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U.S. Department of Health and Human Services

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Enforcement Report for March 23, 2005

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.

March 23, 2005
05-12

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Premier True Color Pigments in 0.5oz containers including the following shades: Areola Highlighter; Light Pink Areola; Pink Areola; Dark Pink Areola; Light Natural Areola; Natural Areola; Dark Natural Areola; Light Brown Areola; Brown Areola; Dark Brown Areola; Light Ebony Areola; Ebony Areola; Dark Ebony Areola; Sheer Bronze; Bliss; Cherry Cheek; Half Naked; Peach Glow; Dark Taupe Shadow; Taupe Mist; Taupe Halo; Taupe Smudge; Antique Pink; Cherry Red; Spiced Cider; Hot Fuchsia; Blush; Hot Coral; Peaches and Crème; Pink Passion; Poetic Wine; Dark Brown Crème; Brown Crème; Tropical Passion; Electric Plum; Cherrywood; Indian Summer; Chestnut; Dark Pecan; Black Fudge; Light Brown Crème; Scarlet; Black Velvet; Wheat; Ash; Khaki Crème; Baby Blue; Purple Slate; Electric Blue; Rich Raspberry; Violet Smoke; Dark Cherry Red; Crimson; Autumn Sunset; Spiced Nude; Dark Chestnut; Light Wheat;
Electric Violet; Dark Wheat; Light Sandalwood; Dark Sandalwood; Cognac; Light Brown Suede; Chocolate Spice; Dark Smoke; Chocolate Mauve; Double Fudge; Black Suede; Double Dark Fudge; Chocolate Raspberry; Chocolate Kiss; Rosewood; Mochaccino; Plum; Flaming Red; Dark Brown; Suede; Copper Kiss; Black Chestnut; Double Black Fudge; Indigo Teal; Toasted Smoke; Bright Blue; Cobalt Blue; Emerald Green; Iced Spice; Blue Slate; Mocha Mauve; Dark Autumn; Autumn; Light Autumn; Warm Blonde; Chocolate Cinnamon; Dusty Rose; Chocolate Ruby; Dark Champagne; Champagne; Light Champagne; Dark Ash; Ash; Light Ash; Caramel; Light Caramel; Mahogany; Cotton Candy; Spice; Electric Fuchsia; Warm Blush; Spiced Melon; Evergreen; Sandalwood; Light Pecan; Pecan; Sage; Chocolate Orchid; Purple Passion; Teal; Dark Fudge; Black Brown Suede; Fudge; Black Slate; Babies Breathe; Burgundy Wine; Candied Raisin; Rich Russet; Blue Bonnet; Double Black Magic; Soft Smoke; Coffee Bean; Naturally Nude; Electric Orchid; Chocolate Grape; Toasted Almond; Rustic Rose; Sienna; Brown Suede; Cool Blonde; Blonde Taupe; Umber; Dark Umber; Black Umber; Beautiful Brown; Lip Highlighter; Dark Brown Sugar; Toasted Taupe; Black Magic; Dark Caramel; Light Porcelain; Porcelain; Buff; Ivory Crème; Shell; Light Beige Crème; Beige Creme; Dark Beige Creme; Cool Beige; Dark Cool Beige; Light Suntan; Suntan; Dark Suntan; Light Bronzing Crème; Bronzing Crème; Dark Bronzing Crème; Honey Bisque; Dark Honey; Bisque; Honey Brown; Chocolate Honey; Dark Chocolate; White Linen; Tangerine; Lemon Crème; True Red; Orange Crème; Black to Brown Eyeliner Corrector; Blue to Black/Brown Corrector; Orange/Peach Eyebrow Corrector; Purple Lip Corrector; Gray/Ash Eyebrow Corrector; Green Eyebrow Corrector; Blue Lip Corrector; Purple Eyebrow Corrector; Pink Eyebrow Corrector; Blue Eyebrow Corrector. Recall # F-222-5.
CODE
All Lots.
RECALLING FIRM/MANUFACTURER
American Institute of Intradermal Cosmetics, Arlington, TX, by letters dated July 7, 2003 and August 30, 2004. Firm initiated recall is ongoing.
