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.

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September 1, 2004
04-35

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

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PRODUCT
a) Mr. Nature brand Unsalted Aloha Mix, 2.0 oz. item 02230.
Recall # F-384-4;
b) Mr. Nature brand Unsalted Energizer Mix, 2.0 oz.
item 01107. Recall # F-385-4;
c) Mr. Nature brand Unsalted Mix'n Yogurt, 2 oz. item 02009.
Recall # F-386-4;
d) Mr. Nature brand Unsalted No Cholesterol Trail Mix,
oz., 2.0 oz., 3.5 oz. Items 02530, 02013, 60007.
Recall # F-387-4.
CODE
21 through 36 and 50 through 55.
RECALLING FIRM/MANUFACTURER
Mr. Nature, Los Angeles, CA, by press release and letter on May 27, 2004. Firm initiated recall is ongoing.
REASON
The product was manufactured using almonds that were recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
38,892 cases.
DISTRIBUTION
Nationwide.

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PRODUCT
a) Ice Cream Umpqua brand Praline N'Cream in 3 gallon
containers identified as Umpqua Dairy Products Co.
Recall # F-388-4;
b) Umpqua brand Premium Lite Praline Pecan ice cream in
1/2 gallon containers, and Praline Pecan Lite ice cream
in 3 gallon containers. Recall # F-389-4;
c) Pacific Crest brand ice cream, Windigo Pass Pecan in
1/2 gallon containers. Recall # F-390-4.
CODE
a) 04111, 04146;
b) 1) 032605, 042005, 052505; 2) 04086, 04146.
c) Product is not coded.
RECALLING FIRM/MANUFACTURER
Umpqua Dairy Products Co, Roseburg, OR, by telephone and fax beginning on June 7, 2004. Firm initiated recall is complete.
REASON
Products labeled as praline pecans actually contained praline peanuts.
VOLUME OF PRODUCT IN COMMERCE
Pralines N'Cream 133 3-gallon containers; Lite 4999 half gallon containers and 152 3-gallon containers, and Windigo Pass 997 half gallon containers.
DISTRIBUTION
OR, and WA.

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PRODUCT
DELI brand Seafood Salad in 8 oz. cups. Recall # F-391-4.
CODE
USED BY date between 6/16/04 and 8/14/04.
RECALLING FIRM/MANUFACTURER
Fresh Food Concepts, Inc., Buena Park, CA, by press release on June 18, 2004. Firm initiated recall is ongoing.
REASON
Seafood Salad contains undeclared shrimp.
VOLUME OF PRODUCT IN COMMERCE
2,373 cases.
DISTRIBUTION
CA, NV, HI, and IL.

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PRODUCT
Rio Grande Hard Cheese, Queso Duro Viejo, in 45 to 80 pound blocks per box and Rio Grande Hard Cheese, Queso Duro Viejo, net weight 16 oz., packaged in plastic wrap and labeled in part *** Product of Central America***or ***Made in CentroAmerica***Queso Duro Viejo, net wt 16 oz, packaged in plastic wrap. Queso Duro Blanco, net wt 16 oz, packaged in plastic wrap, Product of El Salvador. Recall # F-392-4.
CODE
UPC 738529070123 and 738529070128.
RECALLING FIRM/MANUFACTURER
Rio Grande Products, Inc., Beltsville, MD, by press release and letter on May 20, 2004. Firm initiated recall is complete.
REASON
Imported cheese is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,787 boxes.
DISTRIBUTION
Nationwide.

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PRODUCT
a) King's brand California Mix, net wt. 11 oz.
Recall # F-393-4;
b) King's brand Diet Trail Mix, net wt. 10 oz.
Recall # F-394-4;
c) King's brand Nature's Snack Mix, net wt. 11 oz.
Recall # F-395-4;
d) King's Nut Co. brand Trail Mix, net wt. 16 oz.
Recall # F-396-4;
e) Petersons Nature's Pleasures Fruit'N Nut Mix, net wt. 8 oz.
Recall # F-397-4;
f) Nature's Nut & Seed Mix, Net Wt. 16 oz. Recall # F-398-4;
g) King's brand Tropical Trail Mix, net wt. 38 oz.
Recall # F-399-4;
h) Peterson's Raw Natural Whole Almonds, net wt. 16 oz.
Recall # F-400-4;
i) Peterson's brand Energy Mix, net wt. 16 oz.
Recall # F-401-4;
j) Peterson's brand Ambrosia, net wt. 16 oz.
Recall # F-402-4;
k) King's brand Mountain Mix, net wt. 2 oz.
Recall # F-403-4.
CODE
Best by date of April 21, 2004 - January 2005, or a manufacture date of August 21, 2003 - May 24, 2004 or a Julian code date of 3223-4145.
RECALLING FIRM/MANUFACTURER
King Nut Companies, Solon, OH, by facsimile on May 24, 2004 and by press release on June 4, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds that were recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
King Nut appears to have received a total of 3259 - 50# boxes.
DISTRIBUTION
Nationwide.

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PRODUCT
a) Kar's brand Unsalted Trail Mix Original Blend packaged
in 2.25 oz. bags. Item # 8950. Recall # F-404-4;
b) Kar's brand Unsalted Trail Mix, All Energy packaged
in 2.25 oz. and 6.5 oz. bags. Item # 8952. Recall # F-405-4;
c) Kar's brand Unsalted Trail Mix, Nut-N-Yogurt packaged
in 2.25 oz. and 7 oz. bags. Item # 8954. Recall # F-406-4;
d) Kar's brand Raisin, Almond, Cashew Mix packaged in 5.75 oz.
and 12 oz. bags. Item # 1472. Recall # F-407-4.
CODE
a) All bags bearing dates of 11/05/04 through 11/20/04;
b) All 2.25 oz. bags bearing dates of 11/05/04 through
11/19/04 and 6.5 oz. bags bearing the date 11/19/04;
c) All 2.25 oz. bags bearing a date of 11/05/04 through
11/14/04 and 7 oz. bags bearing the date 01/05/05;
d) All 5.75 oz. bags bearing a date of 01/17/05 and 12 oz.
bags bearing a date of 01/19/05.
RECALLING FIRM/MANUFACTURER
Kar Nut Products Co., Ferndale, MI, by letter, e-mail, telephone or fax on May 26, 2004 and, by press release on May 27, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds that were recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
383,088.
DISTRIBUTION
Nationwide.

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PRODUCT
Tekita Brand Pico de Gallo, keep refrigerated, 13 oz. Recall # F-408-4.
CODE
Lot number 1550401.
RECALLING FIRM/MANUFACTURER
Isabella Foods, Inc., El Paso, TX, by press release on June 24, 2004 and by letter on June 25, 2004. Firm initiated recall is complete.
REASON
Product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
1,118 units.
DISTRIBUTION
TX, NM, and AZ.

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PRODUCT
Guacamole cups, 16 oz., under Trader Jose's and Senor Felix brands. Recall # F-409-4.
CODE
Trader Jose's brand had UPC Code of 00320849 and Use by Dates of 02-28-04 to 03-04-04;
Senor Felix brand has UPC Code of 3519655220 and Use by Date of 03-03-04.
RECALLING FIRM/MANUFACTURER
Fresh Food Concepts, Inc., Buena Park, CA, by telephone and visit beginning February 18, 2004, and by press release on February 21, 2004. Firm initiated recall is complete.
REASON
Products contain an ingredient, avocado pulp, which was found to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
926 cases.
DISTRIBUTION
CA, WA, OR, and IL.

