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The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
March 30, 2005
05-13
_______________________________
PRODUCT
"Fresh Batch" Candy Cookies; a toll house type cookie with chocolate
chunks and candy coated chocolate pieces; packaged in 14.4 oz. plastic clamshells,
12 packages per case. UPC 0 21698 01872 6. Recall # 236-5.
CODE
All date codes.
RECALLING FIRM/MANUFACTURER
Parco Foods, L.L.C., Blue Island, IL, by press release on February 25, 2005.
Firm initiated recall is ongoing.
REASON
The product contains undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
302 cases.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Smak³ Mushrooms marinated, Product of
Poland, Net wt. 23,45 oz. (670 g). Product is packaged in a clear glass jar.
Barcode # 8 10263 000309. Recall # F-237-5.
CODE
Best before: 05.20.2006 T/L1241/Z0I/2405 (on the lid).
RECALLING FIRM/MANUFACTURER
Desly International Corp., Brooklyn, NY, by press release on October 5, 2004.
Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (318 ppm) based on sampling &
analysis by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
108 jars.
DISTRIBUTION
NY, MD, CA, CT, NC, WA, FL, MA, KS,
_______________________________
PRODUCT
Cibo Naturals brand Grandi Ravioli Portabella Mushroom, 8 oz. retail packages,
product is sold refrigerated. Recall # F-238-5.
CODE
Use or freeze by January 29, 2005.
RECALLING FIRM/MANUFACTURER
Monterey Pasta Company, Salinas, CA, by press release and letters on January
31, 2005. Firm initiated recall is complete.
REASON
Product labeled as "Grandi Ravioli Portabella Mushroom" actually contains
Lobster Ravioli.
VOLUME OF PRODUCT IN COMMERCE
137 cases/6 units per case.
DISTRIBUTION
WA, OH, GA, KY, VA, and TN.
_______________________________
PRODUCT
a) Minh Vegetable Egg Roll, 10 lbs/4 2.5 bags
(approx. 50 0.8 oz egg rolls/bag)/case.
Recall # F-225-5;
b) Minh Mini Vegetable Egg Roll, 10 lbs/4 2.5 bags
(approx. 50 0.8 oz egg rolls/bag)/case.
Recall # F-226-5;
c) Pagoda Vegetable Spring Roll, 6.8 oz/ 4 spring
rolls/carton, 12 cartons/case. Recall # F-227-5;
d) Pagoda Shrimp Spring Roll, 6.8 oz/ 4 spring
rolls/carton, 12 cartons/case. Recall # F-228-5.
CODE
a) Package Lot/use by code: 384314,
Case Code: 69491;
b) Package Lot/use by code: 384315,
Case Code: 69057;
c) Package Lot/use by code: 384314,
Case Code: 69867;
d) Package Lot/use by code: 384315,
Case Code: 69868.
RECALLING FIRM/MANUFACTURER
SSE Manufacturing, Inc., Pasadena, TX, by fax on February 7, 2005, and by press
release on February 9, 2005. Firm initiated recall is ongoing.
REASON
Products contain glass fragments.
VOLUME OF PRODUCT IN COMMERCE
4,372 cases.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Walmart***Sugar Free***Angle Food Cake, Net Wt. 9 oz. 225 g (and 15 oz. 425
g). Recall # F-229-5.
CODE
Lot #4210 5040.
RECALLING FIRM/MANUFACTURER
Benson Bakeries, Bogart, GA, by telephone and email on March 9, 2005. Firm initiated
recall is ongoing.
REASON
The product labeled as Sugar Free Angle Food Cake actually contains sugar.
VOLUME OF PRODUCT IN COMMERCE
36,032 units.
DISTRIBUTION
AL, AR, FL, GA, KY, TX.
_______________________________
PRODUCT
a) Honey Dipped Papaya Spears, 12 oz., ready to eat.
