Enforcement Report

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.

rule

January 5, 2005
05-01

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Longevity brand Wonton Wrappers, perishable, store at 35 F or lower. Wonton wrapper is a doughy covering for a meat product used in Asian restaurants as an ingredient in wonton soup. The wonton wrapper is 3.25 x 3.25 in. in size and a fraction of an inch thick. The product is packed in a cardboard box with blue labeling which reads in part: (Side panels) "Longevity Brand Wonton Wrapper 12x2 lbs***". (End panel) "Ingredients: High Gluten Flour, Water, Salt, Gluten, Food Coloring [FD&C Yellow #5, Yellow #6, & Red #40] Potassium Sorbate, Citric Acid". ((Top) "STORE AT 35 OR LOWER PERISHABLE". The box contains 2-12 pound packages wrapped in plastic. Each case contains 900-1000 wonton wrappers. The product is shipped frozen. Recall # F-110-5.
CODE
Boxes are encoded with a 6-digit code that contains the month (first digit) and julian date (last 3 digits). All codes are included in the recall.
RECALLING FIRM/MANUFACTURER
Transamerica Food Enterprises, Inc., Miami, FL, by letter beginning on November 14, 2004. Firm initiated recall is complete.
REASON
The product contains undeclared egg white.
VOLUME OF PRODUCT IN COMMERCE
150 cases of 900-1000 wrappers.
DISTRIBUTION
FL.

_______________________________
PRODUCT
EUROPEAN STYLE SMOKED SALMON, cold smoked Atlantic salmon, vacuum packaged. Packages are of various weight between 2 to 2 1/2 lbs. each. The firm utilizes one of two different labels for the front of the packages depending on the intended customer. Product going to the restaurant chain has the blue label stating EUROPEAN-STYLE SMOKE SALMON Jean Banchet¹s Specifications GERARD & DOMINIQUE SEAFOODS WOODINVILLE, WA; the remaining restaurants receive product with a black label stating GERARD DOMINIQUE SEAFOODS EUROPEAN STYLE SMOKED SALMON WOODINVILLE, WA. A white label is placed on the back of the packages providing the name of the product, ingredients, customer name, batch number, pack date, net wt. Recall # F-111-5.
CODE
BATCH #SF4253 PACK DATE OCT.18.4, OCT.19.4, OCT.20.4.
RECALLING FIRM/MANUFACTURER
G & D Superior Food Products Inc dba Gerard & Dominique Sfds, Woodinville, WA, by telephone on November 2, 2004. and by fax on November 3, 2004. Firm initiated recall is complete.
REASON
Product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
226 sides, each side weighing 2 - 2 1/2 lbs.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Sausage, Egg and Cheese Sandwich. 6.65 OZ
Sausage Egg & Cheese on Toast. A pre-packed
sandwich, overwrapped in clear film.
Recall # F-112-5;
b) Classic Cuban Sandwich. 7.56 OZ Classic
Cuban. A hand wrapped sub sandwich,
over-wrapped in white butcher paper.
Recall # F-113-5.
CODE
a) Sell by SEP 23 UPC code: 7-0543200143-3;
b) Sell by SEP 18 UPC code: 7-0543200156-3.
RECALLING FIRM/MANUFACTURER
Dandee Food Company, Jacksonville, FL, by telephone on September 16, 2004. Firm initiated recall is complete.
REASON
Sandwiches are contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
450 sandwiches.
DISTRIBUTION
FL, and GA.

