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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December 8, 2004
04-49

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

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PRODUCT
YING FENG FOODSTUFFS brand “BISCUIT”, NET WT. 6 oz (170g). EXPIRATIONO: 24 MONTHS --- BEST BEFORE: _______ Product is packed in a plastic bag. Barcode # 6 911749 680375. Recall # F-081-5.
CODE
Expiration: 24 Months.
RECALLING FIRM/MANUFACTURER
Eastwell Trading Corp., Brooklyn , NY , by letters dated August 31, 2004 . Firm initiated recall is complete.
REASON
The product contains Ponceau 4R (E124, Acid Red 18), an unapproved color additive. The product also contains the following undeclared color additives: brilliant blue FCF (certifiable as FD&C Blue #1), tartrazine (certifiable as FD&C Yellow #5) and sunset yellow FCF (certifiable as FD&C Yellow #6. VOLUME OF PRODUCT IN COMMERCE
27 cases (50 – 6oz. bags per case).
DISTRIBUTION
NY.

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PRODUCT
ANDROSTENEDIONE, 100 mg, 100 capsule bottle UPC: 0 99907100034 7. Recall # F-082-5.
CODE
Lot number: 111003 Exp. Date: 11/04.
RECALLING FIRM/MANUFACTURER
Ultimate Nutrition Inc., Farmington, CT, by telecopy and letter on May 7, 2004. Firm initiated recall is complete.
REASON
The product is adulterated since it contains the new dietary ingredient, androstenedione, for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
VOLUME OF PRODUCT IN COMMERCE
5,063 bottles.
DISTRIBUTION
CA, CT, FL, ID, MA, NJ, OH, PA, TX, WI, Curaco , UK , and Phillipines.

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PRODUCT
Camel Mug, Ceramic coffee or tea mug in the shape of a camel. Recall # F-083-5.
CODE
UPC Code – 2364047 + one check digit.
RECALLING FIRM/MANUFACTURER
Cost Plus, Inc., Oakland , CA , by memo, signs, and telephone beginning on September 10, 2004 . Firm initiated recall is complete.
REASON
Camel Mug contains elevated leachable levels of lead.
VOLUME OF PRODUCT IN COMMERCE
103 units.
DISTRIBUTION
AZ, CA, CO, NM, OR, and WA.

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PRODUCT
EPA DHA Extra Strength Enteric-Coated Capsules, 60 softgels. Recall # F-084-5.
CODE
Lot numbers 82473, 82472, 81785, 81784, 81613, and 81612.
RECALLING FIRM/MANUFACTURER
Metagenics, San Clemente , CA , by letter on May 19, 2003 . Firm initiated recall is complete.
REASON
Poor Quality Control at manufacturer.
VOLUME OF PRODUCT IN COMMERCE
30,002 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT

a) Top Care®, Distilled Extract of Witch Hazel, Alcohol 14% by Volume, For Relief of Minor Skin Irritations Due to Insect bites, Minor Cuts and Minor Scrapes, 16 FL OZ (1 PT) 473 mL. The Witch Hazel product is filled in a natural-colored (clear) HDPE bottle. Recall # D-064-5;
b) Top Care®, Hydrogen Peroxide Solution usp, First Aid Antiseptic, For Treatment of Minor Cuts and Abrasions, For use as an Antiseptic Gargle or Rinse, 16FL OZ (1 PT) 473 mL. Hydrogen Peroxide is filled in a brown opaque HDPE bottle to protect it from the damaging effects of light. Recall # D-065-5.
CODE
a) and b) Lot #HB1118F.
RECALLING FIRM/MANUFACTURER
Aaron Industries, Inc., Lynwood , CA , by telephone and letter on November 16, 2004 . Firm initiated recall is ongoing.
REASON
Mislabeling: Witch Hazel product is labeled TopCare® Hydrogen Peroxide, instead of TopCare® Witch Hazel.
VOLUME OF PRODUCT IN COMMERCE
663/16 oz. bottles.
DISTRIBUTION
IL.