REASON
The pigments have not been approved for their intended use of tattooing and have been associated with adverse reactions that include swelling, cracking, peeling, blistering, and scarring as well as formation of granulomas (chronically inflamed tissue mass associated with an infection) in the areas of the eyes and lips.
VOLUME OF PRODUCT IN COMMERCE
52,114 containers.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Asian Taste Brand Dried Lily Flower, 6 oz plastic bag. Recall # F-223-5.
CODE
All product sold since January 2004.
RECALLING FIRM/MANUFACTURER
West Honest International, City of Industry, CA, by press release on December 22, 2004, and by letters on December 20, 2004. Firm initiated recall is ongoing.
REASON
The product contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
667 cases.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Dried Potato, net wt. 12 oz. (340g). Product of China. Product is packaged in a flexible plastic bag. Recall # F-224-5.
CODE
Uncoded.
RECALLING FIRM/MANUFACTURER
Blooming Import Inc., Brooklyn, NY, by press release issued on June 23, 2004. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (1300 ppm) based on sampling & analysis by the New York State Department of Agriculture & Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
113 cases (50-12 oz. packages per case).
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
Tattoo Ink: Starbrite brand Black Magic Color, packaged in individual 1?2 oz., 1 oz., 2 oz., 4 oz. and 8 oz. size translucent plastic bottles. Each bottle bears a paper label reading in part: "Starbrite Colors™ BLACK MAGIC pure uncut pigment dispersion XXX Ingredients: Alcohol, Distilled, Water, glycerin, Color #213BM XXX Date Produced: XXX Best if Use By: 2oz Made In The USA XXX". Recall # F-213-5.
CODE
7996988 and 7996989.
RECALLING FIRM/MANUFACTURER
Papillon Supply & Manufacturing, Enfield, CT, by telephone on or about June 25, 2004. Firm initiated recall is complete.
REASON
The product is contaminated with Acremonium mold and Pseudomonas aeruginosa.
VOLUME OF PRODUCT IN COMMERCE
500 gallons.
DISTRIBUTION
Nationwide and Scotland.

_______________________________
PRODUCT
Cake, 6 pieces in a clear plastic clam shell labeled "JUANITA'S Brand Pasteles. Recall # F-214-5.
CODE
"BEST BY" dates up to and including 03/11/05. Product is dated with a one month best by date.
RECALLING FIRM/MANUFACTURER
Dominguez Family Enterprises, Inc., Hood River, OR, by letter on February 12, 2005. Firm initiated recall is complete.
REASON
Misbranded -- Product contains undeclared colors, Yellow #5 Lake, Yellow #6 Lake, Red #40, Red #3, and Blue #1 Lake.
VOLUME OF PRODUCT IN COMMERCE
239 packages.
DISTRIBUTION
WA and OR.

_______________________________
PRODUCT
Escolar, frozen headed and gutted, individually plastic wrapped in plastic-lined cardboard cases. Recall # F-215-5.
CODE
Product is not coded.
RECALLING FIRM/MANUFACTURER
SeaProducts West, Inc., Bellingham, WA, by telephone on November 11, 2004. Firm initiated recall is complete.
REASON
The product was associated with histamine-related illnesses.
VOLUME OF PRODUCT IN COMMERCE
410.5 lbs.
DISTRIBUTION
WA, ID, and BC.

_______________________________
PRODUCT
Ground Reese's Pieces Custom Candy, packed in 19.1 lb plastic lined bulk cardboard containers. Recall # F-216-5;
CODE
GC Lot Code: #426 = Manufacturer Code: 55GRR,
GC Lot Code: #333 = Manufacturer Code: 49KRN.
RECALLING FIRM/MANUFACTURER
Glass City Food Services Co., Inc., Holland, OH, by telephone on February 7, 2005 and by letters on February 11, 2005. Firm initiated recall is ongoing.
REASON
Repacked candies contain undeclared colors including FDC Yellow #6, Blue #1, and Red #40.
VOLUME OF PRODUCT IN COMMERCE
109 cartons.