UPC: 3435601080. Recall # F-230-5;
b) Tropical Trail Mix, 6.5 oz. UPC: 34356 01045.
Recall # F-231-5;
c) Fruit Medley, 16 oz. UPC: 34356 011045.
Recall # F-232-5;
d) Honey Dipped Mango Slices, 8 oz. UPC: 34356 01082.
Recall # F-233-5.
CODE
All lot codes.
RECALLING FIRM/MANUFACTURER
D & C Dist. Co., Inc (DBA) Gust Picoulas Nut Co., Los Angeles, CA, by telephone
and letter on June 8, 2004. Firm initiated recall is complete.
REASON
a) The product contains undeclared colors, FD&C
Yellow # 5 & 6;
b), c), and d) The product contains undeclared color,
FD&C Yellow #6, calcium chloride, and citric acid.
VOLUME OF PRODUCT IN COMMERCE
4 cases.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Lorazepam Intensol Oral Concentrate USP, 2 mg per mL, 30 mL bottle and dropper,
Rx only, NDC 0054-3532-44. Recall # D-150-5.
CODE
Lots 456878A, 457086A, 456856A, 456857A, 457016A, 457087A, 457088A, 457089A,
457425A, 457426A, 457427A, 457474A, 457549A, 457740A, 457741A.
RECALLING FIRM/MANUFACTURER
Roxane Laboratories, Inc., Columbus, OH, by letter, dated January 17, 2005.
Firm initiated recall is ongoing.
REASON
Degradation Failure; 3 month stability.
VOLUME OF PRODUCT IN COMMERCE
113,465 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
DORNASE ALPHA PLUMOZYME Inhalation Solution in 2.5 mg/mL ampule, a recombinant
human deoxyribonuclease (rhDNase), Rx only, The product is supplied on a single
card containing 6 plastic ampoules that are joined together, NDC #50242-100-40.
Recall # D-151-5.
CODE
Lot number L-14222, Exp. date is October 2006.
RECALLING FIRM/MANUFACTURER
Genentech, Inc, South San Francisco, CA, by letters on February 28, 2005. Firm
initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: When a single ampule is separated from the adjacent
ampoules by the user, minor leaks may occur.
VOLUME OF PRODUCT IN COMMERCE
50,400 units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Prempro (conjugated estrogens/medroxyprogesterone acetate), 0.3mg/1.5 mg tablets,
in EZ dial dispenser containing 28 tablets. NDC #0046-0938-08. Firm on label:
Wyeth Pharmaceuticals, Philadelphia, PA. Recall # D-153-5.
CODE
A87961, Exp. 12/2005.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richmond Division of Wyeth, Richmond, VA, by letters dated March
8, 2005.
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY. Firm initiated recall
is ongoing.
REASON
Dissolution failure.
VOLUME OF PRODUCT IN COMMERCE
19,448 cartons x 3 EZ dial packs.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) 5% Benzoyl Peroxide Gel packaged in 1-oz. tubes,
12 per case, OTC, under the following private
labels: (1)Schnucks; (2) Harris Teeter;
(3) Finast; (4) and Quality Choice.
Recall # D-154-5;
b) Invisible Acne Cream (Benzoyl Peroxide 10%),
1-oz. tubes, 12 per case, OTC, under the following
private labels: (1) Western Family Maximum Strength
Invisible Acne Cream; (2) Meijer Invisible Acne
Cream Maximum Strength; (3) Stop & Shop Maximum
Strength Invisible Acne Cream; (4) Best Yet
Absolute Elements Maximum Strength Invisible
Acne Cream; (5) Premier Value Maximum Strength
Invisible Acne Cream; (6) Finast Maximum Strength
Invisible Acne Cream; (7) Personal Expressions
Vanishing Acne Cream; (8) HyVee Maximum Strength
Invisible Acne Cream; (9) Schnucks Maximum
Strength Invisible Acne Cream; (10) Leader Maximum
Strength Invisible Acne Cream; (11) Quality Choice
Maximum Strength Invisible Acne Cream;
(12) May's Drug Maximum Strength Invisible Acne
Cream; (13) ElectHealth Maximum Strength Invisible
Acne Cream; (14) CareOne Maximum Strength Invisible
Acne Cream; (15) Top Care Maximum Strength Invisible
Acne Cream. Recall # D-155-5.
