Firm estimates 1,360
remain on market.
REASON: Some organisms were not growing in the oxacillin 0.25
mcg/ml and 0.5 mcg/ml wells but did grow in the 1,2,4 and
6 mcg/ml wells.
PRODUCT: Components for Interlocking Abutment/Gold Cylinder System,
(non-rotational hexagonal system) used to fabricate the
tooth restoration which is then connected to the
endosseous implant in the jawbone, (a) Gold Cylinder,
hexagon, 4.0 mm; 5 cylinders per plastic box, single use
only, Catalog No. CPA 001; (b) Impression Coping, squared
haxagon, stainless steel, without guide pin; 5 copings per
plastic box, reusable, Catalog No. CPA 002; (c) Impression
Coping tapered haxagon, stainless steel, without guide
pin; 5 copings per plastic box reusable, Catalog No. CPA
003. Recall #Z-1242/1244-2
-10-
CODE: All products distributed prior to May 24, 1989
MANUFACTURER: Nobelpharma AB, Gothenburg, Sweden.
RECALLED BY: Nobelpharma USA Inc., Chicago, Illinois by letter June 12,
1989. Firm initiated recall complete.
DISTRIBUTION: Nationwide.
QUANTITY: (a) 189 units; (b) 104 units; (c) 121 units were
distributed.
REASON: Units do not have correct fit on the titanium abutments.
-11-
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