DISTRIBUTION
OH and MI.

_______________________________
PRODUCT
a) Medline Baby Lotion, packaged in 2 fl. oz. bottles,
96/case (reorder MSC095007) and 4 fl. oz. bottles,
60/case (reorder MSC095018); Made in U.S.A.; the
bottles were sold separately or as components of
custom admission kits or complete delivery systems
(CDS) containing an admission kit. Recall # F-218-5.
b) Medline Hand & Body Lotion, packaged in 2 fl. oz.
bottles, 96.case (reorder MSC095001) and 4 fl. oz.
bottles, 60/case (reorder MSC095004) bottles;
Made in U.S.A.; the bottles were sold separately or
as components of custom admission kits or complete
delivery systems (CDS) containing an admission kit.
Recall # F-219-5;
c) Soothe & Cool Cleansing Bath Oil, packaged in
3.5 fl. oz. bottles, 96/case (reorder MSC090472)
and 1 gallon bottles, 4/case (reorder MSC090474);
Made in U.S.A.; the bottles were sold separately or
as components of custom admission kits.
Recall # F-220.5;
d) Medline Baby Oil, packaged in 2 fl. oz. bottles,
96/case (reorder MSC095050), 4 fl. oz. bottles
60/case (reorder MSC095052), 8 fl. oz. bottles,
36/case (reorder MSC095054) and 16 fl. oz. bottles,
12/case (reorder MSC095056 and MSC095056H); Made
in U.S.A.; the bottles were sold separately or as
components of custom admission kits or complete
delivery systems (CDS) containing an admission kit.
Recall # F-221-5.
CODE
a) All bottle lots beginning with a "3" or 4001, 4002,
4003, 4004, 4005, 4006, 4007, 4008, or have no lot
number. The following kit reorder numbers contain
2 oz. bottles of baby lotion: DYK1001437A1,
DYK1001831D, DYK1004191B, DYK1004272A, DYK1005268A1,
DYK1005268A2, DYK1005268A3, DYK1005389B, DYK1005489B1,
DYK1005577B1, DYK1005969B, DYK1006010B, DYK1008593B,
DYK1008830B1, DYK1008928B, DYK1009313N, DYK1012728B1,
DYK1015727M, DYK1016104N1, DYK1016104N2, DYK1017141M,
DYK1017509C1, DYK1017509C2, DYK1018533B1, DYK1020236B,
DYK1022190P, DYK1022483O1, DYK1066524A, DYK1067380B,
DYK1084936B2, DYK1084936B3, DYK1092442N1, DYK1098495B,
DYK1178464B, DYK1178464B1, DYK1186108B, DYKD1000863N,
DYKD1001089P, DYKD1002116P, DYKD1002212BB, DYKD1002402A,
DYKD1002P, DYKD1002PD, DYKD1003938N, DYKD1004438P,
DYKD1005268A, DYKD1005268A1, DYKD1005417B, DYKD1005457B,
DYKD1005457B1, DYKD1005478B2, DYKD1005489B,
DYKD1005500P, DYKD1005532P, DYKD1005577B, DYKD1005679B,
DYKD1005852A, DYKD1005941B, DYKD1005972B, DYKD1005972B1,
DYKD1005972P, DYKD1006085B, DYKD1006230B, DYKD1006230M,
DYKD1006230M1, DYKD1006272B, DYKD1006789N, DYKD1006854M,
