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.

November 6, 1996 96-45

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Entenmann's Chocolate Chip Cookies, in 12
ounce boxes. Recall #F-028-7.
CODE B1004 HW manufactured on 9/18/96.
MANUFACTURER Entenmann's Inc., Miami, Florida.
RECALLED BY C.P.C. Baking Business (doing business as
Entenmann's, Inc.), Bay shore, New York, by
press release and by notifying the Food
Allergy Network, on September 24, 1996,
followed by letter. Firm-initiated recall
ongoing.
DISTRIBUTION Florida, Georgia, North Carolina, South
Carolina, Virginia.
QUANTITY 3,732 boxes were distributed.
REASON Product contains undeclared walnuts and nonfat
dry milk.

_______________
PRODUCT Various flavors and varieties of ice cream, in
3 gallon tubs, half gallon and quart size
plastic containers:
(a) Maple Walnut Ice Cream
(b) Butter Pecan Ice Cream
(c) Chocolate Peanut Buttercup Ice Cream.
Recall #F-029/031-7.
CODE All misbranded product.
MANUFACTURER M.B.B. Annis Dairy of Avon, Inc., Avon, New
York.
RECALLED BY Manufacturer, by telephone on September 20,
1996. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY (a) 119 3-gallon, 23 half-gallon, 15 quart
size containers; (b) 88 3-gallon, 15 half-
gallon, 3 quart size containers; (c) 51 3-
gallon size containers were distributed.
REASON The products bear partial ingredient
statements which list the ice cream base
ingredients only. The nuts in these products
are not listed in the ingredient statement and
there is a potential for consumers sensitive
to the nuts to think the product is merely
flavored and does not contain the actual
allergen. Product a) contains walnuts;
product b) contains pecans; product c)
contains peanuts.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Pastry Dough Shells (Discos), packaged in
plastic bags of 10, under the Rico, Delicia,
and Goya labels. Recall #F-024-7.
CODE None. All misbranded product is under recall.
MANUFACTURER Rico Products Company, Paterson, New Jersey,
RECALLED BY Manufacturer, by telephone on June 18-19,
1996. Firm-initiated recall complete.
DISTRIBUTION New Jersey, New York, Massachusetts,
Connecticut, Pennsylvania, District of
Columbia.
QUANTITY Firm estimates none remains on the market.
REASON Product contains undeclared FD&C Yellow No. 5.

_______________
PRODUCT Goya Cola Champagne, in 355 ml (12 fluid
ounce) glass bottles. Recall #F-025-7.
CODE Lot number 20895.
MANUFACTURER The Lion Brewery, Wilkes-Barre, Pennsylvania.
RECALLED BY Goya Foods, Inc., Secaucus, New Jersey, by
telephone on June 21-25, 1996. Completed
recall resulted from sample analysis and
follow up by the New York State Department of
Agriculture Markets.
DISTRIBUTION New Jersey, Massachusetts.
QUANTITY Approximately 2,020 cases were distributed;
firm estimates none remains on the market.
REASON Product contained undeclared FD&C Yellow No. 5
and FD&C Yellow No. 6.

-2-_______________
PRODUCT Tofutti brand Non Dairy Original Premium
Frozen Dessert, Chocolate Cookie Crunch
Flavor, in 1-pint containers.
Recall #F-027-7.
CODE 42097-42698 and 42097-62698.
MANUFACTURER Kemps Foods, Inc., Lancaster, Pennsylvania.
RECALLED BY Tofutti Brands, Inc., Cranford, New Jersey, by
telephone followed by letter dated July 23,
1996, and by press release dated June 19,
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 2,880 units were distributed; firm estimates
none remains on the market.
REASON Product contained undeclared almonds.

