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.
January 5, 2000 00-01
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________
PRODUCT
Todd's Sugar Free Taffy, in 6-ounce cartons.
Recall #F-080-0.
CODE
None.
MANUFACTURER
McKeesport Candy Company, Inc., doing business as Todd's Candy,
McKeesport, Pennsylvania.
RECALLED BY
Manufacturer, by telephone, followed by visits on or about
November 17, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Pennsylvania and Ohio.
QUANTITY
Firm estimated that 200 units remained on market at time of
recall initiation.
REASON
Taffy contains undeclared FD&C Yellow No. 6.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________
PRODUCT
Pacific Friend Water Chestnuts, sliced and whole, in 8-ounce
cans. Recall #F-079-0.
CODE
Embossed in can:
Sliced: L71/96 12 03/8241, L71/96 12 09/8241, L71/96 12 10/8241,
L71/96 12 12/8241, L71/96 12 13/8241, L71/96 12 14/8241, L71/96
12 16/8241, L71/96 12 18/8241
Whole: L71/96 12 15/8241, L71/96 12 19/8241.
L71/96 12 30/8241, L71/97 01 03/8241.
MANUFACTURER
Jinhua Canned Food Factory, Jinhua, China.
RECALLED BY
Mulsen Trading Company, Seattle, Washington, by telephone, and by
fax dated October 18, 1999. Ongoing recall resulted from sample
analysis and follow-up by the Oregon State Department of
Agriculture.
DISTRIBUTION
Washington state, Montana, Oregon.
QUANTITY
4,528 cases (24 8-ounce cans) of sliced and 299 cases of whole
water chestnuts were distributed.
REASON
Product was contained in swollen and leaking cans. FDA analyses
found the cans have pinholes and are rusted on the inside.
________
PRODUCT
Acetaminophen Tablets Extra Strength, 500 mg, bottles of 100, OTC
pain reliever under the following brand names:
a) ARBOR brand NON-ASPIRIN PAIN RELIEF EXTRA STRENGTH.
Distributed by Arbor Drugs, Inc., Troy, Michigan.
NDC 50165-405-78.
b) Chateau brand EXTRA STRENGTH Non-Aspirin Tablets,
Distributed by Preferred Products, Inc., Eden Prairie, MN.
[label bears no NDC#].
c) Drug Guild brand EXTRA STRENGTH NON-ASPIRIN PAIN RELIEF,
Distributed by Drug Guild Distributors, Inc., Secaucus, New
Jersey. [label bears no NDC#].
d) Equate brand extra strength NON-ASPIRIN PAIN & FEVER RELIEF.
Manufactured by Perrigo Co., Allegan, MI.
[Label bears no NDC#].
e) FOOD LION brand Extra Strength PAIN RELIEVER, Distributed by
Food Lion, Inc., Salisbury, NC 28144.
[Label bears no NDC#].
f) GOOD SENSE brand EXTRA STRENGTH NON-ASPIRIN PAIN RELIEVER,
Perrigo, Allegan, MI. [Label bears no NDC#]
g) Kroger brand EXTRA STRENGTH Pain Reliever Acetaminophen, 500
mg, Distributed by The Kroger Co., Cincinnati, Ohio. [label
bears no NDC#].
h) Marquee brand EXTRA STRENGTH Non-Aspirin Pain Reliever-Fever
Reducer Acetaminophen, 500 mg, Distributed by Fleming Companies,
Inc., Oklahoma City, OK 73216.
NDC 11205-405-78.
i) NEX brand EXTRA STRENGTH Pain Reliever Acetaminophen, 500 mg,
Distributed by Nexcom, Virginia Beach, Virginia. [label bears no
NDC#].
j) Shurfine brand EXTRA STRENGTH Non-Aspirin, 500 mg Distributed
by Shurfine International, Inc., Northlake, IL 60164-1889.
[label bears no NDC#].
k) spartan brand extra strength pain reliever without aspirin
Acetaminophen - Strong Pain & Fever Relief, 500 mg, Distributed
by Spartan Stores, Inc., Grand Rapids,
Michigan. NDC 11213-405-78.
l) STOP & SHOP brand PAIN RELIEF, 500 mg, Distributed by Stop &
Shop Supermarket Co., Boston, Massachusetts.