_______________________________
PRODUCT
a) Coconut Macaroon Cookies under the following
labels:
a) Lil Dutch Maid Coconut Macaroon
Cookies, NET WT 12 oz (340 g) and NET WT 1
8 oz (510 g),
b) SweetTooth Coconut Macaroon Cookies,
NET WT 12 oz (340 g),
c) Lil Dutch Maid Macarrones de Coco Galletas,
NET WT 18 oz (510 g). Recall # F-115-5;
b) Vanilla Wafer Cookies under the following
labels:
a) Lil Dutch Maid Vanilla Wafers,
NET WT 5 oz (142 g) and NET WT 11 oz
(311 g),
b) Payaso Galletas Vainillas, Vanilla Wafers,
16 oz and 28 oz,. Recall # F116-5;
c) Sugar Cookies under the following labels:
a) Lil Dutch Maid Sugar Cookies, NET WT.
12 oz (340g) and NET WT. 18 oz (510g),
b) Lil Dutch Maid Azucar Galletas,
18 oz (510 g). Recall # F-117-5.
CODE
All codes remaining on the market that do not have a corrected label affixed to the product. Codes from 04301 through 05115.
RECALLING FIRM/MANUFACTURER
Fehr Foods, Inc, Abilene, TX, by press release on October 29, 2004, and by letters on November 3, 2004. Firm initiated recall is ongoing.
REASON
Products contain undeclared whey; vanilla wafer cookies also contain undeclared egg.
VOLUME OF PRODUCT IN COMMERCE
Total 132,107 cases distributed.
DISTRIBUTION
Nationwide and Mexico.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
Micro Italian Gourmet Pastries. Trays contain an assortment of cannoli and tarts: Banana Cannoli filled with banana chantilly cream; Amaretto Cannoli filled with amaretto chantilly cream; Grain of Sugar Cannoli filled with chantilly cream; Coconut Cannoli filled with chocolate chantilly cream; Strawberry Tart filled with chocolate chantilly cream and decorated with chocolate chips; Orange Tart filled with orange chantilly cream and decorated with candied fruit; and Amarena (Italian Cherry) Tart filled with pastry cream and decorated with an amarena (cherry) bit. The cases are 2 lbs 8 oz. and the product is shipped 10 trays to a case. Recall # F-107-5.
CODE
Item #28652; Best before OCT 2005; UPC 8 251019 210054
RECALLING FIRM/MANUFACTURER
Clouch Inc. Divina Dessert USA, Wilmington, DE, by telephone and letter on December 1,04. Firm initiated recall is complete.
REASON
The tarts contained the unapproved color additive Ponceau 4R.
VOLUME OF PRODUCT IN COMMERCE
7,200 units.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
Bulk American Ginseng 550 mg Capsules containing 100% American Ginseng Powder (Panax quinquefolious), Bulk Product No. SW464, Nature¹s Value Bulk Lot # 035609. Product: American Ginseng Caps, Lot #: 035609, Date of Manufacture: 1/2004, P.O. #: 125541 and P.O. # 125229. IMPORTANT: This container is intended for BULK SHIPPING ONLY. The contents should be repacked WITHIN 90 DAYS into tightly closed containers. The manufacturer does not assume responsibility for any changes in physical appearance or potencies when these instructions are disregarded. ---- NOTE: this bulk lot was repackaged into 100 capsule bottles by Swanson Health Products under its own label and sold to its retail customers under lot 127338 BG, Best before 01/06. Recall # F-109-5.
CODE
Bulk Product No. SW464, Bulk Lot # 035609, Best Before 01/06.
RECALLING FIRM/MANUFACTURER
Nature's Value Inc., Bay Shore, NY, by letters on October 18, 2004 and October 20, 2004. Firm initiated recall is ongoing.
REASON
American Ginseng capsules were analyzed by the Northeast Regional Laboratory (NRL) and found to be contaminated with various pesticides.
VOLUME OF PRODUCT IN COMMERCE
149,000 capsules.
DISTRIBUTION
ND.