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PRODUCT
Estrace (estradiol tablets, USP) 1 mg tablets. 100 trade package. Recall # D-067-5.
CODE
Lot 4C82237 exp. 3/07.
RECALLING FIRM/MANUFACTURER
Warner Chilcott Inc, Rockaway, NJ, by telephone and letters on September 8, 2004 . Firm initiated recall is ongoing.
REASON
Mislabeling: Outer carton incorrectly states contains 0.5mg estradiol whereas the bottle label correctly states contains 1.0mg estradiol.
VOLUME OF PRODUCT IN COMMERCE
2,368 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
Bacitracin Ointment USP, (Bacitracin) 500 units, 144 Unit dose packets, NET WT 0.9 grams each, A First Aid Antibiotic, NDC0182-0232-30. Recall # D-061-5.
CODE
Lot number: AW247.
RECALLING FIRM/MANUFACTURER
IVAX Pharmaceuticals, Inc., Miami , FL , by letter on October 29, 2004 . Firm initiated recall is ongoing.
REASON
Mispackaging; product carton labeled as Bacitracin Ointment USP actually contains correctly labeled packets of Triple Antibiotic Ointment.
VOLUME OF PRODUCT IN COMMERCE
6,668 cases.
DISTRIBUTION
Nationwide.

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PRODUCT
GoodSense brand Children’s Allergy Relief, (Loratadine) Oral Solution, 5mg/5mL, 4 fl. oz. (120 mL) bottles, Fruit Flavored Syrup, Antihistamine, Non-Drowsy, over-the-counter, Manufactured by Perrigo Company, Allegan, MI ----- Also sold under the following brand names: Kroger brand Children’s Allergy Relief, Distributed by The Kroger Co., Cincinnati, OH NDC 30142-649-26 -- Walgreens brand Children’s Wal-itin Allergy Relief, Dist. by Walgreen Co., Deerfield, IL NDC 0363-0649-26 -- Good Neighbor Pharmacy brand Allergy Relief for Kids, Distributed by AmerisourceBergen, Valley Forge, PA NDC 24385-531-26 -- Longs brand Children''s Loratadine, Dist. by Longs Drug Stores, Walnut Creek, CA NDC 12333-9113-1 -- Brite-Life brand Allergy Relief for Kids, Dist. by AmerisourceBergen, Valley Forge, PA NDC 24385-531-26 -- Topcare brand Allergy Relief, Dist. by Topco Associates LLC, Skokie, IL NDC 36800-649-26 -- CVS Pharmacy brand Children’s Allergy Relief, Dist. by CVS Pharmacy, Inc., Woonsocket, RI -- HyVee brand Allergy Relief, Dist. by Hy-Vee, Inc., West Des Moines, IA -- Equate brand Allergy Relief, Packaged by: Perrigo, Allegan, MI, Dist. by Wal-Mart Stores, Inc., Bentonville, AR NDC 49035-649-26 -- American Fare brand Allergy Relief, Made for Kmart Corporation, Troy, MI NDC 49738-649-26 -- Publix brand Children’s Allergy Relief, Dist. by Publix Super Markets, Inc., Lakeland, FL NDC 56062-649-26 -- Sunmark brand Children’s Allergy Relief, Loratadine Syrup, Dist. by McKesson, San Francisco, CA NDC 49348-636-34 -- FOOD LION brand Allergy Relief for Kids, Distributed by Food Lion LLC, Salisbury, NC NDC 55316-649-26 -- Safeway brand Children’s Allergy Relief, Dist. by Safeway Inc., Pleasanton, CA NDC 21130-649-26 -- Rite Aid brand Children’s Loratadine Syrup, Dist. by Rite Aid Corporation, Harrisburg, PA -- Family Pharmacy brand Allergy Relief for Kids, Distributed by Family Pharmacy, Valley Forge, PA NDC 52735-374-41 -- Major brand Allergy Relief for Kids, Dist. by Major Pharmaceuticals, Livonia, MI NDC 0904-5671-20 -- Equaline brand Children’s Allergy Relief, Dist. by Albertsons Inc., Boise, ID NDC 41163-649-26 -- Berkley & Jensen brand Children’s Loratadine Syrup, Dist. by BJWC, Natick, MA -- Careone brand Allergy Relief, Dist. by American Sales Company, Lancaster, NY -- Eckerd brand Children’s Allergy Relief, Dist. by Eckerd Drug Company, Clearwater, FL NDC 19458-9403-1 -- Western Family brand Children’s Allergy Relief, Dist. by Western Family Foods, Inc., Portland, OR -- Target brand Children’s Allergy Relief, Dist. by Target Corporation, Minneapolis, MN NDC 11673-649-26 -- Today''s Health brand Children’s Allergy Relief, Dist. by Warehouse Concepts, Inc., West Sacramento, CA NDC 38309-649-26 -- The Medicine Shoppe brand Allergy Relief for Kids, Dist. by Medicine Shoppe International, Inc., St. Louis, MO NDC 49614-174-26 -- Leader brand allergy Relief, Dist. by Cardinal Health, Inc., Dublin, OH NDC 37205-378-26 -- Healthy Generations brand Loratadine Syrup, Dist. by Supervalu Inc, Eden Prairie, MN -- Alavert Children’s Allergy Relief, Dist Wyeth Consumer Healthcare, Madison, NJ – Children’s DimetappND, Dist. Wyeth Consumer Healthcare, Madison, NJ -- Sav-on Osco by Albertson’s brand Children’s Allergy Relief, Dist. by Albertson’s Inc., Boise, ID NDC 41163-649-26 -- H.E.B. Pharmacy brand Children’s Allergy Relief, Dist. by H-E-B, San Antonio, TX NDC 37808-649-26 -- Meijer brand Children’s Allergy Relief, Dist. by Meijer Distribution, Inc., Grand Rapids, MI NDC 41250-649-26 Recall # D-062-5.
CODE
All Lots.
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan , MI , by letters dated November 17, 2004 . Firm initiated recall is ongoing.
REASON
Impurities; product exceeds impurity specification (6 month stability).
VOLUME OF PRODUCT IN COMMERCE
2,851,097 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
Red Blood Cells. Recall # B-0188-5.
CODE
Units 1636581, 1636583, 1636573, 1636585, 1636587, and 1636557.
RECALLING FIRM/MANUFACTURER
Department of the Army, Madigan Army Medical Center , Tacoma , WA , by facsimile dated November 17, 2002 . Firm initiated recall is complete.
REASON
Red Cells, incorrectly tested for HIV/HCV by NAT, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
WA.