DYKD1006881A, DYKD1006948B, DYKD1006948I, DYKD1007059B,
DYKD1007223A, DYKD1007223A1, DYKD1008186M, DYKD1008663A,
DYKD1008786B, DYKD1008829P, DYKD1009018P, DYKD1009313N2,
DYKD1011059P, DYKD1011867B, DYKD1011867B1, DYKD1011888B,
DYKD1011944BC, DYKD1012359I, DYKD1012359I1,
DYKD1012359P, DYKD1012380I, DYKD1012612B, DYKD1012728B,
DYKD1012918B, DYKD1015787NB, DYKD1015787P, DYKD1015811M,
DYKD1016104N, DYKD1016839B, DYKD1017074N, DYKD1017074N1,
DYKD1017074P, DYKD1017407T, DYKD1017518MB, DYKD1017518P,
DYKD1017582B, DYKD1018497P, DYKD1018505N, DYKD1018505P3,
DYKD1018505P4, DYKD1018525B, DYKD1018533B, DYKD1018660P,
DYKD1019082B2, DYKD1019365B, DYKD1019365B1,
DYKD1019412A, DYKD1019412A1, DYKD1019412P, DYKD1019478B,
DYKD1019478B1, DYKD1019580B, DYKD1019580B1,
DYKD1019783B, DYKD1019890P, DYKD1019922B1, DYKD1019933B,
DYKD1021834N1, DYKD1021850M, DYKD1021850M1,
DYKD1022368B, DYKD1022400P, DYKD1022483O, DYKD1023231P1,
DYKD1023471M, DYKD1023513N, DYKD1023674B, DYKD1023682N,
DYKD1023682N1, DYKD1023682N2, DYKD1023797OB,
DYKD1023807S, DYKD1025011C, DYKD1034163N, DYKD1039911P,
DYKD1041379B2, DYKD1041605B1, DYKD1041605B2,
DYKD1046316P, DYKD1055671N, DYKD1055671N1,
DYKD1055671NN, DYKD1064917I, DYKD1065221BC,
DYKD1066577N, DYKD1066599B, DYKD1066599B1, DYKD1067383B,
DYKD1067387N, DYKD1067387P, DYKD1071777A, DYKD1084936B1,
DYKD1087914A, DYKD1088651B, DYKD1161683B, DYKD1166040N,
DYKD11685B1, DYKD13681M, DYKD14142B, DYKD15084A,
DYKD151491B1, DYKD151747B2, DYKD151989B, DYKD152262IC1,
DYKD152262IC2, DYKD152262TT3, DYKD15262B, DYKD15278ICCU,
DYKD15355P1, DYKD15968B, DYKD16051B, DYKD19605P,
DYKD22234N, DYKD35385P, DYKD4238M, DYKD44742BC,
DYKD48003M, DYKD492446P, DYKD50064C, DYKD55258B1,
DYKD5918IC, DYKD704050BX1, DYKD714050B, DYKD821435OB,
DYKDBABYBOY, DYKDBABYGIRL, DYKDN1008523B, DYKDN1085549N,
DYKDN1092442N, DYKN1006838N, DYKN1006838N1,
DYKN1008593B, DYKN1012165N, DYKN1012307B, DYKN1015466N,
DYKN1084936B, DYKN1084936B1, DYKN1153020B

The following kit reorder numbers contain 4 oz.
bottles of baby lotion: DYK1002998A, DYK1008440A,
DYK1008440A1, DYK1012713M, DYK1017369L2, DYK1017369L3,
DYK1018505M, DYK1023735N5, DYK1066649N, DYK1066649N1,
DYK1079670A1, DYKD1002734A, DYKD1003120A, DYKD1007024M,
DYKD1007031A, DYKD1008488B, DYKD1008881A, DYKD1008958N,
DYKD1008958N1, DYKD1011404A, DYKD1011865B,
DYKD1017369L1, DYKD1017369LD, DYKD1018179P,
DYKD1018505I, DYKD1018505P2, DYKD1018514N,
DYKD1018542N, DYKD1018542N1, DYKD1019290A,
DYKD1019927B, DYKD1020287P, DYKD1020376P,
DYKD1021345B1, DYKD1022BW, DYKD1023735N1,