_______________________________
PRODUCT
a) Dietary supplement labeled in part:
NATURE**Sex. Plex for him***Directions:
As an adult supplement, for nutritional
support***30 Tablets. Recall $ F-118-5;
b) Dietary supplement labeled in part:
**Nature**Sex.Plex for her***Directions:
As an adult supplement, for nutritional
support30 Caplets**. Recall $ F-119-5;
c) Dietary supplement labeled in part: **Viga**
Supplements Facts***Serving Size 1 Tablet**
Saw Palmetto Extract 20mg* Androstenedione
10mg*Tribulus Terrestris Extract***
30 Tabletas*** Recall # F-120-5.
CODE
a) Lot no. 02040096 Exp. date 04/2005;
b) Lot no. 02040097 Exp. date 4/2005;
c) Lot no. 04010010 Exp. date 01/2007.
RECALLING FIRM/MANUFACTURER
Caribbean Nutraceuticals, Inc., Las Piedras, PR, by telephone and letter March 18, 2004 and April 27, 2004. Firm initiated recall is ongoing.
REASON
The products are adulterated per 21 USC 342 (f) because they contain androstenedione, which is considered a new dietary ingredient.
VOLUME OF PRODUCT IN COMMERCE
22,542 bottles.
DISTRIBUTION
PR.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Enalaprail Maleate Tablets, USP, 5mg, 100 and 1000 count bottles, Rx only, NDC 0172-4196-80. Recall # D-070-5.
CODE
Lot # 109832A exp. Dec-04 Lot # 115188A exp. April -05 Lot # 117962A exp. May -05 Lot # 117962U exp. May 05.
RECALLING FIRM/MANUFACTURER
Ivax Pharmaceuticals, Inc., Cidra, PR, by letter dated November 18, 2004. Firm initiated recall is ongoing.
REASON
Stability Failure.
VOLUME OF PRODUCT IN COMMERCE
26,424 bottles/units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Glyburide Tablets, USP, 2.5 mg, 1000 count bottles, Rx only, ***** NDC 0093-8343-10. Recall # D-073-5. 1,714 bottles.
CODE
Lot #132255A exp 3/06.
RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals USA, North Wales, PA, by letter dated November 24, 2004. Firm initiated recall is ongoing.
REASON
Presence of foreign tablet (Hydrochlorothiazide 25 mg).
VOLUME OF PRODUCT IN COMMERCE
Bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Warfarin Sodium Tablets, USP, 7 1/2 mg, packaged in 100 count plastic bottles, Rx only, Pomona, NY 10970 *** NDC 0555-0834-02. Recall # D-077-5.
CODE
Lot 408343001, exp 9/05.
RECALLING FIRM/MANUFACTURER
Barr Laboratories, Inc., Forrest, VA, by fax on 11/11/04 and letter on 11/12/04. Firm initiated recall is ongoing.
REASON
Subpotent (12 month stability).
VOLUME OF PRODUCT IN COMMERCE
10,281 bottles (100 count).
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Dabso Gel Relieving Lotion, Net Wt. 4 oz.
(120 gm) and 16 oz. jars. Recall # D-082-5;
b) Fire In Ice Relieving Lotion, Net Wt. 4 oz.
(120 gm) and 16 oz. jars. Recall # D-083-5.
CODE
a) Lots 8050604A, 8AF06AEA, K072204B;
b) V020304D.
RECALLING FIRM/MANUFACTURER
Unit Dose Packaging Inc, Chandler, AZ, by letters on November 11, 2004. Firm initiated recall is complete.
REASON
Unapproved New Drug; contains Dimethyl Sulfoxide (DMSO).
VOLUME OF PRODUCT IN COMMERCE
24/ 16 oz and 65/ 4 oz containers.
DISTRIBUTION
AZ, TX, and FL.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Pacerone (Amiodarone HCl) tablets, 300 mg, 100 tablets, Rx only,.Made in Israel, NDC 0245-0140-01. Recall # D-072-5.
CODE
0415326468, expiration date 08/06 0415906531, expiration date 08/06 0415916532, expiration date 08/06.
RECALLING FIRM/MANUFACTURER