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PRODUCT
Human Tissue for Transplantation. Recall # B-0203-5.
a) Femoral Head;
b) Patellar Bone with attachments;
c) Femoral Condyles.
CODE
a) ID number: 031229010;
b) ID number: 031229008;
c) ID number: 031229001.
RECALLING FIRM/MANUFACTURER
AlloSource, Inc., Denver , CO , by letter, dated October 13, 2004 . 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
3 Tissues.
DISTRIBUTION
CA.

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PRODUCT
a) Red Blood Cells. Recall # B-0233-5;
b) Platelets. Recall # B-0234-5;
c) Recovered Plasma. Recall # B-0235-5.
CODE
a), b), and c) Unit KT06478.
RECALLING FIRM/MANUFACTURER
Innova Health Care Services, Blood Donor Services, Annandale , VA , by letter on June 2, 2004 and by fax on June 3, 2004 . Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk of exposure to Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
VA and NJ.

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PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-0236-5;
b) Fresh Frozen Plasma. Recall # B-0237-5.
CODE
a) and b) Unit KS16926
RECALLING FIRM/MANUFACTURER
Innova Health Care Services, Blood Donor Services, Annandale , VA , by letter on March 22, 2003 . Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk of exposure to Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0242-5.
CODE
Unit number: K57645.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond , VA , by telephone on July 17, 2004 , and by letter, dated August 2, 2004 . Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with Micrococcus sp., was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

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PRODUCT
Source Plasma. Recall # B0243-5.
CODE
Unit numbers: 57862750, 57749242, 57743479, 56818079, 56813869, and 56810844.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Richmond , VA , by facsimile on April 1, 2003 . Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
CA.

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PRODUCT
Source Plasma. Recall # B-0259-5.
CODE
Units 96912577, 96919484, 96896099, 96891483, 96886854, 96873878, 96869758, 96859926, 96853344, 96849873, 96832844, 96829110.
RECALLING FIRM/MANUFACTURER
ZLB Plasma Services, Inc., Kansas City , MO , by letter dated February 10, 2004 . Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who did not answer the CJD questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
CA.

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PRODUCT
Source Plasma. Recall # B-0260-5.
CODE
Unit BHQYPQ.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc. Davenport , IA, by letter dated March 28, 2003 . Firm initiated recall is complete.
REASON
Source Plasma, untested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

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PRODUCT
Source Plasma. Recall # B-0264-5.
CODE
Units BHNLNK, BHNKZC, BHMBFN, BHLZHY, BHLYXN, BHLYFB.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Davenport , IA , by letter dated September 12, 2003 . Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who had a tattoo applied within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
IL.