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PRODUCT
La Fiesta brand Almendras Raw Almonds, UPC 38478-10119; Net Wt. 3/4 oz. plastic bags, 12 bags per box. Recall # F-410-4.
CODE
All product shipped between 11/18/03 and 6/4/04.
RECALLING FIRM/MANUFACTURER
La Fiesta Snack Food Product, Inc., Chicago, IL, by letter dated July 12, 2004 and by visit beginning on July 26, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds that were recalled by Paramount Farms due to their association with a Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
1,066 boxes.
DISTRIBUTION
IL.

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PRODUCT
a) Essensia Milk Chocolate Chunk cookies, 7.2 oz. bag,
12 bags per case; UPC 41163-55282. Recall # F-411-4;
b) Essensia Milk Chocolate Chunk Macadamia Cookies, 7.2 oz. bag,
12 bags per case; UPC 41163-55268. Recall # F-412-4;
c) Essensia Milk Chocolate Chunk Pecan Cookies, 7.2 oz. bag,
12 bags per case; UPC 41163-55266. Recall # F-413-4.
CODE
a) Best if Used By 08 13 04 E and 08 13 04 D;
b) Best if Used By 08 26 04 E and 10 03 04 D;
c) Best if Used By 10 03 04 D.
RECALLING FIRM/MANUFACTURER
Parmalat Bakery Group North America, Kitchener, Ontario Canada, by e-mail, telephone and fax on May 7, 2004 and by press release on May 11, 2004 and May 18, 2004. Firm initiated recall is complete.
REASON
Cookies contained undeclared tree nuts.
VOLUME OF PRODUCT IN COMMERCE
3,333 cases.
DISTRIBUTION
Nationwide.

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PRODUCT
Madena Dried Apricots, net wt. 8 oz. Recall # F-414-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Worldwide Foods Trading, Inc., Newark, NJ, by letter on June 2, 2004. Firm initiated recall is ongoing.
REASON
The product contained undeclared sulfites based on NY Department of Agriculture and Markets' analysis.
VOLUME OF PRODUCT IN COMMERCE
56/45 unit per case.
DISTRIBUTION
NY.

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PRODUCT
Archer Farms MARKET PREMIUM TRAIL MIX EVERYTHING BUT THE KITCHEN SINK. The trail mix is packaged in a clear film, stand-up Ziploc bag. Barcode # 085239086339. Recall # F-415-4.
CODE
Lots 012505 through 040105.
RECALLING FIRM/MANUFACTURER
Setton International Foods, Inc., Commack, NY, by telephone on June 11, 2004 and by letter on July 2, 2004. Firm initiated recall is complete.
REASON
The product contained undeclared walnuts.
VOLUME OF PRODUCT IN COMMERCE
3,312 - 12 oz. units.
DISTRIBUTION
Nationwide.

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PRODUCT
a) Jane-Jane brand Cuttlefish Ball. Origin of Taiwan.
Recall # F-416-4;
b) Jane-Jane brand Pollock Fish Ball. Origin of Taiwan.
Recall # F-417-4;
c) Jane-Jane brand Fish Ball. Origin of Taiwan.
Recall # F-418-4;
d) Jane-Jane brand Squid Nugget. Origin of Taiwan.
Recall # F-419-4;
e) Jane-Jane brand Milkfish Ball. Origin of Taiwan.
Recall # F-420-4;
f) Jane-Jane brand Shrimp Ball. Origin of Taiwan.
Recall # F-421-4;
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Everlasting Distributors, Inc., Bayonne, NJ, by letters on July 13, 2004 and by press release on July 14, 2004. Firm initiated recall is ongoing.
REASON
Seafood products contained undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
NY, NJ, and PA.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

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PRODUCT
Medline Baby Lotion, Reorder: MSC095007, 2 fl oz. (59.14 mL), Made in the USA. Recall # F-369-4.
CODE
Lot #30990253.
RECALLING FIRM/MANUFACTURER
Natural Care Labs Inc., Eden, NC, by letter on March 22, 2004. Firm initiated recall is complete.
REASON
Private lab analysis detected Burkholderia cepacia in the product.
VOLUME OF PRODUCT IN COMMERCE
568 cases (54,528 units).
DISTRIBUTION
IL.

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PRODUCT
a) Clare Burke, Blushing Rose Lathering Scrub, 8 oz.,
Recall # F-370-4;
b) Claire Burke Lathering Scrib, Original Scent, 8 oz.
Recall # F-371-4.
CODE
a) Product Codes 08125.041 and 08125.F41;
b) Product Codes 08125.085, 08125F85.
RECALLING FIRM/MANUFACTURER
Esscentual Brands Inc, Scottsdale, AZ, by letters on May 20, 2004. Firm initiated recall is ongoing.
REASON
Lathering Scrubs have high pH.
VOLUME OF PRODUCT IN COMMERCE
Not able to be determined.
DISTRIBUTION
Nationwide and Internationally.

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PRODUCT
Pie pastry cookies, Net Wt. 12.25 oz. Product of Vietnam Product labeled in part: "PIE PASTRY BANH MEN NET WT.***12.25Oz (350gr) INGREDIENTS: TAPIOCA, SUGAR***PRODUCT OF VIETNAM***". Recall # F-372-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Pacific Blue Trading Co, LLC, Manchester, CT, by telephone on June 28, 2004, Firm initiated recall is ongoing.
REASON
Product contained undeclared color additives - tartrazine (certifiable as FD&C Yellow No. 5), brilliant blue FCF (certifiable as FD&C Blue No. 1), and erythrosine (certifiable as FD&C Red No. 3).
VOLUME OF PRODUCT IN COMMERCE
70 cases.
DISTRIBUTION
CT, MA, NY, PA, RI, VT.

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PRODUCT
SushiChef Brand, Dragon Roll (8 piece), 11.5 oz. Recall # F-373-4.
CODE
Expiration date on or before 02.08.04.
RECALLING FIRM/MANUFACTURER
Fuji Food Products, Inc., Anaheim, CA, by telephone and visit beginning on February 4, 2004. Firm initiated recall is complete.
REASON
Product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
660 units.
DISTRIBUTION
CA.

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PRODUCT
Control Corrective Skincare brand of Gly Peel 33% pH3 facial peel, packaged in 8 fl. oz. plastic bottles, labeled in part *** Professional Use Only*** Recall # F-423-4.
CODE
Batch C7803, EXP 03/05 stamped on bottom of bottle.
RECALLING FIRM/MANUFACTURER
Universal Companies, Inc., Abingdon, VA, by letter on November 21, 2003. Firm initiated recall is ongoing.
REASON
Containers of Gly Peel 33% may have been formulated improperly by the laboratory. The improper formulation results in a lower pH factor for the product, making it as much as 20% stronger. This may cause mild chemical burns, redness or skin sensitivity in certain individuals.
VOLUME OF PRODUCT IN COMMERCE
399 bottles.
DISTRIBUTION
Nationwide.