[label bears no NDC#].
m) TOP CARE brand EXTRA STRENGTH ASPIRIN FREE Pain Relief, 500
mg., Distributed by Topco Associates, Inc., Skokie,
Illinois NDC 36800-405-78. Recall #D-187-0.
CODE
Lot #8EC037.
MANUFACTURER
Perrigo Company, Allegan, Michigan.
RECALLED BY
Manufacturer, by letter dated November 19, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
44,736 bottles of 100 were distributed.
REASON
Tablet discoloration due to mold (penicillin).
________
PRODUCT
Ammonia Inhalants (Alcohol 35%, Ammonia 15%), in 0.33 mL ampoule,
12 units per box, used to prevent or treat fainting via nasal
inhalation. NDC #0839-8080-03. Recall #D-190-0.
CODE
Lot #3398C EXP 3/2003.
MANUFACTURER
James Alexander Corporation, Blairstown, New Jersey (contract
manufacturer/packager).
RECALLED BY
Moore Medical Corporation, New Britain, Connecticut, by letter
dated November 19, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Undetermined.
QUANTITY
282 packers (40,608 inhalants) were distributed.
REASON
Mislabeling - Holding carton incorrectly labeled as amyl nitrite.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________
PRODUCT
Hydromorphone HCL, USP, Rx bulk active ingredient.
Recall #D-159-0.
CODE
Lot Numbers: B1016-980201, B1016-980701, B1016-980802.
MANUFACTURER
Johnson Matthey, West Deptford, New Jersey.
RECALLED BY
Manufacturer, by telephone and letter on May 6, 1998, July 22,
1998, March 3, 1998, and November 17, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Minnesota, Colorado, Texas, Kansas.
QUANTITY
Firm estimates none remains on the market.
REASON
Black specks in product (graphite).
________
PRODUCT
SeptisolÆ Solution, Handwash, Triclosan 0.25%, in 8-ounce, 1-
quart, and 1-gallon plastic containers, OTC broad spectrum, fast
acting handwash to decrease the level of transient microorganisms
on the skin before contact with patients under medical care or
treatment. Recall #D-160-0.
CODE
217034 EXP 12/31/1999
217309, EXP 1/31/2000
218107, EXP 3/31/2000
218134, EXP 3/31/2000
218748, EXP 6/30/2000
219650, EXP 9/31/2000 and EXP 10/31/2000
220065, EXP 11/30/2000.
MANUFACTURER
Steris Corporation, St. Louis, Missouri.
RECALLED BY
Steris Corporation, Mentor, Ohio, by letter dated November 18,
1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
481 (48 8-fluid ounce bottle) cases, 2,426 (12 1-quart bottle)
cases, and 12,106 (4 1-galllon bottle) cases were distributed.
REASON
Subpotency (9-month stability).
________
PRODUCT
Klaron (r) Lotion (Sodium sulfacetamide), 10%, in 2-ounce and 8-
mL units, Rx indicated for the topical treatment of acne vulgaris
in individuals who have sensitive skin.
Recall #D-161-0.
CODE
Lot 85292 EXP 1/00 and Lot 84899 EXP 9/99.
2 ounce bottles, NDC 0066-7500-02
8 ml bottles, NDC 0066-7500-11 -physician samples.
MANUFACTURER
Rhone-Poulenc Rorer Pharmaceuticals, Collegeville, Pennsylvania.
RECALLED BY
Manufacturer, by letter on November 22, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide and the Caribbean.
QUANTITY
Firm estimated that there were no trade units left on the market
and approximately 1000 (12 x 8 ml) units remained in the field at
time of recall initiation.
REASON
Subpotency at stability 21 months.
________
PRODUCT
NovolinÆ 70/30 PenFillÆ (70% NPH, Human Insulin Isophane
suspension 30% Regular, Human Insulin Injection-recombinant DNA
origin), 1.5 mL cartridges, 100 units/mL (U-100) in cartons of 5,
Rx, intended usage is for individuals diagnosed with diabetes
requiring injections of insulin as prescribed by their physician.
NDC #0169-1837-17.
Recall #D-185-0.
CODE
Lot Numbers: 9G14006 EXP 7/01 and 9J14015 EXP 9/01.
