Safety
Enforcement Report for August 9, 2006
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.
August 9, 2006
06-32
RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III
______________________________
PRODUCT
Kitchen Pride Mushroom Farms Fresh, sliced, white mushrooms in corrugated cardboard boxes; 5 lbs. per box, Recall # F-283-6
CODE
Side 1 of box: "SLC ¼ 5# 111";
Side 2 of box: "SLC ¼ 5#******",
Where ****** is a number between 180300 thru 195700
RECALLING FIRM/MANUFACTURER
Kitchen Pride Mushroom Farms, Gonzales, TX, by telephone and letter on April 24, 2006. Firm initiated recall is complete.
REASON
Sliced mushrooms may be contaminated with metal fragments.
VOLUME OF PRODUCT IN COMMERCE
260/5 lb. cases
DISTRIBUTION
TX
______________________________
PRODUCT
a) IDACOL Roha Dyechem Pvt. Ltd. FD&C Blue No. 1 Magic Crystal, Pure Dye 91%,
Date of Mfr.: 08/05/2004, Net Wt.: 50.000 Lb/22.680 KGS, A/44 & 45,
Recall # F-284-6;
b) IDACOL Roha Dyechem Pvt. Ltd. FD&C Red No. 3 Granular, Pure Dye: 92%,
Date of Mfr.: 08/05/2004, Net Wt.: 50.000 Lb/22.680 KGS, A/44 & 45,
Recall # F-285-6;
c) Roha FD&C Yellow No. 5 Sphero, Pure Dye: 90%,
Date of Mfg.: 04/06/05, Net Wt.: 50.00 Lbs,
Recall # F-286-6;
d) Roha FD&C Yellow No. 6 Sphero, Pure Dye: 88%,
Date of Mfg.: 8/28/04, Net Wt. 50.00 Lbs,
Recall # F-287-6
CODE
a) FDA Lot No. AM4054;
b) FDA Lot No. AM4134;
c) FDA Lot No. AN1206;
d) FDA Lot No. AM9087
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roha U.S.A., L.L.C., Saint Louis, MO, by telephone on June 21-23, 2006.
Manufacturer: Roha Dyechem PVT. LTD., Dhatav, India. Firm initiated recall is ongoing.
REASON
Colors do not meet specification for certification.
VOLUME OF PRODUCT IN COMMERCE
a) 3,375 lbs;
b) 400 lbs.;
c) 1,150 lbs;
d) 1,000 lbs
DISTRIBUTION
Nationwide and Canada
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
______________________________
PRODUCT
a) Hydralazine Hydrochloride 100 mg tablets, 30 tablet box,
NDC # 50111-397-01, Recall # D319-6;
b) Hydralazine Hydrochloride 100 mg tablets, 250 tablet bag,
NDC # 50111-397-01, Recall # D320-6
CODE
a) Lot K43263R30, exp. 12/13/06;
b) Lot K43263R25, exp. 12/13/06
RECALLING FIRM/MANUFACTURER
Heartland Repack Services LLC, Toledo, OH, by telephone and fax letter on July 14, 2006. Firm initiated recall is ongoing.
REASON
Packaging mix-up- The outer packaging is labeled as Hydralazine Hydrochloride, 100 mg tablets, but the unit dose blister strips inside the outer packaging may contain and be labeled as Benztropine Mesylate, 0.5 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
655/30 count boxes and 10/150 count bags
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Lorazepam Tablets, 2 mg, 30 tablet bingo cards, NDC # 61332-452-39, Recall # D-321-6
CODE
Lot # 452E0622, expiration date 4/30/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland repack Services LLC, Toledo, OH, by telephone on or about June 5, 2006.
Manufacturer: Sandoz, Inc, Broomfield, CO. Firm initiated recall is ongoing.