Upsher Smith Laboratories, Inc., Maple Grove, MN, by telephone on November 17, 2004, and by letter on November 19, 2004. Firm initiated recall is ongoing.
REASON
Mislabeling: Pacerone Unit dose carton is mislabeled in that UPC code scans as 100 mg strength instead of 300 mg strength which is the strength of the actual tablets. All human readable text of all labeling is accurate, including the unit dose card, carton and package insert.
VOLUME OF PRODUCT IN COMMERCE
1,740 total units distributed.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Potassium Chloride Extended-Release Tablets, USP, 20mEqK, 500 count bottles, Rx only, NDC 62037-720-05. Recall # D- 074-5.
CODE
Lot # 720E022, Expiration Date Jan-2006.
RECALLING FIRM/MANUFACTURER
Andrx Pharmaceuticals, Inc, Davie, FL, by letters on November 19, 2004. Firm initiated recall is ongoing.
REASON
Tablet Weight.
VOLUME OF PRODUCT IN COMMERCE
2,154 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Doxepin Hydrochloride Oral Solution, USP (Concentrate), 10 mg/ml, 120 mL (4 fl.oz.) bottle, Rx only, ***** NDC 0093-9612-12. Recall # D-075-5.
CODE
Lot Number 21451 exp 2/2007.
RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals USA. North Wales, PA, by letters dated November 4, 2004. Firm initiated recall is ongoing.
REASON
Failed pH specification (6 month stability).
VOLUME OF PRODUCT IN COMMERCE
8,618 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Rocaltrol Capsules (calcitriol) 0.5 mcg, bottle of 100 capsules, Rx only, *****NDC 004-0144-01. Recall # D-076-5.
CODE
Lot U2019 Exp. Date 7/2005.
RECALLING FIRM/MANUFACTURER
Hoffmann La Roche Inc, Nutley, NJ, by letters on October 18, 2004. Firm initiated recall is ongoing.
REASON
Presence of Foreign Tablet; bottled labeled as Rocaltrol 0.5mcg capsules contained Rocaltrol 0.5mcg capsules and one Rocaltrol 0.25mcg capsule.
VOLUME OF PRODUCT IN COMMERCE
6,601 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Premarin (conjugated estrogens) tablets, USP, 0.625 mg; Rx only, 1000 tablet bottles-NDC 0046-0867-91; 5000 tablet bottles- NDC 0046-0867-95. Recall # D-078-5.
CODE
A42766, EXP 9/05 - bottles of 1000; and A27633, EXP 3/05 - bottles of 5000.
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA, by letters dated December 10, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
17,124 / 1,000 tab blt. and 2,880 / 5,000 tab. bottle.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Prempro (conjugated estrogens/medroxyprogesterone acetate tablets), 0.45 mg/1.5 mg/ carton of 3 EZ DIAL Dispensers of 28 tablets each, Rx only, NDC 0046-0937-09. Recall # D-079-5.
CODE
A50440, EXP 6/05.
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA, by letters dated December 10, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
17,468 cartons x 3 dial packs distributed to wholesalers.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Visine Advanced Relief Eye Drops, (Dextran 70.0%, Polyethylene glycol 400.1%, Povidone 1%, Tetrahydrozoline HCl 0.05%), 1 fl oz (2). Recall # D-080-5.
CODE
In Case Lot Nos: 010438802, 010438803, 010438804 -- Unit Lot No. 0104388. In Case Lot No: 010440601 -- Unit Lot No. 0104406.
RECALLING FIRM/MANUFACTURER
Pfizer Inc, Morris Plains, NJ, by letter on October 20, 2004. Firm initiated recall is ongoing.
REASON
Defective bottle cap.
VOLUME OF PRODUCT IN COMMERCE
49128 bottles.
DISTRIBUTION
Nationwide and Australia.