_______________
PRODUCT Various flavors and varieties of ice cream, in
3 gallon tubs, half gallon and quart size
plastic containers:
(a) Toffee Bar Krunch Ice Cream
(b) Chocolate Almond Ice Cream
(c) Pistachio Almond Ice Cream
(d) Bubble Gum Ice Cream.
Recall #F-032/035-7.
CODE All misbranded product.
MANUFACTURER M.B.B. Annis Dairy of Avon, Inc., Avon, New
York.
RECALLED BY Manufacturer, by telephone on September 20,
1996. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY (a) 58 3-gallon, 6 half-gallon; (b) 214 3-
gallon, 17 half-gallon, 10 quart size
containers; (c) 69 3-gallon, 8 half-gallon
size containers; (d) 65 3-gallon, 1 half-
gallon size containers were distributed.
REASON The products bear partial ingredient
statements which list the ice cream base
ingredients only. The nuts or color additive
in these products are not listed in the
ingredient statement and there is a potential
for consumers sensitive to the nuts to think
the product is merely flavored and does not
contain the actual allergen. Products (a),
(b), and (c) contain almonds; and product (d)
contains FD&C Yellow No. 5.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Minute Maid Premium Calcium-Rich Orange Juice,
in 64 ounce gable-top cartons.
Recall #F-026-7.
-3-CODE Lot Number:
Container: OCT22PWY XXX CT349
Y= A,B or Filler
XXXX= Time
Shipping Case: OCT22T33407B.
MANUFACTURER Coca-Cola Foods, Paw Paw, Michigan.
RECALLED BY Coca-Cola Foods, Houston, Texas, by telephone
on August 30, 1996. Firm-initiated recall
complete.
DISTRIBUTION Wisconsin, Michigan, Pennsylvania, Iowa,
Illinois, Kentucky, Ohio, Minnesota, Nebraska,
Indiana, Missouri.
QUANTITY 4,425 cases were distributed.
REASON Product is contaminated with yeast.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Sulfatrim Pediatric Suspension
(Sulfamethoxazole and Trimethoprim, USP), in
one pint bottles, used for the treatment of
urinary infections due to susceptible organism
strains, for the treatment of acute otitis
media in children due to susceptible strains
of streptococcus pneumoniae or haemophilus
influenzae, under the Barre-National and
Schein Pharmaceutical labels.
Recall #D-027-7.
CODE Lot #RJ4459 0364-2077-16.
MANUFACTURER Alpharma, U.S. Pharmaceuticals Divisions, also
known as Barre-National, Inc., Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter on or about June 3,
1996. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 3,948 Schein labeled product was distributed.
REASON Some units may appear brown in color with a
licorice flavor instead of red and cherry-
flavored. Taste/color change may be caused by
degradation.

_______________
PRODUCT Glaxo Wellcome brand (a) Zovirax Sterile
Powder for Injection (Acyclovir Sodium), 1000
mg/vial, in 20 ml vials, used in the treatment
of herpes; (b) Mivacron Injection (Mivacurium
Chloride), in 2 mg/ml, 20 ml multi-dose vials
for IV administration, a non-depolarizing
skeletal muscle relaxant.
Recall #D-029/030-7.

-4-CODE Lot numbers: (a) 5W3017, 5W3018, 5X3021. A
portion of lot 5W3017 was packaged and
distributed in Canada as lot #5K190;
(b) Lot numbers: 5S3014, 602362, 6S1819.
A portion of lot #602362 was packaged and
distributed in Canada as lot #6E592.
MANUFACTURER Glaxo Wellcome, Inc., Research Triangle Park,
North Carolina.
RECALLED BY Manufacturer, by letter delivered during the
week of October 21, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY (a) Lot 5W3017 - 23,470 vials in the U.S. and
12,107 vials in Canada; estimate none remains
on the market; 25,240 vials of lot 5W3018 in
the U.S., estimate none remains on the market.
There were 35,520 vials of lot 5X3021
distributed in the U.S., firm estimates 15,000
remain on the market; (b) Lot 5S3014 --
44,810 vials were distributed in the U.S. and
estimate none to be on the market; 25,900
vials of lot 6O2362 were distributed in the
U.S. and 4,800 in Canada, firm estimate 13,000
vials to be on the market in the U.S. and
1,000 on the market in Canada; 54,160 vials of
lot 6S1819 distributed in the U.S., with an
estimated 11,000 vials still on the market.
REASON (a) Defects in the glass vials may result in
product contamination and/or problems with
reconstitution; (b) Defects in the glass may
result in product contamination.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Imipramine Hydrochloride Tablets, USP, 10 mg,
in bottles of 100 and 1000, Rx for the relief
of symptoms of depression, under the following
labels: Par Pharmaceutical, United Research
Laboratories, Martec Pharmaceutical, Parmed
Pharmaceutical. Recall #D-028-7.
CODE control number C28494, EXP 9/96.
MANUFACTURER Par Pharmaceutical, Inc., Spring Valley, New
York.
RECALLED BY Manufacturer, by letter on July 11, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 1,250 bottles of 100 and 279 bottles of 1000
tablets were distributed; firm estimated that
little or no product remained on market at
time of recall initiation.