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PRODUCT
Miami Bake Shoppe brand New York Onion Rolls sold in packages of one dozen rolls. Recall # F-424-4.
CODE
MB 052804.
RECALLING FIRM/MANUFACTURER
Miami Bake Shoppe, Inc., Livonia, MI, by telephone on May 29, 2004. Firm initiated recall is ongoing.
REASON
The product contains undeclared color - FD&C Yellow No. 5.
VOLUME OF PRODUCT IN COMMERCE
35 dozen.
DISTRIBUTION
MI.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

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PRODUCT
CORA brand Sparkling Natural Mineral Water carbonated, ITALIA. Product is sold in .25 liter (8.45 fl. Oz.); 5 liter (16.9 fl. Oz.), 1 liter (33.8 fl. Oz.) glass bottles. Recall # F-346-4.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Casa Imports, Inc., Utica, NY, by letter dated April 16, 2004. Firm initiated recall is complete.
REASON
Mineral water makes unapproved claim. Label claims to reduce cholesterol.
VOLUME OF PRODUCT IN COMMERCE
1 Liter - 12 bottles; .5 Liter - 84 bottles; .25 Liter - 5 bottles.
DISTRIBUTION
MA, NY and PA.

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PRODUCT
a) Acerola (West Indies cherries) fruit juice drinks packaged in 1/2
gallon plastic bottles. Recall # F-365-4;
b) Fruta (Fruit Punch) packaged in 1/2 gallon plastic bottles. Recall
#F-366-4;
c) Parcha (Passion Fruit) packaged in 1/2 gallon plastic bottles.
Recall #F-367-4;
CODE
a), b), and c) 11/30/2004.
RECALLING FIRM/MANUFACTURER
Refrescos Lugo, Bayamon, PR, by visit beginning July 12, 2004. Firm initiated recall is ongoing.
REASON
Products contain undeclared color: FD&C Red #40.
VOLUME OF PRODUCT IN COMMERCE
240 units.
DISTRIBUTION
PR.

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PRODUCT
La Belle Hot Cocoa Mix, Sugar Free, Net Wt. 4.24 oz. box with 8/0.53 oz. packets. Recall # F-422-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Lake Country Foods, Inc., Oconomowoc, WI, by fax beginning December 18, 2003. Firm initiated recall is ongoing.
REASON
The product contained aspartame as an ingredient but failed to bear the warning statement PHENYLKETONURICS: Conains Phenylalanine as required by 21 CFR 172.804(d)(2).
VOLUME OF PRODUCT IN COMMERCE
336 cases, 12 boxes/case.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
DMS brand Lidocaine, USP, BP, & Ph. Eur; Acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), net wt. 25.00 K.G. Recall # D-247-4.
CODE
Lot LA-03E18-C.
RECALLING FIRM/MANUFACTURER
DSM Pharma Chemicals South Haven Inc., South Haven, MI, by letter on May 4, 2004. Firm initiated recall is complete.
REASON
Presence of foreign particles: Failed USP chloride limit test.
VOLUME OF PRODUCT IN COMMERCE
75 kg..
DISTRIBUTION
MI and Japan.

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PRODUCT
Lantus Injection, (insulin glargine (rDNA origin), 100 units/mL (U-100), packaged in 10-ml vials, Rx only, For Subcutaneous Injection Only. Recall # D-263-4.
CODE
40D024, 40D025, and 40D027, Exp. dates for all lots is 02/06.
RECALLING FIRM/MANUFACTURER
Aventis Pharmaceuticals, Inc., Kansas City, MO, by letters on August 2, 2004. Firm initiated recall is ongoing.
REASON
Lack of sterility assurance (media fill failure).
VOLUME OF PRODUCT IN COMMERCE
347,206 vials.
DISTRIBUTION
Nationwide.

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PRODUCT
Embrex 600, Prenatal vitamin plus chewable calcium tablets, Rx only, NDC 62022-026-01. Recall # D-265-4.
CODE
Lot Number/Expiration Date: T-2258 (August 2004),
T-2293 (September 2004), T-2397 (February 2004),
T-2442 (March, 2005).
RECALLING FIRM/MANUFACTURER
Andrx Pharmaceuticals, Inc., Davie, FL, by letter on April 29, 2004. Firm initiated recall is ongoing.
REASON
Labeling. There is no warning for Phenylketonurics, and no list of inactive ingredients; the chewable Calcium tablets contain aspartame. Labeling declares 600 mg of Calcium carbonate; product contains 600 mg of calcium as calcium carbonate. Labeling declares thiamine mononitrate; product contains thiamine hydrochloride. Labeling declares zinc sulfate but product contains zinc oxide.
VOLUME OF PRODUCT IN COMMERCE
90,475 boxes of 91 sets of two tablets, for a total of 16,466,450 tablets.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
Premarin Tablets (conjugated estrogens tablets, USP) 1.25 mg. 100 tablet bottles, Rx only. Recall # D-243-4.
CODE
Lot #034964, Exp. Date: MAY 31, 05
RECALLING FIRM
Recalling Firm: Amerisource Health Services Corp., Columbus, OH, by E-mail, fax and letter on July 20, 2004.
Manufacturer: Ayerst Laboratories Inc, A Wyeth-Ayerst Co, Philadelphia, PA. Firm initiated recall is complete.
REASON
Dissolution Failure by manufacturer (Wyeth).
VOLUME OF PRODUCT IN COMMERCE
19,997 x 100 tablet bottles.
DISTRIBUTION
Nationwide and Canada.

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PRODUCT
Premarin Tablets (conjugated estrogens tablets, USP), 100 tablet bottles, Rx only. Recall # D-244-4.
CODE
Lot Numbers: A49547A, A49547B & A49547C/Expiration Date: 05/05.
RECALLING FIRM
Cardinal Health, Zanesville, OH, by letters dated June 21, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure by manufacturer (Wyeth).
VOLUME OF PRODUCT IN COMMERCE
16,081 x 100 tablet bottles.
DISTRIBUTION
Nationwide.

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PRODUCT
Concentrated Potassium Chloride Injection, USP, (2 mEq K+/mL) Super-vial, 500mL, NDC 0254-1940-10. Recall # D-248-4.
CODE
Batch J4D037.
RECALLING FIRM/MANUFACTURER
B. Braun Medical, Inc., Irvine, CA, by telephone and letter on July 15, 2004. Firm initiated recall is ongoing.
REASON
Presence of particulate matter.
VOLUME OF PRODUCT IN COMMERCE
360 (30 cases).
DISTRIBUTION
Nationwide.

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PRODUCT
Promotional Antibacterial Soap labeled as "Diovan (valsartan tablets), 40mg, 80mg, 160mg, 320mg", 8 fl. Oz. (235mL) bottles, Compliments of Novartis. Recall # D-249-4.
CODE
N/A
RECALLING FIRM/MANUFACTURER
Novartis Pharmaceuticals Corp., East Hanover, NJ, by letter on May 13, 2004. Firm initiated recall is ongoing.
REASON
Misbranded.
VOLUME OF PRODUCT IN COMMERCE
100,000 bottles.
DISTRIBUTION
Nationwide.

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PRODUCT
Cenestin (synthetic conjugated estrogens, A) Tablets, 0.625 mg., Rx only, 1000 count bottles, NDC 51285-442-05. Recall # D-250-4.
CODE
Lot #98387, Expiration Date: JUNE, 2005.
RECALLING FIRM/MANUFACTURER
Barr Pharmaceuticals, Inc., Cincinnati, OH, by letter on July 26, 3004 and July 27, 2004. Firm initiated recall is ongoing.
REASON
Stability Failure: 36 month stability failure due to excessive moisture.
VOLUME OF PRODUCT IN COMMERCE
861 bottles.
DISTRIBUTION
Nationwide.