_______________________________
PRODUCT
Calcitriol Injection, 2 mcg/mL, 1mL Single Dose Vial, 25 pack box, Rx only, For IV Use. Recall # D-081-5.
CODE
Lot 03B139.
RECALLING FIRM/MANUFACTURER
Sicor Pharmaceuticals, Inc, Irvine, CA, by letters on November 9 and December 10, 2004. Firm initiated recall is ongoing.
REASON
Impurity failure (18 month stability).
VOLUME OF PRODUCT IN COMMERCE
92,300.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Source Plasma. Recall # B-0326-5.
CODE
Units HV039391, HV035542, HV035379, HV035087, HV034900, HV034631, HV034503, HV034272, HV034058, HV033805, HV033621, HV033360, HV033136, HV039210, HV032572, HV031863, HV030451, HV024860, HV023950, HV020013, HV019809.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Huntsville, AL, by facsimile transmission dated March 13, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who tested negative for anti-HIV-1/2, but previously tested positive for anti-HIV-1/2, was distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Human Tissue for Transplantation. Recall # B-0358-5.
a) Tissues CryoVein, Saphenous Vein;
b) CryoGraft, Tibialis Tendon;
c) CryoGraft, Achilles Tendon;
d) Semitendinos us/Gracilis Tendons;
e) CryoArtery, Pulmonary Artery;
f) CryoGraft, Quadriceps Tendon;
g) CryoGraft, Hemi Patellar Tendon;
h) CryoGraft, Medial Menicus Bone-Right;
i) CryoVein, Femoral Vein;
j) CryoGraft, Hemi Patellar Tendon;
k) CryoGraft, Lateral Meniscus Bone-Right;
l) CryoGraft, Lateral Meniscus Bone-Left;
m) CryoVein, Femoral Vein;
n) CryoArtery, Pulmonary Monocusp Hemni-Artery;
o) CryoVein, Femoral Vein with Valve;
p) CryoGraft, Plumonary Trunk Patch;
q) CryoGraft, Pulmonary Branch Patch;
r) CryoArtery, Femoral Popliteal Artery;
s) CryoGraft, Plumonary Branch Patch SG;
t) CryoArtery, Aortoiliac Artery.
CODE
a) Donor #40019, Serial #6528228,
Donor #40064, Serial #6532403,
Donor #41193, Serial #6576354,
Donor #42311, Serial #6613233,
Donor #43625, Serial #6652511,
Donor #45465, Serial #6699040,
Donor #45556, Serial #6709928,
Donor #45556, Serial #6714285,
Donor #45607, Serial #6735826,
Donor #45607, Serial #6735837,
Donor #46877, Serial #6780908,
Donor #47432, Serial #6832048,
Donor #49319, Serial #6869084,
Donor #49319, Serial #6873704,
Donor #49338, Serial #6850813,
Donor #49785, Serial #6881356,
Donor #49999, Serial #7102018,
Donor #54956, Serial #7234933,
Donor #54967, Serial #7226138,
Donor #55912, Serial #7165200,
Donor #62532, Serial #7814612;
b) Donor #40047, Serial #4240405,
Donor #41323, Serial #4257294,
Donor #41905, Serial #4265386,
Donor #42311, Serial #4277163,
Donor #43362, Serial #4287512,
Donor #43362, Serial #4287512,
Donor #43383, Serial #4287586,
Donor #43383, Serial #4287600,
Donor #43389, Serial #4289863,
Donor #45459, Serial #6703147,
Donor #45460, Serial #6711179,
Donor #45504, Serial #6715655,
Donor #45610, Serial #6713482,
Donor #45610, Serial #6713572,
Donor #45636, Serial #6705999,
Donor #45636, Serial #6715491,
Donor #46529, Serial #6754688,
Donor #48997, Serial #6904285,
Donor #49164, Serial #6883291,
Donor #49343, Serial #6871538,
Donor #49753, Serial #6884748,
Donor #49763, Serial #6905601,
Donor #49763, Serial #6905628,
Donor #50985, Serial #7042248,
Donor #54932, Serial #7240340,
Donor #59836, Serial #7837532;
c) Donor #40063, Serial #4240529,
Donor #41905, Serial #4265408,
Donor #41905, Serial #4265521,
Donor #45465, Serial #6711236,
Donor #46500, Serial #6771102;
d) Donor #40109, Serial #4236025,
Donor #43362, Serial #4287524,
Donor #45601, Serial #6713247,
Donor #46529, Serial #6754677,
Donor #46529, Serial #6754744,
Donor #48939, Serial #6852658,
Donor #50048, Serial #7103309;
e) Donor #41180, Serial #6574777,
Donor #45401, Serial #6714389,
Model #A030;
f) Donor #41323, Serial #4256735;
g) Donor #41323, Serial #4257413,
Donor #41905, Serial #4265475,
Donor #49300, Serial #6858662,
Donor #49300, Serial #6863528,
Donor #52886, Serial #7068718,
Donor #52886, Serial #7068787;
h) Donor #43058, Serial #6637086,
Donor #45305, Serial #6700044;
i) Donor #43608, Serial #6652591,
Donor #49776, Serial #6883886,
Donor #47206, Serial #6756583;
j) Donor #45305, Serial #6700017,
Donor #46529, Serial #6754644,
Donor #46529, Serial #6754663;
k) Donor #45305, Serial #6700052;
l) Donor #45436, Serial #6704840,
Donor #47804, Serial #6812821;
m) Donor #45563, Serial #6714224,
Donor #54955, Serial #7240212;
n) Donor #46494, Serial #6770937;
0) Donor #49780, Serial #6882437;
p) Donor #49782, Serial #6896617;
q) Donor #51035, Serial #7144860,
Donor #65903, Serial #7955990;
r) Donor #54940, Serial #7155010;
s) Donor #55750, Serial #7253267;
t) Donor #58490, Serial #7410687
Donor #63969, Serial #7893628.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc. Kennesaw, GA, by letter on or about May 6, 2004. Firm initiated recall is complete.
REASON
Human tissues, processed with instruments that may not have been adequately sterilized, were distributed.
VOLUME OF PRODUCT IN COMMERCE
90 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
CryoGraft, Pulmonary Monocusp Hemi-Artery. Recall # B-0360-5.
CODE
Tissue 8353839.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc. Kennesaw, GA, by telephone on August 27, 2004. Firm initiated recall is complete.
REASON
Human tissue, procured from a donor who may have participated in high-risk behaviors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0364-5.
CODE
Unit 6534674.
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL. by facsimile transmission dated March 30, 2004. Firm initiated recall is complete.
REASON
Platelets, with a positive bacterial culture, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-0365-5.
CODE
Units 6563900 B&C.
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL. by telephone on August 16, 2004, and by facsimile transmission dated August 16, 2004. Firm initiated recall is complete.
REASON
Platelets, with a positive bacterial culture, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0373-5.
CODE
Unit E07351.
RECALLING FIRM/MANUFACTURER
Rock River Valley Blood Center, Rockford, IL, by letter dated October 4, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0374-5;
b) Recovered Plasma. Recall # B-0375-5.
CODE
a) and b) Unit G98385.
RECALLING FIRM/MANUFACTURER
Rock River Valley Blood Center, Rockford, IL, by telephone on September 24, 2004, and by letter dated September 24, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL. and Austria.