CODE
a) Lot 3C14A, Exp. 3/05; 3E01A, Exp. 5/05;
3H14A, 8/05; 3H26C, Exp. 8/05; 3J06B, Exp. 10/05;
b) Lot 3B20B, Exp. 2/05; 3C17A, Exp. 3/05,
3D24B, Exp. 4/05; 3E22B, Exp. 5/05;
3F05C, Exp. 6/05; 3G15A, Exp. 7/05;
3G18A, Exp. 7/05; 3G30B, Exp. 7/05;
3H13B, Exp. 8/05; 3H28C, Exp. 8/05;
3J01B, Exp. 10/05; 3J06A, Exp. 10/05;
4F08A, Exp. 6/06; 4F10A, Exp. 6/06;
4G15B, Exp. 7/06; 4G16A, Exp. 7/06;
4J01A, Exp. 10/06; 4J14B, Exp. 10/06;
4K17B, Exp. 11/06.
RECALLING FIRM/MANUFACTURER
Qualis, Inc., Des Moines, IA, by letters on February 10, 2005 and February 11,
2005. Firm initiated recall is ongoing.
REASON
cGMP Deviations: The active ingredient was for industrial use and not manufactured
according to GMP's.
VOLUME OF PRODUCT IN COMMERCE
a) 13,080 tubes;
b) 98,856 tubes.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Heartsine Samaritan AED Defibrillators -- Models: SAM 001, SAM 002,SAM 003.
Recall # Z-0641-05.
CODE
Serial numbers within range of 1270 -- 2324 (not all are affected).
RECALLING FIRM/MANUFACTURER
Heartsine Technologies, Inc., San Clemente, CA, by telephone and letters on
February 14, 2005. Firm initiated recall is ongoing.
REASON
The affected Automatic External Defibrillators (AED) announce a fault warning
and shut themselves off before a shock can be delivered to the patient. This
is reportedly due to slow capacitor charging rates which are interpreted by
the AED software as a fault condition.
VOLUME OF PRODUCT IN COMMERCE
672 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in
a sterile tyvck pouch. Recall # Z-0027-05.
CODE
Lot Number 741105 exp. 11/07.
RECALLING FIRM/MANUFACTURER
Bioteque America Inc., Langhorne, PA, by telephone on February 23, 2005 and
by letter dated February 24, 2005. Firm initiated recall is ongoing.
REASON
Product is marked without a 510(k).
VOLUME OF PRODUCT IN COMMERCE
115 units.
DISTRIBUTION
OH and MI.
_______________________________
PRODUCT
a) BD Exacta 8.5 Fr Percutaneous Sheath Introducer
Tray. Ref. No 680124. Recall # Z-0628-05;
b) Careflow 14Ga x 20cm 2-lumen Central Venous
Catheter Tray. Ref. No. 681714.
Recall # Z-0629-05;
c) Careflow 7Fr x 20cm 3-lumen Central Venous
Catheter Tray. Ref. No. 681725.
Recall # Z-0630-05;
d) BD Exacta 6Fr Percutaneous Sheath Introducer
Tray. Recall # Z-0631-05.
CODE
a) Lot No's. 406462 and 311197;
b) Lot No. 404567;
c) Lot No. 405622;
d) Lot No. 407458.
RECALLING FIRM/MANUFACTURER
Becton Dickinson Infusion Therapy, Sandy, UT, by telephone and letters dated
January 10, 2005. Firm initiated recall is complete.