MANUFACTURER
Novo Nordisk A/S, Bagsvaerd, Denmark.
RECALLED BY
Novo Nordisk Pharmaceuticals, Inc., Princeton, New Jersey, by
letter dated September 7, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Approximately 11,816 cartons (5 cartridges/carton) were
distributed.
REASON
Mislabeling - Label lacks listing of phenol 0.068% as
ingredient/preservative.
________
PRODUCT
Acetaminophen Caplets Extra Strength, 500 mg, bottles of 100, OTC
pain reliever. Recall #D-186-0.
CODE
Lot #9JE0735 EXP 9/02.
MANUFACTURER
Perrigo Company, Allegan, Michigan.
RECALLED BY
Manufacturer, by letter dated November 24, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
71,100 bottles of 100 were distributed.
REASON
Mislabeling - Some bottles were incorrectly labeled as containing
ibuprofen (200 mg).
________
PRODUCT
Ibuprofen Tablets, 200 mg, bottles of 100, OTC pain reliever.
Recall #D-188-0.
CODE
Lot #9GE0151.
MANUFACTURER
Perrigo Company, Allegan, Michigan.
RECALLED BY
Manufacturer, by letter dated September 29, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
4,200 bottles were distributed.
REASON
Superpotency - Some tablets may be oversized.
________
PRODUCT
Muscle MagicÆ Topical Analgesic CrËme (Methyl Salicylate 10%,
Menthol 1%), in 16-ounce and 8-pound units, OTC intended for
effective temporary relief of minor pain and soreness of muscles
and joints. Recall #D-189-0.
CODE
Lot Numbers: 7H39 and 8E53.
NDC #0178-1105-16 - 16 ounces
NDC #0178-1105-08 - 8 ounces.
MANUFACTURER
Mission Pharmacal Company (MPC), San Antonio, Texas.
RECALLED BY
Manufacturer, by letter dated September 27, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nevada, New York, Pennsylvania, Texas.
QUANTITY
1,532 16-ounce and 408 8-pound containers were distributed.
REASON
Stability - Non-uniformity in potency results to support labeled
expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________
PRODUCT
Recovered Plasma. Recall #B-218-0.
CODE
Contact FDA, Center for Biologics Evaluation and Research, Office
of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER
UCLA Medical Center Blood Bank, Los Angeles, California.
RECALLED BY
Manufacturer, by telephone on September 1, 1999, and by fax on
September 2, 1999, followed by letter dated October 15, 1999.
Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
1,181 units were distributed.
REASON
Blood products were not tested for viral markers in accordance
with the test kit manufacturer's instructions.
________
PRODUCT
Plasma, Liquid. Recall #B-247-0.
CODE
Unit #04R45293.
MANUFACTURER
American Red Cross, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by telephone on August 12, 1999, and by letter
dated August 22, 1999. Firm-initiated recall complete.
DISTRIBUTION
Masschusetts.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor with a history of
hepatitis.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-264/265-0.
CODE
Unit #29FG69942.
MANUFACTURER
American Red Cross Blood Services, Norfolk, Virginia.
RECALLED BY
Manufacturer, by letter dated June 9, 1999. Firm-initiated
recall complete.
DISTRIBUTION
North Carolina.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from an unsuitable donor.
________
PRODUCT
Red Blood Cells. Recall #B-270-0.
CODE
Unit #1590828.
MANUFACTURER
Central Kentucky Blood Center (CKBC), Lexington, Kentucky.
RECALLED BY
Manufacturer, by letter dated September 24, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Kentucky.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor taking the drug Minocin.
________
PRODUCT
Various Human Tissue for Transplant including: Cancellous Chips,
Serrated Fibula Wedges, Iliac Crest Wedge, Fibula Shaft, Fascia
Lata, Semitendinosis Tendon, Femur Proximal Right, Acetabulum
Right, Cortical Cancellous Granules, Cortical Cancellous Chips,
Achilles Tendon, Bone Tendon, Humerus Whole Left with Cuff,
Humerus Whole Right with Cuff, Putty, Femoral Cross Section with
Dowel, Patella Wedge, Femoral Head, Allogenic Bone Matrix, Illium
Bicort
Strip. Recall #B-277-0.