DYKD1023735N2, DYKD1023735N3, DYKD1023735N4,
DYKD1023797M1, DYKD1029707M, DYKD1041489A,
DYKD1074113N, DYKD1157463A, DYKD15278P,
DYKD19116N, DYKD29012A, DYKD31019B, DYKD60197B,
DYKD63072B, DYKN1007031A, DYKN1012025L,
DYKN1069704N, DYKN1079670A, MSC095018HH;
b) All bottle lots beginning with a "3" or 4001,
4002, 4003, 4004, 4005, 4006, 4007, 4008,
or have no lot number. The following kit reorder
numbers contain 2 oz. bottles of lotion:
DYK1000867P, DYK1001299A, DYK1001875A,
DYK1001908A, DYK1002261A, DYK1002590M,
DYK1002961A1, DYK1002985A, DYK1002985M,
DYK1003157A1, DYK1003157A2, DYK1003157A3,
DYK1004133A3, DYK1004147A1, DYK1004191A,
DYK1004214A, DYK1004385H, DYK1004385K,
DYK1004427A, DYK1004980A3, DYK1004980A4,
DYK1005385A3, DYK1005386A3, DYK1005386A4,
DYK1005386P2, DYK1005395A, DYK1005395A1,
DYK1005679A, DYK1005959AM, DYK1005961A1,
DYK1006209A, DYK1006272A1, DYK1008104A,
DYK1008179A, DYK1008179B, DYK1008179B1,
DYK1008414A1, DYK1008523A1, DYK1008617A,
DYK1009304A1, DYK1009305A1, DYK1009319A3,
DYK1009319A4, DYK1009319A5, DYK1010766M1,
DYK1010872A3, DYK1011669A1, DYK1011734A1,
DYK1011927A, DYK1012070B1, DYK1012094A,
DYK1012094A1, DYK1012713A1, DYK1013004A,
DYK1013004A1, DYK1013004A2, DYK1013004A3,
DYK1013004A4, DYK1013207A1, DYK1013207A2,
DYK1013208A1, DYK1013540A, DYK1013540A1,
DYK1014053A, DYK1014167A, DYK1015831I1,
DYK1016700A1, DYK1017001A1, DYK1017001A2,
DYK1017001A3, DYK1017141M, DYK1017177A1,
DYK1017369L2, DYK1017369L3, DYK1017369S,
DYK1017479A4, DYK1017484A, DYK1017549A3,
DYK1017718A, DYK1018143A, DYK1018179A,
DYK1018179A1, DYK1018563A, DYK1018645A,
DYK1019116A, DYK1019116X, DYK1021280V,
DYK1021323Y1, DYK1021338P, DYK1022117N2,
DYK1022400A, DYK1022594A, DYK1022594A1,
DYK1022941M5, DYK1023776A1, DYK1024854A,
DYK1034111A1, DYK1040238A, DYK1045359M1,
DYK1046608A, DYK1059826A2, DYK1059995A,
DYK1059995A1, DYK1066514A5, DYK1066515A,
DYK1066550A, DYK1066563A, DYK1066649A,
DYK1067383A, DYK1067383A1, DYK1067387P,
DYK1067410P, DYK1067700M7, DYK1067700M8,
DYK1069880A, DYK1082407A1, DYK1088535A,
DYK1088658A, DYK1092717A, DYK1101090A1,
DYK1101090A2, DYK1165070A, DYK1165686K1,
DYK1174835A, DYK1175962A, DYK1176964A,
DYK1176964A1, DYK1185811A, DYK1188783A,
DYK1191170A1, DYK1194889A, DYK1207466A,
DYK50126A2, DYKD1000849AM, DYKD1000909A,
DYKD1000957A, DYKD1001038H, DYKD1001134A,
DYKD1001183A, DYKD1001191A, DYKD1001457A,
DYKD1001457M, DYKD1001457M1, DYKD1001615A,
DYKD1001847T, DYKD1001906A, DYKD1002,
DYKD1002133A, DYKD1002133A1, DYKD1002140A,
DYKD1002141A, DYKD1002150A, DYKD1002165A,