REASON
Lorazepam 1 mg tablets packaged and distributed as Lorazepam 2 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
1,124 cards/30 tablets per card
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
______________________________
PRODUCT
Actonel® (risedronate sodium tablets), 35 mg, once a week, Rx only, NDC 0149-0472-02. Each physician sample contains 1 tablet in a blister, sealed in a pouch, affixed to a sample card, Recall # D-322-6
CODE
Lot 328121, exp. date 12/2007
RECALLING FIRM/MANUFACTURER
Procter & Gamble Pharm, Inc., Norwich, NY, by letter on June 30, 2006. Firm initiated recall is ongoing.
REASON
Labeling: Incorrect package insert (older version) was sent instead of revised current version.
VOLUME OF PRODUCT IN COMMERCE
229,034 physician samples
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0536-6
CODE
Unit: LP00299
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile dated May 11, 2006, Firm initiated recall is complete.
REASON
Platelets, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who previously tested repeatedly reactive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
______________________________
PRODUCT
Source Plasma, Recall # B-1447-6
CODE
Unit: NG0057019
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches, LLC, Nacogdoches, TX, by telephone and facsimile on February 13, 2003. Firm initiated recall is complete.
REASON
Blood product, which tested negative for hepatitis B surface antigen (HbsAg), but was collected from a donor who subsequently tested positive for HbsAg, was not properly quarantined and was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
______________________________
PRODUCT
Unprocessed, cadaveric tissue, Recall # B-1604-6
CODE
LA05-018
RECALLING FIRM/MANUFACTURER
Life Alaska Donor Services, Anchorage, AK, by letters dated January 25 and 26, 2006. Firm initiated recall is complete.
REASON
Unprocessed, cadaveric tissue that was subsequently found to test repeatedly reactive for antibodies to Hepatitis B Core Total (IgM/lgG) by a different facility was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
TX, GA, and NJ
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1605-6;
b) Platelets, Recall # B-1606-6;
c) Fresh Frozen Plasma, Recall # B-1607-6;
d) Cryoprecipitated AHF, Recall # B-1608-6
CODE
a) Units: 2597240, 2597085, 2596321, 2596720, 2629130, 2599098,
2600915, 2630350, 2630082, 2628579;
b) Unit: 2630350;
c) Units: 2597085, 2600915, 2629130, 2630350;
d) Units: 2597240, 2630082
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile transmission beginning August 3, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose suitability to donate had not been adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
TX, WI, Austria and Switzerland
______________________________
PRODUCT
Decavac Vaccine, 10 x 1 UD Syringe, NDC number: 49281-291-10, Recall # B-1611-6
CODE
Lot number: U1703AA, Expiration date: 7/11/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Bergen, Chesterbrook, PA, by telephone on May 25, 2006, and by letter dated May 30, 2006.
Manufacturer: Sanofi Pasteur, Inc., Swifterwater, PA. Firm initiated recall is complete.
REASON
Vaccines, that were stored under unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
300 units
DISTRIBUTION
TX
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1612-6;
b) Plasma Frozen, Recall # B-1613-6
CODE
a) Units: 04KK14463 and 04KK14471;
b) Unit: 04KK14456
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Dedham, MA, by telephone on May 1, 2006 and by letter dated May 4, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NH and VT
______________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-1614-6
CODE
Units: 0980870, 0980879, 0980882, 0980893, 0990389, and 0990406
