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U.S. Department of Health and Human Services

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Enforcement Report for October 13, 2004

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.

October 13, 2004
04-41

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
Cheetos Yu-Gi-Oh! (Cheese flavored corn snacks), packaged in foil bag, labeled "Cheetos ***Yu-Gi-Uh! ***PESO NETO: 1.37oz. (37.1g)***". Recall # F-002-5.
CODE
2 151 2 IJ 11 exp. 5/24/2004 2 151 2 IJ 12 exp. 5/24/2004.
RECALLING FIRM/MANUFACTURER
Frito Lay Quaker, Barceloneta, PR, by letters beginning on April 6, 2004. Firm initiated recall is ongoing.
REASON
Product is distributed in US Virgin Island with a Spanish label.
VOLUME OF PRODUCT IN COMMERCE
1,100 units.
DISTRIBUTION
VI.

_______________________________
PRODUCT
a) Care brand baby lotion, in 2 oz. and 4 oz. bottles, and sold
in bulk quantities. Products HB60020 and HB60040. Recall # F-
004-5;
b) Medifesh brand baby lotion for adults and babies, in 2 oz.
bottles, sold in bulk quantities; Product BL200. Recall # F-
005-5;
c) Tri-State Centurion brand Newborn Kits, contains latex;
products P621A and W164. Each kit contains Medifesh brand
baby lotion for adults and babies in 2 oz. bottles. Recall #
F-006-5;
d) Tri-State Centurion brand Newborn Kits, contains latex;
product C1410. Each kit contains Care brand baby lotion in 2
oz. bottles. Recall # F-007-5;
e) Tri-State Centurion brand Newborn Kits, latex free; product
B262. Each kit contains Care brand baby lotion in 2 oz.
bottles. Recall # F-008-5;
f) Tri-State Centurion brand Newborn Care Kits, product W163.
Each kit contains Medifresh brand baby lotion for adults and
babies in 2 oz. bottles. Recall # F-009-5;
g) Tri-State Centurion brand Neonatal Kits, product G109. Each
kit contains Medifresh brand baby lotion for adults and
babies in 2 oz. bottles. Recall # F-010-5;
h) Tri-State Centurion brand Maternity Kits, latex free;
products E332 and P810. Each kit contains Medifresh brand
baby lotion for adults and babies in 2 oz. bottles. Recall #
F-011-5.
i) Tri-State Centurion brand C-Section Combi Packs, product
CP200. Each pack contains a new born kit with Medifresh brand
baby lotion for adults and babies in 2 oz. bottles. Recall #
F-012-5;
j) Tri-State Centurion brand Vaginal Delivery Combi Packs;
product CP200. Each pack contains a newborn kit with
Medifresh brand baby lotion for adults and babies in 2 oz.
bottles; Recall # F-013-5;
k) Tri-State Centurion brand L&D Admission Kits, products P628
and P628A. Each kit contains a baby care kit with Medifresh
brand baby lotion for adults and babies in 2 oz. bottles.
Recall # F-014-5;
l) Tri-State Centurion brand Infant Toiletry Kits, latex free;
product B262. Each kit contains Care brand baby lotion in 4
oz. bottles. Recall # F-015-5;
m) Tri-State Centurion brand Infant Care Kits, latex free,
product B262. Each kit contains Care brand baby lotion in 4
oz. bottles. Recall # F-016-5;
n) Tri-State Centurion brand Nursery Kits, contains latex;
products J251, J251A, J251B. Each kit contains Care brand
baby lotion in 2 oz. bottles. Recall # F-017-5;
o) Tri-State Centurion brand Nursery Kits, latex free; product
L1027. Each kit contains Care brand baby lotion in 4 oz.
Bottles. Recall # F-018-5;
p) Tri-State Centurion brand Baby Kits, latex free; product
D453. Each kit contains Care brand baby lotion in 4 oz.
bottles, Recall # F-019-5;
q) Tri-State Centurion brand Baby Admission Kits, latex free,
product F475. Each kit contains Medifresh brand baby lotion
for adults and babies in 2 oz. bottles. Recall # F-020-5;
r) Tri-State Centurion brand Baby Care Kits, contains latex,
product P621. Each kit contains Medifresh brand baby lotion
for adults and babies in 2 oz. bottles. Recall # F-021-5.
s) Tri-State Centurion brand Baby Care Kits, latex free,
products G108, G746 and W801. Each kit contains Medifresh
brand baby lotion for adults and babies in 2 oz. bottles.
Recall # F-022-5;
t) Tri-State Centurion brand Mother Baby Kits, contains latex,
product H965. Each kit contains Care brand baby lotion in 2
oz. bottles. Recall # F-023-5;
u) Tri-State Centurion brand Brookville Pedi Kits, contains
latex, Boys- product B443. Girls - product B444. Each kit
contains Care brand baby lotion in 2 oz. bottles, Recall #
F-024-5;
v) Tri-State Centurion brand Ped; products C1216, S625 and
S2111. Each kit contains Care brand baby lotion in 2 oz.
bottles, Recall # F-025-5;
w) Tri-State Centurion brand Pedi Admission Kits, latex free;
product C1450. Each kit contains Care brand baby lotion in 2
oz. bottles, Recall # F-026-5;
x) Tri-State Centurion brand Admission Kits, latex free; product
C1590. Each kit contains Medifresh brand baby lotion for
adults and babies in 2 oz. bottles. Recall # F-027-5;
y) Tri-State Centurion brand Pediatric Kits, latex free; product
P627. Each kit contains Medifresh brand baby lotion for
adults and babies in 2 oz. bottles, Recall # F-028-5;
z) Tri-State Centurion brand Pediatric Kits, latex free;
product N263. Each kit contains Care brand baby lotion in 2
oz. bottles. Recall # F-029-5;
aa) Tri-State Centurion brand Pediatric Care Kits, latex free;
product B727. Each kit contains Medifresh brand baby lotion
for adults and babies in 2 oz. bottles. Recall # F-030-5;
bb) Tri-State Centurion brand Pediatric Personal Care Kits,
latex free; product S2560. Each kit contains Medifresh brand
baby lotion for adults and babies in 2 oz. bottles. Recall
# F-031-5;
cc) Tri-State Centurion brand VIP Kits, contains latex, product
W835. Each kit contains Care brand baby lotion in 2 oz.
bottles. Recall # F-032-5;
dd) Tri-State Centurion brand Infant Kits, contains latex,
product A52. Each kit contains Care brand baby lotion in 2
oz. bottles. Recall # F-033-5.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Tri-State Hospital Supply Corp., Howell, MI, by letter dated June 1, 2004. Firm initiated recall is ongoing.
REASON
Lotion may be contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
Not available.
DISTRIBUTION
Nationwide.