REASON
Various procedure trays and kits may have an insufficient seal, thus compromising
sterility.
VOLUME OF PRODUCT IN COMMERCE
30 units.
DISTRIBUTION
WI, Puerto Rico, Virgin Islands.
_______________________________
PRODUCT
DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or
plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Recall
# Z-0632-05.
CODE
Lot # 039229, Exp. date 12/23/04.
RECALLING FIRM/MANUFACTURER
Diasorin Inc., Stillwater, MN, by letter on January 22,2004. Firm initiated
recall is ongoing.
REASON
DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.
VOLUME OF PRODUCT IN COMMERCE
16 kits.
DISTRIBUTION
GA, NY, and KS.
_______________________________
PRODUCT
Mikro-Tip Disposable Angiographic Catheter. Recall # Z-0635-05.
CODE
Lot numbers L034403 and L034731.
RECALLING FIRM/MANUFACTURER
Millar Instruments, Inc., Houston, TX, by e-mail on January 14, 2005 and letter
on January 20, 2005. Firm initiated recall is ongoing.
REASON
Wire braiding protruding from the catheter.
VOLUME OF PRODUCT IN COMMERCE
28 catheters.
DISTRIBUTION
MN, CA, and NY.
_______________________________
PRODUCT
Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8060, 8075.
Recall # Z-0639-05.
CODE
Model numbers 8031, 8038, 8060, 8075. 510(k) numbers K983171, K992777, K000277,
K021232, K003782. Product Code DXQ. Product UPN numbers: Domestic: Constellation
31 mm/2mm: M004 US8031 0, M004 US8031 L0, M004 US8031 M0. 38mm/3mm: M004US8038
0, 4004 US8038 L0, M004 US8038P0. 48MM/4MM M004 US8048 0, M004 US8048B0, M004
US8048P0. 60mm/5mm: M004 US8060 0, M004 US8060B0, M004 US8060P0. 75mm/7mm: M004
US0875 0, M004 US0875B0, M004 US8075P0. Outside of US product: Constellation
31 mm/2mm: M004 EPT8031 0, M004 EPT8031 L0, M004 EPT8031 M0. 38mm/3mm: M004EPT8038
0, 4004 EPT8038 L0, M004 EPT8038P0. 48MM/4MM M004 EPT8048 0, M004 EPT8048B0,
M004 EPT8048P0. 60mm/5mm: M004 EPT8060 0, M004 EPT8060B0, M004 EPT8060P0. 75mm/7mm:
M004 EPT0875 0, M004 EPT0875B0, M004 EPT8075P0.
RECALLING FIRM/MANUFACTURER
Boston Scientific, San Jose, CA, by letters on February 14, 2005. Firm initiated
recall is ongoing.
REASON
The coating on the product's surface can generate debris, which could then move
from the heart towards the brain, resulting in Ischemic events.
VOLUME OF PRODUCT IN COMMERCE
6,694 units.
DISTRIBUTION
Nationwide and Internationaly.
_______________________________
PRODUCT
Xcelera R1.2. Cardiology image and information management solution software.
Recall # Z-0640-05.
CODE
Xcelera Software version R1.2.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Sales and Service Region No. America, Bothell, WA, by
letter on December 21, 2004. Firm initiated recall is ongoing.
REASON
Loss of image data from image repository and archive requiring patients to undergo
repeat imaging.
