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
05/07/1991
FDA Enforcement for the week of May 8, 1991
FDA ENFORCEMENT REPORT
FOR MAY 8, 1991
May 8, 1991
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: Various styles of peanuts, in 16 ounce and 24 ounce vacuum
packed glass jars with plastic pop off tops:
(a) Dry Roasted Peanuts, in 16 ounce jars under the
following labels: Albertsons, Azar, Flav-o-rite,
-1-
Good Day, Grand Union, Lady Lee (Milan Dist. Co.),
Ladey Lee (LKS Products, Inc.), Party Pride,
Perry Snack Shop, Price Chopper, Ralphs, Slim Price,
Sunny Select, Thrifty, Townhouse, Vons, Western Family.
Generic labels distributed by Azar Nut Co.; Dublin
Generics, Inc; Milan Dist. Co.; Preferred Products, Inc.;
Ralphs Grocery Co., Inc. In 24 ounce jars under the
following labels: Azar, Flav-o-rite, Furr's, Lady Lee
Milan Dist. Co.), Thrifty, Townhouse, Vons;
(b) Dry Roasted Unsalted Peanuts, in 16 ounce jars,
under the following labels: Albertsons, Azar, Big Star,
Flav-o-rite, Furr's Good Day, Grand Union, Pan 'n Save,
Perry Snack Shop, Price Chopper, Ralphs, Slim Price,
Sunny Select, Thrifty, Vons, Western Family.
Generic labels distributed by: Azar Nut Co., Dublin
Generics, Inc., Milan Dist. Co., Ralphs Grocery Co., Inc.
In 24 ounce jars under the following labels: Azar, Furr's
Thrifty, Vons;
(c) Dry Roasted Honey Roasted Peanuts, in 16 ounce jars
under the following labels: Grand Union, Price Chopper,
Albertsons, Azar, Big Star, Flav-o-rite, Furr's, Good Day,
Lady Lee (Milan Dist. Co.), Lady Lee (LKS Products, Inc.),
Pan 'n Save, Party Pride, Perry Snack Shop, Ralphs, Slim
Price, Sunny Select, Thrifty, Townhouse, Vons,
Western Family. Generic labels distributed by: Azar Nut
Co., Dublin Generics, Milan Dist. Co., Preferred Products,
Inc., Ralphs Grocery Co. (NOTE: Party Pride and Western
Family labels have been discontinued by Azar.)
Recall #F-368/370-1.
Code: All lots.
Manufacturer: Azar Nut Company, El Paso, Texas.
Recalled by: Manufacturer, by telephone April 5, 1991 followed by
letter and FAX. Firm-initiated recall ongoing.
Distribution: Arizona, California, Colorado, Georgia, Indiana,
Maryland, Michigan, Minnesota, New Jersey, Nevada, New York,
Oklahoma, Oregon, Texas, Utah, Washington state.
Quantity: (a) 16,461 cases (12 16 oz jars) and 4,238 (12 24 oz
jars); (b) 9,932 cases (12 16 oz jars), 1,682 cases
12 24 oz jars); (c) 407 cases (12 16 oz. jars) were
distributed.
Reason: Product is contaminated with glass fragments.
----
Product: (a) Chocolate Mint or (b) White Chocolate Mint, with
pink or green monograms packaged in gift boxes
containing either 5 or 20 mints or packaged in bulk
quantities. Recall #F-371/372-1.
Code: 10103 (5 pack), 10116 (20 pack), 10101 (bulk).
Manufacturer: Monogramme Confections, Maryland Heights, Missouri.
Recalled by: Manufacturer, by letter on or about March 25, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
-2-
Quantity: 30,000 pink monogramed mints and 287,880 green
monogramed mints were distributed; firm estimates:
Pink - 3,000 mints; Green - 300 5-packs and 50 bulk
(576 mints/case) remain on the market.
Reason: Product contains undeclared FD&C Yellow No. 5 and
nonpermitted Red No. 3 Lake.
----
Product: Hermitage Pastry Orange Chef Cake, 72 ounces, distributed
by Robert Orr/Sysco. Recall #F-367-1.