DYKD1002172A1, DYKD1002257A, DYKD1002259A,
DYKD1002295A, DYKD10022A, DYKD1002355A,
DYKD1002401A, DYKD1002437A, DYKD1002463A,
DYKD1002656A, DYKD1002656A1, DYKD1002705A,
DYKD1002705A1, DYKD1002718A, DYKD10028M1,
DYKD1003157A, DYKD1004133A, DYKD1004133A2,
DYKD1004147A, DYKD1004158A, DYKD1004190S,
DYKD1004239A, DYKD1004280M, DYKD1004509P,
DYKD1004633M, DYKD1004633M1, DYKD1005216A,
DYKD1005384A, DYKD1005386A1, DYKD1005386A2,
DYKD1005386P1, DYKD1005388H, DYKD1005400A,
DYKD1005419A, DYKD1005419A1, DYKD1005431A,
DYKD1005435A, DYKD1005500A, DYKD1005500M,
DYKD1005532A, DYKD1005534B, DYKD1005549A,
DYKD1005688A, DYKD1005914P, DYKD1005941A,
DYKD1005961A, DYKD1005961D, DYKD1005972A,
DYKD1005972Y, DYKD1005972Y1, DYKD1006108A,
DYKD1006195A2, DYKD1006211M, DYKD1006272A,
DYKD1006558A, DYKD1006558P, DYKD1006766A2,
DYKD1006841A, DYKD1006841A1, DYKD1006905A1,
DYKD1006905A2, DYKD1006948P, DYKD1006954A,
DYKD1006989A, DYKD1007145A, DYKD1007876A,
DYKD1007876P, DYKD1007893A, DYKD1007893A1,
DYKD1007990P, DYKD1008000A, DYKD1008011A,
DYKD1008182A, DYKD1008829A, DYKD1008869A,
DYKD1008923A, DYKD1008978A1, DYKD1008978A2,
DYKD1009010A, DYKD1009237A, DYKD1009261A,
DYKD1009292A, DYKD1009292A1, DYKD1009301H,
DYKD1009302A, DYKD1009305A, DYKD1009312A,
DYKD1009315A, DYKD1009319A, DYKD1009319A1,
DYKD1009319A2, DYKD1009326A, DYKD1009584A,
DYKD1009709A, DYKD1009709M, DYKD100COLP3,
DYKD100COLP4, DYKD1010372A, DYKD1010731A,
DYKD1010731A1, DYKD1010751A, DYKD1010766A,
DYKD1010766A1, DYKD1010766M, DYKD1010855A,
DYKD1011054OB, DYKD1011438A, DYKD1011555A,
DYKD1011594A1, DYKD1011669A, DYKD1011857A,
DYKD1011946A, DYKD1011946A2, DYKD1011946A3,
DYKD1012070B, DYKD1012238P, DYKD1012288MH,
DYKD1012288P, DYKD1012291A, DYKD1012308A,
DYKD1012308A1, DYKD1012341A, DYKD1012341A1,
DYKD1012480A, DYKD1012612L1, DYKD1012713A,
DYKD1012735A, DYKD1012738A, DYKD1012918A,
DYKD1013192A, DYKD1013207A, DYKD1013214A,
DYKD1013275A2, DYKD1013541A, DYKD1013541A1,
DYKD1013579A, DYKD1013659A, DYKD1014173A1,
DYKD1014185B1, DYKD1014781A, DYKD1014781A1,
DYKD1014997Y, DYKD1015016A, DYKD1015045A,
DYKD1015051A, DYKD1015051P, DYKD1015127A,
DYKD1015127A1, DYKD1015650A, DYKD1015650M,
DYKD1015661A1, DYKD1015661M, DYKD1015711A,
DYKD1015795A, DYKD1015831I, DYKD1015887A,
DYKD1015887A1, DYKD1015898A, DYKD1016465A,
DYKD1016555A, DYKD1016580A1, DYKD1016700A,
DYKD1017001A, DYKD1017074A, DYKD1017177A,
DYKD1017369A, DYKD1017369L1, DYKD1017369LD,
DYKD1017407A, DYKD1017407I, DYKD1017489A1,
DYKD1017489A2, DYKD1017493N, DYKD1017550A,
DYKD1017582A2, DYKD1017681A, DYKD1017783A,