_______________________________
PRODUCT
a) Fresh Frozen Plasma. Recall # B-0393-5;
b) Recovered Plasma. Recall # B-0394-5.
CODE
a) Unit number: 6527065;
b) Unit number: 6499785.
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL, by facsimile on April 16, 2004, and August 26, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL, and Austria.

_______________________________
PRODUCT
Source Plasma. Recall # B-0405-5.
CODE
Unit numbers 02GWIH8504, 03GWIA2218, 03GWIA3811, 03GWIA4423, 03GWIA5977, 03GWIA6930, and 03GWIA7479.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Green Bay, WI, by facsimile on September 24, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for variant Creutzfeldt-Jacob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0409-5.
CODE
Unit number FE66458.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone on October 25, 2004, and by letter on November 8, 2004. Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced but had an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0410-5.
CODE
Unit number FE50646 (distributed as three split units).
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone on September 22, 2004, and by letter on September 27, 2004.
REASON
Blood products, that tested out of specification for pH, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AL, and GA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0419-5;
b) Fresh Frozen Plasma. Recall # B-0420-5.
CODE
a) and b) Unit number: S32854.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter, dated January
31, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported receiving immune serum globulin for possible exposure to Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0421-5.
CODE
Unit number: S30898.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Delta Blood Bank, Stockton, CA, by letter, dated January 15, 2002.
Manufacturing Firm: Delta Blood Bank, Stockton, CA. 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
CA.