-5-REASON Product is not stable: This lot failed
dissolution test (72%; Spec is NLT 75%) at the
12-month stability timepoint.

_______________
PRODUCT Purepac Pharmaceutical brand Metoprolol
Tartrate Tablets, USP 50 mg, in bottles of
1000, Rx indicated for the treatment of
hypertension and angina. Recall #D-031-7.
CODE Lot #187A6 EXP 2/98.
MANUFACTURER Faulding Pharmaceutical Company (Purepac
Pharmaceutical Co.), Elizabeth, New Jersey.
RECALLED BY Manufacturer, by letter on July 19, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,128 bottles were distributed; firm estimated
that 980 bottles remained on market at time of
recall initiation.
REASON Some tablets may be overweight and
superpotent.

_______________
PRODUCT Cimetidine Tablets, USP, 800 mg; an oral Rx
drug used in the treatment of ulcers, erosive
gastroesophageal reflux disease, and the
treatment of pathological hypersecretory
conditions; packaged under the following
labels and package sizes:
(a) Novopharm, manufactured for: Novopharm
USA, Schaumburg, IL, in 500 tablet bottles,
(b) H.L. Moore, distributed by: H.L. Moore
Drug Exchange, New Britain, Conn., in 100
tablet bottles
(c) W/C Warner Chilcott, manufactured for
Warner Chilcott Labs, Div. of Warner-Lambert
Co., Morris Plains, NJ USA, in 100 tablet
bottles
(d) Schein Pharmaceutical Inc., manufactured
for Schein Pharmaceutical, Inc., Florham Park,
NJ 07932 USA, in 100 tablet bottles
(e) Martec Pharmaceutical Inc.; manufactured
for Martec Pharmaceutical, Inc., Kansas City,
MO in 100 tablet bottles
(f) GG, distributed by Geneva Pharmaceuticals,
Inc., Broomfield, CO, in 100 tablet bottles,
(g) Warrick Pharmaceuticals, Manufactured by:
Novopharm Ltd., Toronto, Canada, Warrick
Pharmaceuticals Corporation, Niles, Illinois,
in 100, 500, and 1000 tablet bottles.
Recall #D-032-7.

-6- CODE Lot 55476 EXP 1/97. Note: The lot number has
various suffixes, dependent on the bottle
size, i.e. 55476A, 55476B, 5547640, 5547670,
and 5547680.
MANUFACTURER Novopharm Ltd., Scarborough, Ontario, Canada.
RECALLED BY Novopharm USA, Inc., Schaumburg, Illinois, by
letter dated October 18, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9,010 bottles of 100 tablets, 698 bottles of
500 tablets and 265 bottles of 1000 tablets
were distributed, with the firm estimating
that very little, if any, remains on the
market.
REASON Lot failed dissolution test at the 18-month
stability timepoint.

_______________
PRODUCT Parke-Davis brand Phenelzine Sulfate Tablets,
USP Nardil, 15 mg, in bottles of 100, Rx used
in the treatment of depression.
Recall #D-033-7.
CODE Lot #07425D.
MANUFACTURER The Park-Davis Division of Warner-Lambert
Company, Morris Plains, New Jersey.
RECALLED BY Manufacturer, by letter on June 17, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 18,432 bottles were distributed.
REASON Lot failed content assay (subpotent) at the
12-month stability timepoint.