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PRODUCT
Clinimix/Clinimix E Nutrient Profile Guide, Lit #800516; the laminated pocket guide is applicable to Clinimix E sulfite-free amino acid with electrolytes in dextrose with calcium injections in 2L vertical peel seal, Rx only. Recall # D-253-4.
CODE
Literature #800516.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL, by letters dated July 28, 2004. Firm initiated recall is ongoing.
REASON
Mislabeling: The Pocket Guide for the Clinimix/Clinimi E parenteral nutritionals has incorrect dosing/formulation for multiple two-liter size product codes.
VOLUME OF PRODUCT IN COMMERCE
1,189 guides.
DISTRIBUTION
Nationwide, Puerto Rico, and Canada.

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PRODUCT
a) Zovia 1/50E-28 Tablets (Ethynodiol Diacetate and Ethinyl
Estradiol, USP), 1.0 mg/0.050 mg, Each pink tablet (21)
contains ethynodiol diacetate 1mg and ethinyl estradiol
50 mcg, Each white tablet (7) contains inert
ingredients, 6 tablet dispensers, 28 tablets each, Rx
only, NDC 52544-384-28. Recall # D-259-4;
b) Zovia 1/35E-28 (Ethynodiol Diacetate and Ethinyl
Estradiol, USP) 1.0 mg/0.035 mg, Each light pink tablet
(21) contains ethynodiol diacetate 1mg and ethinyl
estradiol 35 mcg, Each white tablet (7) contains inert
ingredients, 3 tablet dispensers, 28 tablets each, Rx
only, NDC 52544-383-31. Recall # D-260-4.
CODE
a) Lot Numbers / Exp Dates 38401B03 - 9/30/2004, 38401D03 -
11/30/2004, 38402D03 - 11/30/2004, 38402J03 - 2/28/2005,
38401R03 -5/30/2005;
b) Lot Numbers with 8/31/2004 exp dates: 38305A03 Lot
Numbers with 10/31/2004 exp dates: 38307C03, 38308C03,
38309C03, 38310C3, 38301D03, 38302D03, 38303D03,
38317D09 ,38318D03, 38319D03 Lot Numbers with 11/30/2004
exp date: 38304D03, 38305D03, 38306D03, 38307D03,
38308D03, 38309D03, 38310D03, 38311D03, 38312D03,
38313D03, 38314D03, 38315D03, 38316D03, 38301E03,
38302E03, 38303E03, 38304E03 Lot Numbers with 12/31/2004
exp dates: 38301G03, 38302G03, 38303G03, 38305G03,
38309G03, 38310G03, 38311G03, Lot Numbers with 4/30/2005
exp dates: 38301M03, 38302M03, 38303M03, 38304M03, Lot
Numbers with 5/31/2005 exp dates: 38306M03, 38307M03,
38301R03 Lot Numbers with 6/30/2005 exp date: 38304R03,
38305R03, 38306R03, 38301X03, 38302X03, 38303X03,
38304X03, 38305X03 Lot Numbers with 8/31/2005 exp dates:
38302A04, 38303A04.
RECALLING FIRM/MANUFACTURER
Watson Laboratories, Inc., Corona, CA, by letter on August 13, 2004. Firm initiated recall is ongoing.
REASON
There is potential for film/foil separation in the blister packaging of the product.
VOLUME OF PRODUCT IN COMMERCE
566,951 cartons.
DISTRIBUTION
Nationwide.

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PRODUCT
Niaspan Tablets (niacin extended release tablets), 1000 mg, 100 count bottles, Rx only, NDC 60598-003-01. Recall # D-262-4.
CODE
Lot #0208000003, Exp. 03/05.
RECALLING FIRM/MANUFACTURER
KOS Pharmaceuticals, Inc., Miami Lakes, FL, by letter on July 1, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
4,152 bottles.
DISTRIBUTION
Nationwide.

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PRODUCT
Premarin (Conjugated Estrogens Tablets USP), 1.25mg, 100 tablets, Rx only, NDC # 00046-0866-81. Recall # D-264-4.
CODE
Lot 08586, Exp. 05/05 and Lot 09727, Exp. 05/05.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rx PAK, Memphis, TN, by letter dated June 21, 2004. Manufacturer: Ayerst Laboratories Inc, A Wyeth-Ayerst Co, Philadelphia, PA. Firm initiated recall is complete.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
88,022 bottles of 100.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1728-4.
CODE
Unit 30187-5584.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fargo, ND, by telephone on September 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
ND.

_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1730-4;
b) Cryoprecipitated AHF. Recall # B-1731-4.
CODE
a) and b) Unit: 30187-4485
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Fargo, ND, by telephone on September 23, 2003 and by letter dated October 21, 2003.
Manufacturer: United Blood Services, Bismarck, ND. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
ND and CA.
______________________________
PRODUCT
Source Plasma. Recall # B-1805-4.
CODE
Units 148DK195B, 148DK337B, 148DK448B, 148DK553B, 148DK820B, 148DK976B, 148DL065B, 148DL194B, 148DL406B, 148G8081B, 148G8221B, 148G8263B, 148G8398B, 148G8461B, 148G8613B, 148G8641B, 148G8765B, 148G8946B, 148W8883B, 148W9303B, 1494U012B, 1494U059B, 1494U254B, 1494U386B, 1494U455B, 1498E593B, 1498E626B, 1498E785B, 1498E889B, 1498E932B, 1498F070B, 1498F272B, 1498F319B, 1498F465B, 1498FI09B, 149CK232B, 149CK281B, 149CK452B, 149CK530B, 149CK618B, 149CK719B, 149CK811B, 149CK896B, 149CL000B, 149CL095B, 149CL216B, 149CL318B, 149CL409B, 149CL512B, 149CL590B, 149CL701B, 149CL796B, 149CL896B, 149CL984B, 149EX576B, 149EX683B, 149EX787B, 149EX878B, 149EX999B, 149LL135B, 149LL268B, 149LL319B, 149LL405B, 149LL496B, 149LL702B, 149LL883B, 149LM082B, 149LM305B, 149LM806B, 149LM887B, 149NB587B, 149NB762B, 149NC144B, 149NC287B, 149NC335B, 149NC457B, 149YT035B, 149YT147B, 149YT221B, 149YT324B, 149YT402B, 14CHBZMGB, 14CHBZVQB, 14CHBZYSB, 14CHCBFRB, 14CHCBJCB, 14CHCBPYB, 14CHCBSFB, 14CHCBYWB, 14CHCCBYB, 14CHCCKNB, 14CHCCRMB, 14CHCCTRB, 14CHCCZWB, 14CHCDCJB, 14CHCDJNB, 14CHCDMYB, 14CHCDXNB, 14CHCFBPB, 14CHCFGPB, 14CHCFKTB, 14CHCFQVB, 14CHCFZDB, 14CHFHJBB, 14CHFHNBB, 14CHFHSFB, 14CHFJCLB, 14CHFJFRB, 14CHFJLFB, 14CHFJNTB, 14CHFJWDB, 14CHFJYDB, 14CHKLPZB, 14CHKLQHB, 14CHKLTGB, 14CHKLTSB, 14CHKLWFB, 14CHKLXJB, 14CHKLYVB, 14CHKMCJB, 14CHKMCMB, 14CHKMDJB, 14CHKTVVB, 14CHKVBDB, 14CHKVDPB, 14CHKVPLB, 14CHKVWJB, 14CHKVZNB, 14CHKWFYB, 14CHLVZGB, 14CHLWCMB, 14CHLWFWB, 14CHLXBMB, 14CHLXDRB, 14CHLXGPB, 14CHLXJVB, 14CHLXMDB, 14CHLXNTB, 14CHLXSSB, 14CHLXTRB, 14CHLXXHB, 14CHLXYJB, 14CHLYBZB, 14CHLYDGB, 14CHLYGRB, 14CHLZHPB, 14CHLZPTB, 14CHLZQVB, and 14W8958B.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Minneapolis, MN, by facsimile on February 19, 2002. Firm initiated recall is complete.
REASON
Blood products, which tested initially reactive for an infectious disease on an invalidated test run but subsequently tested negative on a single repeat run, were distributed.
VOLUME OF PRODUCT IN COMMERCE
149 units.
DISTRIBUTION
IL, Germany and Switzerland.