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by facsimile on October 27, 2004. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
NJ
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1615-6
CODE
Unit: 13FC61595
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by telephone on December 30, 2005 and by letter dated January 4, 2006. 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
MI
______________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-1616-6
CODE
Unit: 1851268
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone and letter on May 26, 2006. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
______________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-1617-6;
b) Platelets, Recall # B-1618-6
CODE
a) and b) Unit: 3015049
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile dated December 17, 2003. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
SC and GA
______________________________
PRODUCT
Red Blood Cells (Apheresis), Recall # B-1619-6
CODE
Unit: S85997
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by telephone on January 17, 2006 and by letter dated February 8, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1620-6;
b) Platelets, Recall # B-1621-6;
c) Cryoprecipitated AHF, Recall # B-1622-6;
d) Recovered Plasma, Recall # B-1623-6
CODE
a) and d) Units: 1029180 and 3105267;
b) and c) Unit: 1029180
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA. , by facsimile on March 13, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for HIV-1 Group O infection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
GA and Germany
______________________________
PRODUCT
Source Plasma, Recall # B-1625-6
CODE
Units: 83906770, 83900587
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Spokane Valley, WA, by facsimile dated September 17, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor that tested reactive for hepatitis C virus (HCV), by the polymerase chain reaction (PCR) assay, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1631-6
CODE
Unit: LW12875
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by fax on January 27, 2006. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the firm’s specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1657-6
CODE
Units: 3006637, 3005136
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on April 6, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
______________________________
PRODUCT
Red Blood Cells, Recall # B-1658-6
CODE
Unit: 7003531
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on May 21, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
______________________________
PRODUCT
Red Blood Cells, Recall # B-1659-6
CODE
Unit: 2018616
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on August 7, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1660-6;
b) Platelets, Recall # B-1661-6
CODE
a) and b) Unit: 1030740
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on March 13, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
Recall # B-1663-6;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated,
Recall # B-1664-6
CODE
a) Units: 04FP64617P1, 04FP64617P2, 04FP64707, 04FP64901P1,
04FP64901P2, 04FP64957, 04FP64965, O4FP64996P1,
O4FP64996P2, 04FP65015, 04FP65040P1, 04FP65040P2,
04FP65068, 04FP65103, 04FP65153, 04FP65314P1, 04FP65314P2,
04FP65329P, 04FP65361, 04FP65371P1, 04FP65371P2,
04FP65374P2, 04FP65385P1, 04FP65385P2, 04FP65422,
04FP65460, 04FP65483, 04FP65672, 04FP65691, 04FP65760,
04FP65784, 04FP65804, 04FP65916P1, 04FP65916P2,
04FP65967P1, 04FP65967P2, 04FP65969, 04FP65987,
04FP66080P1, 04FP66080P2, 04FP66093, 04FP66111P1,
04FP66111P2, 04FP66175P1, 04FP66175P2, 04FP66230,
04FP66288, 04FP66357P1, 04FP66357P2, 04FP66360P1,
