JANUARY 2004
PRODUCT Huston Wayne Horse Feed, Equine -
Maintenance, in 50 pound bags.
CODE 8/5/03 production date.
RECALLING FIRM/MANUFACTURER Cottage Grove Cooperative, Cottage Grove,
WI.
REASON Monensin, a drug intended only for use in cattle feed, was
present in horse feed and resulted in the deaths of 12 horses.
VOLUME OF PRODUCT IN COMMERCE 1,484 pounds.
DISTRIBUTION WI.
PRODUCT Liver Powder, Super Gallo (brand), 16 oz. bag.
CODE All codes.
RECALLING FIRM/MANUFACTURER Thomas Veterinary Drug, Tolleson, AZ.
REASON Product is not labeled "Do not feed to cattle or other
ruminants".
VOLUME OF PRODUCT IN COMMERCE 320.
DISTRIBUTION AR, NC, WV, KY, LA, TN, HI, CA and AL.
PRODUCT Optigen 1200 Controlled Release Nitrogen Protein Supplement. The
product is sold in 50 lb. bags and 2000 lb. "super sacks".
CODE 081903MPRA02, 081903PRA00, and 071803MBLI1.
RECALLING FIRM/MANUFACTURER CPG Nutrients, Adrian, PA.
REASON Product contains unapproved food additive.
VOLUME OF PRODUCT IN COMMERCE 6,931,280 lbs.
DISTRIBUTION Nationwide.
PRODUCT Grand Vite, Nutritional Supplement, in tubs.
5, 10 and 25 pounds. Designed for horses only. Recall # V-006-4.
CODE Lot 1473.
RECALLING FIRM/MANUFACTURER Grand Meadows, Inc., Orange, CA.
REASON Product contains prohibited animal protein and is not labeled to
prevent feeding to ruminants.
VOLUME OF PRODUCT IN COMMERCE 131 packages of 5, 10 and 25 pounds.
DISTRIBUTION Nationwide.
PRODUCT
a) Halter 15% Pig Meal, in 50 pound paper bags.
b) Halter 18% Layer Pellet, in 50 pound paper bags.
CODE No codes.
RECALLING FIRM/MANUFACTURER Halter Feed & Grain Inc., Massillon, OH.
REASON Animal feed that contains protein derived from mammalian tissue
was not labeled with the required BSE caution statement, "Do not feed to
cattle and other ruminants".
VOLUME OF PRODUCT IN COMMERCE 80 bags (4 tons).
DISTRIBUTION OH.
PRODUCT 3-Nitro 20, Roxarsone Type-A Medicated Article, packaged in
50-lb bags. Active ingredient is 3-Nitro-4-hydroxyphenylarsonic acid
(roxarsone) 20%.
CODE Lot Number: AB 720575, EXP 08-05.
RECALLING FIRM/MANUFACTURER Land O Lakes Inc., Washington Courthouse,
OH.
REASON Type-A Medicated Feed Article was shipped illegally to an
unlicensed Feed Mill.
VOLUME OF PRODUCT IN COMMERCE 20-50 Lb. bags.
DISTRIBUTION OH.
PRODUCT Animal feed component, bulk processed waste by-product (dryer
waste, wet waste, and vacuum waste) containing ruminant material. The label is
the bill of lading that accompanies the trailer with waste material.
CODE No Code.
RECALLING FIRM/MANUFACTURER Iams Co., Lewisburg, OH.
REASON The product is an ingredient for animal feed that contains
ruminant material and lacks the required BSE cautionary statement.
VOLUME OF PRODUCT IN COMMERCE 1,227,824 KG.
REASON OH and IN.
PRODUCT
a) Custom Blend Encore Complete Equine Supplement, packaged in 50-lb. bags.
b) Unlabeled 5-lb. white plastic jars of Interfarma CartiFlex, 4 jars per
case.
CODE
a) Lot #121931;
b) Lot #121832.
RECALLING FIRM/MANUFACTURER Ameri-Pac, Inc., Saint Joseph, MO.
REASON Product lacks the BSE warning statement
"Do Not Feed to Cattle or Other Ruminants".
VOLUME OF PRODUCT IN COMMERCE
a) 6/50-lb. bags;
b) 25/4/5-lb. bags.
REASON MN, and FL.
PRODUCT Entire Rabbit Ration packaged in 50 lb. bags.
CODE Lot number: F14933896.
RECALLING FIRM/MANUFACTURER Ranchway Feeds, Incorporated, Fort Collins,
CO.
REASON Rabbit feed contains high levels of Vitamin D, when formulation
calls for none.
VOLUME OF PRODUCT IN COMMERCE 8,000 pounds.
REASON CO, WY, and NM.
PRODUCT
a) "Whole Corn "Maiz Entero" in 50 lbs bags (205042). Animal
Feed manufactured using Corn (whole, chopped, pellets, mashed and/or crumble:
(All labels are in Spanish since product is for local distribution).
b) Chopped Corn "Maiz Partido" in 50 lbs bags (205142). Animal feed
manufactured using Corn (whole, chopped, pellets, mashed, and/or crumble: (All
labels are Spanish since product is for local distribution).
c) 16% Calf Ration feed for calf, pellets in 50 lbs. bags (217222) Animal Feed
manufactured using Corn (whole, chopped, pellets, mashed and/or crumble: (All
labels are in Spanish since product is for local distribution).
d) 18% Dairy Milk Producer, feed for dairy cattle, mashed product in 50 lbs
bags (231712) Animal feed manufactured using corn. All labels are in Spanish
since product is for local distribution.