CODE
Donor Numbers: 03610788 (54 tissues), 03606576 (47 tissues),
03612141 (12 tissues).
MANUFACTURER
Musculoskelatal Transplant Foundaton, Edison, New Jersey.
RECALLED BY
Manufacturer, by telephone and letter on March 25, 1999, and
letter dated September 28, 1999, followed by telephone. Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Donor Numbers: 03610788 (54 tissues), 03606576 (47 tissues),
03612141 (12 tissues).
REASON
Tissues for transplant, which were incorrectly tested for HBsAg,
or anti-HIV-1/2, were distributed.
_________
PRODUCT
Platelets. Recall #B-286-0.
CODE
Unit #1597234.
MANUFACTURER
Central Kentucky Blood Center (CKBC), Lexington, Kentucky.
RECALLED BY
Manufacturer, by letter dated October 6, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Kentucky.
QUANTITY
1 unit was distributed.
REASON
A unit of platelets was prepared from a whole blood unit
collected from a donor who had taken aspirin within 72 hours of
donation.
________
PRODUCT
Platelets, Pheresis, Leukocyte Reduced. Recall #B-290-0.
CODE
Unit #4056616.
MANUFACTURER
Community Blood Center, Dayton, Ohio.
RECALLED BY
Manufacturer, by telephone on August 26, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product had an inadequate rest time.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-295/297-0.
CODE
Unit #042Y98571.
MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letter dated October 11, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Ohio and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products tested negative for anti-HCV but were collected
from a donor who previously tested reactive for anti-HCV, RIBA
indeterminate.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________
PRODUCT
Red Blood Cells. Recall #B-275-0.
CODE
Unit #049Y57565.
MANUFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY
Manufacturer, by telephone on January 30, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Oklahoma.
QUANTITY
1 unit was distributed.
REASON
Blood product was tagged as crossmatched that had not been
crossmatched.
________
PRODUCT
Red Blood Cells, Leukodepleted, Washed. Recall #B-287-0.
CODE
4360420, 1095560, 2278498.
MANUFACTURER
New York Blood Services (Center West), A Division of New York
Blood Center, Inc., New York, New York.
RECALLED BY
Manufacturer, by telephone on September 1, 1999. Firm-initiated
recall complete.
DISTRIBUTION
New York.
QUANTITY
3 units were distributed.
REASON
Red Blood Cells, leukoreduced by filtration greater than five
days past the time of collection were distributed for
transfusion.
________
PRODUCT
Fresh Frozen Plasma, Pheresis. Recall #B-291-0
CODE
Unit #3444193.
MANUFACTURER
Gulf Coast Regional Blood Center, Houston, Texas.
RECALLED BY
Manufacturer, by fax on August 24, 1998. Firm-initiated recall
complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
A pheresis blood product with discrepant collection times was
distributed.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-306/307-0.
CODE
Unit #22404-2629.
MANUFACTURER
Blood Services, Inc., Henderson, Nevada.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letters dated April
22, 1999, and June 8, 1999. Firm-initiated recall complete.
DISTRIBUTION
Nevada and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who received a tissue
transplant within a year of donation.
________
PRODUCT
Julian Anesthesia Machine. Recall #Z-226-0.
CODE
Catalog #8601110.
MANUFACTURER
Drager Medizintechnik GMBH, Luebeck, Germany.
RECALLED BY
North American Drager, Telford, Pennsylvania, by letter on
October 1, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Pennsylvania and California.
QUANTITY
8 units were distributed.
REASON
The oxygen can contaminate the air supply line and/or air can
contaminate the oxygen supply line under certain conditions.
________
PRODUCT
Nu-TRAKE Emergency Cricotyrotomy Device, Catalog #B10100.
Recall #Z-250-0.
CODE
Lot #754870.
MANUFACTURER
Bivona Medical Technologies, Division of UroQuest Medical
Corporation, Gary, Indiana.
RECALLED BY
Manufacturer, by telephone and letter on August 11, 1999, and by
fax. Firm-initiated recall complete.
DISTRIBUTION
Nationwide, Canada, Germany, The Netherlands.
QUANTITY
499 units were distributed.
REASON
The cannula body may be missing in unopened packages.