04FP66360P2, 04FP66492P1, 04FP66492P2, 04FP66493P1,
04FP66493P2, 04FP66509P1, 04FP66509P2, 04FP66532P1,
04FP66532P2, 04FP66548P1, 04FP66548P2, 04FP66572,
04FP66586P1, 04FP66586P2, 04FP66587P1, 04FP66587P2,
04FP66599P1, 04FP66599P2, 04FP66662, 04FP66706P1,
04FP66706P2, 04FP66712, 04FP66728P1, 04FP66728P2,
04FP66797, 04FP66799, 04FP66902P1, 04FP66902P2,
04FP66905P2, 04FP66933P1, 04FP66933P2, 04FP66935P1,
04FP66935P2, 04FP66936P1, 04FP66936P2, 04FP66950,
04FP66986P1, 04FP66986P2, 04FP67005, 04FP67018P1,
04FP67018P2, 04FP67030, 04FP67069P1, 04FP67069P2,
04FP67074, 04FP67121P1, 04FP67121P2, 04FP67122P1,
04FP67122P2, 04FP67123P2, 04FP67171, 04FP67190,
04FP67347P1, 04FP67347P2, 04FP67383P1, 04FP67383P2,
04FP67415P1, 04FP67415P2, 04FP67416, 04FP67556P1,
04FP67556P2, 04FP67559, 04FP67580P1, 04FP67580P2,
04FP67595P1, 04FP67595P2, 04FP67652, 04FP67663,
04FP67702P1, 04FP67702P2, 04FP67774P1, 04FP67774P2,
04FP67804P1, 04FP67804P2, 04FP67806P1, 04FP67806P2,
04FP67821, 04FP67833P1, 04FP67833P2, 04FP67857P1,
04FP67857P2, 04FP67858P1, 04FP67858P2, 04FP67939P1,
04FP67939P2, 04FP67941P1, 04FP67941P2, 04FP67968,
04FP68032, 04FP68067, 04FP68153P1, 04FP68153P2,
04FP68173, 04FP68272P1, 04FP68272P2, 04FP68291P1,
04FP68291P2, 04FP68311P1, 04FP68311P2, 04FP68387P1,
04FP68387P2, 04FP68390P1, 04FP68390P2, 04FP68406,
04FP68412P2, 04FP68429P1, 04FP68429P2, 04FP68527P1,
04FP68527P2, 04FP68529P1, 04FP68529P2, 04FP68584P1,
04FP68584P2, 04FP68601P1, 04FP68601P2, 04FP68613,
04GP53958P1, 04GP53958P2, 04GP53988P1, 04GP53988P2,
04GP54167P1, 04GP54167P2, 04GP54196P1, 04GP54196P2,
04GP54579P1, 04GP54579P2, 04GP54618P1, 04GP54618P2,
04GP54678P1, 04GP54678P2, 04P50398, 04P50504P1,
04P50504P2, 04P50580, 04P50655, 04P51092P1, 04P51092P2,
04P51299P1, 04P51299P2, 04P51428P1, 04P51428P2, 04P51442P1,
04P51442P2, 04P51477P1, 04P51477P2, 04P51478P1, 04P51478P2,
04P51540P1, 04P51540P2, 04P51624P1, 04P51624P2, 04P51766P1,
04P51766P2, 04P51958, 04P52007P1, 04P52007P2, 04P52094P1,
04P52094P2, 04P52135P1, 04P52135P2, 04P52375, 04P52652,
04P52738P1, 04P52738P2, 04P52772, 04FP64831P1, 04FP64831P2;
b) Units: 04FP65329P1, 04FP67020, 04FP67859P1, 04FP67859P2,
04FP67123P1, 04P52750, 04FP65374P1, 04FP65851, 04P52027P1,
04P52027P2, 04P52241P1, 04P52241P2, 04FP64962, 04FP66905P1,
04FP67734, 04FP68412P1
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by facsimile dated April 29, 2004 and letters dated May 11, 2004. Firm initiated recall is ongoing.
REASON
Platelets, collected in apheresis collection kits that may have exceeded their acceptable period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
233 units
DISTRIBUTION
GA, MA, PA, ME, NH, VA, and VT
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1665-6
CODE
Units: 22KG91790
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on January 15, 2006 and by letter dated January 18, 2006. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA and NJ
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
______________________________
PRODUCT
Source Plasma, Recall # B-0533-6
CODE
Units: ST0870889, ST0872003, ST0872145, ST0872414, ST0872737, and ST0873021
RECALLING FIRM/MANUFACTURER
Stillwater Plasma Center LLC, Stillwater, OK, by facsimile dated June 11, 2004. Firm initiated recall is complete.
REASON
Source Plasma, which had not been tested for HIV NAT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
UK
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1453-6;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1454-6;
c) Plasma Frozen, Recall # B-1455-6
CODE
a) Units: 12LL21379, 12LL21380, 12LL21382, 12LL21383,
and 12LL21384;
b) Units: 12GL83396, 12GL83397, 12GL83398, 12GL83400,
12GL83401, 12GL83402, 12GL83403, 12GL83404, 12GL83405,
12GL83407, 12GL83408, 12GL83409, 12GL83410, 12GL83411,
