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
04/15/1992
Recalls and Field Corrections: April 15, 1992
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: Gist Pheasant Farms Young Smoked Pheasant, 1/2 smoked
pheasant in a gift box. Recall #F-212-2.
Code: None.
Manufacturer: Country Pride Meats, Ipswich, South Dakota (processor).
Recalled by: Paramount Technical Products, Inc., Spearfish, South
Dakota, by facsimile December 17, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 57 boxes were distributed.
Reason: The manufacturer's (processor's) labeling failed to state
"store under refrigeration" and storage without
refrigeration provides the potential for Clostridium
botulinum growth.
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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: Mini Cupcakes, 10 ounces, in clear plastic trays:
(a) Chocolate Mini Cupcakes/Chocolate Icing;
(b) White Mini Cupcakes/White Icing. Recall #F-210/211-2.
Code: None.
Manufacturer: Freed's Bakery, Inc., Manchester, New Hampshire.
Recalled by: Manufacturer, by telephone March 16, 1992. Firm-initiated
recall ongoing.
Distribution: Massachusetts, Connecticut, Vermont, New York, New Jersey,
Pennsylvania.
Quantity: Approximately 10,000 cases (16 packages per case) were
distributed; firm estimates 1,200 cases remain on
the market.
Reason: Product contains undeclared eggs.
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Product: Various flavors of ice cream and sherbet:
(a) Golden Vanilla Flavored Royal Premium Ice Cream, in
1/2 gallon containers;
(b) Egg Nog French Ice Cream, in 1/2 gallon containers;
(c) Bubble Gum Ice Cream, in 3 gallon containers;
(d) Lime Sherbet, in 3 gallon containers.
Recall #F-213/216-2.
Code: Lot numbers: (a) 92059; (b) 91315; (c & d) not coded.
Manufacturer: Royal Ice Cream Company, Cleveland, Ohio.
Recalled by: Manufacturer, on or about March 19, 1992 except for the
Egg Nog Ice Cream which was initiated at a later date,
followed by visit. Firm-initiated recall ongoing.
Distribution: Ohio.
Quantity: (a) 96 containers; (b) 1,995 containers; (c) 26 containers;
(d) 69 containers were distributed; firm estimates (a) none;
(b) none; (c) 5 containers; (d) 5 containers remain on the
market.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Dairy Ease, liquid, in 7 ml bottles with a dropper top,
an enzyme used by people who are lactose intolerant.
Recall #F-217-2.
Code: Lot #S041HF EXP 10/92.
Manufacturer: Goto Shusei Ltd., Tokyo, Japan.
Recalled by: Sterling Drug, Inc., New York, New York, by letter
the end of February 1992. Firm-initiated recall ongoing.
Distribution: Nationwide.
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Quantity: 122,676 bottles were distributed.
Reason: Subpotency of lactase enzyme.
----
Product: Bulk Soybean Flour for food use and further manufacturing.
Recall #F-218-2.
Code: 614, 641, 652.
Manufacturer: AG Processing, Inc., St. Joseph, Missouri.
Recalled by: Manufacturer, by telephone December 10, 1991. Firm-
initiated recall complete.
Distribution: Kansas.
Quantity: Approximately 69-72 tons were distributed.
Reason: Product was contaminated with salmonella.
----
Product: Various dairy products and Lemon-Lime Drink:
(a) Regular Chocolate Milk 3.3%;
(b) Chocolate Lowfat Milk 1.0%;
(c) Lemon-Lime Drink;
(d) 8% Chocolate Milk. Recall #F-219/222-2.
Code: (a, b & d) Pull date NOV 1 or NOV 2; (c) Pull date
DEC 16.
Manufacturer: Maplehurst Farms, Inc., Indianapolis, Indiana.
Recalled by: Manufacturer, by telephone October 18, 1991.
Firm-initiated recall complete.
Distribution: Indiana.
Quantity: (a) 2,000 gallons; (b) 3,000 gallons; (c) 2,787 gallons;
(d) 3,360 quarts, 6,482 pints; 2,473 1/2 pints.
Reason: Products contain undeclared sulfites.
----
Product: Blue Marlin fresh unlabeled fish. Recall #F-223-2.
Code: None.
Manufacturer: Western Edge, Inc., Miami, Florida.
Recalled by: Waterfront Seafoods, Cleveland, Ohio, by telephone
March 16, 1992. Firm-initiated recall ongoing.
