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
12/01/1993
Recalls and Field Corrections: Foods -- Class I -- 12/01/1993
December 1, 1993 93-48
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
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PRODUCT Ready-To-Eat Twin Chili Dogs with Cheese. Recall #F-105-4.
CODE Pull dates of 09/03/93 and 09/14/93.
MANUFACTURER The Sandwich Man, Inc., Pearl River, Louisiana.
RECALLED BY Manufacturer, by visit on or about September 12, 1993.
Firm-initiated recall complete.
DISTRIBUTION Louisiana.
QUANTITY 35 sandwiches.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
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PRODUCT Porcelain Dinnerware in yellow Dynasty Pattern, 5-piece
setting (dinner, salad, bread and butter, plates and
saucer). Recall #F-047-4.
CODE None.
MANUFACTURER Fim Herend China, Hungary.
RECALLED BY Martin's Herend Imports, Inc., Sterling, Virginia, by letter
May 1993. Firm-initiated recall complete.
DISTRIBUTION New York, Pennsylvania, Massachusetts, California.
QUANTITY 20 5-piece settings
REASON Product contains excessive levels of leachable lead.
_______________
PRODUCT Old Fashioned Corn Muffins produced by J.J. Nissen Baking
Company, 18 ounces. Recall #F-107-4.
CODE Last sale dates up to and including NOV 5.
MANUFACTURER J.J. Nissen Baking Company, Portland, Maine.
RECALLED BY Manufacturer, by telephone October 25, 1993, and by
memorandum November 3, 1993. Firm-initiated recall
complete.
DISTRIBUTION New York and New England.
QUANTITY Approximately 22,000 packages were distributed; firm
estimates none remains on the market.
REASON Product contained undeclared FD&C Yellow No. 5.
_______________
PRODUCT Diet Nestea Drink, 16 ounces. Recall #F-108-4.
CODE 3261CC.
MANUFACTURER Coca Cola Bottling Company of Chattanooga, United Packers,
Inc., Chattanooga, Tennessee.
RECALLED BY Coca Cola/Nestle Refreshments, Tampa, Florida, by electronic
mail October 7, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Ohio, Nebraska, Illinois, Indiana, Missouri, Virginia, West
Virginia, Arkansas, Florida, Mississippi, North Carolina,
Louisiana, Maryland.
QUANTITY 8700 cases.
REASON Product contains undeclared sucrose.
_______________
PRODUCT Munchie Bunny, crisp rice and marshmallow bunny-shaped
snack. Recall #F-109-4.
CODE All codes.
MANUFACTURER Angela Marie's, Kaysville, Utah.
RECALLED BY Manufacturer, by telephone May 26-28, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 10,995 cases (1,187,460 bunnies) were distributed.
REASON Product contains undeclared FD&C yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
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PRODUCT Green, in-shell boiled peanuts in hermetically sealed metal
cans, 8 ounces, under The Roddenberry's Peanut Patch Green
Boiled Peanuts label. Recall #F-104-4.
CODE 210R3 over SBPB1 or SBPB2.
MANUFACTURER W.B. Roddenberry Company,. Division of Dean Foods, Cairo,
Georgia.
RECALLED BY Manufacturer, by telephone September 3, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Alabama, Georgia, Florida.
QUANTITY Approximately 1,033 cases (24 cans per case) were
distributed.
-2- REASON Product is contained in cans with defective seams which may
result in product spoilage.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
=====================
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PRODUCT Compact containing 16 shades of powder eyeshadow, labeled
JCPenny Signature Collection. Recall #F-091-4.
CODE Lot #3317.
MANUFACTURER Chao Ling Chemical Industry Company, Hsinchu, Tawian, R.O.C.
RECALLED BY St. John Products Int'l, Livermore, California, by letter
August 24, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 24,048 kits.
REASON Product is contaminated with Pseudomonas stutzeri.
_______________
PRODUCT Aloe Vesta Body Wash & Shampoo, in 4-fluid ounce 8-fluid
ounce, 16-fluid ounce 27-fluid ounce, 1-gallon and 4-liter
plastic containers. Recall #F-102-4
CODE Lot numbers: 201152, 201425, 201595, 201603, 201632, 201636
201774, 201795, 202043, 202198, 202199, 202200, 202348,
202357, 202358, 202557, 202659, 203357, 203361, 203379,
203381, 203396, 203419, 203422, 203432.
MANUFACTURER Calgon Vestal Laboratories, St. Louis, Missouri.
RECALLED BY Manufacturer, by telephone and by letters of August 3 and
19, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 4,825 cases (72 4-ounce bottles); 5,096 (48 8-ounce
bottles); 504 (24 16-ounce bottles); 370 cases (12 27- ounce
bottles); 1,426 (6 4-liter bottles); 7,204 cases (4 1-gallon
bottles) were distributed.
REASON Product is contaminated with Klebsiella oxytoca.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
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PRODUCT Quickly weight-loss capsules, promoted to enhance weight
loss, in single-unit dose packets. Recall #D-030-4.
CODE All lots.
MANUFACTURER Neways, Inc., Salem, Utah.
RECALLED BY Manufacturer, by letter November 8, 1993. Firm-initiated
recall ongoing. See also FDA press release P93-41, November
12, 1993.
DISTRIBUTION Nationwide, Canada, Puerto Rico.
QUANTITY 4,903 units (20 dose packages per container).
REASON Product contains undeclared furosemide (a prescription drug)
and was marketed without approval.