12GL83412, 12GL83413, 12GM09065, 12GM09066, 12GM09067,
12GM09068, 12GM09069, 12GM09070, 12GM09072, 12GM09073,
12GM09074, 12GM09075, 12GM09076, 12GM09077, 12GM09078,
12GM09079, 12GM09080, 12GM09082, 12GM09083, 12GM09084,
12GM09085, 12GM09086, 12GM09087, 12GM09088, 12GN92999,
12GN93000, 12GN93002, 12GN93003, 12GN93004, 12GN93005,
12GN93006, 12GN93007, 12GN93008, 12GN93009, 12GN93010,
12GN93011, 12GN93012, 12GN93013, 12GN93014, 12GN93015,
12GN93016, 12GN93017, 12GN93019, 12GN93020, 12GN93021,
12GN93022, 12GN93023, 12GN93024, 12GN93025, 12GN93026,
12GN93027, 12GN93028, 12GN93029, 12GN93030, 12GN93031,
12GN93032, 12GN93033, 12GN93034, 12GN93035, 12GN93036,
12GN93037, 12GN93039, 12GN93040, 12GN93041, 12GN93042,
12GN93043, 12GN93044, 12GN93045, 12KP90079, 12KP90080,
12KP90081, 12KP90083, 12KP90084, 12KP90085, 12KP90086,
12KP90088, 12KP90089, 12KP90090, 12KP90093, 12KP90094,
12KP90095, 12KP90096, 12KP90097, 12KP90098, 12KP90099,
12KP90100, 12KP90101, 12KP90102, 12KP90103, 12KP90104,
12KP90105, 12KP90106, 12KP90107, 12KP90108, 12KP90109,
12KP90110, 12KP90111, 12KP90119, 12KP90120, 12KP90121,
12KP90122, 12KP90123, 12KP90124, 12KP90125, 12KP90127,
12KP90128, 12KP90129, 12KP90130, 12KP90132, 12KP90134,
12KP90135, 12KP90136, 12LJ63210, 12LJ63211, 12LJ63212,
12LJ63214, 12LJ63215, 12LJ63216, 12LJ63217, 12LJ63218,
12LJ63219, 12LJ63220, 12LJ63221, 12LJ63222, 12LJ63223,
12LJ63225, 12LJ63227, 12LJ63228, 12LJ63229, 12LJ63231,
12LJ63232, 12LJ63233, 12LJ63234, 12LJ63235, 12LJ63236,
12LJ63237, 12LJ63238, 12LJ63239, 12LJ63240, 12LK69114,
12LK69115, 12LK69116, 12LK69117, 12LK69118, 12LK69119,
12LK69120, 12LK69121, 12LK69123, 12LK69124, 12LK69125,
12LK69126, 12LK69127, 12LK69129, 12LK69130, 12LK69131,
12LL21381, and 12LL21385.
c) Units: 12GL83398, 12GM09066, 12GM09075, 12GN93001,
2GN93012, 2LJ63231 and 12LJ63238.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by facsimile, letter, and telephone between May 20, 2005 and June 2, 2005. Firm initiated recall is complete.
REASON
Blood products, for which shipping conditions were undocumented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
183 units
DISTRIBUTION
GA, NE, NC, VA, SC, and TN
______________________________
PRODUCT
Source Plasma, Recall # B-1603-6
CODE
Units: ST0870666, ST0870893
RECALLING FIRM/MANUFACTURER
Stillwater Plasma Center LLC, Stillwater, OK, by facsimile dated June 11, 2004. Firm initiated recall is complete.
REASON
Source Plasma, which had not been tested for HIV NAT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UK
______________________________
PRODUCT
Recovered Plasma, Recall # B-1609-6
CODE
Unit: 2597240, 2596321, 2596720, 2599098, 2630082, 2628579, 2601579
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile transmission beginning August 3, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose suitability to donate had not been adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
TX, WI, Austria and Switzerland
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1624-6
CODE
Units: 03LR76868, 03GR10492, 03GF10441, 03GF10582, 03GF10619, 03KM31460, 03LE25494, 03GF10435, 03GF11098, 03GF10869, 03K 31892, 03FJ78587, 03FJ78751, 03GF11087, 03GF10809, 03FG42813, 03LR77069, 03GF11145, 03GF10507, 03GF10440, 03GX31757, 03LX30116, 03LR76902, 03FF78312, 03LE26546, 03LE26532, 03GX32043, 03V 35328, 03LE26442, 03LR76881, 03GF11298, 03GF10630, 03GF10430, 03GF10537, 03GG11828, 03GP63149, 03GZ62987, 03LE26223, 03LX30001, 03GF11362, 03GC18782, 03LR76870, 03FV90781, 03FY06900, 03GG11872, 03FJ78610
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by facsimile transmissions and by letters dated November 17, 2004. Firm initiated recall is complete.
REASON
Red Cells, mislabeled as to M antigen phenotype, were distributed.
