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
03/13/1990
FDA Enforcement for the week of March 14, 1990
FDA ENFORCEMENT REPORT
FOR MARCH 14, 1990
March 14, 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: Caffeine Free Diet Coke, in 2 liter, non-returnable
plastic bottles. Recall #F-450-0.
Code: 9331 MP2XXXX.
Manufacturer: Coca Cola Bottling Company of Memphis, Memphis, Tennessee.
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Recalled by: Manufacturer, by telephone and by letter January 5, 1990.
Firm-initiated recall complete.
Distribution: Arkansas, Mississippi, Tennessee.
Quantity: 7,198 cases (8 bottles/case) were distributed; firm
estimates none remains on market.
Reason: Elemental copper contamination.
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Class III - A situation in which the use of, or exposure to
a violative product is not likely to cause adverse health
consequences.
Product: Nutcracker Unsalted Whole Cashews, in 10 ounce cans.
Recall F-#429-0.
Code: 346 embossed on can bottoms and printed on master cartons.
Manufacturer: Nutcracker Snacks, Inc., Billerica, Massachusetts.
Recalled by: Manufacturer, by letter January 30, 1990. Firm-initiated
recall ongoing.
Distribution: Florida, New Jersey, New York.
Quantity: 461 cases (12 cans/case) were distributed.
Reason: Product is contaminated with insects.
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Product: (a) Unlabeled Chopped Ocean Clams, in 51 ounce metal cans;
(b) Unlabeled Ocean Clam Juice, in 146 ounce metal cans.
Recall #F-443/444-0.
Code: All unlabeled codes.
Manufacturer: Mid-Atlantic Foods, Inc., Pocomoke City, Maryland.
Recalled by: Manufacturer, by telephone February 7, 1990 followed by
letter. Firm-initiated recall ongoing.
Distribution: (a) New York; (b) New Jersey.
Quantity: (a) 302 cases (12 cans/case); (b) Unknown number of cans
were distributed.
Reason: Lack of labeling on cans.
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Product: Ferrous Sulfate Red Tablets, enteric coated (ectablets),
324 mgs, a food supplement product distributed under the
Goldline Laboratories label. Recall #F-448-0.
Code: Lot #8869552 EXP 5/91.
Manufacturer: OHM Laboratories, Inc., Franklin Park, New Jersey,
Repacker: Goldline Laboratories, Fort Lauderdale, Florida.
Recalled by: Manufacturer, by telephone to repacker December 5, 1989
followed by letter December 29, 1989. Subrecalled by
repacker by letter March 13, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide.
Quantity: 2,521,760 tablets were distributed.
Reason: Product failed USP disintegration requirements.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
NONE
Class III -
Product: (a) Chronulac, 30 ml unit dose, 8 ounces and 32 ounces;
(b) Cephulac, 30 ml unit dose, 16 ounces and 64 ounces,
lactulose syrup USP Rx products used to relieve constipation.
Recall #D-168/169-0.
Code: All products with an EXP date of 5/91 or earlier.
Manufacturer: Merrell Dow Pharmaceuticals, Inc., Cincinnati, Ohio.
Recalled by: Manufacturer, by letters dated February 26-27, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 166,000 trays (30 ml.), 608,000 bottles (8 oz.),
448,000 bottles (32 oz.);
(b) 243,000 trays (30 ml.), 768,000 bottles (16 oz.),
108,000 bottles (64 oz) were distributed. (each tray
contains 10/30 ml unit dose containers).
Reason: Some lots are adulterated with penicillium mold.
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Product: Griseofulvin Oral Tablets, 500 mg, an Rx antifungal
for systemic use, in bottles of 100 and 500 tablets.
Recall #D-170-0.
Code: Lot numbers (100's) 19D116 EXP 4/94, 19D117 EXP 4/94,
19D118 EXP 4/94, 19D119 EXP 4/94; (500's) 19C114 EXP 3/94,
19D119 EXP 4/94.
Manufacturer: Ortho Pharmaceutical Corporation, Raritan, New Jersey.
Recalled by: Manufacturer, by letter November 10, 1989. Firm-initiated
recall ongoing.
Distribution: Nationwide, Puerto Rico.
Quantity: 5,024 bottles of 100 and 622 bottles of 500 were distributed.
Reason: Presence of surface mold on some tablets.
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MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
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Class II -
Product: USCI Probe Dilatation System, Balloon-on-a-Wire Device:
(a) Catalog No. 006258, 2.0 mm Balloon, 2 cm Tip;
(b) Catalog No. 006339, 2.5 mm Balloon, 2cm Tip;
(c) Catalog No. 006340, 3.0 mm Balloon, 2 cm Tip;
(d) Catalog No. 006391, 2.0 mm Balloon, 1 cm Tip;
(e) Catalog No. 006393, 2.5 mm Balloon, 1 cm Tip;
(f) Catalog No. 006394, 3.0 mm Balloon, 1 cm Tip.