_______________________________
PRODUCT
Source Plasma. Recall # B-1806-4.
CODE
Unit 79273374.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Dallas, TX, by facsimile on August 8, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who tested positive for hepatitis B surface antigen (HbsAg) by PCR testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1810-4.
CODE
Unit K39505.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI, by telephone on April 27, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to Platelets that were contaminated with Streptococcus agalactiae, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
a) Plasma, Frozen. Recall # B-1826-4;
b) Cryoprecipitated AHF. Recall # B-1827-4;
c) Recovered Plasma. Recall # B-1828-4.
CODE
a) Unit number: 11GR34665;
b) and c) Unit number: 11GZ36568.
RECALLING FIRM/MANUFACTURER
American Red Cross, Missouri-Illinois Region, St. Louis, MO, by telephone on January 16, 2003, by letter dated January 22, 2003, and by facsimile on January 28, 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 for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MO and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1835-4;
b) Recovered Plasma. Recall # B-1836-4.
CODE
a) and b) Unit number 04G56432.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on May 3, 2004, by letter on May 11, 2004, and electronically on May 5, 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 subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA, and MA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1839-4.
CODE
Units 40FG47029, 40FG47335.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Heart of America Region, by telephone on June 15, 2004 and by letter dated June 18, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1840-4.
CODE
Unit numbers G-05363-018, G-06599-018, G-07063-018, G-07865-018,
G-08354-018, G-09151-018, G-09534-018, G-11511-018, G-11944-018,
G-12817-018, G-13273-018, G-14104-018, G-14485-018, G-17025-018,
G-24172-018, G-25509-018, G-26696-018, G-27484-018, G-28080-018,
G-28777-018, G-30076-018, G-31158-018, G-31738-018, G-32388-018,
G-33077-018, G-33648-018, G-34329-018, G-34937-018, G-35669-018,
G-36411-018, G-36895-018, G-37951-018, G-38728-018, G-39157-018,
G-39979-018, G-40470-018, G-41206-018, G-41656-018, G-42535-018,
G-42803-018, G-43705-018, G-44014-018, G-44947-018, G-45210-018,
G-46183-018, G-46414-018, G-47269-018, G-47545-018, G-48409-018,
G-48636-018, G-49600-018, G-49901-018, G-50855-018, G-51156-018,
G-51990-018, G-52454-018, G-53114-018, G-53580-018, G-54266-018,
G-54753-018, G-55483-018, G-55899-018, G-56627-018, G-57053-018,
G-57768-018, G-58249-018, G-58947-018, G-59409-018, G-60144-018,
G-60580-018, G-61380-018, G-61780-018, G-62416-018, G-62923-018,
G-63585-018, G-64057-018, G-64738-018, G-65207-018, G-65912-018,
G-66470-018, G-67564-018, G-68215-018, G-68689-018, G-69341-018,
G-69812-018, G-70537-018, G-70996-018, G-71696-018, G-81895-018,
G-82437-018, G-83584-018, G-83668-018, G-84131-018, G-84381-018,
G-84774-018, G-84833-018, G-85165-018, G-85702-018, G-85766-018,
G-86109-018, G-86389-018, G-86586-018, G-87055-018, G-87116-018,
G-87677-018, G-88418-018, G-88947-018, G-89698-018, G-90186-018,
G-90956-018, G-91487-018, G-92177-018, G-92811-018, G-93534-018,
G-93928-018, G-94657-018, G-95231-018, G-95884-018, G-96914-018,
G-97297-018, G-98251-018, G-98786-018, G-99452-018, N-65795-018, and N-65811-018.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corp, Bakersfield, CA, by letter on May 13, 2002.
Manufacturer: Alpha Therapeutic Corporation, Fresno, CA. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to intravenous (IV) drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
125 units.
DISTRIBUTION
CA, NC, Spain, Switzerland, and the United Kingdom.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1841-4.
CODE
Unit numbers 12GM86253, 12GM86286, 12GM86255, and 12GM86317.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on February 6, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Human Tissue for Transplantation, Femoral-Popliteal Artery SG.
Recall # B-1842-4.
CODE
Model number SGR020, serial number 7966894.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on August 4, 2003. Firm initiated recall is complete.
REASON
Human tissue for transplantation was incorrectly tested for viral markers in that the blood sample used for testing was likely hemodiluted.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-1843-4;
Fresh Frozen Plasma. Recall # B-1844-4;
Plasma, Cryoprecipitate Reduced. Recall # B-1845-4.
CODE
a) and c) Unit number 20T42372;
b) Unit numbers 20K68084, 20S54835, 20S55086, and 20S58380.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone on August 21, 2003, and letter on August 22, 2003.
Manufacturer: The American National Red Cross, Salt Lake City, UT. Firm initiated recall is complete.
REASON
Blood products, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
UT and CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1848-4.
CODE
Unit numbers: 9VG914 O, 91V437 O, 91V706 O, 91W012 O, 91W159 O, 91W566 O, 91W778 O, 97R050 O, 97R254 O, 91X052 O, 91X215 O, 97S095 O, 97S847 O, 97S998 O, BSCYPD O, BSCZZN O, BSDBTH O, BSDCDW O, BSFGPL O, BSFGWF O, BSFHTQ O.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., St. Paul, MN, by facsimile, dated January 22, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor who had been permanently deferred due to drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
IL, and Switzerland.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1850-4;
Platelets Pheresis, Leukocytes Reduced. Recall # B-1851-4.
CODE
Unit numbers: 4710054, 3723225.
RECALLING FIRM/MANUFACTURER
LifeSource Blood Services, Glenview, IL, by telephone on June 22, and 23, 2004. Firm initiated recall is complete.
REASON
Blood products, failing to meet quality control requirements, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1852-4;
b) Platelet. Recall # B-1853-4.
CODE
a) Units 4610489, 4502323;
b) Unit 4610489.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on September 26, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of cancer, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1859-4.
CODE
Unit number: 6026373.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, Alaska, by letter, dated July 25, 2002. 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
AK.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1874-4.
CODE
Unit numbers: 004GC09671P1, 004GC09671P2, 004GC09675, 004GC09684, 004GC09693, 004GC09702, 004GC09722, 004GC09738, 004GC09746, 004GC09750, 004GC09753, 004GC09756, 004GC09763, 004GC09768, 004GC09770, 004GC09774, 004GC09776P1, 004GC09776P2, 004GJ10173, 004GJ10174, 004GJ10186, 004GJ10199P1, 004GJ10199P2, 004GJ10203, 004GJ10207P1, 004GJ10207P2, 004GJ10213, 004GJ10216, 004GJ10218P1, 004GJ10218P2, 004GJ10220, 004GJ10237P1, 004GJ10237P2, 004GJ10241, 004GJ10242P1, 004GJ10242P2, 004GJ10243, 004GJ10244, 004GJ10245, 004GJ10251, 004GJ10260, 004GR18125P1, 004GR18125P2, 004GR18146P1, 004GR18146P2, 004GR18155P1, 004GR18155P2, 004GR18192, 004GR18203, 004GR18213, 004GR18214, 004GR18215, 004GR18218, 004GR18221, 004GR18232, 004GR18249, 004GR18250, 004GR18251P1, 004GR18251P2, 004GR18255, 004GR18256P1, 004GR18256P2, 004GR18257, 004GR18258, 004GR18260, 004GR18266P1, 004GR18266P2, 004GR18267, 004GR18272, 004GR18282, 004GR18283, 004GR18284, 004GR18285, 004GR18287, 004GR18290, 004GR18297P1, 004GR18297P2, 004GR18298, 004GR18300P1, 004GR18300P2, 004GR18301P1, 004GR18301P2, 004GR18303, 004GR18308P1, 004GR18308P2, 004GR18309, 004GR18313P1, 004GR18313P2, 004GR18317P1, 004GR18317P2, 004GR18327P1, 004GR18327P2, 004GR18340, 004GR18365, 004GR18377, 004GR18394, 004GR18400, 004GR18403, 004GR18408, 004GR18409, 004GR18421, 004GR18427, 004GR18437, 004GR18438, 004GR18439.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by facsimile on February 13, 2004, and by letters, dated February 25, and March 30, 2004. Firm initiated recall is complete.
REASON
Platelet pheresis products, lacking monthly quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
105 units.
DISTRIBUTION
MA.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1877-4.
CODE
Units 7016575, 7015305.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE, by facsimile on January 14, 2004 and February 12 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who disclosed a history of testing positive for hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1880-4.
CODE
Units 71 W50715-6 (split unit).
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on January 5, 2004. Firm initiated recall is complete.
REASON
Platelets, prepared with an insufficient plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL, and FL.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1881-4.
CODE
Units 71 W49499-2 (split unit).
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on January 20, 2004. Firm initiated recall is complete.
REASON
Platelets, prepared with an insufficient plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.