 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Diet Coke in 11.27 oz metal cans, 11.27 fl. oz.; distributed in cases of 24 cans. Recall # F-001-5.
CODE
Diet Coke Dec0803CY 3253.
RECALLING FIRM/MANUFACTURER
Coca Cola Puerto Rico Bottling Co., Cayey, PR, by telephone beginning on September16, 2003. Firm initiated recall is ongoing.
REASON
Product contains undeclared ingredient Saccharin rather than Aspartame.
VOLUME OF PRODUCT IN COMMERCE
10,500 cases.
DISTRIBUTION
PR.
 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Protonix I.V. for Injection (pantoprazole sodium) Equivalent to
40 mg pantoprazole per vial, 10 cartons per vial, For I.V.
Infusion only, Rx only, NDC 0008-0923-51. Recall # D-026-5.
CODE
Lot number 14047A exp. 3/06, Lot number 14048A exp. 3/06, Lot number 14049A exp. 3/06, Lot number 14050A exp. 3/06, Lot number 14051A exp. 3/06, Lot number 14052A exp. 3/06, Lot number 14053A exp. 3/06, Lot number 24056A exp. 4/06, Lot number 24057A exp. 4/06, Lot number 24059A exp. 4/06, and Lot number 24060A exp. 4/06.
RECALLING FIRM/MANUFACTURER
Wyeth Pharmaceuticals, Philadelphia, PA, by letter dated September 3, 2004. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility due to loose seal caps on vials (manufacturer).
VOLUME OF PRODUCT IN COMMERCE
41,282 vials.
DISTRIBUTION
Nationwide and Guam.