CODE
a) 6476, 6477, 6491, 6492, 6511, 6526, 6563, 6564, 6573, 6574, 6575, 6603,
6604, 6610, 6625, 6630, 6631, 6652, 6657, 6660, 6661, 6678, 6710, 6711, 6726,
6727, 6741, 6742, 6768, 6776, 6777, 6793, 6805, 6818, 6826, 6827, 6849, 6850,
6884, 6885, 6927, 6928, 6952, 6953, 6975, 7003, 7010, 7011, 7040, 7041, 7070,
7071, 7082, 7083, 7120, 7121, 7137, 7140, 7150, 7155, 7156, 7162, 7205, 7222,
7223, 7231, 7249, 7250, 7259, 7265, 7270, 7271, 7308, 7309, 7390, 7391, 7424,
7439, 7440, 7441, 7469, 7500, 7516, 7524, 7538, 7539, 7561, 7578, 7579, 7593,
7594, 7602, 7606, 7616, 7617, 7621, 7622, 7702;
There is no expiration date.
b) 6478, 6493, 6512, 6520, 6537, 6565, 6576, 6577, 6605, 6611, 6632, 6653,
6662, 6679, 6708, 6709, 6728, 6739, 6740, 6778, 6794, 6806, 6828, 6851, 6875,
6886, 6910, 6926, 6954, 6976, 6990, 7004, 7012, 7042, 7064, 7072, 7073, 7118,
7119, 7138, 7157, 7190, 7214, 7232, 7251, 7252, 7272, 7289, 7310, 7381, 7392,
7393, 7409, 7410, 7421, 7437, 7438, 7470, 7492, 7501, 7517, 7536, 7540, 7557,
7580, 7589, 7601, 7623, 7669, 7670, 7703;
There is no expiration date.
c) 6800, 6967, 7569. There is no expiration date.
d) Uncoded.
RECALLING FIRM/MANUFACTURER Federacion de Asociaciones Pecuarias de P.R.
Inc., Mayaguez, PR.
REASON Laboratory analysis revealed the presence of FENITROTHION.
VOLUME OF PRODUCT IN COMMERCE 192,306 lbs.
REASON PR.
PRODUCT
Xylazine hydrochloride, 100 mg/ml, packaged in 50-ml. vials, NADA #139-236, RX.
The product is packaged under the following private labels: (1) AnaSed
Injectable. The responsible firm on the label is listed as Manufactured for
LLoyd Laboratories, Shenandoah, Iowa, and manufactured by Akorn Inc., Decatur,
IL; (2) Cervizine Injectable. The responsible firm is listed on the label as
Manufactured for Wildlife Pharmaceuticals Inc, Fort Collins, CO; (3) Butler
Xylazine-100 Injectable, The responsible firm is listed on the label as
Manufactured for The Butler Company, Columbus Ohio, and Manufactured by Taylor
Pharmaceuticals, Decatur, IL; (4) nv AnaSed. The responsible firm is listed on
the label as Manufactured by Vet-A-Mix, Shanendoah, Iowa, and Manufactured for
Novopharm Limited, Toronto, Canada.
CODE KA34401, KB09802, KB09802A, and KB09802B.
RECALLING FIRM/MANUFACTURER Lloyd Inc., Shenandoah, IA.
REASON Product may not have been manufactured under aseptic conditions.
VOLUME OF PRODUCT IN COMMERCE 32,449 bottles.
REASON Nationwide, Canada and UAE.
PRODUCT NEXABAND S/C Tropical Adhesive (2-octyl cyanoacrylate), each
package containing one 1.5ml bottle, with disposable pipettes and package
insert.
CODE Lot 83-002-3G01, Product Code: 5297, Lot Number 111144.
RECALLING FIRM/MANUFACTURER Closure Medical, Raleigh, NC.
REASON Insert Mix-up. NEXABAND Liquid package inserts were discovered in
NEXABAND S/C product containers.
VOLUME OF PRODUCT IN COMMERCE 5,506 units.
REASON Nationwide.
PRODUCT
a) IVERHART Plus (ivermectin/pyrante), contains 6 Flavored Chewables.
Recommended for dogs up to 25 lbs body weight.
b) IVERHART Plus (ivermectin/pyrante), contains 6 Flavored Chewables.
Recommended for dogs 26 to 50 lbs body weight.
c) IVERHART Plus (ivermectin/pyrante), contains 6 Flavored Chewables.
Recommended for dogs 51 to 100 lbs body weight.
CODE
a) IVERHART Plus lot number 03046 (small) tablets, 0170DS, display containing
10 boxes, each with a blister card holding 6 doses and 0180TS, towers
containing 20 blister cards, each holding 6 doses;
b) IVERHART Plus lot number 03047 (medium) tablets, 0170DM, display containing
10 boxes, each with a blister card holding 6 doses and 0180TM, towers
containing 20 blister cards, each holding 6 doses.
c) IVERHART Plus lot number 03048 and 03049 (large) tablets, 0170DL, display
containing 10 boxes, each with a blister card holding 6 doses and 0180TL, tower
containing 20 blister cards, each holding 6 doses.
RECALLING FIRM/MANUFACTURER Virbac AH, Inc., Fort Worth, TX.
REASON The firm is recalling 4 lots of IVERHART Plus Flavored Chewables
due to contamination of Minocycline, a FDA approved human drug which has not
been approved in species other than humans.
VOLUME OF PRODUCT IN COMMERCE 1,179,840 tablets.
REASON Nationwide.