Code: Not coded -- All outstanding cakes are subject to recall.
Manufacturer: Clayborn's Bakery, Lebanon, Tennessee.
Recalled by: Manufacturer, by letter March 21, 1990. Firm-initiated
field correction (relabeling) ongoing.
Distribution: Tennessee.
Quantity: 16 cases (4 per case) remain at the distributor.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
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: (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF; (d) Recovered Plasma. Recall #B-194/197-1.
Code: Unit numbers: (a) 2206098, 2213232, 2243271, KE14049,
KC44429; (b) 2213232, 2243271, KC44429; (c) 2206098;
(d) 2206098, 2213232, 2243271, KE14049, KC44429.
Manufacturer: The Blood Center of Central Iowa, Des Moines, Iowa.
Recalled by: Manufacturer, by letter January 22, 1991. Firm-initiated
recall ongoing.
Distribution: Iowa, Tennessee, Illinois, North Carolina, Florida,
California, New York, New Jersey.
Quantity: (a) 5 units; (b) 3 units; (c) 1 unit; (d) 5 units.
Reason: Blood components, collected from a donor who
participated in high risk behavior, were distributed.
----
-3-
Product: (a) Whole Blood; (b) Whole Blood Modified, Platelets
Removed; (c) Red Blood Cells; (d) Platelets;
(e) Cryoprecipitated AHF; (f) Recovered Plasma.
Recall #B-209/214-1.
Code: Unit numbers: (a) 201575; (b) 180938; (c) 217472, 223677,
9034136, 9038595, 9040469, 9045639; (d) 180938, 223677,
9034136, 9045639; (e) 9038595; (f) 217472, 223677,
9034136, 9038595, 9040469, 9045639.
Manufacturer: Community Blood Bank of Lancaster County Medical
Society, Lincoln, Nebraska.
Recalled by: Manufacturer, by letter September 17, 1990. Firm-
initiated recall ongoing.
Distribution: California, New York, Missouri, Nebraska.
Quantity: (a) 1 unit; (b) 1 unit; (c) 6 units; (d) 4 units;
(e) 1 unit; (f) 6 units.
Reason: Blood products, which tested non-reactive for the
antibody to the human immunodeficiency virus type 1
(anti-HIV-1), but were collected from donors who
previously tested repeatably reactive for anti-HIV-1,
were distributed.
----
Product: Recovered Plasma. Recall #B-216-1.
Code: Unit #UMH 90-0937.
Manufacturer: The Union Memorial Hospital, Baltimore, Maryland.
Recalled by: Manufacturer, by telephone December 10, 1990. Firm-
initiated recall complete.
Distribution: Maryland.
Quantity: 1 unit.
Reason: Recovered Plasma, which tested initially reactive for the
hepatitis B surface antigen (HBsAg) and non-reactive by
a single repeat test, was distributed.
----
Product: (a) Red Blood Cells, Expired; (b) Recovered Plasma.
Recall #B-226/227-1.
Code: Unit #59J85239.
Manufacturer: American Red Cross, Flint, Michigan.
Recalled by: Manufacturer, by telephone April 4, 1991 followed by
letter April 8, 1991. Firm-initiated recall complete.
Distribution: Minnesota, Michigan.
Quantity: 1 unit of each component.
Reason: Blood products collected from a donor who reported
high risk behavior, were distributed.
----
Class III -
Product: (a) Red Blood Cells; (b) Fresh Frozen Plasma;
(c) Recovered Plasma. Recall #B-228/230-1.
-4-
Code: Unit numbers: (a) 33KJ50025, 33KS72106;
(b) 33KS72106; (c) 33KJ50025, 33KS80637.
Manufacturer: American Red Cross, Farmington, Connecticut.
Recalled by: Manufacturer, by telephone between October 31,
1990 and November 20, 1990, and by letter November 8, 1990.
Firm-initiated recall complete.
Distribution: (a & b) Connecticut; (c) California.
Quantity: (a) 2 units; (b) 1 unit; (c) 2 units.
Reason: Blood products which tested non-reactive for
anti-HIV-1, but were collected from a donor who
previously tested repeatably reactive for anti-HIV-1.
were distributed.