VOLUME OF PRODUCT IN COMMERCE
33 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Manual Mechanical Wheelchair, 18" seat,
maximum patient weight: 250 lbs.; Made in China;
the wheelchairs were sold in the following
configurations: reorder 16-7901: Fixed Full Arm,
Fixed Footrest reorder 16-7902: Fixed Full Arm,
Swing Footrest reorder 16-7903: Fixed Full Arm,
Elevating Adjustable Legrest reorder 16-7904:
Removable Desk Arm, Swing Footrest reorder 16-7905:
Removable Desk Arm, Elevating Adjustable Legrest
reorder 16-7906: Removable Full Arm, Elevating
Adjustable Legrest. Recall # Z-0642-05;
b) Manual Mechanical Wheelchair, 16" seat, maximum
patient weight: 250 lbs.; Made in China; the
wheelchairs were sold in the following
configurations: reorder 16-7910: Fixed Full
Arm, Swing Footrest reorder 16-7911: Fixed
Full Arm, Elevating Adjustable Legrest reorder
16-7912: Removable Desk Arm, Swing Footrest
reorder 16-7913: Removable Desk Arm, Elevating
Adjustable Legrest reorder 16-7914: Removable
Full Arm, Elevating Adjustable Legrest.
Recall # Z-0643-05;
c) Manual Mechanical Wheelchair, 24" seat,
maximum patient weight: 450 lbs.; Made
in China; the wheelchairs were sold in the
following configurations: reorder 16-7920:
Removable Desk Arm, Swing Footrest reorder
16-7921: Removable Desk Arm, Elevating
Adjustable Legrest reorder 16-7922: Removable
Full Arm, Elevating Adjustable Legrest.
Recall # Z-0644-05;
d) Manual Mechanical Wheelchair, 20" seat,
maximum patient weight: 350 lbs., Made in
China; the wheelchairs were sold in the
following configurations: reorder 16-7942:
Removable Desk Arm, Swing Footrest reorder
16-7943: Removable Desk Arm, Elevating
Adjustable Legrest reorder 16-7944: Removable
Full Arm, Elevating Adjustable Legres.
Recall # Z-0645-05;
e) Manual Mechanical Wheelchair, 22" seat,
maximum patient weight: 350 lbs.; Made in
China; the wheelchairs were sold in the
following configurations: reorder 16-7952:
Removable Desk Arm, Swing Footrest reorder
16-7953: Removable Desk Arm, Elevating Adjustable
Legrest reorder 16-7954: Removable Full Arm,
Elevating Adjustable Legrest. Recall # Z-0646-05.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cypress Medical Products, Ltd., McHenry, IL, by telephone on
May 3, 2004, and by telephone and letters dated March 3, 2005.
Manufacturer: Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond,
VA. Firm initiated recall is ongoing.
REASON
The seat of the wheelchair may come loose from the frame with the screws and
the collars still attached when the seat is pulled upward to fold the wheelchair.
VOLUME OF PRODUCT IN COMMERCE
332 chairs.
DISTRIBUTION
Nationwide, and Canada.
_______________________________
PRODUCT
ETI-MP IgM Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection
of specific IgM antibodies to Mycoplasma pneumoniae in human serum. Test kit
for 192 determinations. Catalog No. 4700. For In Vitro Diagnostic use. Recall
# Z-0633-05.
CODE
Lot # E052660D, E052790D.
RECALLING FIRM/MANUFACTURER
DiaSorin Inc., Stillwater, MN, by letters on October 20, 2004. Firm initiated
recall is ongoing.
REASON
2 lots of ETI-MP IgM assay kits showed a decline in Optical Density (OD) reading
of the positive control and calibrators, P10 and P50. The decline in OD of the
positive control and calibrators (P10 & P50) would cause the assay validation
criteria to fail.
VOLUME OF PRODUCT IN COMMERCE
12.
DISTRIBUTION
MA, OH, and IL.
_______________________________
PRODUCT
DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725. for
the quantitative determination of androstenedione levels in serum. Recall #
Z-0634-05.
CODE
Lot # 05144.
RECALLING FIRM/MANUFACTURER
DiaSorin, Stillwater, MN, by letter. Firm initiated recall is ongoing.
REASON
Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared
yellowish in color and were gelatinous upon reconstitution.
VOLUME OF PRODUCT IN COMMERCE
258.
DISTRIBUTION
MN, MA, KY, and Internationally.