PRODUCT The recalled product is a liquid packaged in a plastic bottle
with the following labeling: DVM brand ChlorhexiDerm Shampoo, 4% Chlorhexidine,
in 8 oz, 12 oz, and one gallon plastic container sizes. The label has the NDC
number 47203-687-08.
CODE Lot numbers V2F075A (8 oz.), V2F075C (12 oz.), and V2F075B (one
gallon).
RECALLING FIRM/MANUFACTURER DVM Pharmaceuticals, Miami, FL.
REASON The recalled shampoo may be subpotent for its active ingredient
based on stability study results.
VOLUME OF PRODUCT IN COMMERCE 22,192
REASON Nationwide and Internationally.
PRODUCT Fort Dodge Nolvasan Antiseptic Ointment, 1% Chlorhexidine
acetate in a Hydrophilic Ointment base which contains 10% stearyl alcohol,
packaged in 16-oz. jars.
CODE 371530, 371531, 371533, 371534, and 371535, all bearing an
expiration date of SEP03.
RECALLING FIRM/MANUFACTURER Fort Dodge Laboratories, Inc., Fort Dodge,
IA.
REASON Out-of-specification assay result as the 15-month stability test
point.
VOLUME OF PRODUCT IN COMMERCE 9,107 jars.
REASON Nationwide.
PRODUCT WT 13 Pellets with Rumensin.
CODE Product code 9349394051.
RECALLING FIRM/MANUFACTURER Tennessee Farmers Cooperative, LaVergne, TN.
REASON Non-medicated feed was inadvertently mixed with medicated feed
and distributed.
VOLUME OF PRODUCT IN COMMERCE 23.1 tons.
DISTRIBUTION TN.
PRODUCT
a) Smell Tamers. Rawhide dog chews, for dogs under 20 lbs. The product is sold
in jars containing 100 pieces. The Product is packaged as a display box
containing 6 jars, and shipped as either a display box, as individual
units, or as a 3 box combination display package (1 jar of each size - item
68009).
b) Smell Tamers. Rawhide dog chews, for dogs 20-50 lbs. The product is sold in
jars containing 40 pieces.
The product is packaged as a display box containing 6 jars, and shipped as
either a display box, as individual
units, or as a 3 box combination display package (1 jar of each size - item
68009).
c) Smell Tamers. Rawhide dog chews, for dogs over 50 lbs. The product is sold
in jars containing 36 pieces.
The product is packaged as a display box containing 6 jars, and shipped as
either a display box, as individual
units, or as a 3 box combination display package (1 jar of each size - item
68009).
CODE
a) Item 68000;
b) Item 68020;
c) Item 68040.
RECALLING FIRM/MANUFACTURER The Leathercraft Company, Inc.,
Conshohocken, PA.
REASON Product contains microorganism.
VOLUME OF PRODUCT IN COMMERCE 4,950 jars.
DISTRIBUTION Nationwide.
PRODUCT BIODINE 110 TEAT Dip. Active Ingredient - Iodine 1%.
CODE 7-30-C.
RECALLING FIRM/MANUFACTURER Artco Chemicals, Inc., Glenmont, NY.
REASON Product fails to meet potency specifications.
VOLUME OF PRODUCT IN COMMERCE 30/50-gallon drums and 25/5-gallon pails.
DISTRIBUTION NY.
PRODUCT Calf Primer II-R (Monensin) sold in bulk.
CODE 93125 (1-7-04).
RECALLING FIRM/MANUFACTURER Tennessee Farmers Cooperative, La Vergne,
TN.
REASON Calf feed, which had a medicated swine feed inadvertently mixed
into it, was distributed.
VOLUME OF PRODUCT IN COMMERCE 28,040 pounds.
DISTRIBUTION TN.
PRODUCT Consolidated Nutrition Metabalance 25/45 10485APY Medicated, A
Complete Feed for Starting Pigs, containing 0.0055% Carbadox, packaged in 50-lb
Bags.
CODE Lot #G114303.
RECALLING FIRM/MANUFACTURER ADM Alliance Nutrition, Inc., Quincy, IL.
REASON Product was subpotent.
VOLUME OF PRODUCT IN COMMERCE 121/50 lb. Bags.
DISTRIBUTION NE.
PRODUCT ZuPreem Feline Diet, 14.0 oz cans for Non-Domesticated
Carnivores in the families Fedlidae, Canidea, and Hyenadea.
CODE 6910 S1 SF01 military time of production: 06:05.
RECALLING FIRM/MANUFACTURER Menu Foods, Inc., Pennsauken, NJ.
REASON LACF Feiline Diet for non-domestic carnivores does not carry the
BSE warning statement.
VOLUME OF PRODUCT IN COMMERCE 1,620 cases.
DISTRIBUTION KS.
PRODUCT Product is a horse supplement packed into a 5 lb. Plastic
container with a yellow/green/red/brown label printed in part "FORMULA:
Each 5 pounds contains: Chondroitin Sulfate 27,000 mg D-Glucosamine HCL 100,000
mg Collagen hydrolyzed 27,000 MSM (methysulfonylmethane) 2,500 mg. Carti-Flex
COMPLEX net wt. 5 lbs, a concentrated natural joint supplement containing
Glucosamine HCL, Chondroitin sulfate,
Hydrolixed collagen and MSM".
CODE All codes without the required cautionary
statement are under recall.
RECALLING FIRM/MANUFACTURER Interfarma Corporation, Miami, FL.
REASON This animal feed product does not contain the required BSE
cautionary statement: "Do Not Feed to Cattle or Other Ruminants".