_______________________________
PRODUCT
a) Platelets. Recall # B-1895-4;
b) Fresh Frozen Plasma. Recall # B-1896-4.
CODE
a) and b) Units 71W50187-1.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Suwanne Valley Region, Lake City, FL, by facsimile on January 27, 2004. Firm initiated recall is complete.
REASON
Blood products were collected in a manner that may compromise the sterility of the products.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL, and AL.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1898-4.
CODE
Unit number 6001173.
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Erie County, Erie, PA, by letter on January 22, 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
PA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1904-4.
CODE
Unit number 04C83537.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on March 24, 2004 and by letter on March 31, 2004. Firm initiated recall is complete.
REASON
Blood product was not properly quarantined after a report that the donor had possibly been exposed to hepatitis A.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1729-4.
CODE
Unit 30187-5584.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fargo, ND, by fax on September 10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1732-4.
CODE
Unit: 30187-4485.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Fargo, ND, by fax on September 24, 2003.
Manufacturer: United Blood Services, Bismarck, ND. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1849-4.
CODE
Unit: 40FT17276.
RECALLING FIRM/MANUFACTURER
By telephone on June 8, 2004, and by letter on June 17, 2004. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably high hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
a) Source Leukocytes. Recall # B-1854-4;
b) Recovered Plasma. Recall # B-1855-4.
CODE
a) and b) Unit 4502323.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone on September 26, 2003 and September 30, 2003 and by facsimile on September 26, 2003 and October 2, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of cancer, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
a) Platelet Pheresis, Leukoreduced. Recall # B-1856-4;
b) Platelet Pheresis, Leukoreduced, Irradiated. Recall # B-1857-4.
CODE
a) Units: 21FP16494, 21FP16498, 21KP43312, 21KP43324, 21KP43368,
21KP43399, 21KP43401, 21KP43403 (2 units), 21KP43407, 21KP43409,
21KP43410 (2 units), 21KP43417, 21KP43419, 21KP43420 (2 units),
21KP43421, 21KP43422, 21KP43423, 21KP43426 (2 units), 21KP43436,
21KP43438, 21KP43440, 21KP43442, 21LQ05649 (2 units), 21LQ05675,
21LQ05676, 21LQ05677, 21LQ05680, 21LQ05681, 21LQ05684, 21LQ05686
(2 units), 21LQ05687, 21LQ05691;
b) Units: 21KP43364, 21KP43409, 21KP43428, 21KP43431 (2 units),
21lQ05675, 21LQ05685.
RECALLING FIRM/MANUFACTURER
By telephone on January 12, 2003, and by letter on February 3, 2003. Firm initiated recall is complete.
REASON
Blood products that were exposed to unacceptable temperatures during shipping were distributed.
VOLUME OF PRODUCT IN COMMERCE
45 units.
DISTRIBUTION
WA, and OR.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1897-4.
CODE
Unit number 71L40707-9.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by facsimile on March 5, 2004. Firm initiated recall is complete.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
Shiley TracheoSoft® XLT Extended Length Tracheostomy tube, Model Numbers: 72110-050, size 5;
Proximal Extension, Uncuffed, 72110-060, size 6;
Proximal Extension, Uncuffed; 72110-070, size 7;
Proximal Extension, Uncuffed; 72110-080, size 8;
Proximal Extension, Uncuffed; 72120-050, size 5;
Promixal Extension, Cuffed; 72120-060, size 6;
Promixal Extension, Cuffed; 72120-070, size 7;
Promixal Extension, Cuffed; 72120-080, size 8;
Promixal Extension, Cuffed; 73110-050, size 5;
Distal Extension, Uncuffed; 73110-060, size 6;
Distal Extension, Uncuffed; 72110-070, size 7;
Distal Extension, Uncuffed; 73110-080, size 8;
Distal Extension, Uncuffed; 73120-050, size 5;
Distal Extension, Cuffed; 73120-060, size 6;
Distal Extension, Cuffed; 73120-070, size 7;
Distal Extension, Cuffed; 73120-080, size 8;
Distal Extension, Cuffed; 77100-050, size 5;
XLT Disposal Inner Cannula; 77100-060, size 6;
XLT Disposal Inner Cannula; 77100-070, size 7;
XLT Disposal Inner Cannula; 77100-080, size 8.
Recall # Z-1312-04.
CODE
All unit of above models.
RECALLING FIRM/MANUFACTURER
Nellcor Puritan Bennett, Pleasanton, CA, by letter on July 8, 2004, and by press release on August 6, 2004. Firm initiated recall is ongoing.
REASON
Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death.
VOLUME OF PRODUCT IN COMMERCE
71,021 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Sollux Systeme commercial tanning beds; Soleil Systems, Inc. The following models are affected by this recall: a) Sollux Systeme 32 - 32 x 100 w tanning bulbs, no facial tanner bulbs b) Sollux Systeme 32.3 - 32 x 100 w tanning bulbs, plus 3 x 400 w facial tanner bulbs c) Sollux Systeme 36 - 18 x 100 w reflective tanning bulbs, 18 x 100 w tanning bulbs, no facial tanner bulbs d) Sollux Systeme 36.3 - 18 x 100 w reflective tanning bulbs, 18 x 100 w tanning bulbs, plus 3 x 400 w facial tanner bulbs e) Sollux System 40 - 20 x 160 w reflective tanning bulbs, 20 x 100 w reflective tanning bulbs, no facial tanner bulbs f) Sollux System 40.3 - 20 x 160 w reflective tanning bulbs, 20 x 100 w reflective tanning bulbs, 3 x 400 w facial tanner bulbs. Recall # Z-1065-04.
CODE
Each sunbed has two serial numbers, one on the canopy and another on the bench. The serial numbers listed below list the canopy/bench.serial numbers followed by the manufacturing date. a) Sollux Systeme 32 - 22 units, serial numbers 320002/320007 May 03; 320008/320014 May 03; 320010/320010 May 03; 320012/320012 May 03; 320015/321207 May 03; 320016/320016 May 03; 320017/320017 May 03; 320018/320018 May 03; 320019/320019 May 03; 320020/321202 May 03; 320021/321211 May 03; 320095/321264 Oct 03; 320096/321325 Oct 03; 320104/321284 Jun 03; 320106/321320 Jun 03; 320109/320109 May 03; 320111/321319 Aug 03; 320112/321314 Aug 03; 320123/321317 Sep 03; 320214/320214 May 03; 321211/321211 May 03; 321324/320113 Aug 03; b) Sollux Systeme 32.3 - 7 units, serial numbers 320007/321104 May 03; 320008/321109 May 03; 320009/321112 May 03; 320011/321316 Aug 03; 320093/321269 Oct 03; 320126/321268 Oct 03; 320127/321323 Oct 03; c) Sollux Systeme 36 - 8 units, serial numbers 360004/360016 Sep 03; 360009/360015 May 03; 360012/361003 May 03; 360013/360021 Jun 03; 361001/360013 Aug 03; 361003/360017 Aug 03; 361041/361004 Oct 03; 361042/361001 Aug 03; d) Sollux Systeme 36.3 - 8 units, serial numbers 360011/360019 May 03; 360012/360015 May 03; 360013/360020 Jun 03; 360015/360010 May 03; 360016/360011 May 03; 360018/360014 My 03; 360020/360023 May 03; 360021/360027 May 03; e) Sollux System 40 - 1 unit, serial number 400002/400008 May 03; f) Sollux System 40.3 - 24 units, serial numbers 400002/400010 May 03; 400003/400021 Jul 03; 400004/400005 May 03; 400005/400020 Jun 03; 400006/400014 Jun 03; 400007/400004 Jun 03; 400008/400019 Aug 03; 400009/400094 Aug 03; 400010/400005 Jul 03; 400011/400023 Aug 03; 400012/400016 Apr 03; 400013/400017 Oct 03; 400116/400001 Sep 03; 400019/400020 Oct 03; 400021/400013 Aug 03; 400090/400015 Aug 03; 400095/400010 Aug 03; 400096/400021 Sep 03; 400097/400013 Oct 03; 400099/400018 Sep 03; 400102/400015 Sep 03; 400113/400012 Jul 03; 400114/400002 JUL 03; 400115/400009 Jul 03;
RECALLING FIRM/MANUFACTURER
Soleil Systems, Inc., Elk Grove Village, IL, by letters dated June 28, 2004. Firm initiated recall is ongoing.
REASON
The sunlamp products failed to incorporate a timer system and a control for termination of radiation emission in accordance with the Federal Sunlamp Product Performance Standard.
VOLUME OF PRODUCT IN COMMERCE
70 beds.
DISTRIBUTION
MO, TX, VA, KY, and IL.