_______________________________
PRODUCT
a) Lp(a) Diluent packaged into 60 mL bottles,
Catalog #23817, 480 mL bulk catalog # 95046B;
b) 60 mL bottles can be part of DiaSorin Lp(a)
Antibody Reagent Kits Catalog # 86084, for
use in DiaSorin Antibody Reagent Set for
Lp(a) SPQ Test System. Recall # Z-0636-05.
CODE
a) Lot #s 238017-01 & 238017-03,
Lot # 238017-02;
b) Lot #s 1144332, 114432A,13656, 113656A, and 113656B.
RECALLING FIRM/MANUFACTURER
DiaSorin, Inc., Stillwater, MN, by letters on January 10, 2004. Firm initiated
recall is ongoing.
REASON
QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered
that the background was failing high of the specification. Through substitution
testing it was determined that the Lp(a) diluent, part #238017 was the cause
of the failing background specification.
VOLUME OF PRODUCT IN COMMERCE
631 as individual vials, 1 bulk unit and 401 sold in kits.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Liaison 25 OH Vitamin D Assay, catalog # 310900. Recall # Z-0637-05.
CODE
Lot 114439E.
RECALLING FIRM/MANUFACTURER
DiaSorin, Inc., Stillwater, MN, by letters dated February 14, 2005. Firm initiated
recall is ongoing.
REASON
Results of an internal inspection show Lot 114439E to have calibrator 1 and
calibrator 2 switched in their position in the integral. This results in an
inability to calculate a curve, due to the reversal of calibrator values.
VOLUME OF PRODUCT IN COMMERCE
131.
DISTRIBUTION
MI, NJ, Germany, Spain and Belgium.
_______________________________
PRODUCT
Liaison 25 OH Vitamin D Assay, Manufacturer part # 310900. Recall # Z-0638-05.
CODE
Lot # 114668.
RECALLING FIRM/MANUFACTURER
DiaSorin, Inc., Stillwater, MN, by letters dated February 14, 2005. Firm initiated
recall is ongoing.
REASON
An internal inspection indicates that calibrator 2 and conjugate are switched
in their positions in the integral. This will result in calibrator 1 RLU's similar
to that of background RLU, and calibrator 2 RLU's near expected range. A curve
can not be calculated from this data.
VOLUME OF PRODUCT IN COMMERCE
31.
DISTRIBUTION
MA, Spain, Germany, and Belgium.
_______________________________
PRODUCT
Elanco brand Tylan soluble (tylosin tartrate) powder, 100 g. Lilly item code
AF130067X. Recall # V-080-5.
CODE
Lot 6RF77N; exp. October 1, 2005.
RECALLING FIRM/MANUFACTURER
Lilly, Eli & Co., Indianapolis, IN, by letter dated February 4, 2005. Firm
initiated recall is ongoing.
REASON
The product is labeled solely in Spanish.
VOLUME OF PRODUCT IN COMMERCE
1,032 Bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
ISE-Electrolyte Systems VetLyte ISE Fluid Pack, for use only in VetLyte electrolyte
analyzers, product 98-05318-00. Recall # V-081-5.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp, Indianapolis, IN, by letter dated January 6, 2005.
Firm initiated recall is ongoing.
REASON
A defective seam in the two chamber pouch may result in the mixing of reagents,
which would either result in an inability to calibrate the analyzer or would
bias patient results.
VOLUME OF PRODUCT IN COMMERCE
86,479 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Safe-Guard (Fenbendazole) 0.5% Pellets; Type B Category II medicated dewormer
for beef and dairy cattle. Net Weight 25 pound bags. Recall # V-045-5.
CODE
Lot numbers QW29004, QW32104, QW32704 and QW01005.
RECALLING FIRM/MANUFACTURER
ADM Alliance Nutrition, Inc., Quincy, IL, by telephone on February 2, 2005.
Firm initiated recall is complete.