-3- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
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PRODUCT Inocor Lactate Injection (brand of amrinone lactate),
Sterile Intravenous Solution 100 mg/20 ml, indicated for the
short-term management of congestive heart failure.
Recall #D-032-4.
CODE Lot numbers: B989KF, B990KF, B986KE, B987KE, B654KF,
B988KF.
MANUFACTURER Sterling Pharmaceuticals, Inc., a division of Sanofi
Winthrop, Barceloneta, Puerto Rico.
RECALLED BY Sanofi Winthrop Pharmaceuticals, New York, New York, by
letter November 11, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Puerto Rico, India, Argentina.
QUANTITY 86,734 units were distributed.
REASON Package insert contains a typographical error in the dosage
and administration section.
_______________
PRODUCT Banalg Fast Vanishing Lotion, in 16 fluid ounce bottles,
OTC, for the temporary relief of minor aches and pains of
muscles and joints. Recall #D-033-4.
CODE Lot #20910.
MANUFACTURER Forest Pharmaceuticals, Inc., St. Louis, Missouri.
RECALLED BY Manufacturer, by telephone April 30, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 3,860 bottles were distributed.
REASON Some bottles do not bear a lot number.
_______________
PRODUCT Forest Armour Thyroid (Thyroid Tablets, USP), 2 gr, in 100-
tablet bottles, Rx used as replacement or supplemental
therapy in patients with hypothyroidism.
Recall #D-034-4.
CODE FP0050 EXP 2/95.
MANUFACTURER Rhone Poulenc Rohrer, Manati, Puerto Rico.
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis, Missouri, by letter
October 20, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 27,678 bottles were distributed.
REASON Some bottles do not bear a lot number and/or expiration
date.
_______________
PRODUCT G.B.S. Tablets, in 100 and 1,000 tablet bottles, Rx, for use
as an adjunct, in the management of certain conditions
involving the biliary tract. Recall #D-035-4.
CODE Lot # 11905 EXP 1/94.
MANUFACTURER Forest Pharmaceuticals, Inc., Cincinnati, Ohio.
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis, Missouri, by
telephone August 17, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
-4- QUANTITY 394 100-tablet bottles and 89 1000-tablet bottles were
distributed.
REASON Product failed stability specifications.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Recovered Plasma. Recall #B-044-4.
CODE Unit #FF72345.
MANUFACTURER Continental Services Group, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter September 15, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Italy.
QUANTITY 1 unit.
REASON Blood product tested repeatedly reactive for the antibodies
to the human immunodeficiency virus types 1 and 2
(anti-HIV-1/2).
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Kontur 55 Toric Hydrophilic Contact Lens, Daily Wear.
Recall #Z-108-4.
CODE Lot #872153 and D102R through D1057.
MANUFACTURER Kontur Kontac Lens Company, Inc., Richmond, California.
RECALLED BY Manufacturer, by letter September 15, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 712 lenses (lot 872153) and 680 lenses (lot D102R through
D1057).
REASON Eighty-three units were potentially distributed nonsterile.
_______________
PRODUCT Intra-Arterial Blood Gas Monitor, Model PB3300, intended for
the real time measurement and display of arterial blood gas
parameters, as well as calculation and display of calculated
parameters. Recall #Z-113-4.
CODE All serial numbers distributed from 9/1/92 through 9/19/93.
These are: 4005 through 4026, 4028 through 4033, 4035
through 4055, 4058 through 4110, 4112 through 4365.
MANUFACTURER Puritan-Bennett Corporation, Carlsbad, California.
RECALLED BY Manufacturer, by telephone September 17, 1993, followed by
letter September 20, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 284 units.
REASON Defective software. If the monitor is used in the "user
select" or "sensor temp" modes of temperature correction,
the monitor incorrectly calculates and displays values for
base excess, bicarbonate, oxygen saturation, and total C02.
-5- _______________
PRODUCT Storz brand Occucoat, a viscoelastic solution used in
ophthalmic surgery. Recall #Z-118-4.
CODE Batch number 221.
MANUFACTURER Storz Ophthalmics, Clearwater, Florida.
RECALLED BY Manufacturer, by letters of August 30, 1993 and September
27, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Germany, Venezuela, Chile.
QUANTITY 3,885 units.
REASON Product was potentially distributed nonsterile.
CRIMINAL INFORMATION
======================================================
_______________
AGAINST Barry David Garfinkel, Child Psychiatrist and Clinical
Investigator, University of Minnesota, who headed a study of
the drug, Anafranil, manufactured by Ciba-Geigy.
CHARGES Dr. Garfinkel was convicted of two counts of mail fraud (18
U.S.C. 1341) and 3 counts of making false statements (18
U.S.C. 1001). He was sentenced to six months imprisonment,
followed by six months home detention, and three years
probation. Dr. Garfinkel was fined $25,000 ($5,000 for each
conviction) and $250 (special assessment due immediately).
He was ordered to make restitution to Ciba-Geigy in the
amount of $170,394. To pay for his incarceration Dr.
Garfinkel was ordered to pay $1,000 for each month of
incarceration, and $180 a month for the three years
probation. Dr. Garfinkel was further ordered to perform 400
hours of community service.
FILED November 19, 1993 - Sentencing; U.S. District Court for the
District of Minnesota, Fourth Division; Case No. 4-93-34;
FDC #66144.
-6-
END OF ENFORCEMENT REPORT FOR DECEMBER 1, 1993. BLANK PAGES MAY
FOLLOW.
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