VOLUME OF PRODUCT IN COMMERCE
46 units
DISTRIBUTION
GA
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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1626-6
CODE
Unit: A226093
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center Program, Seattle, WA, by telephone on December 19, 2003. Firm initiated recall is complete.
REASON
Platelets, untested for infectious disease markers, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1627-6
CODE
Unit: 22KE08954
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on February 17, 2006, and by letter dated February 27, 2006. Firm initiated recall is complete.
REASON
Red Cells, mislabeled as to the C antigen phenotype, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1632-6
CODE
Unit: 027LL12902
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on January 9, 2006 and by letter dated January 16, 2006. Firm initiated recall is complete.
REASON
Blood product, out of controlled storage for an undocumented length of time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
______________________________
PRODUCT
Red Blood Cells, Recall # B-1646-6
CODE
Unit: 22KV02633
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by facsimile dated March 8, 2006, and by letter dated March 9, 2006. Firm initiated recall is complete.
REASON
Red Cells, mislabeled as to unexpected antibodies, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
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PRODUCT
TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach, Recall # Z-1305-06
CODE
Lot number 48275, exp. 1/07
RECALLING FIRM/MANUFACTURER
Kensey Nash Corp., Exton, PA, by letter on April 17, 2006. Firm initiated recall is complete.
REASON
Alarm activation-A priming issue involving the flow control unit due to a software problem has caused false positive Extraction Line Block (ELB) alarming. Use of this product may result in a health hazard resulting from early termination of the flush and extraction procedure after stenting.
VOLUME OF PRODUCT IN COMMERCE
69 kits
DISTRIBUTION
Germany and Italy
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PRODUCT
Beckman Coulter Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200, Recall # Z-1313-06
CODE
All CODEs
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter the week of April 10, 2006.
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
Firm has confirmed that the Access CEA Assay may generate decreased values with certain frozen platelet specimens.
VOLUME OF PRODUCT IN COMMERCE
775 units
DISTRIBUTION
Nationwide and Canada
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PRODUCT
Medplus ER Drug Screen Test, Model # 5800KAB, packaged as 25 individually pouched devices in a labeled kit box, Recall # Z-1315-06
CODE
a) Lot number: 85699 and
b) Lot number: 85671
RECALLING FIRM/MANUFACTURER
Applied Biotech, Inc., San Diego, CA, by fax dated May 31, 2005. Firm initiated recall is ongoing.
REASON
The firm has discovered that a number of distributed devices of the Medplus ER Drug Screen Test may be incorrectly assembled which may give incorrect results. The product is an in vitro test for rapid detection of various drugs such as Amphetamines, Barbiturates, Phencyclidine, Cocaine, Methamphetamine, Tricyclic Antidepressants, Morphine, Tetrahydrocannabinol, & Benzodiazepines in human urine.
VOLUME OF PRODUCT IN COMMERCE
a) 71 kits (1775 devices) & b) 44 kits (1100 devices)
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
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PRODUCT
D 744 Chloride membrane, CI, REF Model #942-061, accessory to the ABL700 blood analyzer, Recall # Z-1314-06
CODE
Lot number: R0053
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America, Inc., Westlake, OH, by letter dated February 2005.
Manufacturer: Radiometer Medical, Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON
The CI membrane units generate to low values for status and sensitivity during calibration.
VOLUME OF PRODUCT IN COMMERCE
85/4 units per box
DISTRIBUTION
Nationwide
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PRODUCT
Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed one per box. Model #.S7180, Part Number: 944040, Recall # Z-1316-06 Package Insert which accompanies the Hematocrit and Metabolite QUALICHECK LEVEL 2 Quality Control of Hematocrits and Metabolites, used with the ABL 77/70/555 Blood Gas & Electrolyte Analyzers. The QC reagents are packaged in a box of 30 glass vials of (1.5 ml) per box. The package insert is packed one per box. Model #.S7180, Part Number: 944040, Recall # Z-1316-06
CODE
Lot # 15
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America, Inc., Westlake, OH, by letter dated May 24, 2005.