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Class II -
Product: Intermedics brand "Sterile Natural-Knee Tibial Insert,
Size A, 9 mm LEFT. Recall #Z-532-1.
Code: Catalog #6200-02-209 - Lot #23761.
Manufacturer: Intermedics Orthopedics, Inc., Austin, Texas.
Recalled by: Manufacturer, by telephone on or about September 10,
1990. Firm-initiated recall complete.
Distribution: Texas, California, Illinois, Florida.
Quantity: 10 units were distributed.
Reason: The outer cardboard box and engraved component were
identified as "9 mm, Size A, Left ***" but the tibial
insert was actually "9 mm, SIZE A, RIGHT.
----
Product: Sterile Natural-Knee Tibial Insert, Size B, 11 mm,
LEFT, used with baseplate and packaged in a plastic tyvek
tray which is packaged in a cardboard box, a component of
Intermedics brand "Natural Knee" Sterile System.
Recall #Z-533-1.
Code: Catalog #6200-02-211, lot #41931.
Manufacturer: Intermedics Orthopedics, Inc., Austin, Texas.
Recalled by: Manufacturer, by telephone on or about December 17, 1990.
Firm-initiated field correction complete.
Distribution: Utah, California, Florida, Louisiana.
Quantity: 13 units were distributed.
channels or have been implanted.
Reason: The label reads Natural-Knee Tibial insert "9 mm",
Size B, LEFT, Lot No. 41913, but the inserts were
actually "11 mm size.
----
-5-
Product: Test Tube Agglutination Viewer, used for blood typing,
cross matching and other agglutination, flocculation
and serodiagnostic tests. Recall #Z-551-1.
Code: Catalog #5384, lot numbers: 0185 through 0490. All
units manufactured between January 1985 through
April 1990.
Manufacturer: Clay Adams, Division of Becton Dickinson, Parsippany,
New Jersey.
Recalled by: Becton Dickinson, Sparks, Maryland, by letter
October 1, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 5,115 units were distributed.
Reason: The electrical light bulb sockets used in the device
may result in failure involving breakdown of the insulating
components. This may result in arcing, sparks, flames,
and occasionally forceful expulsion of the socket
and bulb from the housing.
----
Product: Softip Catheters, used for guiding and supporting balloon
dilatation catheters:
(a) Visiguide/79 Softip Catheters, 8 French Size Coronary
Guiding Catheters. Model numbers M28-001 through M28-069;
(b) Superflow Softip Catheters, 8 French Coronary Guiding
Catheters. Model numbers S28-001 through S28-069.
(c) Visiguide/79 Softip Catheters, 8 French Size Renal
Guiding Catheters. Model numbers RM28-001 through RM28-004.
(d) Superflow Softip Catheters, 8 French Size Renal Guiding
Catheters. Model numbers RS28-001 through RS28-004.
Recall #Z-569/572-1.
Code: Product lot numbers begin with three letters on the left
hand side followed by 5 numbers. All product, identified
above, with 89 just to the right of the letters in the
lot number, is recalled. Only some of the product with 90
to the right of the letters is recalled. When 90 appears
as the first two numbers, the next two numbers determine
whether or not the product is recalled. The product is
recalled when the two numbers to the right of 90 are:
(a) 01 to 29, if the product is one of the Visiguide/79 8
French Coronary Guiding Catheters (Model numbers M28-001
thru M28-069).
(b) 01 to 16, if the product is one of the Superflow 8
French Coronary Guiding Catheters (Model numbers S28-001
thru S28-069).
(c) 01 to 9, if the product is one of the Visiguide/79 8
French Renal Guiding Catheters (Model numbers RM28-001 thru
RM28-004);
(d) 01 to 9, if the product is one of the Superflow 8
French Renal Guiding Catheters (Model numbers RS28-001 thru
RS28-004).
Manufacturer: Schneider (USA), Inc., Minneapolis, Minnesota.
Recalled by: Manufacturer, by letter dated April 3, 1991. Firm-initiated
recall ongoing.
-6-
Distribution: Nationwide, Japan, The Netherlands, Canada, Switzerland,
Australia.