Distribution: Ohio.
Quantity: 100 pounds were distributed.
Reason: Product is contaminated with histamine.
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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.
NONE
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Disopyramide Phosphate 100 mg and 150 mg oral capsules,
an Rx antiarrhythmic. Recall #D-291/292-2.
Code: Lot numbers: L00190 and L00290.
Manufacturer: Interpharm, Inc., Plainview, New York.
Recalled by: Manufacturer, by telephone followed by letter March 13,
1992. Firm-initiated recall ongoing.
Distribution: Florida, Georgia, Michigan, New York, Tennessee.
Quantity: 200 units of lot L00190 and 4000 units of lot L00290.
Reason: Lack of assurance of bioequivalency and abbreviated new
drug application discrepancies.
----
Product: Recovered Plasma. Recall #B-233-2.
Code: Unit #MS0602652.
Manufacturer: Personal Blood Storage of Memphis, Inc., Memphis,
Tennessee.
Recalled by: Manufacturer, by telephone February 28, 1992 and March
2, 1992, followed by letter February 29, 1992.
Firm-initiated recall ongoing.
Distribution: Florida.
Quantity: 1 unit.
Reason: Blood component, which tested repeatably reactive for
antibody to Hepatitis C Virus Encoded Antigen (anti-HCV),
but labeled as non-reactive for anti-HCV, was distributed.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-239/241-2.
Code: Unit #1590431.
Manufacturer: Palm Beach Blood Bank, West Palm Beach, Florida.
Recalled by: Manufacturer by letter September 24, 1991. Firm-initiated
recall ongoing.
Distribution: California, Florida.
Quantity: 1 unit of each component.
Reason: Blood products from a donor who previously tested
repeatably reactive for the antibody to the human
immunodeficiency virus type 1 (anti-HIV-1) were
distributed.
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Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-243/244-2.
Code: Unit numbers: 18023-2561, 18023-5696, 18024-1391,
18023-8529
Manufacturer: United Blood System, Inc., Cheyenne, Wyoming.
Recalled by: United Blood Services, Scottsdale, Arizona, (a) by letters
of January 26 and 30, 1990; (b) by telefax April 24, 1990,
and May 18, 1990. Firm-initiated recall ongoing.
Distribution: Wyoming, Tennessee, Switzerland.
Quantity: 4 units of each component.
Reason: Blood products from a donor who previously tested
repeatedly reactive for the antibody to the human
immunodeficiency virus type 1 (anti-HIV-1) were distributed.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-246/248-2.
Code: Unit #05J15619.
Manufacturer: American Red Cross Washington Region (Washington Research
Project), Washington, D.C.
Recalled by: Manufacturer, by letters of July 10, 1991, April 19, 1991
and June 24, 1991. Firm-initiated recall ongoing.
Distribution: Illinois, Maryland, North Carolina.
Quantity: 1 unit of each component.
Reason: Blood products which test nonreactive for the hepatitis B
surface antigen (HBsAg), but were collected from a donor
who previously tested repeatably reactive for HBsAg,
were distributed.
----
Class III -
Product: Phenolated Calamine Lotion, USP, in 4 ounce bottles.
Recall #D-290-2.
Code: Lot #5486.
Manufacturer: Hydrox Laboratories, Elgin, Illinois.
Recalled by: Manufacturer, by letter March 20, 1992. Firm-initiated
recall ongoing.
Distribution: Pennsylvania.
Quantity: 25,400 bottles were distributed.
Reason: Subpotency of phenol ingredient.
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Product: Levothroid 200 mcg, Levothyroxine Sodium USP, in 100
tablet bottles, a Rx oral drug for use as replacement or
substitution therapy for diminished or absent thyroid
function. Recall #D-293-2.
Code: 417-1 EXP 2/1/94.
Manufacturer: Pharmacy Dispensing Quantities, Inc., Fort Scott, Kansas
(repacker/responsible firm).
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Recalled by: Repacker, by letter March 27, 1992. Firm-initiated recall
ongoing.
Distribution: Texas, North Dakota, Illinois, Missouri, Kansas, Puerto
Rico.
Quantity: 123 bottles were distributed.
Reason: Repacking firm used incorrect expiration date of 2/1/94
instead of 2/1/93.
----
Product: Golden Harvest Herbal Laxative Herb Tea, 24 bags per
box, 1.7 ounces. Recall #D-294-2.