_______________
PRODUCT Parke-Davis brand Procanbid, Procainamide HCl
Extended Release Tablets, 1000 mg, Rx, in
bottles of 60, indicated for the treatment of
documented ventricular arrhythmias.
Recall #D-034-7.
CODE Lot #788N5D EXP 8/98.
MANUFACTURER The Parke-Davis Division of Warner-Lambert
Company, Morris Plains, New Jersey.
RECALLED BY Manufacturer, by letter on June 18, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9,747 bottles were distributed; firm estimates
none remains on the market.
REASON Lot failed dissolution test (low at the 8-hour
interval) at the 3-month stability timepoint.

-7-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I ========
_______________
PRODUCT Albuminar Albumin (Human), U.S.P, (a)
Albuminar - 25 (Albumin 25%, Human, USP); (b)
Albuminar - 5 (Albumin 5%, Human, USP).
Recall #B-001/002-7.
CODE (a) 25% 50 ml - lot P61205 EXP 12 MAY 99,
M60902 EXP 09 FEB 97, M54512 EXP 02 DEC 97;
100 ml - lot L58211 EXP 12 NOV 96, M61403 EXP
28 FEB 97, M63204 EXP 14 APR 97, M54912
EXP 05 DEC 97, P61805, EXP 22 MAY 99.
(b) 5% 50 ml - lot P18607 EXP 26 JUN 99
500 ml - lot L8212 EXP 20 DEC 96.
MANUFACTURER Centeon L.L.C., Kankakee Industrial
Operations, Kankakee, Illinois.
RECALLED BY Centeon L.L.C., King of Prussia, Pennsylvania,
by telephone on September 20 and 23, 1996,
followed by letter. Firm-initiated recall
ongoing. See also FDA talk papers T96-65,
October 3, 1996, and T96-69, October 9, 1996.
DISTRIBUTION Nationwide and international.
QUANTITY 18,508 50-ml vials and 1,677 500-ml vials of
5%, and 52,759 50-ml vials and 42,957 100-ml
vials of 25% were distributed. The firm
estimates that 18,000 vials remained on market
at time of recall initiation.
REASON Biological products which either tested
positive for Enterobacter cloacae and is
associated with cases of septicemia or the
vials may have been damaged during product
handling possibly resulting in cracked vials.
Cracked vials have the potential for microbial
contamination.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF.
Recall #B-032/033-7.
CODE Unit #KC34846.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on February 8,
1996. March 12, 1996. Firm-initiated recall
complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the
antibody to the human T-lymphotropic virus
type I (anti-HTLV-I), were collected from a
donor who previously tested repeatedly
reactive for anti-HTLV-1, Western blot
indeterminate, and RIPA reactive.

-8-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Recovered Plasma. Recall #B-034-7.
CODE Unit #KC34846.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by fax on March 12, 1996. Firm-
initiated recall complete.
DISTRIBUTION Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for the antibody
to the human T-lymphotropic virus type I
(anti-HTLV-I), but was collected from a donor
who previously tested repeatedly reactive for
anti-HTLV-1, Western blot indeterminate, and
RIPA reactive.

_______________
PRODUCT Red Blood Cells. Recall #B-035-7.
CODE Unit numbers: 4435375 and 4435381.
MANUFACTURER Inland Northwest Blood Center, Spokane,
Washington.
RECALLED BY Manufacturer, by letter dated July 12, 1995.
Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 2 units were distributed.
REASON Blood products were collected from donors for
which donor suitability was not adequately
determined.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Surgitek and Microvasive brand Gastrostomy
feeding tube kits:
(a) (Surgitek) Surgi-Peg Initial Placement
Gastrostomy Tray, Pull System, 15 FR size;
(b) Surgi-Peg Replacement Gastrostomy Device,
15 FR size; and the Microvasive brand, Initial
Placement Gastrostomy Kit, Pull Method, 15 FR
size, and the Microvasive brand, Initial
Placement Gastrostomy Kit, Guidewire Method,
15 FR size. Recall #Z-030/031-7.
CODE (a) (Surgitek) Surgi-Peg Pull System, Product
Code #1101115, Box Lot #9505412, Tray Lot
#9562511; (Microvasive) Pull Method, Product
Code #6415, Box Lot #9625101 and #957312, Tray
Lot #9562611 and #9512512; (Microvasive)
Guidewire Method, Product Code #6416, Box Lot
#9653901, #9627501, and #9627801, Tray
Lot #9560012 and #9557712;
(b) Product Code #1102315, Box Lot #9626001,
Tray Lot #9523812.