VOLUME OF PRODUCT IN COMMERCE 80 cases 4-5 lb. Containers per case.
DISTRIBUTION Venezuela, Nicaragua and Guatemala.
PRODUCT Custom deer feed made for a Wisconsin farm.
The product was in bags holding about 40 pounds each.
CODE 1-30-04 on the product invoice and mixing record.
RECALLING FIRM/MANUFACTURER Crivitz Feed Mill, Crivitz, WI.
REASON The recalled deer feed contained steamed bone meal which is
prohibited material in feed for ruminants.
VOLUME OF PRODUCT IN COMMERCE 515 pounds.
DISTRIBUTION WI.
PRODUCT Custom dairy cattle feed made for two customers.
CODE None.
RECALLING FIRM/MANUFACTURER Maribel Grain Co., Maribel, WI.
REASON Possible cross contamination of cattle feed by steamed bone meal
which is prohibited material.
VOLUME OF PRODUCT IN COMMERCE 2,040 pounds.
DISTRIBUTION WI.
PRODUCT Suppressor( brand Flunixin Meglumine Injection 50 mg/mL in 100mL
& 250mL bottles for animal use only.
CODE All codes (NADA # 200-124).
RECALLING FIRM/MANUFACTURER Walco International, Inc., Ceres, CA.
REASON The animal drug product is mistakenly labeled with route of
administration as "IM or IV," it is for IV use only and is likely to
cause violative residues if used as IM.
VOLUME OF PRODUCT IN COMMERCE Bottles are labeled at sale (upon filling
client's order).
DISTRIBUTION CA.
PRODUCT B & G Seed Co., PIG GROWER, 50 lbs.
CODE All.
RECALLING FIRM/MANUFACTURER B & G Seed Company, Inc., Hull, GA.
REASON Feed contains meat & bone meal (prohibited material), without
the mandatory ruminant warning on the label.
VOLUME OF PRODUCT IN COMMERCE 25/50 lb. bags.
DISTRIBUTION GA.
PRODUCT Dexium (Dexamethasone) Tablets.
CODE Lot 2206004.
RECALLING FIRM/MANUFACTURER Bimeda, Inc., Le Sueur, MN.
REASON Failure to meet USP dissolution requirements during product
stability testing.
VOLUME OF PRODUCT IN COMMERCE 606 bottles, 1000 tablets/bottle.
DISTRIBUTION Nationwide.
PRODUCT Custom dairy cattle feed made for two customers.
CODE None.
RECALLING FIRM/MANUFACTURER Maribel Grain Co., Maribel, WI.
REASON Possible cross contamination of cattle feed by steamed bone meal
which is prohibited material.
VOLUME OF PRODUCT IN COMMERCE 2,040 pounds.
DISTRIBUTION WI.
PRODUCT Suppressor( brand Flunixin Meglumine Injection 50 mg/mL in 100mL
& 250mL bottles for animal use only.
CODE All codes (NADA # 200-124).
RECALLING FIRM/MANUFACTURER Walco International, Inc., Ceres, CA.
REASON The animal drug product is mistakenly labeled with route of
administration as "IM or IV," it is for IV use only and is likely to
cause violative residues if used as IM.
VOLUME OF PRODUCT IN COMMERCE Bottles are labeled at sale (upon filling
client's order).
DISTRIBUTION CA.
PRODUCT B & G Seed Co., PIG GROWER, 50 lbs.
CODE All.
RECALLING FIRM/MANUFACTURER B & G Seed Company, Inc., Hull, GA.
REASON Feed contains meat & bone meal (prohibited material), without
the mandatory ruminant warning on the label.
VOLUME OF PRODUCT IN COMMERCE 25/50 lb. bags.
DISTRIBUTION GA.
PRODUCT Dexium 0.25 mg Dexamethasone Tablets, 1000 tablets/bottle.
CODE Lot 22060004.
RECALLING FIRM/MANUFACTURER Bimeda, Inc., Le Sueur, MN.
REASON Failure to meet USP dissolution requirements during product
stability testing.
VOLUME OF PRODUCT IN COMMERCE 606 bottles, 1000 tablets/bottle.
DISTRIBUTION Nationwide.
PRODUCT Cloverbelt 38% (38% protein concentrate for use in animal feed)
in bulk.
CODE The recall product is a bulk feed commingled in a bin prior to sale
- no lot number.
RECALLING FIRM/MANUFACTURER Cloverbelt Lumber & Feed Co., Conrath,
WI, by telephone on February 23, 2004. Firm initiated recall is complete.
REASON Possible cross contamination of the 38% protein concentrate with
prohibited material (bone meal).
VOLUME OF PRODUCT IN COMMERCE 18 tons.
DISTRIBUTION WI.
PRODUCT Regu-Mate (altrenogest) Oral Progestin 1,000
ml Solution 0.22%. The product is sold in one liter bottles and shipped in
cases that contain 6 bottles.
CODE Item # 069285, Lot numbers THAR and TIEH.
RECALLING FIRM/MANUFACTURER Intervet, Inc., Millsboro, DE.
REASON Product may leak.
VOLUME OF PRODUCT IN COMMERCE 8,037 bottles.
DISTRIBUTION Nationwide and Puerto Rico.
JUNE 2004
PRODUCT Fort Dodge ProHeart 6 (moxidectin) Sustained Release Injectable
for Dogs, Sterile Vehicle 17 ml. to be used to constitute moxidectin
microspheres, 10% w/w moxidectin microspheres, packed in 5-unit packs of 20-ml.
moxidectin microsphere and vehicle vials, RX, NADA 141-189, NDC 0856-3670-20.