Code: All lots.
Manufacturer: PFP Specialty Foods (Portland Food Products), doing
business as Golden Harvest Foods, Fargo, North Dakota.
Recalled by: General Nutrition, Inc., Pittsburgh, Pennsylvania, by
letter March 3, 1992. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Unknown.
Reason: Product contains frangula, an ingredient not permitted
by regulation 310.545.
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Product: Red Blood Cells. Recall #B-242-2.
Code: Unit #4612125.
Manufacturer: Central Florida Blood Bank, Inc., Orlando, Florida.
Recalled by: Manufacturer, by telephone October 1, 1991. Firm-
initiated recall complete.
Distribution: California.
Quantity: 1 unit.
Reason: Blood product labeled with the incorrect expiration
date was distributed.
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Product: Source Plasma. Recall #B-245-2.
Code: Unit numbers: 614851, 614854, 614860, 614862, 614865,
614866, 614869, 614871, 614872, 614874, 614877, 614878,
614880, 614881, 614882, 614884, 614885, 614887, 614888,
614889, 614890, 614892, 614893, 614894, 614896, 614897,
614898, 614900, 614902, 614903, 614906, 614907, 614908,
614910, 614914, 614916, 614918, 614919, 614921, 614924,
614928, 614930, 614931, 614933, 614939, 614940, 614941,
614942, 614944, 614945, 614947.
Manufacturer: United Blood Services Blood Systems, Inc., Albuquerque,
New Mexico.
Recalled by: United Blood Services Blood Systems, Inc., Scottsdale,
Arizona, by telephone April 24, 1990. Firm-initiated
recall complete.
Distribution: California.
Quantity: 51 units.
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Reason: Source Plasma, containing an anticoagulant unapproved
for use by the firm and different than the anticoagulant
indicated on the product label, were distributed.
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DEVICES AND RADIOLOGICAL PRODUCTS
Class I - NONE
Class II -
Product: Impra Expanded Polytetrafluoroethylene (PTFE) Vascular
Grafts, indicated for blood access, bypass, or
reconstruction of occluded or diseased arterial blood
vessels. The product numbers are as follows:
20S06, 30S06, 30S06TW, 35S06, 40S04, 40S05, 40S06, 40S07,
40S08, 40S10, 40T6-4, 40T7-4, 50S04, 50S05, 50S06, 50S06TW,
50S07, 50S08, 50S10, 50S19, 60S06, 60T7-4, 70S05, 70S05TW,
70S06, 70S06TW, 70S07, 70S08, 70S08TW, 70S10, 70S10TW,
70T7-4, 70T7-4TW, 708T-5, 70T8-5TW, 80S04TW, 80S06, 80S06TW,
80S07, 80S07TW, 80S08, 80S08TW, 80S10, 80S10TW, 90S06,
CF4006, CF4008, CF40T7-4, CF5006, CF5008, CF6006, CF8006,
CFT404-7, CFT454-7, CFT455-8, F3008, F3522, F4008S, F5006,
F500TWS, F5007, F5008, F5008TWS, F6006, F600FTWS, F6008TWS,
F6013, F7005TWS, F7006, F7600S, F7006TW, F7006TWS, F7007,
F7007TWS, F7008, F7008S, F7008TWS, F70T7-4, F70T7-4S,
F70T7-4TW, F70T7-4TWS, F70T8-5, F70T8-5TW, F7T8-5TWS, F8006,
F6006S, F8006TW, F8006TWS, F8007TWS, F8008, F8008S, F8008TW,
F8008TWS, F8010, F8010S, T454-6, T454-7, T455-8, T505-8,
T554.5-6.5. Recall #Z-452-2.
Code: Sterile codes: PK, PL, PM, PN, PO, PP, PQ, PR, PS, PT,
PU, PW, PX, PY, PZ, QA.
Manufacturer: Impra, Inc., Phoenix, Arizona.
Recalled by: Manufacturer, by letter January 2, 1992. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 8,298 grafts were distributed; firm estimates 5,000
grafts remain on the market.
Reason: A small pin hole in the outer packaging tray may
compromise the sterility of the device.
----
Product: Enhanced Torque Coronary Guiding Catheter with Soft Tip.
Recall #Z-508-2.
Code: All catalog and lot numbers distributed from October 10,
1991 to the present.
Manufacturer: Advanced Cardiovascular Systems, Inc., Temecula, California.