_______________________________
PRODUCT
a) Battery-operated Cautery Low Temperature, fine/elongated Tip.
Recall # Z-1238-04;
b) Battery-operated Cautery High Temperature, fine/Loop/Vasectomy
Tip. Recall # Z-1239-04.
CODE
a) Sterile lot numbers: 0204B 0204D 0204E 0304A 0304C 0304D 0404A
0404E 0404G 0404H 0404J 0504A 0504C 0504E 0504F. EXP DATES 2/1/08-
5/1/04;
b) Sterile lot numbers: 0104E 0204B 0204C 0204E 0304A 0304C 0404A
0404C 0404H 0404J 0404G 0504A 0504F 0204A 0304E 0504B 0204D 0504D
0504C 0504E 0504F. EXP DATES 2/1/08-5/1/04.
RECALLING FIRM/MANUFACTURER
Aaron Medical Industries, Inc., St. Petersburg, FL, by facsimile on June 29, 2004. Firm initiated recall is ongoing.
REASON
The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.
VOLUME OF PRODUCT IN COMMERCE
173,130 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) EasyDiagnost Eleva Part Number 9896 050 71921. Recall # Z-1306-04;
b) MultiDiagnost Eleva, Part Numbers: 9896 001 41501 and 9896 001
41502. Recall # Z-1307-04;
c) ViewForum Review Station Part Numbers: 9896 507 71830, 9896 507
71831, and 9896 507 71832.
CODE
a) The firm uses site numbers instead of serial numbers. 103164,
105323, 505806, 500032, 105589, 105337, 506439, 505063, 505749,
505653, 505295, 105152, 505385, 505003, 506211, 504541, 505015,
504981, 504611, 104179, 505754, 505671, 505104, 103539, 102551,
505069, 102549, 504962, 104812, 504743, 105777, 103515, 103522,
103523, 103588, 504966, 504882, 505056, 504879, 105921, 505798,
105640, 105776, 506199, 504804, 504803;
b) 505039, 104530, 506247, 102666, 104136, 104838, 506155, 105194;
c) 83616, 103380, 102578, 105315, 504608, 104095, 104900, 103620,
505119, 105295, 103540, 105735, 105608, 105493, 101585, 225694,
102492, 504979, 102101, 105290, 105486, 505784, 104079, 504925,
504952, 505815, 505960.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Sales & Service Region No. America, Bothell, WA, by letters beginning on June 8, 2004. Firm initiated recall is ongoing.
REASON
When reviewing images in the module before sending them to PACS or printer the order can be erratic and out of sequence and may cause confusion with the interpretation of the examination.
VOLUME OF PRODUCT IN COMMERCE
81 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Merit MAK Mini Access Kit, 4 French (1.3mm). Catalog Number
MAK401. Recall # Z-1309-04;
b) Merit MAK Mini Access Kit, 4 French (1.3mm). Catalog Number
MAK401N. Recall # Z-1310-04;
c) Merit MAK Mini Access Kit, 4 French (1.3mm). Catalog Number
MAK405. Recall # Z-1311-04;
CODE
a) Lot Numbers: G322819, M9337627, MR314384, MR314386, MR317164,
MR320056.
b) Lot Numbers: G331723, G338460, M9337635, MR314388, MR317166,
MR320063;
c) Lot Numbers:G338462, M9337638, MR314387, MR317165, MR320060.
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by telephone and letter on July 20, 2004. Firm initiated recall is ongoing.
REASON
Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.
VOLUME OF PRODUCT IN COMMERCE
3,722 kits.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Private Eyes, Diam 14.0 BC 8.6, Contents: one sterile daily wear soft contact lenses, 38% water, 62% polymacon, immersed in 0.9% buffered saline solution USP, Cosmetic Use Daily Wear ***Decorative Theatrical Contact Lenses, packed in vials labeled sterile. Types include: Zombie, Banshee, Green Leaf, Green Reptile, White Cat, Manson, Green Rave, Moon & Stars, Blackwolf, Fire, Black Out, Pink Rave, Spiral, Flower Power, Starfire, Yellow Cat Eye, Computer Chip, Target, Red Cat, Blue Rave, Smiley, White Snowflake and Red Vampire. Recall # Z-1313-04.
CODE
The majority of the vials in stock at the firm have lot number BB43 Expiration Date 08/06.
RECALLING FIRM/MANUFACTURER
The Contact Lens Store, Inc., Marietta, GA, by telephone and letter on June 7, 2004. Firm initiated recall is ongoing.
REASON
The contact lenses were repacked in vials that were not sterile as indicated on the vial labeling.
VOLUME OF PRODUCT IN COMMERCE
618 vials.
DISTRIBUTION
MA, TX, WA.