-9-MANUFACTURER Applied Medical Technology, Independence,
Ohio.
RECALLED BY Manufacturer, by letter dated January 24,
1996. Firm-initiated recall complete.
DISTRIBUTION Massachusetts and Wisconsin.
QUANTITY Firm estimates none remains on the market.
REASON The bolsters used for these kits had been
punched with 20FR holes rather than the
correct 15FR holes.

_______________
PRODUCT Surgitek brand Surgi-Peg Initial Placement
Gastrostomy Tray - Pull System, 15 FR size,
gastrostomy feeding tube kits.
Recall #Z-032-7.
CODE Product #1101115, box lot #9520108, tray lot
#9530307.
MANUFACTURER Applied Medical Technology, Independence,
Ohio.
RECALLED BY Manufacturer, by letter dated October 5, 1995,
and by telephone on September 30, 1996. Firm-
initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY Firm estimates none remains on the market.
REASON The bolsters used for these kits had been
punched with 20FR holes rather than the
correct 15FR holes.

_______________
PRODUCT Signature Edition Infusion Pumps, Models 7100
and 7200. Recall #Z-034/035-7.
CODE All pumps.
MANUFACTURER Ivac Medical Systems, Inc. San Diego,
California.
RECALLED BY Manufacturer, by recall notification dated
August 8, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 4,069 units were distributed.
REASON A defective pressure sensing system causes the
pump to alarm and shutdown, and in some
situations not restart until the instrument is
serviced.

_______________
PRODUCT Sterile Gauze Sponges, 4" x 4", Reorder #4482.
Recall #Z-057-7.
CODE Lot #1407122.
MANUFACTURER China National Medicines & Health Products
Import & Export Corporation, Yangzhou, China.
RECALLED BY Dav-Mar Medical Products, Inc. (D.M.M.P.),
Yonkers, New York, by letter dated September
17, 1996. Firm-initiated recall ongoing.
-10-DISTRIBUTION New York, New Jersey, Connecticut.
QUANTITY 1,355 cases were distributed; firm estimates
none remains on the market.
REASON Sponges were found to be non-sterile by FDA
analysis.

_______________
PRODUCT Newport Breeze Ventilator, Model #E150.
Recall #Z-058-7.
CODE Serial numbers 8908BR021J through 8908BR021J
and 8903BR001 through 9103JB100.
MANUFACTURER Newport Medical Instruments, Inc., Costa Mesa,
California.
RECALLED BY Manufacturer, by letter June 28, 1991. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 752 units were distributed.
REASON The diaphragm on the spontaneous flow valve
may rupture or leak, possibly resulting in
hypoxemia to the patient.

_______________
PRODUCT Sphygmomanometer, blood pressure meter.
Recall #Z-060-7.
CODE All lots shipped to Ciba-Geigy, Summit, NJ on
or about August 1995.
MANUFACTURER Kam Ma Trading Company, a subsidiary of Golden
Pacific Industrial Ltd., Tsuen Wan, Hong Kong.
RECALLED BY BHS International, Crofton, Maryland
(importer), by letter dated September 23,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 27,000 units were distributed.
REAS0N The device was being marketed without a
cleared premarket notification submission
under section 510(k) of the Act.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT BacT/View Software Version A.00, distributed
as a part of the BacT/VIEW Manual/Software
Assemblies, Part numbers 22105-16 and 22111-4,
used with Organon Teknika's BacT/Alert and
MB/Bact Microbial Detection Systems' data
management system. Recall #Z-038-7.
CODE All units.
MANUFACTURER Organon Teknika, Oklahoma, City, Oklahoma.
RECALLED BY Manufacturer, by issuing a "Technical Bullet"
dated September 5, 1996, and by letter
September 13, 1996. Firm-initiated field
correction complete.