Recalled by: Manufacturer, by letter December 13, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
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Quantity: 2,713 units were distributed.
Reason: The catheter has exhibited detachment of the luer, with
fluid leakage reported.
----
Product: Double Three-Way Clear Body Stopcock with Male Luer Lock
Adapter, used in I.V. lines where multiple access and
a minimum number of venipuncture sites are desired.
Recall #Z-509-2.
Code: Catalog #K176A, lot #C1E021.
Manufacturer: Baxter Healthcare Corporation, Irwindale, California.
Recalled by: Baxter Healthcare Corporation, Valencia, California, by
letter December 12, 1991. Firm-initiated recall ongoing.
Distribution: Arkansas, California, Florida, Georgia, Hawaii, Kansas,
Massachusetts, Maryland, Michigan, North Carolina, New
Jersey, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas,
Utah, Virginia, Washington state, California.
Quantity: 5,500 units were distributed.
Reason: The male and female stopcocks are joined together
too tightly causing stress on the female (outer) connector
which may result in cracking thereby destroying the liquid
and air tight seal.
----
Product: (a) Coulter Hematology Analyzer Model JT2;
(b) Coulter Hematology Analyzer Model JT3.
Recall #Z-522/523-2.
Code: Serial numbers 000000 through S35590.
Manufacturer: Coulter Electronics, Inc., Hialeah, Florida.
Recalled by: Manufacturer, by letter September 7, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 246 units.
Reason: Due to two software anomalies, if the power is
interrupted, two conditions may occur upon restoration
of power which can cause the device to generate erroneous
results.
----
Product: 2 or 3 Gang Cardiac Manifold, sold separately as a manifold
or as part of a Cardiac Catheter Lab Kit, a shut-off
valve with 2 or 3 ports that are used to conduct/direct
fluids:
(a) Model TA2000; (b) Model TA2001; (c) Model TA2100;
(d) Model TA2101; (e) Model TA3000; (f) Model TA3001;
(g) Model TA3100; (h) Model TA3101. Recall #Z-528/535-2.
Code: All lot numbers.
Manufacturer: L.O.N. Research, Sanford, Florida (manifold component).
Recalled by: Viggio-Spectramed, Oxnard, California, by letter
September 24, 1991. Firm-initiated recall ongoing.
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Distribution: Nationwide, Puerto Rico, Argentina, Brazil, Canada,
Mexico, Venezuela, Uruguay.
Quantity: 129,785 units were distributed; FDA estimates that
very little product remains on the market.
Reason: Products may leak air during usage.
----
CORRECTION: Recall #Z-253-2, Model KXO-50N Control/Generator, which
appeared in the January 29, 1992 Enforcement Report is
being rescinded since this model was not involved in this
field correction.
----
Class III -
Product: Spor-Test Biospore Biological Indicators, a bacterial spor
test monitor for chemiclave and steam sterilizers.
Product sold in bulk - Part PB3505, bag of 500 strips;
Part #530700, bag of 2000;
Assembled into various test kits as follows:
Catalog #30-2000-01: 1 test kit with culturing service;
Catalog #30-2005-01, 3-test kit with culturing service;
Catalog #30-2010-01, 12-test with culturing service;
Catalog #30-2020-01, 12-test without culturing service;
Catalog #30-2040-01, 100-strip bulk pack;
Catalog #30-2050-01, 500-strip bulk pack;
Catalog #260055, 4 each 12-test with culturing service.
Recall #Z-456-2.
Code: Lot #324 EXP 11/92.
Manufacturer: MDT Biologic Company, Rochester, New York.
Recalled by: Manufacturer, by letter January 24, 1992 and subrecalled
by MDT Biologic Company, Rancho Dominguez, California, by
letter January 30, 1992. Firm-initiated recall complete.
Distribution: Nationwide, Canada, Switzerland.
Quantity: 132,000 strips were distributed.
Reason: Meeting specifications at a lower range may increase
the potential for inaccurate test results if the
product is not stored under proper conditions.
----
Product: Stat-PACK Enzymatic Triglycerides, Glycerol Test
(3 vial), for the quantative determination of triglycerides
and/or glycerol in human serum or plasma. Recall #Z-457-2.
Code: Catalog #869263, lot #0301 EXP 8/92.
Manufacturer: E M Diagnostics Systems, Gibbstown, New Jersey.