Quantity: 103,582 units were distributed.
Reason: Cracks have been noted in the exterior of the catheter
shafts of some of the catheters.
----
Product: Povidone Iodine Cleansing Gel, an Rx gastroenterological
device for use with periotneal dialysis sets.
Recall #Z-565-1.
Code: Catalog #N4310, lot #L5-25 EXP 8/91.
Manufacturer: Huntington Laboratories, Inc., Huntington, Indiana.
Recalled by: McGaw, Inc., Irvine, California, by letter March 5, 1991.
Firm-initiated recall ongoing.
Distribution: Colorado.
Quantity: 47,680 units were distributed.
Reason: The label claims it contains 1% available iodine when the
product actually contains 0.81% available iodine.
----
Product: Tandem-R PSA Immunoradiometric Assay, an in-vitro
diagnostic kit used for the quantitative measurement
of prostate-specific antigen (PSA) in human serum to aid
in the prognosis and management of patients with prostate
cancer. Recall #Z-573-1.
Code: Lot #991550 EXP 11/27/89.
Manufacturer: Hybritech Inc., San Diego, California.
Recalled by: Manufacturer, by telephone October 19-25, 1989 followed
by letter October 20, 1989. Firm-initiated recall complete.
Distribution: Nationwide and Canada.
Quantity: 126 kits were distributed; firm estimates none remains
on the market.
Reason: Samples with extremely high PSA (prostate-specific anatigen)
may read within the calibration range of the assay, and on
dilution, may read higher.
----
Product: Welch Allyn brand Pneumocheck Printer/Charger, Model 76l00
part of a spirometer kit which is used to measure and
record spirometry tests compared to published studies.
Recall #Z-575-1.
Code: There were 2,708 units distributed, each with an
individual serial number.
Manufacturer: Welch Allyn, Inc., Skaneateles Falls, New York.
Recalled by: Manufacturer, by letter February 1, 1991. Firm-
initiated field correction ongoing.
Distribution: Nationwide and Canada.
Quantity: 2,708 units were distributed.
-7-
Reason: Two software errors were discovered involving the accuracy
of the values preprogrammed into the printer/charger and
used to calculate predicted norms. The Knudson 1976
predicted values are incorrect for females aged 18 and
above; MVV values are incorrect for males aged 19 to 24.
----
Product: ImmuAdd Low Ionic Strength Medium (potentiator) for
antibody detection tests, in 10 ml vials. Recall #Z-605-1.
Code: Lot #0E5534-3 -- Product Codes: 2007 (1 x 10 ml),
2008 (10 x 10 ml), 2009 (100 x 10 ml).
Manufacturer: Immuncor, Inc., Norcross, Georgia.
Recalled by: Manufacturer, by telephone February 1, 1991. Firm-
initiated recall ongoing.
Distribution: Nationwide, Italy, Germany, Australia, Canada.
Quantity: 12,401 units were distributed; firm estimates 3,500
units remain on the market.
Reason: Evidence of fungal contamination was found, which
could change the product's color.
----
Product: (a) Sonos 500/l000 Ultrasound Imaging Systems,
Model 77025A/77030A;
(b) Sonos 500/1000 Ultrasound Imaging Systems,
Model 77760A. Recall #Z-608/609-1.
Code: Serial numbers: (a) 2833A04990 to 3003A06427;
(b) 2914A00101 to 3003A00692.
Manufacturer: Hewlett Packard company, Andover, Massachusetts.
Recalled by: Manufacturer, by letter July 27, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 1,386 systems were distributed.
Reason: Some systems have been found with the power cord strain
relief loose which may allow undue strain on the power
cord connections.
----
Product: Tandem-E CEA Immunoenzymetric Assay, an in-vitro diagnostic
test for the quantitative measurement of carcinoembryonic
antigen (CEA) in human serum to aid in the prognosis and
management of cancer patients in whom changing
concentrations of CEA are observed. Recall #Z-577-1.
Code: Kit lot numbers: 990907, 990645.
Manufacturer: Hybritech Inc., San Diego, California.
Recalled by: Manufacturer, by letter October 20, 1989. Firm-initiated
recall complete.