_______________________________
PRODUCT
CryoVein, Saphenous Vein. Recall # B-0426-5.
CODE
Tissue numbers 8235475, 8137618, 8137605.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, by telephone on October 19, 2004, and/or by letter dated November 10, 2004. Firm initiated recall is complete.
REASON
Human tissue, associated with tissue that tested positive for microorganisms at a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 tissues.
DISTRIBUTION
PA, TX, and WV.

_______________________________
PRODUCT
Red Blood Cells, Irradiated. Recall # B-0427-5.
CODE
Unit numbers FE57624 and FE60765.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Aurora, IL, by telephone on September 5, 2004. Firm initiated recall is complete.
REASON
Blood products, for which documentation of irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0428-5.
CODE
Unit number W91198.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Traverse City, MI , by facsimile on October 27, 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
MI.

_______________________________
PRODUCT
Platelets. Recall # B-0429-5.
CODE
Unit number M46095.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI, by facsimile on October 26, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Fresh Frozen Plasma (Apheresis), Recall # B-0430-5.
CODE
Unit number 7797534.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on November 3, 2004. Firm initiated recall is complete.
REASON
Blood product, collected by a method that may have compromised the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated. Recall # B-0431-5.
CODE
Unit number 4804491.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on November 4, 2004. Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0432-5.
CODE
Unit number 3422468.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on November 10, 2004, and by letter on November 23, 2004. Firm initiated recall is complete.
REASON
Blood product, that tested out of specification for pH, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Source Plasma. Recall # B-0433-5.
CODE
Unit number 03OWIA3620.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Oshkosh, WI, by facsimile on February 12, 2003. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0434-5;
b) Platelets. Recall # B-0435-5.
CODE
a) and b) Unit number: K32262.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter, dated September 27, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0436-5.
CODE
Units LK24844-1 and LK24844-2.
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by letter dated April 12, 2002. Firm initiated recall is complete.
REASON
Blood products, which were labeled leukoreduced but were not tested to determine the white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0439-5;
b) Recovered Plasma. Recall # B-0440-5.
CODE
a) and b) Unit number: 042J51578.
RECALLING FIRM/MANUFACTURER
American Red Cross, Northern Ohio Region, Cleveland, OH, by telephone and electronic submission on August 26, 2004, and by letter, dated August 30, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH, and CA.

_______________________________
PRODUCT
a) Platelets. Recall # B-0441-5;
b) Fresh Frozen Plasma. Recall # B-0442-5.
CODE
a) Units L82921, K54601, L83135, T69532;
b) Units K54601, T69532, K94271.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated September 22, 2004. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0443-5.
CODE
Unit number: Y12037.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter, dated November 16, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated. Recall # B-0445-5.
CODE
Unit number: 029FP97354.
RECALLING FIRM/MANUFACTURER
American Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone on September 23, 2004. Firm initiated recall is complete.
REASON
Platelets, not manufactured according to manufacturer¹s specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall B-0448-5;
b) Cryoprecipitated AHF. Recall # B-0449-5.
CODE
a) and b) Unit number: FS72453.
RECALLING FIRM/MANUFACTURER
Inova Health System, Annandale, VA, by letter, dated April 1, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to behavior known to increase the risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0454-5;
b) Recovered Plasma. Recall # B-0455-5.
CODE
a) and b) Unit number: 0669962.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone on March 20, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who used beef bovine insulin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0456-5;
b) Platelets. Recall # B-0457-5;
c) Fresh Frozen Plasma. Recall # B-0458-5.
CODE
a), b), and c) Unit number: 0653997.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone on March 14, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who used beef bovine insulin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets. Recall B-0464-5.
CODE
Unit L37059.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by telephone on August 26, 2004, and by letter dated September 10, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the corresponding red blood cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0465-5.
CODE
Unit 40P01928.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Peoria, IL, by telephone on October 26, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MO.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0466-5.
CODE
Units 40LV03632, 40GK54648, and 40FW32069.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Peoria, IL, by telephone on October 26, 2004, and by letter dated November 2, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL, and MA.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0467-5.
CODE
Units 40LV03633, 40GK54649, and 40FW32067.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Peoria, IL, by telephone on October 26, 2004, and by letter dated November 2, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0468-5.
CODE
Unit 1198540.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on March 15, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0469-5.
CODE
Unit 0679326.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on January 3, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0470-5.
CODE
Unit 0683159.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA, by telephone on March 26, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall# B-0472-5.
CODE
Unit numbers 1670989A and 1670989C.
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, Inc., East Orange, NJ, by telephone on February 12, 2004. Firm initiated recall is complete.
REASON
Blood products, that were labeled leukoreduced but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0473-5.
CODE
Unit number 6207723.
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, Inc., East Orange, NJ, by telephone on April 15, 2004, and by letter on September 7, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0476-5;
b) Platelets, Leukocytes Reduced.
Recall # B-0477-5.
CODE
a) and b) Unit numbers FG97141, LE89604.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by letter on October 21, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MI, RI, and NY.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0479-5.
CODE
Unit number: 0662304.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter, dated March 20, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a hematocrit or hemoglobin test performed during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Blood Cells, Leukocytes Reduced. Recall # B-0482-5.
CODE
Unit number: 261185685.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on September 3, 2003. Firm initiated recall is complete.
REASON
Blood product, collected using a hematocrit centrifuge that did not have quality control performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AR.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Source Plasma. Recall # B-0327-5.
CODE
Unit HV012591.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Huntsville, AL, by facsimile transmission dated March 13, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who tested negative
for anti-HIV-1/2, but previously tested positive for anti-
HIV-1/2, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0363-5.
CODE
Unit 6522550.
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL, by letter dated February 19, 2004. Firm initiated recall is complete.
REASON
Blood product, which tested initially reactive for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Source Plasma. Recall # B-0404-5.
CODE
Unit numbers 02GWIH3456, 02GWIH4254, 02GWIH5367, 03GWIA3906, 03GWIA4625, 03GWIA8339, 03GWIA8738, and 03GWIA9863.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Green Bay, WI, by facsimile
on September 24, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for variant Creutzfeldt-Jacob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0406-5.
CODE
Unit numbers 19250-5141, 19250-5140; and the following units were distributed as two split products: unit numbers 19250-1188 and 19250-1189.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by letter on September 20, 2002. Firm initiated recall is complete.
REASON
Blood products that were possibly out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
NV, and CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0407-5.
CODE
Unit numbers 19249-2029, 19249-3938, 19248-4299, 19248-3265, 19248-4438, 19248-4103, 19248-4572, 19248-5332, 19248-5306, 19248-4592, 19248-3921, 19248-5021, and 19248-4832.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by letter on June 12, 2002. Firm initiated recall is complete.
REASON
Blood products that were manufactured using expired antigen typing reagents were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 Units.
DISTRIBUTION
NV, and CA.