_______________________________
PRODUCT
BETCO brand E-2 Food Industry Hand Cleaner, (Benzalkonium Chloride) 2.5%, Hand Washing Sanitizer, Net Contents 30.4 fl. oz. (U.S./E.U.) 900 mL, 84 oz (U.S./E.U.) 2500mL, and 1 gallon (U.S./E.U.) 3.78L size containers, ---- Also produced under the private brand name Northwoods Germ Stuff, and CleanChoice Food Industry Hand Cleaner/Sanitizer. Recall # D-028-5.
CODE
1634, 1644, 1664, 1674, 1684, 1694, 1704, 1714, 1734, 1744, 1754, 1764, 1774, 1784, 1804, 1814, 1824, 1834, 1844, 1854, 1874, 1884, 1894, 1904, 1914, 1924, 1944, 1954, 1964, 1974, 1984, 1994, 2014, 2024, 2034, 2044, 2054, 2064, 2084, 2094, 2104, 2114, 2124, 2134, 2154, 2164, 2174, 2184.
RECALLING FIRM/MANUFACTURER
Betco Corp. Ltd, Toledo, OH, by letter on September 13, 2004. Firm initiated recall is ongoing.
REASON
Bacterial contamination (photobacterium logei).
VOLUME OF PRODUCT IN COMMERCE
72/gallon size containers, 22/900 mL containers, and 31/2500 mL containers.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
a) CombiPatch 50/140 Transdermal Patch, stradiol/norethindrone
acetate transdermal system, 0.05/0.14 mg per day, Rx
contraceptive patch, 8 patches per box, 3 boxes per case,
NDC 0078-0377-42, Walgreen item 673868. Recall # D-001-5;
b) CombiPatch 50/250 Transdermal Patch, stradiol/norethindrone
acetate transdermal system, 0.05/0.25 mg per day, Rx
contraceptive patch, 8 patches per box, 3 boxes per case,
NDC 0078-0378-45, Walgreen item 673705. Recall # D-002-5;
c) Bausch & Lomb Desmopressin Acetate Nasal Solution, 0.01%, 5
mL bottle with spray attachment, delivering 0.1 mL per
actuation, Rx antidiuretic hormone, NDC 24208-342-05,
Walgreen item 675618. Recall # D-003-5;
d) Erythromycin Ethylsuccinate Oral Suspension, USP, 200 mg/5
mL, one pint bottle, Rx, NDC 0074-3747-16, Walgreen item
677076. Recall # D-004-5;
e) Erythromycin Ethylsuccinate Oral Suspension, USP, 400 mg/5
mL, one pint bottle, Rx, NDC 0074-3748-16, Walgreen item
677077. Recall # D-005-5;
f) Ethezyme 830 Papain-Urea Debriding Ointment, 8.3 x 105 units
papain, 100 mg Urea, 30 g tube, Rx only, NDC 58177-816-02,
Walgreen item 676517. Recall # D-006-5;
g) Foradil Aerolizer, formoterol fumarate inhalation powder, 12
mcg capsules, 12 and 60 capsule blister pack w/aerolizer
inhaler, Rx only, , NDC 0085-1401-01, Walgreen item 676713.
Recall # D-007-5;
h) Leuprolide Acetate Injection, 1 mg/0.2 mL leuprolide acetate,
Rx only, 2.8 mL vial in 14 day patient administration kit,
NDC 0185-7400-85, Walgreen item 680339. Recall # D-008-5;
i) Miacalcin Nasal Spray, calcitonin-salmon nasal solution, 30
dose bottle, 200 I.U. calcitonin-salmon per 0.09 mL spray
dose, 3.7 mL bottle, Rx only, NDC 0078-0311-54, Walgreen item 672454. Recall # D-009-5;
j) NuvaRing Etonogestrel/Ethinyl Estradiol Vaginal Ring,
delivers 0.120 mg etonogestrel and 0.015 mg ethinyl estradiol
per day for 3 weeks, Rx only, 1 ring sachet per box, NDC
0052-0273-01, Walgreen item 680703. Recall # D-010-5;
k) Orapred Oral Solution, 20.2 mg/5mL prednisolone sodium
phosphate equivalent to 15 mg prednisolone base, Rx only,
8 fl. oz. (237 mL) bottle, NDC 59439-455-02, Walgreen item 680765. Recall # D-011-5;
l) G & W Promethegan (Promethazine HCl Suppositories, USP), 12.5
mg., 12 suppositories per box, Rx only, NDC 0713-0536-12,
Walgreen item 682540. Recall # D-012-5;
m) G & W Promethegan (Promethazine HCl Suppositories, USP), 25
mg., 12 suppositories per box, Rx only, NDC 0713-0526-12,
Walgreen item 684051. Recall # D-013-5;
n) Promethazine HCl Suppositories, USP, 50 mg., 12 suppositories
per box, Rx only, NDC 53265-764-12, Walgreen item 683099.
Recall # D-014-5;
o) Falcon Trifluridine Ophthalmic Solution 1%, 7.5 mL
bottle, Rx only, NDC 61314-044-75, Walgreen item 684644.
Recall # D-015-5;
p) Regular Human Insulin Injection (rDNA origin) U-100, 100
units/mL, OTC, 10 mL vials, distributed under the following
labels: a) Humulin R Regular Human Insulin Injection, USP,
HI-210, NDC 0002-8215-01, Walgreen item 676095 b) Novolin R
Regular Human Insulin Injection, NDC 0169-1833-11, Walgreen
item 681247. Recall # D-016-5;
q) NPH Human Insulin (rDNA origin) Isophane Suspension, U-100,
100 units/mL, OTC, distributed under the following labels and
containers: a) Humulin N NPH Human Insulin (rDNA origin)
Isophane Suspension, HI-310, 10 mL vials, NDC 0002-8315-01,
Walgreen item 676096; b) Humulin N Pen, 5 x 3 mL Disposable
Pen Insulin Delivery Devices, HP-8730, NDC 0002-8730-59,
Walgreen item 681596; c) Novolin N NPH Human Insulin Isophane
Suspension (rDNA origin),10 mL vials, NDC 0169-1834-11,
Walgreen item 681245; d) Novolin N PenFill, 5 x 3 mL
cartridges for use with NovoPen 3 Insulin Delivery Device,
NDC 0169-3474-18, Walgreen item 681008. Recall # D-017-5;
r) 70% Human Insulin Isophane Suspension 30% Human Insulin
Injection (rDNA origin), U-100, 100 units/mL human insulin,
OTC, distributed under the following labels and containers:
a) Humulin 70/30, HI-710, 10 mL vials, NDC 0002-8715-01,
Walgreen item 678064, b) Humulin 70/30 Pen, 5 x 3 mL
Disposable Pen Insulin Delivery Devices, HP-8770, NDC 0002-
8770-59, Walgreen item 680333, c) Novolin 70/30, 10 mL vials,
NDC 0169-1837-11, Walgreen item 679253, d) Novolin 70/30
InnoLet Insulin Pen, 5 x 3 mL pre-filled disposable insulin
dosers, Walgreen item 672061, e) Novolin 70/30 PenFill, 5 x 3
mL cartridges for use with NovoPen 3 Insulin Delivery Device,
NDC 0169-3477-18, Walgreen item 681599. Recall # D-018-5;
s) Humulin 50/50, 50% Human Insulin Isophane Suspension 50%
Human Insulin Injection (rDNA origin), U-100, 100 units/mL
human insulin, OTC, HI-1510, 10 mL vials, NDC 0002-9515-01,
Walgreen item 677858. Recall # D-019-5;
t) Humulin L Lente Human Insulin (rDNA origin) Zinc Suspension,
70% crystalline and 30% amorphous insulin suspension, 100
units/mL human insulin (rDNA), OTC, HI-410, 10 mL vials, NDC
0002-8415-01, Walgreen item 678097. Recall # D-020-5;
u) Humulin U Ultralente Human Insulin (rDNA origin) Extended
Zinc Suspension, U-100, 100 units/mL human insulin, OTC, HI-
610, 10 mL vials, NDC 0002-8615-01, Walgreen item 681349.
Recall # D-021-5;
v) Humalog Insulin Lispro Injection (rDNA origin), U-100, 100
units/mL human insulin, Rx, distributed in the following
containers: a) Humalog, 10 mL vials, VL-7510, NDC 0002-7510-
01, Walgreen item 673093 b) Humalog Pen, 5 x 3 mL Disposable
Insulin Delivery Devices, HP-8725, NDC 0002-8725-59, Walgreen
item 680332. Recall # D-022-5;
w) Humalog Mix 75/25, 75% Insulin Lispro Protamine Suspension
25% Insulin Lispro Injection (rDNA origin), U-100, 100
units/mL human insulin, Rx, distributed in the following
containers: a) Humalog Mix 75/25, 10 mL vial, VL-7511, NDC
0002-7511-01, Walgreen item 676801 b) Humalog Mix 75/25 Pen,
5 x 3 mL Disposable Insulin Delivery Devices, HP-8794, NDC
0002-8794-59, Walgreen item 677240. Recall # D-023-5;
x) Novolog Insulin Aspart Injection (rDNA origin), U-100, 100
units/mL human insulin, Rx, distributed in the following
containers: a) Novolog, 10 mL vials, NDC 0169-7501-11,
Walgreen item 680728 b) Novolog PenFill, 5 x 3 mL PenFill
cartridges for use with NovoPen 3, insulin delivery devices,
NDC 0169-3303-12, Walgreen item 675572 c) Novolog Flexpen
Prefilled Syringe, 5 x 3 mL pre-filled insulin syringes, NDC
0169-6339-10, Walgreen item 680670. Recall # D-024-5;
y) Novolog Mix 70/30, 70% Insulin Aspart Protamine Suspension
and 30% Insulin Aspart Injection, (rDNA origin), U-100, 100
units/mL human insulin, Rx only, distributed in the following
containers: a) Novolog Mix 70/30,10 mL vial, NDC 0169-3685-
12, Walgreen item 675106 b) Novolog Mix 70/30 PenFill, 5 x 3
mL PenFill cartridges for use with 3 mL PenFill cartridge
compatible delivery devices, NDC 0169-3682-13, Walgreen item
675491 c) Novolog Mix 70/30 FlexPen Prefilled Syringe, 5 x 3
mL pre-filled insulin syringes, NDC 0169-3696-19, Walgreen
item 675492. Recall # D-025-5.
CODE
Shipment numbers 0485217 through 0485373, all processed on 8/13/04 and shipped on 8/16/04.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Walgreen Company, Deerfield, IL, by telephone on August 17, 2004. Firm initiated recall is ongoing.
REASON
Inadvertent distribution of refrigerated drugs which had been subject to a two day power outage resulting from hurricane Charley.
VOLUME OF PRODUCT IN COMMERCE
604 vials, 120 bottles, 163 vials, 6 tubes, 127 blister packs, 60 pens, 10 syringes.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Pegaspargase Oncaspar (PEG-L-asparaginase), 750 I.U. per mL, one 5.0 mL single dose vial, Sterile, For intramuscular use only, Contains no preservative, Rx only, NDC 57665-002-02. Recall # D-027-5.
CODE
Lot AG0314 Exp. 9/17/2005.
RECALLING FIRM/MANUFACTURER
Enzon Pharmaceuticals, Inc., South Plainfield, NJ, by fax on July 12, 1004, and by letter on July 16, 2004. Firm initiated recall is ongoing.
REASON
Superpotent; product exceeds enzyme levels (9 month stability).
VOLUME OF PRODUCT IN COMMERCE
2,184 vials.
DISTRIBUTION
Nationwide, Canada, Australia and New Zealand.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0005-5;
b) Fresh Frozen Plasma. Recall # B-0006-5.
CODE
a) and b) Unit S52686.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw Valley, Saginaw, MI, by facsimile on July 29, 2004. Firm initiated recall is complete.
REASON
Blood products, corresponding to Platelets that were contaminated with coagulase negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-0007-5.
CODE
Unit number 6687510.
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Sarasota, FL, by telephone on August 31, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall B-0008-5.
CODE
Unit number 6684748 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Sarasota, FL, by telephone on October 28, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0013-5.
CODE
Unit number 7018895.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., aka Blood Bank of Delmarva, Newark, DE, by telephone on January 16 and 20, 2004. Firm initiated recall is complete.
REASON
Blood product, that was initially incorrectly tested for viral markers and re-tested repeatedly reactive for hepatitis B surface antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
DE.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0014-5;
b) Recovered Plasma. Recall # B-0015-5.
CODE
a) Unit number 1074687;
b) Unit numbers 598013, 598023, 598225, 1074654, and 1074687.
RECALLING FIRM/MANUFACTURER
Avera McKennan Hospital and University Health Center, Sioux Falls, SD, by letter on March 30, 2000. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for antibodies to hepatitis C virus (anti-HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
MN and FL.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0017-5;
b) Platelets. Recall # B-0018-5;
c) Fresh Frozen Plasma. Recall # B-0019-5.
CODE
a), b), and c) Unit number 9242652.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., aka Blood Bank of Delmarva, Newark, DE, by letter on June 8, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
DE, and MD.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0020-5;
b) Fresh Frozen Plasma. Recall # B-0021-5;
c) Plasma, Recall # B-0022-5;
d) Red Blood Cells for Further Manufacture, Recall # B-0023-5;
e) Recovered Plasma, Recall # B-0024-5.
CODE
a) Units 4136359, 4134337, 4133208, and 4132313;
b) Units 4133208 and 4132313;
c) Unit 4134337;
d) Unit 4135422;
e) Units 4136359 and 4135422.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on August 6-8, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
IL and FL.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0025-5;
b) Cryoprecipitated AHF, Recall # B-0026-5;
c) Plasma Cryoprecipitate Reduced, Recall # B-0027-5.
CODE
a), b), and c) Unit 20GM75704.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Boise, ID, by telephone on April 4, 2003 and by letter dated August 6, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for Creuztfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MT.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0029-5.
CODE
Unit 2290423.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Centers, Spokane, WA, by telephone on September 19, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was taking a nonsteroidal anti-inflammatory drug (NSAID), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0030-5.
CODE
Unit 1237992.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Centers, Spokane, WA, by letter dated September 5, 2002. Firm initiated recall is complete.
REASON
Blood product, which tested repeated reactive for the antibody to the human t-lymphotropic virus type I/II (anti-HTLV-I/II) but tested negative by a confirmatory test, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0032-5.
CODE
Unit LE84602.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., DBA Rhode Island Blood Center, Providence, RI, by letter dated August 3, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Source Plasma. Recall # B-0035-5.
CODE
Unit number 07330902.
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Hammond, IN, by facsimile on August 11, 2004. Firm initiated recall is complete.
REASON
Blood product tested negative for viral markers but was collected from an ineligible donor due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0036-5;
b) Fresh Frozen Plasma. Recall # B-0037-5.
CODE
a) and b) Unit number 2383755.
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on February 4, 2003, and August 13, 2003. Firm initiated recall is complete.
REASON
Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS , CLASS III