Distribution: Alabama, California, Connecticut, Florida, Iowa, Illinois,
Louisiana, Massachusetts, Minnesota, New Jersey,
New York, Ohio, Pennsylvania, Tennessee, Texas,
Washington state, Puerto Rico.
-8-
Quantity: 176 kits were distributed; firm estimates none remains
on the market.
Reason: The quantitation of patient and control samples of these
lots drifted upward approximately 10 percent.
----
Product: Brown Milled Rubber Surgeon's Gloves, packed in bags
of 800. Recall #Z-599-1.
Code: Lot numbers: 1-28-91 8R, 1-18-91 8L, 1-30-91 7-1/2L,
1-28-91 7-1/2R, 1-21-91 7R, 1-25-91 7L, 1-29-91 7-1/2R,
1-29-91 7-1/2L, 1-29-91 7R, 1-29-91 7L, 1-23-91 7L,
1-30-91 8R, 1-30-91 8L, 1-30-91 7R, 1-30-91 7L, 1-31-91 7R,
1-31-91 7L, 1-25-91 7R.
Manufacturer: North Hand Protection, Clover, South Carolina.
Recalled by: Manufacturer, by telephone February 25, 1991. Firm-
initiated recall complete.
Distribution: Florida.
Quantity: 14,400 gloves were distributed.
Reason: Ten percent of the gloves examined by FDA were found
to contain holes.
----
Product: Baxter Interlink Cannulas, also known as Baxter
Needle*Less Cannulas with Lever Locks and Threaded
Locks (a) Product code 2N3388 and (b) Product code 2N3389.
for use with Baxter's Needle*Less Injection Sites and
any administration set for the delivery of intravenous
fluids by health professionals and home care patients.
Recall #Z-600/601-1.
Code: All lots.
Manufacturer: Baxter PTE Ltd., Singapore.
Recalled by: Baxter Healthcare Corporation, Round Lake, Illinois, by
letter March 26, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and Japan.
Quantity: Approximately 25,000 cases were distributed; firm
estimates 14,000 cases remain on the market.
Reason: The cannulas may crack and leak when used to infuse
fat emulsions/lipids, especially 20 percent fat
emulsions infused at low flow rates.
----
Product: Intermed, Inc., urinary drainage products:
(a) Urinary Leg Bag, disposable, sterile/single use
twist emptying valve, large, 32 ounce, packed in
cases containing 4 boxes of 12 bags each;
(b) Closed Urinary Drainage Unit with plastic strap for
hanging or carrying, 2000 ml capacity, packed 20 units
per case;
(c) Closed Urinary Drainage Unit with universal hook
with tubing support, 2000 ml capacity, packed 20 units
per case. Recall #Z-602/604-1.
-9-
Code: Catalog No. Lot No.
(a) 6035 516324
(b) 6210 757320, 758321, 759323, 760324,
761324, 762326
(c) 6221H-VA 1168.
Manufacturer: Intermed, Inc., El Paso, Texas.
Recalled by: Intermed, Inc., Sparta, New Jersey, by telephone on or
about January 22, 1991 followed by letter. Firm-
initiated recall complete.
Distribution: Alabama, California, Delaware, Florida, Illinois, Kansas,
Louisiana, Massachusetts, Maryland, Montana, North
Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas,
Virginia, West Virginia.
Quantity: 3,040 units were recovered from the market.
Reason: The devices were exposed to only one half the required
exposure time to ethylene oxide gas sterilization.
----
Product: ACD Latex C.D.T. Kit, a latex agglutination test used
to detect Clostridium difficile toxins in human feces.
Recall #Z-606-1.
Code: All kits.
Manufacturer: Advanced Clinical Diagnostics, Toledo, Ohio.
Recalled by: Manufacturer, by telephone and by letter on or about
February 11, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 30 to 40 kits were distributed; firm estimates none remains
on the market.
Reason: The device was marketed from January 1990 to January 28,
1991 without the required Premarketing Approval
Application. The labeling did not include the instruction
that the device's diagnosis must also be confirmed by an
established procedure.