DYKD1018497A, DYKD1018497G, DYKD1018497G1,
DYKD1018512B, DYKD1018512B1, DYKD1018513A,
DYKD1018562A, DYKD1018563A1, DYKD1018578A,
DYKD1018578A1, DYKD1018595D, DYKD1018595M,
DYKD1018595O, DYKD1018663AK, DYKD1019004A,
DYKD1019249A, DYKD1019286A, DYKD1019455P,
DYKD1019558A, DYKD1019580AM, DYKD1019580M1,
DYKD1019743A, DYKD1020287A, DYKD1020325A,
DYKD1020633A, DYKD1021267H, DYKD1021268A,
DYKD1021310P, DYKD1021310P1, DYKD1021311A,
DYKD1021323A, DYKD1021323A1, DYKD1021323A2,
DYKD1021323A3, DYKD1021323P, DYKD1021323P1,
DYKD1021323P2, DYKD1021323P3, DYKD1021323Y,
DYKD1021323Y1, DYKD1021323Y2, DYKD1021366A,
DYKD1021642A, DYKD10216442A, DYKD1021850A,
DYKD1021850M, DYKD1021850M1, DYKD1021856A,
DYKD1021856M, DYKD1021856M1, DYKD1021856M2,
DYKD1021865A, DYKD1021901A, DYKD1022012A,
DYKD1022012A1, DYKD1022012M, DYKD1022012M1,
DYKD1022012M2, DYKD1022109A1, DYKD1022109A2,
DYKD1022117N, DYKD1022117N1, DYKD1022117P,
DYKD1022208A, DYKD1022208A1, DYKD1022665A,
DYKD1022941A, DYKD1022941A1, DYKD1022941M,
DYKD1022941M1, DYKD1022941M2, DYKD1022941M3,
DYKD1022941M4, DYKD1023036P, DYKD1023131A1,
DYKD1023151A1, DYKD1023188A, DYKD1023482A,
DYKD1023550L, DYKD1023550L1, DYKD1023550PC,
DYKD1023577A, DYKD1023674A, DYKD1023707A,
DYKD1023726A, DYKD1023733A, DYKD1023748A,
DYKD1023766AE, DYKD1023776A, DYKD1023786A,
DYKD1023790A, DYKD1023807A, DYKD1025559A,
DYKD1027534A, DYKD1028186A, DYKD1029707A,
DYKD1034131A, DYKD1039892A, DYKD1039911A,
DYKD1039921A, DYKD1040105A, DYKD1041379A1,
DYKD1041385A, DYKD1041862A, DYKD1044791A,
DYKD1049313A, DYKD1057399C, DYKD1058359A,
DYKD1058359A1, DYKD1058363A, DYKD1058367A,
DYKD1059698A1, DYKD1059826A, DYKD1059826A1,
DYKD1062839M, DYKD1062839W, DYKD1064283A,
DYKD1064364A, DYKD1064634A, DYKD1064917A,
DYKD1065425A, DYKD1065545A, DYKD1065545M,
DYKD1065545M1, DYKD1066509A, DYKD1066514A,
DYKD1066514A1, DYKD1066514A2, DYKD1066514A3,
DYKD1066514A4, DYKD1066577A1, DYKD1066618A,
DYKD1066618A1, DYKD1066705A, DYKD1066A,
DYKD1067282A, DYKD1067282A1, DYKD1067380A,
DYKD1067380A1, DYKD1067381A, DYKD1067387A,
DYKD1067387A1, DYKD1067700M5, DYKD1067700M6,
DYKD1067959A, DYKD1070075A, DYKD1070118A,
DYKD1070118T, DYKD1071574A, DYKD1072153A,
DYKD1072227A, DYKD1073231P, DYKD1074113N,
DYKD1075210M, DYKD1075210M1, DYKD1075210M2,
DYKD1075641A, DYKD1077047A, DYKD1078243A,
DYKD1078899A, DYKD1078899A1, DYKD1081924A,
DYKD1082407A, DYKD1082407M, DYKD1082407M2,
DYKD1084108M, DYKD1084108M1, DYKD1084108M2,
DYKD1084144A1, DYKD1086294A, DYKD1086294M,
DYKD1089881A, DYKD11002A3, DYKD1101090A,