_______________________________
PRODUCT
Varian Mdical device and software systems. Version Numbers 6.2.27 and 6.2.35, 510k number K001643. Recall # Z-1314-04.
CODE
Serial numbers H8__ (31901, 50044, 50149, 50181, 50187,50260, 50284, 50315, 50357, 50397, 50430, 50804, 50873, 51096, 51152, 51186, 51082, 51463, 51534, 51580, 51658, 51773, 51787, 59032, 59040, 59041, 59045).
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Palo Alto, CA, by letter on June 14, 2004. Firm initiated recall is ongoing.
REASON
A malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters to null for future treatments if a patient receives treatment on a non-varian machine and a varian machine and a non-varian field is loaded in the treatment session.
VOLUME OF PRODUCT IN COMMERCE
28 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
ProLumen Rotational Thrombectomy System. Catalog No. 86311, sold as a single unit packaged in a shelf carton. Recall # Z-1315-04.
CODE
Lot Numbers--Exp.Date: M354580 -- 2004-03; M357300-- 2004-05; M401160-- 2004-08; M401170 -- 2004-08; M413790 --2004-09; M414240 -- 2004-09; M437260 -- 2004-10.
RECALLING FIRM/MANUFACTURER
Datascope Interventional Products Division, Mahwah, NJ, by letter dated July 16, 2004. Firm initiated recall is ongoing.
REASON
The motor may fail to activate when the on/off switch is pressed.
VOLUME OF PRODUCT IN COMMERCE
892 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Neuro Adapter 2 used with the Berchtold B-810 Surgical Table or Getinge USA Fortis Surgical Table Catalog No: MDTNA2. Recall # Z-1327-04.
CODE
131613, 131614, 131615, 131616,152144, 152145, 152147, 152148 219039, 219040, 219042, 219043, 232800, 232801, 232802, 232803, 232804, 205395, 205396, 235327, 235329, 235330, 237473, 237465, 237467, 237468, 237469, 237470, 237471.
RECALLING FIRM/MANUFACTURER
Allen Medical Systems, Acton, MA, by telephone and letter on July 12, 2004 and July 16, 2004.
REASON
Neuro adapter may fail to engage and adequately clamp to the surgical table, resulting in movement.
VOLUME OF PRODUCT IN COMMERCE
29 units.
DISTRIBUTION
SC.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS I

_______________________________
PRODUCT
a) Bly-F-3 Barrow Country Swine 800 CX25 Medicated,
containing 25 g/ton of Carbadadox, (bulk feed). Recall #
V-132-4;
b) Bly-F-3 Gilt Country Swine 900 CX25 Medicated,
containing 25 g/ton of Carbadadox, (bulk feed). Recall #
V-133-4;
c) Bly-F-3 Barrow Country Swine 800 CX50 Medicated,
containing 50 g/ton of Carbadadox, (bulk feed). Recall #
V-134-4;
d) Bly-F-4 Barrow Country Swine 700 BMD30 Medicated,
containing 30 g/ton of Bacitracin, (bulk feed). Recall #
V-135-4;
e) Bly-F-4 Gilt Country Swine 800 BMD30 Medicated,
Containing 30 g/ton of Bacitracin, (bulk feed). Recall #
V-136-4;
f) Bly-F-3 Barrow Country Swine 800 BMD30 Medicated,
Containing 30 g/ton of Bacitracin, (bulk swine feed).
Recall # V-137-4;
g) Bly #2 Lactation D-25# 1100 Corn (bulk swine feed.
Recall # V-138-4;
h) Country Swine 700 (bulk feed). Recall # V-139-4;
i) Custom DDG Supplement (a bulk animal feed supplement for
swine). Recall # V-140-4;
j) Groplex 15/45 Starter Supplement (a bulk animal feed
supplement for swine). Recall # V-141-4;
k) EFC Swine Balancer (a bulk animal feed concentrate).
Recall V-142-4;
l) Six-In-One (bulk swine feed supplement). Recall # V-
143-4.
m) Chicoine Barrow 100-140 BMD30 Medicated, containing 30
g/ton of Bacitracin, (bulk swine feed). Recall # V-144-
4;
n) Sioux Nation Sjoval Gluten Supplement For Feedlot
Cattle. Recall # V-145-4;
o) Sioux Nation 16% Heifer Grower S-100 Medicated For
growing heifers containing 100 g/ton of Chortetracycline
and 0.011% of Sulfamethazine (bulk complete cattle
feed). Recall # V-146-4;
p) Sioux Nation 16% Heifer Grower DC Medicated For
growing heifers, bulls, and dairy/beef containing
0.0025% of Decoquinate (bulk complete cattle feed).
Recall # V-147-4;
q) Musick Complete Horse Feed in bulk. Recall # V-148-4.
CODE
a) Feed delivered on 3/24/04;
b) Feed delivered on 3/25/04;
c) Feed delivered on 3/24/04;
d) Feed delivered on 3/25/04;
e) Feed delivered on 3/26/04;
f) Feed delivered on 3/24/04;
g) Feed delivered on 3/25/04;
h) Feed delivered on 3/25/04;
i) Feed delivered on 3/31/04;
j) Feed delivered on 3/31/04;
k) Feed delivered on 3/30/04;
l) Feed delivered on 3/19/04;
m) Feed delivered on 4/02/04;
n) Feed delivered on 4/01/04;
o) Feed delivered on 3/25/04;
p) Feed delivered on 3/24/04;
q) Feed delivered on 3/29/04.
RECALLING FIRM/MANUFACTURER
CHS Inc, (Cenex Harvest States), Corson, SD, by telephone on April 2, and April 5, 2004. Firm initiated recall is complete.
REASON
Animal feeds, containing 100 times their intended selenium level, were responsible for some animal deaths.
VOLUME OF PRODUCT IN COMMERCE
79 tons.
DISTRIBUTION
SD.

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS III

_______________________________
PRODUCT
a) Sebolux Medicated Shampoo for Dogs and Cats,
Antiseborrheic Keratoplastic, 8 fl. Oz., Active
Ingredients: Solubilized Sulfur (equivalent to 2%
elemental Sulphur) and 2% salicylic acid. Recall #
V-162-4;
b) Epi-Otic Ear Cleanser for dogs, cats, puppies, and
kittens. Cleansing, drying, non-irritating. Recall #
V-163-4.
CODE
a) and b) WJ363.
RECALLING FIRM/MANUFACTURER
Virbac AH, Inc., Fort Worth, TX, by telephone on July 15, 2004. Firm initiated recall is ongoing.
REASON
Bottles labeled at Sebolux Medicated Shampoo for dogs and cats contain EPI-Otic Ear Cleanser for Dogs, Cats, Puppies, and kittens.
VOLUME OF PRODUCT IN COMMERCE
22,824 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
C.E.T. Home Dental Care Oral Hygiene Gel for Dogs and Cats, NDC 051311-502-32, 1.4 fl. Oz. (32 mL). 0.12% Chlorhexidine Gluconate. Recall # V-164-4.
CODE
All lots of the product on the market are being recalled . The subpotent lots are WF363, WF313, WH352, WL307, and WC433.
RECALLING FIRM/MANUFACTURER
Virbac AH, Inc., Fort Worth, TX, by letter on July 14, 2004. Firm initiated recall is ongoing.
REASON
Subpotency.
VOLUME OF PRODUCT IN COMMERCE
88,366 units.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR September 1, 2004

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