CODE Lot 367158214, Exp. April 05, and Lot 367158215, Exp. June 05.
RECALLING FIRM/MANUFACTURER Fort Dodge Laboratories, Inc., Fort Dodge,
IA.
REASON Failing dissolution results for the moxidectin microspheres at
the 6-month stability time point.
VOLUME OF PRODUCT IN COMMERCE 7,390/5-unit packs.
DISTRIBUTION Nationwide.
PRODUCT Metacam (meloxicam) 1.5 mg/mL Oral Suspension, Non-steroidal
anti-inflammatory drug for oral use in dogs only, packaged in 10-ml bottles,
RX, NADA #141-213.
CODE Lot # 113ZM71.
RECALLING FIRM/MANUFACTURER Boehringer Ingelheim Vetmedica Inc., MO.
REASON A kilogram dosing syringe was packaged with the product rather
than a dosing syringe calibrated in pounds.
VOLUME OF PRODUCT IN COMMERCE 65,890 packages.
DISTRIBUTION TN, GA, and IA.
PRODUCT Sprout Chick Starter Grower Medicated Crumble with Active Drug Ingredients Amprolium at 0.0125% and Ethopabate at 0.0004%, in 50 pound bags. The product is distributed by Mills Fleet Farm.
CODE Production codes: 4NR097, 4NR098, 4NR111, NR113,
4NR117, and 4NR118.
RECALLING FIRM/MANUFACTURER Cargill, Inc., Animal Nutrition Division,
New Richland, MN.
REASON The product did not contain Ethopabate declared as an active
ingredient on the label.
VOLUME OF PRODUCT IN COMMERCE 1090/50 lb. bags.
DISTRIBUTION IA, MN, ND, and WI.
PRODUCT
a) Bulk whole corn.
b) Bulk rolled corn.
c) Bulk rolled corn with added fat.
CODE No coding information is used.
RECALLING FIRM/MANUFACTURER Fresno Farming LlC, Traver, CA.
REASON Corm for feed may be contaminated with ruminant meat and bone
meal.
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Unknown.
PRODUCT
a) Fort Dodge Amiglyde-V Injection, Amikacin Sulfate, Veterinary Injection,
Equivalent to 50 mg. Amikacin
per mL, packaged in 50-ml. vials, 48 vials per case, RX, NADA 127-892, NDC
0856-2326-20.
b) Fort Dodge Cal-Dextro No. 2 Sterile Solution, packaged in 500-ml. bottles
(12 per case), each mL
contains 16.84 mg. (8.42 g/500mL) calcium (as gluconate salt), 9.8 mg. (4.9
g/500 mL) phosphorus, 3.84 mg.
(1.92 g/500 mL) magnesium, and 165 mg. (82.5 g/500 ml) dextrose, RX, NDC
#0856-0263-01.
c) Fort Dodge Cal Dextro Special Sterile Solution, packaged in 500-mL bottles
(12 per case), each mL contains 22 mg. (11 g/500/mL) calcium (as glucontate
salt), 1.022 mg. (511 mg/500 mL) phosphorus, 0.402 mg. (201 mg/500 mL)
magnesium, and 150 mg. (75 g/500 mL) dextrose, RX, NDC 0856-0271-01.
d) Fort Dodge Factrel, Gonadorelin Hydrochloride, 50 mcg/mL Sterile Solution,
packaged in 20 mL and 50 mL multidose vials (24 per case), RX, NADA 139-237,
NDC 0856-4311-02. The product is also distributed to Canada under the Ayerst
Factrel label.
e) Fort Dodge Flucort Flumethasone Solution, Sterile, each mL contains 0.5 mg.
flumethasone, packaged in 100-mL multidose vials (72 per case), RX, NADA
030-414, NDC 0856-0820-20. The product is also distributed to
Canada under the Ayerst Flucort Flumethasone Injection Label.
f) Ketamine Hydrochloride Injection, USP, packaged under the Fort Dodge Vetalar
and Fort Dodge Ketaset labels, 100 mg/mL, packaged in 10-mL vials (144 vials
per case), RX, NADA 045-290, NDC 0856-2012-01. The product is also distributed
to Canada under the Ayerst Ketaset label.
g) Fort Dodge ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs,
packaged in 5-packs (20/5-packs per case) and 10-packs (10/10 packs per case),
RX, NADA 141-189, NDC 0856-3670-25 (5-pack), NDC 0856-3670-20 (10-pack).
Foreign distribution is made to Canada under the Ayerst ProHeart 6 label, and to
Italy under the Fort Dodge Guardian SR label.
h) Fort Dodge PromAce Injectable, Acepromazine Maleate
Injection, USP, equivalent to 10 mg/mL Acepromazine
Maleate, USP, packaged in 50-mL multiple dose vials (24 per case), RX, NADA
015-030, NDC 0856-3020-01.
The product is also distributed under the following foreign label for Canadian
distribution: Ayerst Atravet
10 mg. Injectable.
i) Fort Dodge Torbugesic Butorphanol Tartrate Veterinary Injection containing
10 mg. butophanol base per mL as butorphanol tartrate, USP, packaged in 10-ml
and 50-ml. vials (24/10-ml. per case and 48/50-ml per case), RX,
NADA 135-780, NDC 0856-2033-20. Foreign distribution is made to: (1) Canada
under the Wyeth Torbugesic label; (2) United Kingdom under the Fort Dodge Torbugesic
Injection label. (3) Denmark under the Fort Dodge
Torbugesic Vet label.