_______________________________
PRODUCT
Platelets. Recall # B-0408-5.
CODE
Unit numbers 4835518, 4835519, and 4835520.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on September 28, 2004. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood stored at incorrect temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0471-5.
CODE
Unit number: 0830615.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter, dated April 9, 2002. Firm initiated recall is complete.
REASON
Blood product that was labeled as leukoreduced, but failed quality control testing due to an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets, Irradiated. Recall # B-0474-5.
CODE
Unit number 0799631.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone and letter on November 22, 2002.
Manufacturer: Blood Centers of the Pacific, North Bay Center, Fairfield, CA, Firm initiated recall is complete.
REASON
Blood product that was removed from controlled storage for more than allowed was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0475-5.
CODE
Unit number 04KT65714.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on September 14, 2004, and by letter on September 15, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a history of a chronic ulcerative condition, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VT.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS III

______________________________
PRODUCT
a) P12192 MCCORMICK FOCUS HFR W/95G BOV,
active drug ingredient: Lasalocid 95.0
g/ton. Recall # V-013-5;
b) TP09241 JD's CUSTOM HFR W/95g BOVA,
active ingredient: Lasalocid 95.0 g/ton.
Recall # V-014-5;
c) TP01081 BROUGHTON FOCUS HFR W/95G BOVATC,
active ingredient: Lasalocid 95.0 g/ton.
Recall # V-015-5;
d) P06174 TORVIEW HFR GRW PELLET W/BOVATEC,
active ingredient: Lasalocid 90.0 g/ton.
Recall # V-016-5;
e) P07134 RO-LA HEIFER CONC. W/BOVTEC,
active ingredient: Lasalocid 250.0 g/ton.
FOR RUMINANTS ONLY. Recall # V-017-5;
f) 06085 KIDDER 19% MEDICATED PL W/BOV,
active ingredient: Lasalocid 199.9 g/ton.
Recall # V-018-5;
g) SP05063 GOLDBERG HFR PL MED W/BOVA,
active ingredient: Lasalocid 120.0
g/ton. Recall # V-019-5;
h) PO4054 LAMB FARM 1 HFR PEN 18
W/BOVATEC, active ingredient:
Lasalocid 54.4 g/ton. FOR RUMINANTS
ONLY. Recall # V-020-5;
i) P10103 SWYERS MEDICATED HEIFER
95 G BOVTC, active ingredient:
Lasalocid 95.0 g/ton.
Recall # V-021-5;
j) P02063 BRANDES CALF PL W/BOV,
active ingredient: Lasalocid
88.4 g/ton. FOR RUMINANTS ONLY.
Recall # V-022-5;
k) P08073 HEISEY BEEF FINISH PL
W/31.5 BOV, active ingredient:
Lasalocid 31.5 g/ton.
Recall # V-023-5;
l) P08274 LOR-ROB 16% HFR MED W/90G
BOVATC, active ingredient:
Lasalocid 90.0 g/ton.
Recall # V-024-5;
m) P04014 OAK ORCHARD 16% HEIFER
W/80G BOV, active ingredient:
Lasalocid 80.0 g/ton.
Recall # V-025-5;
n) P04033 OFFHAUS CALF PELLET W/BOV,
active ingredient: Lasalocid 80.0
g/ton. Recall # V-026-5;
o) TP04019 KENT DAIRY HFR PL MED
W/200G BOV, active ingredient:
Lasalocid 200.0 g/ton.
Recall # V-027-5;
p) TP03141 HAINSWORTH FOCUS HFR W/95G
BOV, active ingredient: Lasalocid
95.0 g/ton. Recall # V-028-5;
q) P06114 MARZLOF HFR GRW 20% W/BOVATEC,
active ingredient: Lasalocid 80.0 g/ton
(FOR RUMINANTS ONLY). Recall # V-029-5;
r) SPO9204 PLATOBROOK FARM 22% GROWER PL,
active ingredient: Lasalocid 80.0 g/ton
(FOR RUMINANTS ONLY). Recall # V-030-5;
s) P03184 LAWNELL FOCUS HEIFER PELLET, active
ingredient: Lasalocid 95.0 g/ton.
(FOR RUMINANTS ONLY). Recall- # V-031-5;
t) TP10020 LANDMARK FOCUS HFR W/240G
BOVATC, active ingredient:
Lasalocid 240.0 g/ton. Recall # V-032-5;
u) TP09241 HOWES MARK CUSTOM HFR W/95G
BOVA, active ingredient: Lasalocid
95.0 g/ton. Recall # V-033-5;
v) P11112 GASPORTVIEW FOCUS HFR MEDICATED,
active ingredient: Lasalocid 80.0 g/ton.
Recall # V-034-5;
w) TP09270 LAMB 20% AA FOCUS W/BOVATEC
active ingredient: Lasalocid 114.3 g/ton.
Recall # V-035-5;
x) P01124 GRACE HOLLOW MED HFR GRWR 80G BOV
PU, active ingredient: Lasalocid 80.0
g/ton (FOR RUMINANTS ONLY). Recall # V-036-5;
CODE
a) 137545_MC, 09/02/2004;
b) 137706_JD, 09/02/2004;
c) 137545_BR, 09/07/2004;
137545_BR, 09/22/2004;
d) 137540_TV, 09/08/2004;
137540_TV, 09/14/2004;
e) 137540_RO, 09/08/2004;
f) 137542_33, 09/09/2004;
g) 137542_60, 09/17/2004;
h) 137545_18, 9/10/2004;
i) 137550_10, 08/26/2004;
137550_10, 09/03/2004;
137550_10, 09/17/2004;
137550_10, 09/21/2004;
j) 137540_BR, 09/10/2004;
k) 137540_DH, 08/26/2004;
l) 137541_L2, 08/25/2004;
137541_L2, 09/01/2004;
137541_L2, 09/03/2004;
137541_L2, 09/07/2004;
137541_L2 09/15/2004;
m) 137541_N2, 08/27/2004;
n) 137541_OF, 08/27/2004;
137541_OF, 09/09/2004;
137541_OF 09/17/2004;
o) 137542_K1, 09/07/2004;
p) 137545_SV, 08/31/2004;
137545_SV, 09/14/2004;
137545_SV, 09/20/2004;
q) 137644_MG, 09/22/2004;
r) 137644_PG, 09/02/2004;
137644, 09/10/2004;
s) 137545_LN, 08/30/2004;
137545_LN, 09/08/2004;
137545_LN, 09/17/2004;
137545_LN, 09/20/2004;
t) 137542_01, 08/30/2004;
137542_01, 09/07/2004;
137542_01, 09/14/2004;
137542_01, 09/22/2004;
u) 137706_MH, 08/30/2004;
137706_MH, 09/17/2004;
v) 137541_GP, 08/25/2004,
137541_GP, 09/02/2004;
137541_GP, 09/09/2004;
137541_GP, 09/15/2004;
w) 137545_L1, 08/31/2004;
137545_L1, 09/07/2004;
137545_L1, 09/14/2004;
137545_L1, 09/21/2004;
x) 137613_G1, 09/14/2004.
RECALLING FIRM/MANUFACTURER
Cargill Inc, Animal Nutrition Division, Alexander, NY, by
letters on October 8, 2004. Firm initiated recall is
complete.
REASON
Label contains inadequate feeding directions for medicated feed containing Lasalocid.
VOLUME OF PRODUCT IN COMMERCE
267.95 tons.
DISTRIBUTION
NY and PA.

END OF ENFORCEMENT REPORT FOR January 5, 2005

###

rule