Manufacturer: Radiometer Medical, Bronshoj, Denmark. Firm initiated recall is complete.
REASON
The package insert, which accompanied the QC reagents used with ABL blood gas analyzers, referenced incorrect control ranges for Hct (hematocrit) testing. The range stated on the package insert was too low to generate accurate Hct test results (The control ranges were acceptable for the glucose and lactate testing).
VOLUME OF PRODUCT IN COMMERCE
55 boxes
DISTRIBUTION
Nationwide, London, and Canada
RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
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PRODUCT
Bulk custom made dairy feed, Recall # V-115-6
CODE
None
RECALLING FIRM/MANUFACTURER
Hiseville Feed & Seed Co., Hiseville, KY, by telephone and letter on or about July 14, 2006. FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,223 tons
DISTRIBUTION
KY
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PRODUCT
Bulk custom made dairy feed, Recall # V-116-6
CODE
None
RECALLING FIRM/MANUFACTURER
Rips Farm Center, Tollesboro, KY, by telephone and letter on July 14, 2006. FDA initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak which may contain ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
1,220 tons
DISTRIBUTION
KY
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PRODUCT
Bulk custom made dairy feed, Recall # V-117-6
CODE
None
RECALLING FIRM/MANUFACTURER
Kentwood Co-op, Kentwood, LA, by telephone on June 27, 2006. FDA initiated recall is completed.
REASON
Possible contamination of animal feed ingredients, including ingredients that are used in feed for dairy animals, with ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
40 tons
DISTRIBUTION
LA and MS
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PRODUCT
Bulk Dairy Feed, Recall V-118-6
CODE
None
RECALLING FIRM/MANUFACTURER
Cal Maine Foods, Inc., Edwards, MS, by telephone on June 26, 2006. FDA initiated recall is complete.
REASON
Possible contamination of animal feed ingredients, including ingredients that are used in feed for dairy animals, with ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
7,150 tons
DISTRIBUTION
MS
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PRODUCT
Bulk custom dairy pre-mixes, Recall # V-119-6
CODE
None
RECALLING FIRM/MANUFACTURER
Walthall County Co-op, Tylertown, MS, by telephone on June 26, 2006. Firm initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
87 tons
DISTRIBUTION
MS
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PRODUCT
Bulk custom dairy pre-mixes, Recall # V-120-6
CODE
None
RECALLING FIRM/MANUFACTURER
Ware Milling Inc., Houston, MS, by telephone on June 23, 2006. Firm initiated recall is complete.
REASON
Possible contamination of dairy animal feeds with ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
350 tons
DISTRIBUTION
AL and MS
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PRODUCT
a) Tucker Milling, LLC Tm 32% Sinking Fish Grower, #2680-Pellet,
50 lb. bags, Recall # V-121-6;
b) Tucker Milling, LLC #31120, Game Bird Breeder Pellet,
50 lb. bags, Recall # V-122-6;
c) Tucker Milling, LLC #31232 Game Bird Grower,
50 lb. bags, Recall # V-123-6;
d) Tucker Milling, LLC 31227-Crumble, Game Bird Starter, BMD
Medicated, 50 lb bags, Recall # V-124-6;
e) Tucker Milling, LLC #31120, Game Bird Breeder, 50 lb bags,
Recall # V-125-6;
f) Tucker Milling, LLC #30230, 30 % Turkey Starter, 50 lb bags,
Recall # V-126-6;
g) Tucker Milling, LLC #30116, TM Broiler Finisher,
50 lb bags, Recall # V-127-6
CODE
All products manufactured from 02/01/2005 until 06/20/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tucker Milling LLC, Guntersville, AL, by telephone and visit on June 20, 2006, and by letter on June 23, 2006.
Manufacturer: H. J. Baker and Brothers Inc., Stamford, CT. Firm initiated recall is ongoing.
REASON
Poultry and fish feeds which were possibly contaminated with ruminant based protein were not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
7,541-50 lb bags
DISTRIBUTION
AL, GA, MS, and TN
END OF ENFORCEMENT REPORT FOR AUGUST 9, 2006
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