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0009-5;
b) Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-
0010-5.
CODE
a) Unit numbers 01GY86243, 01GY86247, 01GY86260, 01GY86275,
01KJ56432, 01KJ56526, 01LC50201, 01LH55711, 01LJ30292,
01LJ30293, 01LJ30294, 01LJ30296, 01LJ30298, 01LJ30299,
01LJ30301, 01LN32855, 01LN38237, 01LN38239, 01LN38246,
01LN38247, 01LN38252, 01LN38254, 01LN38259, 01LN38260,
01LS45587, 01LS45591, 01LS45598, 01LS45612, 01LS45613,
01LS45617, 01LT46600, 01LT46650, 01LV60753, 01LV60757,
01LV60764, 01LV60768, 01LV60772, 01LV60780, 01LV60781,
01LV60782, 01LV60795, and 01LW34025;
b) Unit numbers 01GE45096, 01LJ30289, 01LJ30303, 01LN38245,
01LN38250, 01LN38256, and 01Y51565.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letters on October 6, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested out of specification for hematocrit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
49 units.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-
0011-5.
CODE
Unit number LR85787.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI, by facsimile on November 15, 2002. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0012-5.
CODE
Unit numbers D03-02509 and D04-00404.
RECALLING FIRM/MANUFACTURER
Metrowest Medical Center, Farmingham, MA, by letter on August 10, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0016-5.
CODE
Unit numbers 1074627, and 598009.
RECALLING FIRM/MANUFACTURER
Avera McKennan Hospital and University Health Center, Sioux Falls, SD, by letter on March 30, 2000. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for antibodies to hepatitis C virus (anti-HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MN and FL.