Recall #Z-270/275-0.
Code: Various lot numbers, corresponding to products shipped
between 1/1/87 and 2/22/90.
Manufacturer: USCI Division of C.R. Bard, Inc., Billerica, Massachusetts.
Recalled by: Manufacturer, by letter February 26, 1990. Firm-
initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 80,778 units were distributed; firm estimates 1,800 to
2,500 units remain on market.
Reason: GMP deviations and failure to submit MDR reports.
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Product: Medstone STS Lithotripter System, used for the
destruction of kidney stones. Recall #Z-433-0.
Code: Formally Model 1050ST.
Manufacturer: Medstone International, Inc., Irvine, California.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan September 25, 1989. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 30 units were distributed.
Reason: Noncompliance with performance standards for x-ray products
The area of noncompliance is with a modified center-pedestal
x-ray table with the aluminum-equivalent thickness
limitations.
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Product: Dispomed 16 Gauge Fistula Needle. Recall #Z-434-0.
Code: Catalog #069356-000 - Lot #87L10.
Manufacturer: Sud Duetscher Fein Mechanisch, GMDH, West Germany.
Recalled by: Cobe Laboratories, Inc., Lakewood, Colorado, by
telephone January 16, 1990 followed by letter
January 18, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 10,000 units were distributed.
Reason: There is a potential for separation of the flexible
tubing from the plastic sleeve which connects the tubing
to the butterfly grips. There is also a potential for
the metal needle to pull out of the plastic sleeve which
connects the needle to the butterfly grips.
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Product: Terumo AV Fistula Needle Set, an Rx medical device for
hemodialysis. Recall #Z-435-0.
Code: All codes beginning with the letter L.
Manufacturer: Terumo Medical Corporation, Elkton, Maryland.
Recalled by: Manufacturer, by letter December 5, 1989. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada.
Quantity: Approximately 100,000 units were distributed.
Reason: The joint between the tubing and the luer connector
may leak and could possibly separate.
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Product: Mini-Profile PTCA Balloon Dilatation Catheter, an Rx
device indicated for transluminal coronary angioplasty:
Catalog #006474 - 2.0 mm Balloon;
Catalog #006475 - 2.25 mm Balloon;
Catalog #006476 - 2.5 mm Balloon;
Catalog #006477 - 2.75 mm Balloon;
Catalog #006478 - 3.0 mm Balloon;
Catalog #006479 - 3.25 Balloon;
Catalog #006480 - 3.5 mm Balloon. Recall #Z-437-0.
Code: All devices marketed from 6/88 to the present. All
lot numbers are involved.
Manufacturer: USCI Division of C.R. Bard, Inc., Haverhill, Massachusetts.
Recalled by: USCI Division of C.R. Bard, Inc., Billerica, Massachusetts,
by letters February 15 and 20, 1990. Firm-initiated recall
ongoing.
Distribution: Nationwide.
Quantity: 107,160 units were distributed; firm estimates 5,000 -
7,500 remain on market.
Reason: The device has been marketed without an approved premarket
approval (supplement) necessary because a significant
design change was made to the device.
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Class III -
Product: Cholesterol Calibrator, part number 115641, a reference
standard for in-vitro diagnostic use. Recall #Z-436-0.
Code: The calibrator bottle is coded C20J. These bottles are
incorporated into kits identified with the lot number
C67JK or H77JK.
Manufacturer: Ciba Corning Diagnostics Corporation, Oberlin, Ohio.
Recalled by: Manufacturer, by letter February 9, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, international.
Quantity: 752 kits were distributed; firm estimates none remains
on market.
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Reason: The 400 mg/dl calibrator has a loss of activity that
may result in test values that are too high.
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VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: C-M-P-K Sterile Solution, an Rx veterinary parenteral, in
500 ml. bottles, under the Vet Labs Ltd., Ezell Sales, VEDCO,
and The Butler Co. labels;
(b) Calcium Gluconate Sterile Solution, a non-Rx
veterinary parenteral, in 500 ml bottles, under the
Vet Labs Ltd., The Butler Co., Rx Veterinary Products and
Polydex Pharmaceuticals labels. Recall #V-034/035-0.
Code: Lot numbers: (a) 884396 EXP 6/90, 884354 EXP 5/90,
884134 EXP 3/90, 884198 EXP 3/90, 884107 EXP 3/90;
(b) 884393 EXP 3/90.
Manufacturer: Veterinary Laboratories, Inc., Lenexa, Kansas.
Recalled by: Manufacturer, by letter January 24/25, 1990. Firm-
initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 1,893 liters; (b) 5,678 liters were distributed;
firm estimates none remains on market.
Reason: Particulate matter in product.
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Class III -
NONE