REASON
The label containing the guarantees and feeding directions was not attached
to the bag of Type B medicated dewormer.
VOLUME OF PRODUCT IN COMMERCE
963 -- 25 lb. bags.
DISTRIBUTION
IL, OH, TX, and IA.
_______________________________
PRODUCT
a) Medicated feed identified as: Coleman R Heifer
Mix (bulk) with active drug ingredient and caution
statement. Recall # V-046-05;
b) Medicated feed identified as: Tub Griskauskas
Calf Pellet (bulk) with active ingredient Monensin
Sodium 79.2 grams per ton, 39.6 mg per pound.
Recall # V-047-05;
c) Medicated feed identified as: Tub Anderson, Chris &
Steph Calf Pellet (bulk) with active drug ingredient
Monensin Sodium 53.3 grams per ton, 26.6 mg per pound.
Recall # V-048-05;
d) Medicated feed identified as: Space, Ron 22% Calf
Pellet with Bovetec (bulk) with active ingredient
Lasalocid, 63 grams per ton, 31.5 mg per pound.
Recall # V-049-05;
e) Medicated feed identified as: Space Heifer Mineral-80
(bagged), with active ingredient Monensin Sodium
1,186 gms per ton/593 mg per lb. Recall # V-050-5;
f) Medicated feed identified as: Charter Cornmeal/
Rumensin Heifer Mix - 100 (bagged) with active
ingredient: Monensin Sodium, 4,000 gms per
ton/2000 mg per lb. Recall # V-051-5;
g) Medicated feed identified as: Tub Briggs Calf
Pellet (bulk), active ingredient Monensin Sodium, 46
gms per ton / 23 mg per lb. Recall # V-052-5;
h) Medicated feed identified as: Leubner, Ed Calf Pellet
(bulk), active ingredient Decoquinate, 68 gms per ton /
34 mg per lb. V-053-5;
i) Medicated feed identified as: Rounsaville Heifer
Pellet (bulk), active ingredient Monensin Sodium,
40 gms per ton / 20 mg per lb. Recall # V-054-5;
j) Medicated feed identified as: Bud Nurse Calf Mix --
50 (bagged), active ingredients: Monensin Sodium --
501.6 gms per ton / 250.8 mg per lb.; Chlortetracycline
350 mg per lb; and Sulfamethazine - 350 mg per lb.
Recall # V-055-5;
k) Medicated feed identified as: Cleverly Calf Pellet
(bulk), active ingredient: Monensin Sodium, 59.4
gms per ton / 29.7 mg per lb. Recall # V-056-5;
l) Medicated feed identified as: Cleverly, Tom Heifer
Protein Mix (bulk), active ingredient Monensin
Sodium, 188 gms per ton / 94 mg per lb.
Recall # V-057-5;
m) Medicated feed identified as: Silvanic Heifer (bulk),
active ingredient Monensin Sodium, 85.7 gms per ton /
42.8 mg per lb. Recall # V-058-5;
n) Medicated feed identified as: Tub Fisher,
Floyd Calf Pellet (bulk), active ingredient:
Monensin Sodium, 66 gms per ton / 33 mg per lb.
Recall # V-059-5;
o) Medicated feed identified as: Jones Heifer Mix
(bulk), active ingredient: Monensin Sodium,
66 gms per ton / 33 mg per lb. Recall # V-060-5;
p) Medicated feed identified as: Harvey L Special
Heifer Pellet (bulk), active ingredient:
Lasalocid, 67.7 gms per ton / 33.86 mg per lb.
Recall # V-061-5;
q) Medicated feed identified as: Murray, Tom
Calf Feed - 100 (bagged), active ingredient:
Monensin Sodium 28 gms per ton / 14 mg per lb.
Recall # V-062-5;
r) Medicated feed identified as: Lawnhurst Dairy
Heifer Mineral (bulk), active ingredient:
Lasalocid, 1,304 gms per ton / 652 mg per lb.