_______________________________
PRODUCT
Platelets. Recall # B-0028-5.
CODE
Units 0365321, 0365325, and 0365330.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by telephone on July 18, 2004. Firm initiated recall is complete.
REASON
Blood products, which were not stored under continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
WA.

_______________________________
PRODUCT
Plasma. Recall # B-0031-5.
CODE
Unit numbers 20LC59848, 20LS15336, 20LS15340, 20LN27348, 20LN27349, and 20LN27350.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Boise, ID, by telephone on April 11, 2003 and by letter dated April 17, 2003. Firm initiated recall is complete.
REASON
Blood products, which were not frozen within 24 hours of whole blood collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
OR and ID.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0033-5.
CODE
Unit numbers 42R74167, 42FX30132, 42FX30156, 42FX30175, 42FX30193, 42FX30195, 42FC13879, 42FP00505, 42FP00506, 42FZ03799, 42FS85142, 42H41195, 42F58387, 42FZ03282, 42FZ03283, 42H41196, 42FH27540, 42FX30176, 42K70920, 42K70923, 42J51637, 42K70967, 42K70969, 42FE87170, 42FG06901, 42FR06289, 42G49553, 42FH27541, 42FH27912, 42FS85479, 42K70968, 42FJ22847, 42G49191, 42FG06885, 42FG06886, 42FG06903, 42FG06919, 42FG06920, 42FG06922, 42FG06923, 42T26932, 42FG07011, 42FH27499, 42FP00145, 42W36011, 42W36013, 42FH27542, 42GE12115, 42GE12116, 42FH27575, 42FH27577, 42FH27949, 42X89178, 42FE88022, 42FS85143, 42GC07518, 42T26627, 42FG06902, 42FG06921, 42FH27534, 42FP00146, 42GE12118, 42R74719, 42FH27574, 42W36041, 42FH27909, 42FS85481, 42K70921, 42FP00504, 42FJ22846, 42W36400, 42FZ03797, 42FZ03798, 42FZ03800, 42FZ03801, 42X89179, 42F58382, 42FR06288, 42S00226, 42FG07014, 42W36039, 42FC13907, 42FP00534, 42GC07963, 42GC07965, 42GC07967, 42FR07288, 42J51636, 42R74740, 42FH27573, 42GC07519, 42FE87171, 42FX30159, 42FX30194, 42K70924, 42FP00147, 42R74720, 42R74721, 42FH27543, 42FG07012, 42W36012, 42W36037, 42FZ03765, 42FZ03796, 42GE12117, 42FJ22845, 42FG07013, 42FE88023, 42T26933, 42GE12119, 42FX30174, 42W36396, 42FX30128, 42FX30129, 42FX30134, 42FX30157, 42FX30177, 42FX30196, 42FC13906, 42FC13909, 42W36397, 42FZ03763, 42FZ03764, 42X89181, 42G49190, 42T26613, 42T26615, 42T26628, 42W35835, 42W35836, 42FC13550, 42FC13552, 42FR06287, 42H41193, 42H41194, 42S00225, 42T27069, 42T27070, 42FH27498, 42GE12132, 42FH27576, 42FS85480, 42FX30158, 42W36372, 42FC13908, 42W36395, 42GC07966, 42FC13551, 42FR06290, 42G49554, 42S00224, 42FH27500, and 42GE12133.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on March 27, 2004, and by letter on April 2, 2004. Firm initiated recall is complete.
REASON
Blood products, manufactured by a method that may have resulted in the products being out of specification for hematocrit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
153 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Plasma. Recall # B-0034-5.
CODE
Unit numbers K85547, L82458, L82489, L82912, N03092, N03136, N03726, N04400, N04424, N03085, N04428, N01338, N02334, N02333, N02165, N02169, N02174, N02182 and N02187.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Valley Blood Program, Grand Rapids, MI, by facsimile on June 21, 2004. Firm initiated recall is complete.
REASON
Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units.
DISTRIBUTION
MI.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT
Aquasorb ? Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***. Recall # Z-0001-05.
CODE
Lot 360025.
RECALLING FIRM/MANUFACTURER
DeRoyal Wound Care, Rose Hill, VA, by telephone and letter on July 8, 2004 and July 13, 2004. Firm initiated recall is complete.
REASON
Wound dressing failed to meet sterility specifications.
VOLUME OF PRODUCT IN COMMERCE
4 cases.
DISTRIBUTION
CA, OH and PA.