-11-DISTRIBUTION Nationwide.
QUANTITY 34 domestic BacT/Alert and MB/AacT units had
been upgraded with BacT/VIEW A.00 software.
REASON The computerized data bases of BacT/Alert and
MB/BacT Microbiological Detection Systems
running BacT/VIEW software may become
corrupted and the system may stop reporting
sample results.

_______________
PRODUCT Total Bilirubin Test Kit, for the quantitative
determination of total bilirubin in serum.
Recall #Z-039-7.
CODE Lot numbers: 60941 EXP 4/98 and 61441 EXP
5/98.
MANUFACTURER Horizon Diagnostics, Inc., Ann Arbor,
Michigan.
RECALLED BY Manufacturer, by letter dated September 23,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,135 kits were distributed.
REASON Product may not contain a validated standard
at the concentration stated on the label,
which could yield inaccurate results.

_______________
PRODUCT LuMax Cystometry System with Uroflow and
Volume Infused Options, used to measure
pressures in the bladder, abdomen, and urethra
for the diagnosis of urinary incontinence,
bladder outflow obstruction, and other bladder
disorders. Recall #Z-052-7.
CODE Only units with the volume infused transducer
option are affected.
MANUFACTURER MedAmicus, Inc., Minneapolis, Minnesota.
RECALLED BY Manufacturer, by letter on October 7, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Alabama, California, Colorado, Florida,
Georgia, Maryland, North Carolina, New York,
Pennsylvania, Tennessee, Texas, Utah, West
Virginia.
QUANTITY 23 units were distributed.
REASON The amount of liquid infused into the bladder
to perform tests may be recorded erroneously
high.

_______________
PRODUCT CLOTrac RACT Abnormal Coagulation Control,
used to confirm the performance of Automated
Coagulation Timers, or other versions and
methodologies for performing a recalcified
activated clotting time test.
Recall #Z-055-7.
-12-CODE Lot #9608000094.
MANUFACTURER Medtronic Blood Management, Parker, Colorado.
RECALLED BY Manufacturer, by letter on September 23, 1996,
followed by telephone on September 26-27,
1996. Firm-initiated recall ongoing.
DISTRIBUTION California, Florida, Iowa, Michigan,
Mississippi, New York, Texas, Washington
state.
QUANTITY 36 boxes (540 units) were distributed.
REASON The clotting range listed in the package
insert for this lot number is higher than the
actual clotting range for this control. Use
of this control will indicate that the device
is out of calibration.

_______________
PRODUCT Herpes Simplex Virus (HSV)-CF Antigen.
Recall #Z-056-7.
CODE Catalog #CF-02-05, Lot numbers 02009A and
02011E1.
MANUFACTURER Microbix Biosystems, Inc., Toronto, Ontario,
Canada.
RECALLED BY Manufacturer, by letter followed by telephone
on August 22, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 11 vials.
REASON Testing revealed a potential loss of
stability.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II ====
_______________
PRODUCT Cyanamid Aureomycin Sulmet Soluble Powder
(chlortetracycline HCl and sulfamethazine
bisulfate), in 4 ounce pouches, antibacterial
for oral veterinary use in swine only..
Recall #V-018-7.
CODE Lot #950780 EXP 5/99.
MANUFACTURER PM Resources, Inc., Bridgeton, Missouri.
RECALLED BY American Cyanamid Company, Fort Dodge, Iowa,
by letter on September 17, 1996. Firm-
initiated recall complete.
DISTRIBUTION Indiana, Iowa, Missouri, Nebraska, North
Carolina, Wisconsin.
QUANTITY 279 40-pouch pails were distributed.
REASON Sulfamethazine levels were below
specifications at 12 months stability. Low
sulfamethazine potency was attributed to low
formulation by the manufacturer.

####
END OF ENFORCEMENT REPORT FOR NOVEMBER 6, 1996. BLANK PAGES MAY FOLLOW.
-13-

End of Enforcement Report for