________
PRODUCT
Heart Access Plus, a portable, battery-operated, cardiac memory
electrocardiogram (ECG) event recorder and a voice diary. Recall
#Z-289-0.
CODE
All units shipped between 5/11/98 to 7/15/99 (PLEASE CHECK)
MANUFACTURER
Paceart Asscoiates, L.P , Fairfield, New Jersey.
RECALLED BY
Manufacturer, by letter on or about July 23, 1999, and by Product
Information Bulletin dated July 23, 1999. Firm-initiated field
correction ongoing.
DISTRIBUTION
Delaware, Florida, Maryland, New York, Australia, China.
QUANTITY
35 units were distributed.
REASON
The device fails to comply within performance standard for
electrode lead wires and patient cables, 21 CFR 898.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________
PRODUCT
Sterile Drape Bag and Coupler for Endoscopic Camera System.
Recall #Z-263-0.
CODE
Lot Numbers: 08484C1585, 0885C2088, 09215C0297, 09296C0895.
MANUFACTURER
Advanced Medical Designs, Marietta, Georgia.
RECALLED BY
Manufacturer, by letter on July 7, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide, Canada, Australia.
QUANTITY
5,540 units were distributed.
REASON
The assembled components were inadequately glued resulting in the
plastic lens cap separating from the sterile drape bag.
________
PRODUCT
IMMUNOCARD TOXIN A, a rapid enzyme immunoassay for the detection
of Clostridium difficile Toxin A in human stool.
Recall #Z-286-0.
CODE
Kit Catalog Number: 711050.
Kit Lot Numbers: 711050.116, 711050.117, 711050.118, and
711050.119. Exp Date: 9/23/2000 (same for all 4 lots).
MANUFACTURER
Meridian Diagnostics, Inc., Cincinnati, Ohio.
RECALLED BY
Manufacturer, by letter on December 22, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide, Canada, Japan, Germany, Italy.
QUANTITY
597 kits were distributed.
REASON
The substrate reagent exhibits a blue color which may affect
final test results.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
________
PRODUCT
Chorionic Gonadotropin for Injection, Rx veterinary medication
indicated for parenteral use in cows for the treatment of
nymphomania (frequent or consistant "heat") due to cystic
ovaries:
a) Veterinary Chorionic Gonadotropin for Injection, distributed
under the labels of Steris Laboratories and The Butler Company
(10,000 units per sterile 10 ml multiple dose monovial)
b) MU-SE brand of Selenium & Vitamin E for Injection, in 100 ml
vial; MYOSEL-M brand of Selenium & Vitamin E for Injection, in
100 ml vial sold under two labels - Schering -Plough Animal
Health and Professional Pharmaceutical Corporation. Recall #V-
055/056-0.
CODE
a) Steris - 97H670, 97J190, 97J410, 97K710, 98A310, 98B560
Butler - 97J410 and 97J150
b) Schering and PPC - 97H710, 97J241, 97K530, 97L040, 97L040,
97L260, 97L820, 97M120 97M130, 97M200, 97M340, 98A980, 98A900,
98B010, 98B020, 98B030, 98B040, 98D340, 98D500, 98D690, 98E250,
98E320, 98E370, 98E490, 98E550, 98E560, 98E610, 98E670, 98E850.
MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY
Manufacturer, by letter dated October 8, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
a) LOT # EXPIRY FINAL YIELD*
97H670 9-99 6,375
97J190 9-99 5,925
97J410 9-99 16,077
97J510 11-99 3,995
97K710 10-99 10,400
98A310 1-00 14,995
98B560 2-00 10,975
b) LOT # EXPIRY FINAL YIELD*
97H710 10-99 7,242
97J241 10-99 6,957
97K530 11-99 6,982
97L040 11-99 7,256
97L260 12-99 7,037
97L820 12-99 6,983
97M120 12-99 7,086
97M130 12-99 7,203
97M200 12-99 7,211
97M340 12-99 7,143
98A980 2-00 7,248
98A990 2-00 7,309
98B010 3-00 7,207
98B020 3-00 6,933
98B030 4-00 7,211
98B040 4-00 7,291
98D340 4-00 7,324
98D500 5-00 7,194
98D690 5-00 7,164
98E250 6-00 7,230
98E320 5-00 6,981
98E370 5-00 7,117
98E490 6-00 7,246
98E550 6-00 6,896
98E560 6-00 5,700
98E610 7-00 6,678
98E670 7-00 7,067
98E850 7-00 7,260
* = Final Yield Is Quantity Yielded After Inspection, Samples
Pulled, And Rejects Discarded.