CODE
a) Lot 410206;
b) Lots 263952, 263953, 263954,263955, 263956, 263957, 263958,263959, and
263960;
c) Lot 271749;
d) Lots 431334 and 431336 (50mL only);
e) Lots 005529, 005230, and 005231;
f) Ketaset - Lots 440641, 440642, 440643, 440644, 440645, 440646, and 440647;
Vetalar - Lot 440642;
g) Lots 367162220, 367162221, 367164223, and 367164224;
h) Lots 020118 and 020119;
i) Lots 454416, 454417 (10-mL only), and 454418.
RECALLING FIRM/MANUFACTURER Fort Dodge Laboratories Inc, Fort Dodge, IA.
REASON GMP deviations cited during an inspection cause the sterility of
the products to be questionable.
VOLUME OF PRODUCT IN COMMERCE 443,096 vials.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
a) Bly-F-3 Barrow Country Swine 800 CX25 Medicated, containing 25 g/ton of
Carbadadox, (bulk feed).
b) Bly-F-3 Gilt Country Swine 900 CX25 Medicated, containing 25 g/ton of
Carbadadox, (bulk feed).
c) Bly-F-3 Barrow Country Swine 800 CX50 Medicated, containing 50 g/ton of
Carbadadox, (bulk feed).
d) Bly-F-4 Barrow Country Swine 700 BMD30 Medicated, containing 30 g/ton of
Bacitracin, (bulk feed).
e) Bly-F-4 Gilt Country Swine 800 BMD30 Medicated, Containing 30 g/ton of
Bacitracin, (bulk feed).
f) Bly-F-3 Barrow Country Swine 800 BMD30 Medicated, Containing 30 g/ton of
Bacitracin, (bulk swine feed).
g) Bly #2 Lactation D-25# 1100 Corn (bulk swine feed.
h) Country Swine 700 (bulk feed).
i) Custom DDG Supplement (a bulk animal feed supplement for swine).
j) Groplex 15/45 Starter Supplement (a bulk animal feed supplement for
swine).
k) EFC Swine Balancer (a bulk animal feed concentrate).
l) Six-In-One (bulk swine feed supplement).
m) Chicoine Barrow 100-140 BMD30 Medicated, containing 30 g/ton of Bacitracin,
(bulk swine feed).
n) Sioux Nation Sjoval Gluten Supplement For Feedlot Cattle.
o) Sioux Nation 16% Heifer Grower S-100 Medicated For growing heifers
containing 100 g/ton of Chortetracycline
and 0.011% of Sulfamethazine (bulk complete cattle feed).
p) Sioux Nation 16% Heifer Grower DC Medicated For growing heifers, bulls, and
dairy/beef containing
0.0025% of Decoquinate (bulk complete cattle feed).
q) Musick Complete Horse Feed in bulk.
CODE
a) Feed delivered on 3/24/04;
b) Feed delivered on 3/25/04;
c) Feed delivered on 3/24/04;
d) Feed delivered on 3/25/04;
e) Feed delivered on 3/26/04;
f) Feed delivered on 3/24/04;
g) Feed delivered on 3/25/04;
h) Feed delivered on 3/25/04;
i) Feed delivered on 3/31/04;
j) Feed delivered on 3/31/04;
k) Feed delivered on 3/30/04;
l) Feed delivered on 3/19/04;
m) Feed delivered on 4/02/04;
n) Feed delivered on 4/01/04;
o) Feed delivered on 3/25/04;
p) Feed delivered on 3/24/04;
q) Feed delivered on 3/29/04.
RECALLING FIRM/MANUFACTURER CHS Inc, (Cenex Harvest States), Corson, SD.
REASON Animal feeds, containing 100 times their intended selenium level,
were responsible for some animal deaths.
VOLUME OF PRODUCT IN COMMERCE 79 tons.
DISTRIBUTION SD.
PRODUCT
a) Sebolux Medicated Shampoo for Dogs and Cats, Antiseborrheic Keratoplastic, 8
fl. Oz., Active Ingredients: Solubilized Sulfur (equivalent to 2%
elemental Sulphur) and 2% salicylic acid.
b) Epi-Otic Ear Cleanser for dogs, cats, puppies, and kittens. Cleansing,
drying, non-irritating.
CODE a) and b) WJ363.
RECALLING FIRM/MANUFACTURER Virbac AH, Inc., Fort Worth, TX.
REASON Bottles labeled at Sebolux Medicated Shampoo for dogs and cats
contain EPI-Otic Ear Cleanser for Dogs, Cats, Puppies, and kittens.
VOLUME OF PRODUCT IN COMMERCE 22,824 units.
DISTRIBUTION Nationwide.
PRODUCT C.E.T. Home Dental Care Oral Hygiene Gel for
Dogs and Cats, NDC 051311-502-32, 1.4 fl. Oz. (32 mL). 0.12% Chlorhexidine
Gluconate.
CODE All lots of the product on the market are being recalled . The
subpotent lots are WF363, WF313, WH352, WL307, and WC433.
RECALLING FIRM/MANUFACTURER Virbac AH, Inc., Fort Worth, TX.
REASON Subpotency.
VOLUME OF PRODUCT IN COMMERCE 88,366 units.
DISTRIBUTION Nationwide.
Fort Dodge to Recall ProHeart 6 Injectable Heartworm Product
Fort Dodge Animal Health, of Overland Park, Kansas has agreed to immediately cease production and recall its heartworm medication ProHeart®6 from the market.