----
Class III -
Product: Tandem-R PSA Immunoradiometric Assay, an in-vitro
diagnostic kit used for the quantitative measurement
of prostate-specific antigen (PSA) in human serum to
aid in the prognosis and management of patients with
prostate cancer. Recall #Z-574-1.
Code: Lot #991671 EXP 11/20/89.
Manufacturer: Hybritech Inc., San Diego, California.
Recalled by: Manufacturer, by telephone from September 28, 1989
through October 2, 1989 followed by letter October 16,
1989. Firm-initiated recall complete.
Distribution: California, Colorado, Georgia, Maryland, Minnesota,
Missouri, Nebraska, Ohio, Texas.
Quantity: 100 kits were distributed; firm estimates none remains
on the market.
-10-
Reason: Product was packaged with a wrong component. The Tandem-R
PSA kits contained an Icon II HCG wash concentrate instead
of a Tandem-R wash concentrate.
----
Product: 25-OH-D3 Standard/Etalon in 25-Hydroxyvitamin D3H RIA
(test) Kits, used for the quantitative determination
of 25-OH-D and other hydroxylated metabolites in
human serum or plasma by in-vitro radioimmunoassay.
Recall #Z-576-1.
Code: Catalog #58100, Lot numbers: 9044026-30 and 9037015-20
of the standard sets in the kits.
Manufacturer: Incstar Corporation, Stillwater, Minnesota.
Recalled by: Manufacturer, by telephone starting on February 25,
1991 followed by letter March 8, 1991. Firm-initiated
recall ongoing.
Distribution: California, Colorado, Georgia, Minnesota, Missouri,
New Jersey, New York, North Carolina, North Dakota,
Orgeon, Virginia, Wisconsin, international.
Quantity: 758 kits and 29 separate sets of standards from the
two defective lots were distributed.
Reason: The product is not performing to specifications resulting
in erroneous analytical results.
----
Product: E. (Enterococcus) Faecalis Bacteria Pellets for in-vitro
use only (screening and identification tests for strep
bacteria causing disease). Recall #Z-598-1.
Code: Lot #367251 EXP 9/91.
Manufacturer: Environmental Protection Laboratories, doing business as
Micro-Bio-Logics, Inc., St. Cloud, Minnesota.
Recalled by: Manufacturer, by telephone March 22, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and Canada.
Quantity: 29 vials were distributed.
Reason: Bacterial controls were misidentified. Some product
vials labeled as containing E. faecalis, actually contain
S. aureus bacteria.
----
Product: Glucose HK program on the 550 Express Software
(version 2.05), used on an Express 550 analyzer for the
quantitative determination of glucose concentration in
serum. Recall #Z-607-1.
Code: All 550 Express analyzers which have the software
for the Glucose HK program.
Manufacturer: Ciba Corning's Diagnostics Corporation, Oberlin, Ohio.
Recalled by: Manufacturer, by letter September 19, 1990. Firm-
initiated field correction ongoing.
-11-
Distribution: Nationwide and international.
Quantity: 1,375 software packages were distributed.
Reason: The software is not appropriate with the labeling claims
of the Glucose HK reagent.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
NONE
Class III -
Product: Kent Pasture Aid Mineral 1440B Medicated, 1,440 grams/
ton Lasalocid, for use as a medicated animal feed.
Recall #V-070-1.
Code: SC077.
Manufacturer: Kent Feeds, Inc., Sioux City, Iowa.
Recalled by: Manufacturer, by telephone. Firm-initiated recall complete.
Distribution: Nebraska.
Quantity: Six 50 pound bags were distributed. The bags were
returned 1/28/91.
Reason: Analyses of the product averaged below the allowable
assay limits for Lasalocid (75%-125%).
----
Seizure Actions Filed:
Product: Elekiban Magnetic Disks (90-602-967).
Charge: Adulterated - Product is a Class III device and it
does not have an approved premarket approval application in
effect; Misbranded -- The labeling fails to bear adequate
directions for use.
Firm: Physio-Meditec Corporation, Amherst, New York.
Filed: April 11, 1991 - U.S. District court for the Wastern
District of New York; Civil # 91-0244S, FDC #66045.