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PRODUCT
Platelets. Recall # B-0265-5.
CODE
Unit V18099.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond , VA. , by telephone on May 20, 2004 , and by fax on June 8, and July 16, 2004 . Firm initiated recall is complete.
REASON
Blood Product, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0290-5.
CODE
Unit number: 150262186.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock , TX , by telephone on June 16, 2004 . Firm initiated recall is complete.
REASON
Blood product, associated with a positive bacterial culture, which identified coagulase negative, Staphylococcus sp., was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

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PRODUCT
Human Tissue for Transplantation, Cornea. Recall # B-0292-5.
CODE
Number 00404344.
RECALLING FIRM/MANUFACTURER
East Tennessee Lions Eye Bank, Knoxville , TN , by telephone on July 1, 2004 . Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis and human immunodeficiency virus (HIV) prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) and anti-HIV by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
TN.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0307-5.
CODE
Unit number 7193855.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeShare Blood Centers , Shreveport , LA , by letter on June 9, 2004.
Manufacturer: LifeShare Blood Centers , Alexandria , LA. 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
IL.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0308-5.
CODE
Unit number 7193215.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeShare Blood Centers , Shreveport , LA , by letter on January 9, 2004.
Manufacturer: LifeShare Blood Centers , Alexandria , LA. 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
LA.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0309-5.
CODE
Unit number 8355537.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeShare Blood Centers , Shreveport , LA , by telephone on July 2, 2003 , and by letter on July 17, 2003.
Manufacturer: LifeShare Blood Centers , Alexandria , LA. 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
LA.

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PRODUCT
Source Plasma. Recall # B-0310-5.
CODE
Unit number XF261748.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., New Orleans , LA , by facsimile on October 15, 2001 . Firm initiated recall is complete.
REASON
Blood product was collected from an ineligible donor based on previous reactive testing for syphilis.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Germany.

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PRODUCT
Red Blood Cells, Irradiated. Recall # B-0318-5.
CODE
Unit number E88786.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Miller Memorial Blood Center, Bethlehem, PA, by telephone on June 21, 2004, and by letter on June 25, 2004. Firm initiated recall is complete.
REASON
Blood product, for which documentation of irradiation was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

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PRODUCT
Red Blood Cells, Irradiated. Recall # B-0319-5.
CODE
Unit number E71962.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Miller Memorial Blood Center, Bethlehem, PA, by telephone on April 12, 2004, and by letter on April 28, 2004. Firm initiated recall is complete.
REASON
Blood product, for which documentation of the time of irradiation was not in accordance with specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0320-5.
CODE
Unit number 4144864.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford , TX , by letter dated April 2, 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
TX.

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PRODUCT
Platelets. Recall # B-0321-5.
CODE
Unit number 3016988.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford , TX , by letter on October 21, 2003 . Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

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PRODUCT
Platelets. Recall # B-0322-5.
CODE
Unit number 3011303.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford , TX , by letter on October 21, 2003 . Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

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PRODUCT
Platelets. Recall # B-0324-5.
CODE
Unit number 4153097.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford , TX , by telephone and letter on December 18, 2003 . Firm initiated recall is complete.
REASON
Blood product, that tested reactive for the antibody to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT
Red Blood Cells. Recall # B-0189-5.
CODE
Units 1636543, 1636544, 1636545, 1636546, 1636548, 1636549, 1636550, 1636551, 1636552, 1636554, 1636555, 1636556, 1636558, 1636559, 1636560, 1636561, 1636562, 1636563, 1636567, 1636568, 1636569, 1636571, 1636572, 1636575.
RECALLING FIRM/MANUFACTURER
Department of the Army, Madigan Army Medical Center , Tacoma , WA , by facsimile dated November 17, 2002 . Firm initiated recall is complete.
REASON
Red Cells, incorrectly tested for HIV/HCV by NAT, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units.
DISTRIBUTION
WA.

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PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced. Recall # B-0291-5.
CODE
Unit numbers 15024-8397, 15025-2982, 15025-2945, and 15025-2969; and the following units were distributed as two split products, unit numbers 15025-2956, 15025-2922, and 15025-2971.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock , TX , by telephone on January 27, 2004 . Firm initiated recall is complete.
REASON
Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
TX and NM.

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PRODUCT
Platelets. Recall # B-0323-5.
CODE
Unit number 3008046.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford , TX , by letter on February 19, 2004 . Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that had a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

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