_______________________________
PRODUCT
a) Automated Differential Cell Counter. Recall # Z-0002-05;
b) Automated Differential Cell Counter. Recall # Z-0003-05.
CODE
a) Part Numbers: Pentra 80 P8000000NUA10;
b) Part Numbers: Pentra 80XL P80XL000NUA10.
RECALLING FIRM/MANUFACTURER
ABX Diagnostics, Inc., Irvine, CA, by letter on August 13, 2004. Firm initiated recall is ongoing.
REASON
Device can generate overestimated platelet results.
VOLUME OF PRODUCT IN COMMERCE
94 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Ameriwater Portable RO+, model numbers MR01 and MR02. The device is reverse osmosis system for dialysis. Recall # Z-0004-05.
CODE
Serial Numbers effected: 21013, 21014, 21026, 21031, 21042, 21052, 21053, 21071, 21072, 21073, 21079, 21080, 21090, 21091, 21092, 21100, 21101, 21110, 21111, 21121, 21122, 21125, 21127, 21193, 21194, 21200, 21201, 21203, 21204, 21205, 21208, 21210, 21215, 21222, 21223, 21236, 21237, 21240, 21258, 21259, 21263, 21270, 21328, 21333, 21336, 21338, 21352, 21371, 21379, 21384, 21387, 21388, 21015, 21016, 21017, 21021, 21023, 21024, 21032, 21033, 21034, 21035, 21036, 21043, 21049, 21050, 21051, 21054, 21066, 21089, 21093, 21094, 21095, 21097, 21098, 21108, 21109, 21123, 21126, 21128, 21142, 21143, 21156, 21157, 21160, 21162, 21163, 21164, 21165, 21166, 21167, 21168, 21169, 21176, 21178, 21179, 21180, 21183, 21185, 21186, 21191, 21192, 21212, 21216, 21217, 21224, 21225, 21228, 21229, 21244, 21249, 21260, 21268, 21269, 21271, 21272, 21274, 21275, 21276, 21282, 21283, 21298, 21299, 21300, 21302, 21307, 21311, 21316, 21329, 21332, 21339, 21342, 21343, and 21346.
RECALLING FIRM/MANUFACTURER
Ameriwater Inc., Dayton, OH, by letter on September 3, 2004. Firm initiated recall is ongoing.
REASON
The device has a potential risk of failure caused by faulty wiring within the electrical component. The wires can overheat and eventually break in two.
VOLUME OF PRODUCT IN COMMERCE
148 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21. Recall # Z-0006-05.
CODE
Lot #: 18357Q100, 18357Q101 (France), 18357Q102, 18357Q103 and 18357104(France). Exp. date 11/11/04.
RECALLING FIRM/MANUFACTURER
Abbott Health Products, Inc., Barceloneta, PR, by letters dated August 24, 2004. Firm initiated recall is ongoing.
REASON
Assay may give elevated patients results.
VOLUME OF PRODUCT IN COMMERCE
7,830 kits.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Protege GPS Biliary Stent System (6Fr 9mm x 30mm). Recall # Z-0008-05.
CODE
SERB65-09-30-120 (.035) (Biliary) LOT #: 257441.
RECALLING FIRM/MANUFACTURER
Ev3, Plymouth, MN, by letter dated September 01, 2004. Firm initiated recall is ongoing.
REASON
A customer complaint received indicated that a Prot?g? stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The Prot?g? GPS Stent System is 'double barrier' packaged and consists of a sealed inner tray in a sealed pouch. The pouch seal ensures sterility of the external surface of the inner tray. The inner tray seal containing the device was not affected.
VOLUME OF PRODUCT IN COMMERCE
5 systems.
DISTRIBUTION
SC, NC, and TX.