Recalled by: Behring Diagnostics, Inc., Somerville, New Jersey, by
telephone on or about June 13, 1991, followed by letter
dated January 14, 1991 and sent June 14, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide, Australia.
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Quantity: 118 kits were distributed.
Reason: Turbidity forms in the "A" vial of this lot of reagent caused
complaints of cloudy appearance, failed calibration and
"error" message and non-recovery of triglycerides in the
upper limit of linearity.
----
Product: Low Cholesterol Calibrators, components of kit
catalog #115641. Recall #Z-518-2.
Code: Kit lot numbers: K31JK, M49JK, D58LK;
Calibrator lot numbers: K10J, M41J, C39L.
Manufacturer: CIBA Corning Diagnostics, Corporation, Oberlin, Ohio.
Recalled by: Manufacturer, by letters of April 16 and 19, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 1,303 units were distributed.
Reason: The low calibrator (200 mg/dl) has a loss of activity
that can result in elevated test values and cause
inaccurate test results.
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Product: Latex-Crypto Antigen Detection System; Detacher
Enzyme (DE), used for qualitative and semi-quantitative
detection of capillary polysaccharide antigens of
cryptococcus
neoformans in human serum and central spinal fluids.
Recall #Z-519-2.
Code: Lot #10WDE and anti-globulin control (AGC) lot #10NR2.
Manufacturer: Immuno-Mycologics, Washington, Oklahoma.
Recalled by: Manufacturer, by letter February 6, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada, England, France.
Quantity: 672 vials were distributed.
Reason: False positive reactions occurred when the anti-Globulin
Control was used for quality control testing of the
detacher enzyme.
----
Product: Honey (91-575-694).
Charge: Adulterated - Another substance, sugar (from cane
or corn), has been substituted in part for the honey.
Firm: Mardale, Inc., Waukegan, Illinois.
Filed: February 25, 1992 - U.S. District Court for the
Central District of Illinois, Springfield Division,
Civil #92-3041, FDC #66335.
Seized: March 25, 1992 - 105 cases valued at approximately $600.
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Product: Frozen Sea Scallops (91-649-174).
Charges: Adulterated - Product consists in whole or in part of
decomposed scallops.
Misbranded - Product is fabricated from two or more
ingredients and the label fails to bear the common or usual
name of each ingredient.
Firm: Mar-Lees Seafood, Inc., New Bedford, Massachusetts.
Filed: November 26, 1991 - U.S. District Court for the
District of Massachusetts; Civil #91-13103S, FDC #66326.
Seized: December 6, 1991 - 54 cartons valued at approximately $8,000.
----
Product: Frozen Sea Scallops (92-638-332).
Charges: Adulterated - Product consists in whole or in part of
decomposed scallops.
Firm: Mar-Lees Seafood, Inc., New Bedford, Massachusetts.
Filed: January 31, 1992 - U.S. District Court for the
District of Massachusetts; Civil #92-10245WF, FDC #66360.
Seized: February 18, 1992 - 44 cartons valued at approximately
$14,000.
----
Mass Seizure:
Product: Various Foods (92-661-256).
Charge: Adulterated - Products have been held under
insanitary conditions whereby they may have become
contaminated with filth due to rodent infestation.
Firm: Ziyad Brothers, Division of Syrian Bakery and Grocery
Company, Inc., Chicago, Illinois.
Filed: April 1, 1992 - U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #92C2230,
FDC #66415.
Seized: April 6, 1992 - All food products in rodent susceptible
containers that have been shipped in interstate commerce,
valued at approximately $150,000.
----
Disposition of Prosecution:
Defendant: Dr. Robert E. Sacher, doing business as Ressel Scientific
Company, Weston, Massachusetts.
Charges and Dr. Sacher pleaded guilty to one count of a three-
Disposition: count indictment that was handed up by a federal
grand jury on November 20, 1991. Dr. Sacher
entered his plea to count three, charging him with
obstruction of an FDA administrative proceeding by
performance of a fraudulent demonstration of an
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analysis on Multi Shield before FDA scientists and
investigators. The maximum penalties facing Dr.
Sacher are five years imprisonment and a fine of
$250,000. Sentencing for Dr. Sacher is scheduled
for June 1, 1992. This joint investigation was
done by the Food and Drug Administration and the
Office of the Inspector General of the Department
of Defense.
Filed: April 6, 1992 - U.S. District Court for the District
of Massachusetts; Criminal #91-10310-K, FDC #66143.
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