REASON
Products were manufactured under significant deviations from
current good manufacturing practice regulations.
________
PRODUCT
Loweís 40% Hog Concentrate - swine feed for mixing grower and
finisher rations, in 50-pound bulk bags.
Recall #V-057-0.
CODE
All codes between August 1, 1999 and November 23, 1999.
MANUFACTURER
Lowe's Feed & Grain, Inc., Bowling Green, Kentucky.
RECALLED BY
Manufacturer, by letter dated November 18, 1999, and by
telephone. Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
12.46 tons were distributed.
REASON
Product contained protein derived from mammalian tissue and
according to regulation must bear the statement "Do not feed to
cattle or other ruminants" on the label. This regulation is
designed to prevent the establishment and amplification of BSE
through feed. This statement does not appear on the label.
________
PRODUCT
#1558100 Calf Primer II R30 - Medicated animal feed - bulk.
Recall #V-058-0.
CODE
Uncoded. All product distributed 7/30/99, 8/6/99 and 8/17/99.
MANUFACTURER
Land O'Lakes, Inc., Washington Court House, Ohio.
RECALLED BY
Manufacturer, by telephone on August 17, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Ohio.
QUANTITY
11 tons were distributed
REASON
Products is superpotent in Rumensin (monensin).
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS - CLASS III
________
PRODUCT
Synovex Plus, implants for steers and heifers - contains 200-mg
trenbolone acetate and 28 mg estradiol benzoate - ten 10-dose
cartridges per pouch. Recall #V-059-0.
CODE
Lot # 605108 - EXP Mar 2001.
MANUFACTURER
Fort Dodge Animal Health, Fort Dodge, Iowa.
RECALLED BY
Manufacturer, by letter dated November 12, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nebraska, Missouri, Colorado, Texas, Idaho, Indiana, Iowa,
Kansas, Kentucky, Ohio, Pennsylvania and South Dakota.
QUANTITY
2,702 pouches were distributed.
REASON
Lot failed content uniformity testing.
________
PRODUCT
Nolvasan Antiseptic Ointment - 1% chlorhexidine acetate, in 1-
ounce tubes, 7-ounce plastic jars, and 16-ounce plastic jars, for
use a topical antiseptic ointment for dogs, cats and horses.
Recall #V-060-0.
CODE
371456, EXP Feb00 - 1-oz. Tube and 7-oz. Jar
371457, EXP Jan00 - 16-oz. Jar
371458, EXP Feb00 - 16-oz. Jar
371459, EXP Feb00 - 16-oz. Jar
371460, EXP Feb00 - 16-oz. Jar
371461, EXP Feb00 - 7-oz. Jar
371462, EXP Sep00 - 16-oz. Jar
371463, EXP Oct00 - 16-oz. Jar
371464, EXP Sep00 - 7-oz. Jar
371465, EXP Nov00 - 16-oz. Jar
371467, EXP Nov00 - 7-oz. Jar
371468, EXP Dec00 - 16-oz. Jar
371469, EXP Dec00 - 16-oz. Jar
371470, EXP Dec00 - 16-oz. Jar
371471, EXP Dec00 - 7-oz. Jar
371472, EXP Dec00 - 7-oz. Jar
371473, EXP Jan01 - 16-oz. Jar
371474, EXP Jan01 - 16-oz. Jar
371475, EXP Feb01 - 16-oz. Jar
371477, EXP Jun01 - 16-oz. Jar
371478, EXP Apr01 - 1-oz. Tube and 7-oz. Jar.
MANUFACTURER
Fort Dodge Animal Health, Fort Dodge, Iowa.
RECALLED BY
Manufacturer, by letter dated October 15, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
The firm has distributed the following approximate amounts of
product: 1-oz. Tubes - 27,074; 7-oz. Jars - 36,199;
16-oz. Jars - 36,276.
REASON
Product failed stability testing and is subpotent.
END OF ENFORCEMENT REPORT FOR JANUARY 5, 2000.
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