_______________________________
PRODUCT
Applied Blunt Tip Trocar Models C0717 and C0718. Recall # Z-0009-05
CODE
Trocars are assembled into procedure kits. Trocars have thier own serial number but the kit lots are relevant and include: 45036301001 to 45036301007 containing 1 each of lot 126803 = 71 each; 45208001001 to 452084001008 containing 1 each of lot 127322=8 each; 452451005001 to 452451005003 containing 1 each of lot 127322=3 each; 453029001001 to 453029001017 containing 1 each of lot 127322 = 17 each; 453715004002 containing 1 each of lot 126803 = 1 each; 454116005001 to 454116005002 containing 1 each of lot 127322 = 2; 454608003001 to 454608003006 containing 1 each of lot 172528 = 6 each.
RECALLING FIRM/MANUFACTURER
Applied Medical Resources, Corp., Rancho Santa Margarita, CA, by letter on September 16, 2004. Firm initiated recall is ongoing.
REASON
Inadequate trocar tip assembly that might yield parts to patients.
VOLUME OF PRODUCT IN COMMERCE
1,025 Systems.
DISTRIBUTION
Nationwide and Ireland.

_______________________________
PRODUCT
Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205. Recall # Z-0013-05.
CODE
Lot 439010 Exp. 2006-11.
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated July 7, 2004. Firm initiated recall is complete.
REASON
Mislabeled as to size; 1.55 mm pins are labeled as 2mm.
VOLUME OF PRODUCT IN COMMERCE
37 pins.
DISTRIBUTION
CO, MS, MO, MT, NY, OH, PA, TX, and WI.
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Mystic M-Style Mushroom Cup Mityvac Vacuum Assisted Delivery System Product No: 10047. Recall # Z-0005-05.
CODE
Lot Number: 30115.
RECALLING FIRM/MANUFACTURER
CooperSurgical, Inc., Trumbull, CT, by telephone on August 18, 2004. Firm initiated recall is ongoing.
REASON
Product is mislabeled as a Mushroom Cap Vacuum but actually contains a Bell Style Assisted Delivery System.
VOLUME OF PRODUCT IN COMMERCE
495 units.
DISTRIBUTION
Nationwide and Italy.

_______________________________
PRODUCT
BC Thrombin Reagent. Thrombin Time Test. Recall # Z-0007-05.
CODE
Lot 540624, Lot 540625, and Lot 540626.
RECALLING FIRM/MANUFACTURER
Dade Behring, Inc., Newark, DE, by letter dated July 21, 2004. Firm initiated recall is ongoing.
REASON
The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients receiving heparin.
VOLUME OF PRODUCT IN COMMERCE
3,942 kits.
DISTRIBUTION
CT, FL, IA, IL, NJ, PA, WI, and Internationally.

_______________________________
PRODUCT
a) Medtronic MiniMed Paradigm Model 712. Recall # Z-0010-05;
b) Medtronic MiniMed Paradigm Model 512. Recall # Z-0011-05.
CODE
a) Serial numbers that end in ?-Dxx3?. Where ?x? can be any
number or letter;
b) Serial numbers that end in ?-Axx4?. Where ?x? can be any
number or letter.
RECALLING FIRM/MANUFACTURER
Medtronic MiniMed, Northridge, CA, by letter on September 14, 2004. Firm initiated recall is ongoing.
REASON
Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish.
VOLUME OF PRODUCT IN COMMERCE
10,600 units.
DISTRIBUTION
Nationwide and Spain.
 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS I

_______________________________
PRODUCT
a) Blue Seal AVI Pels for Zoo Avians, 50 Lb Bag, Product No.:
807. Recall # V-165-4;
b) Blue Seal Breeder Pels, 50 Lb Bag, Product No.: 634.
Recall # V-166-4;
c) Blue Seal Broiler Crumbles-CB, Medicated 50 Lb Bags, Product
No.: 801. Recall # V-167-4;
d) Blue Seal Chick Starter-AM Medicated, 25 Lb and 50 Lb Bags,
Product No.: 601. Recall # V-168-4;
e) Blue Seal Chick Starter-AM Crumbles Medicated, 25 lb and 50
lb bags Product No: 602. Recall # V-169-4;
f) Blue Seal Fat and Finish Pels, 50 lb bag Product No: 803.
Recall # V-170-4;
g) Blue Seal Game Bird Starter and/Grower Crumbles. Recall # V-
171-4;
h) Blue Seal Grower-CAL Crumbles, 50 lb bags Product No: 606.
Recall # V-172-4;
i) Blue Seral Grower-Cal Mash, 25 lb and 50 lb bags Product No:
605. Recall # V-173-4;
j) Blue Seal Grower-Cal Pels, 25 lb and 50 lb. bags Product No:
607. Recall # V-174-4;
k) Blue Seal Layer Crumbles, 50 lb bags Product No: 624. Recall
# V-175-4;
l) Blue Seal Layer Mash, 25 lb and 50 lb bags Product No: 623.
Recall # V-176-4;
m) Blue Seal Layer Pellets, 25 lb and 50 lb bags Product No: 625
Recall # V-177-4;
n) Blue Seal Turkey Grower Pels, 50 lb bag Product No: 809.
Recall # V-178-4;
o) Blue Seal Turkey Starter Crumbles-Medicated, 50 Lb. Bags,
Product No: 808. Recall # V-179-4.
CODE
Code Dates: A1414 thru A1564.
RECALLING FIRM/MANUFACTURER
Blue Seal Feeds, Inc., Londonderry, NY, by telephone on July 2, 2004 and by letter on July 7, 2004. Firm initiated recall is ongoing.
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.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