ProHeart®6 is an approved injectable sustained-release heartworm prevention product for dogs. Heartworm disease is a serious and potentially fatal condition of dogs, cats, and other species of mammals. The parasite that causes heartworm disease is transmitted through the bite of a mosquito.
Pet owners should consult their veterinarians regarding their pet's health care needs.
Fort Dodge Animal Health has agreed to recall any product that has already been distributed to veterinarians.
OCTOBER 2004
PRODUCT
a) Blue Seal AVI Pels for Zoo Avians, 50 Lb Bag, Product No.: 807.
b) Blue Seal Breeder Pels, 50 Lb Bag, Product No.: 634.
c) Blue Seal Broiler Crumbles-CB, Medicated 50 Lb Bags, Product No.: 801.
d) Blue Seal Chick Starter-AM Medicated, 25 Lb and 50 Lb Bags, Product No.:
601.
e) Blue Seal Chick Starter-AM Crumbles Medicated, 25 lb and 50 lb bags Product
No: 602.
f) Blue Seal Fat and Finish Pels, 50 lb bag Product No: 803.
g) Blue Seal Game Bird Starter and/Grower Crumbles.
h) Blue Seal Grower-CAL Crumbles, 50 lb bags Product No: 606.
i) Blue Seral Grower-Cal Mash, 25 lb and 50 lb bags Product No: 605.
j) Blue Seal Grower-Cal Pels, 25 lb and 50 lb. bags Product No: 607.
k) Blue Seal Layer Crumbles, 50 lb bags Product No: 624.
l) Blue Seal Layer Mash, 25 lb and 50 lb bags Product No: 623.
m) Blue Seal Layer Pellets, 25 lb and 50 lb bags Product No: 625
n) Blue Seal Turkey Grower Pels, 50 lb bag Product No: 809.
o) Blue Seal Turkey Starter Crumbles-Medicated, 50 Lb. Bags, Product No:
808.
CODE Code Dates: A1414 thru A1564.
RECALLING FIRM/MANUFACTURER Blue Seal Feeds, Inc., Londonderry, NY.
REASON Phosphorus levels below label claim.
VOLUME OF PRODUCT IN COMMERCE 3748 bags.
DISTRIBUTION MA, ME, NH, MD, PA, NC, NJ, NY, WV, and VA.
PRODUCT
a) Blue Seal Turkey Starter Crumbles-Medicated , 50 Lb. Bags Product No:
808.
b) Blue Seal Refresher Dry 32 Pellet, 50 Lb Bag.
c) Blue Seal Antler King Deer and Elk Pellets, 50 Lb Bag.
d) Blue Seal Natural 40 Pellets, 50 Lb Bag.
e) NYS-RM-22 Starter, Medicated, Bulk.
f) Blue Seal Energizer 36, bulk.
CODE
a), b), c), d), and f) Code Dates: A1414 thru A1564;
e) Code Dates: A1484.
RECALLING FIRM/MANUFACTURER Blue Seal Feeds, Inc., Londonderry, NY.
REASON Phosphorus levels below label claim.
VOLUME OF PRODUCT IN COMMERCE 3210 bags.
DISTRIBUTION MA, ME, NH, MD, PA, NC, NJ, NY, WV, and VA.
PRODUCT
a) Product is 9 Mile Steer Feed, packaged in white poly weaved bags, each
containing 100 lbs. A white label tied to the inlet of each bag with twine
identifies the product.
b) Product is 9 Mile Pig and Sow Feed, packaged in white poly weaved bags, each
bag containing 100 lbs. A white label tied to the inlet of each bag with twine
identifies the product.
CODE The products contain no code date.
RECALLING FIRM/MANUFACTURER Farmers Elevator, Co., Houston, OH.
REASON Products may contain protein derived from mammalian tissues which
is prohibited in ruminant (steer) feed. FDA regulation, if the feed is intended
for non-ruminants (pigs), the bag labels must bear the statement ěDo not feed
to cattle or other ruminantsî.
VOLUME OF PRODUCT IN COMMERCE 700 lbs. Steer feed and 1,500 lb. Pig and
sow fed.
DISTRIBUTION OH.
PRODUCT Ivermectin
Bio-bullet, They are distributed in 10 count clips. One bullet per 300 lbs. Of bodyweight
in large flat muscle or as directed by veterinarian.
CODE All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER The Veterinary Pharmacy, Newcastle, OK.
REASON Unapproved new animal
drug.
VOLUME OF PRODUCT IN COMMERCE 820 bio-bullets.
DISTRIBUTION OK, TX, LA, KY, AR.
PRODUCT
a) Premier Catfish Food, packaged in 50 pound bags (white paper with an orange
label).
b) Happy Fisherman Fish Food, pellet form, 50 pound bags.
CODE
a) T1 Best By 08/27/05;
b) T21 Best By 11 DEC 05 and T11 Best By 02 OCT 05.
RECALLING FIRM/MANUFACTURER Sunshine Mills, Inc., Tupelo, MS.
REASON The catfish food contains prohibited material (meat & bone
meal) but does not contain the cautionary statement, "Do not feed to
cattle or other ruminants" on the label.
VOLUME OF PRODUCT IN COMMERCE 1,092 ‚ 50 pound bags.
DISTRIBUTION TX and MO.
PRODUCT
a) Kent 3% Floating Fish Food, 50 lb. bags, Product No. 125.
b) Blue Seal Floating Fish Food 40/10, 50 lb. bags, Product No.
c) Blue Seal Furry Friends Guinea Pig Pels, 25 and 50 lb. bags Product No.