Recall # V-063-5;
s) Medicated feed identified as: Lawnhurst Farms
Custom Heifer Pellet (bulk), active ingredient:
Lasalocid, 67.2 gm per ton / 33.6 mg per lb.
Recall # V-064-5;
t) Medicated feed identified as: Luchsinger,
Chuck Heifer Mix, 100 (bagged), active ingredient:
Lasalocid, 90.3 gms per ton / 45.15 mg per lb.
Recall # V-065-5;
u) Medicated feed identified as: Fouts B Calf Pellet
(bulk), active ingredients: Lasalocid, 81 gms
per ton / 40.5 mg per lb; Oxytetracycline 8 mg
per lb. Recall # V-066-5;
v) Medicated feed identified as: Fouts Heifer Pellet
(bulk). Active ingredients: Lasalocid, 54 gms
per ton / 27 mg per lb; Oxytetracycline, 5 mg per lb.
Recall # V-067-5;
w) Medicated feed identified as: Tub Hathorn Heifer
Mineral (bulk), active ingredient: Monensin
Sodium, 884.36 gms per ton, 442.18 mg per lb.
Recall # V-068-5;
x) Medicated feed identified as: Fox Heifer Mix
(bulk), active ingredient: Monensin Sodium,
79 gms per ton / 39.5 mg per lb. Recall # V-069-5;
y) Medicated feed identified as: Tub Fox Bros Calf
(bulk), active ingredient Monensin Sodium,
98.86 gms per ton / 49 mg per lb.
Recall # V-070-5;
z) Medicated feed identified as: Holland,
Jamie Heifer Mix, 100 (bagged), active
ingredient: Lasalocid, 50 gms per ton,
25 mg per lb. Recall # V-071-5;
aa) Medicated feed identified as: Slades Heifer
Pellet (bulk), active ingredient: Monensin
Sodium, 39.6 gms per ton / 19.8 mg per lb.
Recall # V-072-5;
bb) Medicated feed identified as: CMG Calf
Starter Pellet (bulk), active ingredient:
Monensin Sodium 100 gms per ton, 50 mg per lb.
Recall # V-073-5;
cc) Medicated feed identified as: Tub Baker A Calf
Starter (bulk), active ingredient: Monensin
Sodium, 27 gms per ton, 13.5 mg per lb.
Recall # V-074-5;
dd) Medicated feed identified as: Tub Quinlin
Special Calf and Deccox (bulk), active ingredient:
Decoquinate, 27.2 gms per ton / 13.6 mg per lb.
Recall # V-075-5;
ee) Medicated feed identified as: Tim's Heifer
Pellet (bulk), active ingredient: Monensin Sodium,
100 gms per ton / 50 mg per lb. Recall # V-076-5;
ff) Medicated feed identified as: Masker Farms Calf
Pellet 24% (bulk), active ingredient: Lasalocid
67.7 gm per ton / 33.86 mg per lb.
Recall # V-077-5;
gg) Medicated feed identified as: RH Hi Energy 18% +
Rumensin (bulk), active ingredient: Monensin
Sodium, 100 gms per ton / 50 mg per lb.
Recall # V-078-5;
hh) Medicated feed identified as: Snow Heifer
Pellet (bulk), active ingredient: Lasalocid,
67.7 gms per ton / 33.86 mg per lb.
Recall # V-079-5.
CODE
Not coded.
RECALLING FIRM/MANUFACTURER
Round House Mill, Inc, Cortland, NY, by letters dated December 8, 2004. Firm
initiated recall is complete.
REASON
Product shipped with no labeling and therefore lacks indications for use, directions
for use, active drug ingredient and caution statement.
VOLUME OF PRODUCT IN COMMERCE
252,484 lbs.
DISTRIBUTION
NY.
END OF ENFORCEMENT REPORT FOR MARCH 30, 2005
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