_______________________________
PRODUCT
a) Blue Seal Turkey Starter Crumbles-Medicated , 50 Lb. Bags
Product No: 808. Recall # V-180-4;
b) Blue Seal Refresher Dry 32 Pellet, 50 Lb Bag. Recall # V-
181-4;
c) Blue Seal Antler King Deer and Elk Pellets, 50 Lb Bag.
Recall # V-182-4;
d) Blue Seal Natural 40 Pellets, 50 Lb Bag. Recall # V-183-4;
e) NYS-RM-22 Starter, Medicated, Bulk. Recall # V-184-4;
f) Blue Seal Energizer 36, bulk. Recall # V-185-4.
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, by telephone on July 2, 2004 and by letter on July 7, 2004. Firm initiated recall is ongoing.
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. Recall
# V-187-4;
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.
Recall # V-188-4.
CODE
The products contain no code date.
RECALLING FIRM/MANUFACTURER
Farmers Elevator, Co., Houston, OH, by telephone and letters dated September 8, 2004. Firm initiated recall is ongoing.
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 ?Do not feed to cattle or other ruminants?.
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. Recall # V-189-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
The Veterinary Pharmacy, Newcastle, OK, by telephone on August 13, 2004. Firm initiated recall is complete.
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). Recall #V-190-4;
b) Happy Fisherman Fish Food, pellet form, 50 pound bags.
Recall # V-191-4.
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, by telephone beginning on April 14, 2004. Firm initiated recall is complete.
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.
Recall # V-192-4;
b) Blue Seal Floating Fish Food 40/10, 50 lb. bags, Product No.
Recall # V-193-4;
c) Blue Seal Furry Friends Guinea Pig Pels, 25 and 50 lb. bags
Product No. 310. Recall # V-194-4;
d) Blue Seal Sunshine Plus, 50 lb. bags, Product No. 415.
Recall # V-195-4;
e) Blue Seal AVI Pels for Zoo Avians, 50 Lb Bag Product No. 807.
Recall # V-196-4;
f) NYS-RM-22 Starter Medicated (bulk), Product No. 616. Recall #
V-197-4;
g) NYS-RM-28 Breeder (bulk), Product No. 618. Recall # V-198-4;
h) Blue Seal Breeder Pels, 50 Lb. Bag Product Number: 634.
Recall # V-199-4;
i) Blue Seal Broiler Crumbles-CB, Medicated 50 Lb Bags Product
No: 801. Recall # V-200-4;
j) Blue Seal Chick Starter-AM Medicated, 25 Lb and 50 Lb bags
Product No: 601. Recall # V-201-4;
k) Blue Seal Chick Starter-AM Crumbles Medicated, 25 lb and 50
lb bags Product No: 602. Recall # V-202-4;
l) Blue Seal Fat and Finish Pels, 50 lb bag Product No: 803.
Recall # V-203-4;
m) Blue Seal Game Bird Starter and/Grower Crumbles, Product No.
806. Recall # V-204-4;
n) Blue Seal Grower-CAL Crumbles, 50 lb bags Product No: 606.
Recall # V-205-4;
o) Blue Seal Grower-Cal Mash, 25 lb and 50 lb bags Product
No:605. Recall # V-206-4;
p) Blue Seal Grower-Cal Pels, 25 lb and 50 lb. bags Product No:
607. Recall # V-207-4;
q) Blue Seal Layer Crumbles, 50 lb bags Product No: 624. Recall
# V-208-4;
r) Blue Seal Layer Mash, 25 lb and 50 lb bags Product No: 623.
Recall # V-209-4;
s) Blue Seal Layer Pellets, 25 lb and 50 lb bags Product No:
625. Recall # V-210-4;
t) Blue Seal Turkey Grower Pels, 50 lb bag Product No: 809.
Recall # V-211-4;
u) Blue Seal Turkey/Pheasant Starter Crumbles-Medicated, 50
lb. bags Product No: 808. Recall # V-212-4;
v) Blue Seal Pig & Sow Pellets in 50 lb. bags, Product No. 813.
Recall V-213-4;
w) Blue Seal Pork Maker Mash in 50 lb. bags, Product No. 814.
Recall # V-214-4;
x) Blue Seal Hog Pellets in 50 lb. bags, Product No. 878.
Recall # V-215-4;
y) Blue Seal Egg Maker Crumbles, Product No. 635. Recall # V-
216-4.
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, by letter on July 20, 2004. Firm initiated recall is ongoing.
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. Recall # V-217-4.
CODE
Date Code 8/26/04.
RECALLING FIRM/MANUFACTURER
Purina Mills, Llc, Saint Louis, MO, by telephone on September 2, 2004. Firm initiated recall is complete.
REASON
Potential sulfamethazine contamination.
VOLUME OF PRODUCT IN COMMERCE
10,860 lbs.
DISTRIBUTION
PA.
 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS III

_______________________________
PRODUCT
Breath-eze Breath and Gas Relief Tablets for Dogs (activated charcoal, simethicone). Recall # V-186-4.
CODE
Lot PJ315.
RECALLING FIRM/MANUFACTURER
Virbac AH, Inc., Fort Worth, TX, by telephone on August 26, 2004, and by fax on September 7, 2004. Firm initiated recall is ongoing.
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.

END OF ENFORCEMENT REPORT FOR OCTOBER 13, 2004

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