310.
d) Blue Seal Sunshine Plus, 50 lb. bags, Product No. 415.
e) Blue Seal AVI Pels for Zoo Avians, 50 Lb Bag Product No. 807.
f) NYS-RM-22 Starter Medicated (bulk), Product No. 616.
g) NYS-RM-28 Breeder (bulk), Product No. 618.
h) Blue Seal Breeder Pels, 50 Lb. Bag Product Number: 634.
i) Blue Seal Broiler Crumbles-CB, Medicated 50 Lb Bags Product No: 801.
j) Blue Seal Chick Starter-AM Medicated, 25 Lb and 50 Lb bags Product No:
601.
k) Blue Seal Chick Starter-AM Crumbles Medicated, 25 lb and 50 lb bags Product
No: 602.
l) Blue Seal Fat and Finish Pels, 50 lb bag Product No: 803.
m) Blue Seal Game Bird Starter and/Grower Crumbles, Product No. 806.
n) Blue Seal Grower-CAL Crumbles, 50 lb bags Product No: 606.
o) Blue Seal Grower-Cal Mash, 25 lb and 50 lb bags Product No:605.
p) Blue Seal Grower-Cal Pels, 25 lb
and 50 lb. bags Product No: 607.
q) Blue Seal Layer Crumbles, 50 lb bags Product No: 624.
r) Blue Seal Layer Mash, 25 lb and 50 lb bags Product No: 623.
s) Blue Seal Layer Pellets, 25 lb and 50 lb bags Product No: 625.
t) Blue Seal Turkey Grower Pels, 50 lb bag Product No: 809.
u) Blue Seal Turkey/Pheasant Starter Crumbles-Medicated, 50 lb. bags Product
No: 808.
v) Blue Seal Pig & Sow Pellets in 50 lb. bags, Product No. 813.
w) Blue Seal Pork Maker Mash in 50 lb. bags, Product No. 814.
x) Blue Seal Hog Pellets in 50 lb. bags, Product No. 878.
y) Blue Seal Egg Maker Crumbles, Product No. 635.
CODE
a), b), c), e), f), g), k), n), q), u), x), y). Code Dates: A1354 thru A1674;
d), h), i), j), l), m), o), p), r), s), t), v), w), Code Dates: A1354 thru
A1674 and R1324 thru R1384.
RECALLING FIRM/MANUFACTURER Blue Seal Feeds, Inc., Londonderry NH.
REASON Vitamin D3 was not added to products.
VOLUME OF PRODUCT IN COMMERCE 35,267 bags and 55 tons (bulk).
DISTRIBUTION Nationwide.
PRODUCT Purina CU NE Maxi-Ext Ransom Complete (1H9Y).
Non-medicated animal feed.
CODE Date Code 8/26/04.
RECALLING FIRM/MANUFACTURER Purina Mills, Llc, Saint Louis, MO.
REASON Potential sulfamethazine contamination.
VOLUME OF PRODUCT IN COMMERCE 10,860 lbs.
DISTRIBUTION PA.
PRODUCT Breath-eze Breath and Gas Relief Tablets for Dogs (activated
charcoal, simethicone).
CODE Lot PJ315.
RECALLING FIRM/MANUFACTURER Virbac AH, Inc., Fort Worth, TX.
REASON Product contains Breath-eze chewable breath mints which have no
active ingredient for gas relief.
VOLUME OF PRODUCT IN COMMERCE 2,100 units.
DISTRIBUTION PA, MA, OH, NJ, AZ, NC, NE, and Canada.
PRODUCT Product is custom made steer/cattle feed
packaged in 100 lb. poly bags. The product has no labeling.
CODE The product has no lot code. All custom made feed purchased between
June 24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER Farmers Elevator Co, Houston, OH.
REASON Feed may contain protein derived from mammalian tissues which is
prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE Approximately 80 1ű2 tons of steer/cattle
feed.
DISTRIBUTION OH.
PRODUCT Product is custom made sheep/goat feed
packaged in 100 lb. poly bags. The product has no labeling.
CODE The product has no lot code. All custom made feed purchased between
June 24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER Farmers Elevator Co, Houston, OH.
REASON Feed may contain protein derived from mammalian tissues which is
prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE Approximately 8 tons.
DISTRIBUTION OH.
PRODUCT Product is custom made deer feed packaged in
100 lb. poly bags. The product has no labeling.
CODE The product has no lot code. All custom made feed purchased between
June 24, 2004 and September 8, 2004.
RECALLING FIRM/MANUFACTURER Farmers Elevator Co, Houston, OH.
REASON Feed may contain protein derived from mammalian tissues which is
prohibited in ruminant feed.
VOLUME OF PRODUCT IN COMMERCE Approximately 6 tons.
DISTRIBUTION OH.
NOVEMBER 2004
PRODUCT Fort Dodge ProHeart 6
(moxidectin) Sustained Release Injectable for Dogs, Sterile Vehicle 17 ml. to
be used to constitute moxidectin microspheres, 10% w/w moxidectin microspheres,
packaged in 5- and 10-unit packs 20/5-packs per case and 10/10-packs per case,
RX, NADA 141-189.
CODE All lots within expiry.
RECALLING FIRM/MANUFACTURER Fort Dodge Laboratories Inc, Fort Dodge, IA.
REASON FDA requested due to serious health concerns.
VOLUME OF PRODUCT IN COMMERCE U.S.: 17,207/5/20-ml vial packs and
26,364/10/20-ml vial packs; Foreign: 19,971/10-ml vials; 43,357/20-ml vials;
300/5 packs & 80/10 packs.
DISTRIBUTION Nationwide and Internationally.