DYKD11081A, DYKD1150603A, DYKD1151108T,
DYKD1154308A, DYKD1154308A1, DYKD1154643A,
DYKD1165686C, DYKD1168572A, DYKD1175041A, DYKD1186A,
DYKD124357A1, DYKD139027A, DYKD14109A, DYKD14152A,
DYKD14320A, DYKD14320P, DYKD151105A, DYKD151194A,
DYKD151198A, DYKD151216A, DYKD151301A, DYKD151592A,
DYKD152262A2, DYKD15262A, DYKD15278A, DYKD15498A1,
DYKD15750A, DYKD16393A, DYKD17507MS1, DYKD19138A,
DYKD2004AD, DYKD2004BD, DYKD21139A, DYKD21630A,
DYKD22087AM, DYKD23083A, DYKD23093P, DYKD23141A,
DYKD23153A, DYKD25832A, DYKD26747A1, DYKD27788A,
DYKD32643P, DYKD39021M, DYKD4082M, DYKD43362A,
DYKD43557A3, DYKD44074A, DYKD44075A, DYKD44205A,
DYKD46334A, DYKD46437A, DYKD49572A, DYKD4970A1,
DYKD49892A2, DYKD50019A3, DYKD500318A, DYKD500318AX1,
DYKD50126A, DYKD50176A1, DYKD50620A, DYKD5081A,
DYKD5086A, DYKD51325A1, DYKD5241A, DYKD53043A,
DYKD53191A, DYKD53191P, DYKD54833A1, DYKD5539A,
DYKD5825A, DYKD5891A1, DYKD612A, DYKD61526A,
DYKD61599A, DYKD61682A, DYKD739102A, DYKD743415A,
DYKD751468A2, DYKD762320P, DYKD780210J, DYKD828200A,
DYKD90814OP, DYKD91272AD, DYKDG695A, DYKDG695A2,
DYKDN1008523A, DYKDN1011060A, DYKDN1011734A,
DYKDN1013307A, DYKDN1063571A, DYKDN1085549A,
DYKN1004256A1, DYKN1005518F1, DYKN1005386A,
DYKN1005386P, DYKN1005518M1, DYKN1005518M2,
DYKN10055386A, DYKN1006159A, DYKN1008064A,
DYKN1008608P, DYKN1009314A, DYKN1011012C,
DYKN1011012V, DYKN1011679M, DYKN1011734BP,
DYKN1012165M, DYKN1012171A, DYKN1014293A, DYKN1014293A1,
DYKN1014971A, DYKN1015466A, DYKN1016569A, DYKN1016569A1,
DYKN1019004A, DYKN1019004A1, DYKN1019004P,
DYKN1019004P1, DYKN1021944A, DYKN1022200P, DYKN1022384P,
DYKN1034134A, DYKN1040955M, DYKN1040955N, DYKN1040955N1,
DYKN1055656A, DYKN1064827A, DYKN1069704A, DYKN1069704A1,
DYKNPU1 and MSC095001H.

The following kit reorder numbers contain 4 oz. bottles of lotion: DKY1172636A,
DYK1001650A1, DYK1001793A1, DYK1002287A, DYK1003138A1,
DYK1003944A, DYK1006383A, DYK1007893A3, DYK1007893A4,
DYK1007893A5, DYK1008064A1, DYK1008104A1, DYK1008847A1,
DYK1009304A, DYK1009904A, DYK1010581A, DYK1011034A,
DYK1011495A, DYK1011593A, DYK1011606A, DYK1011891A1,
DYK1011891M, DYK1011945B1, DYK1012026A, DYK1012119A,
DYK1012183P1, DYK1012232A1, DYK1012422H1, DYK1013275A3,
DYK1014493A, DYK1015258A, DYK1015258A1, DYK1015595A,
DYK1015836A, DYK1015836M, DYK1016989M, DYK1017582A3,
DYK1018503A, DYK1018514A, DYK1018533A1, DYK1019292A,
DYK1021652A, DYK1022117A1, DYK1022197A, DYK1022591A,
DYK1022591A1, DYK1023735A1, DYK1029682A, DYK1034130A,
DYK1040139A2, DYK1040139A3, DYK1040139A4, DYK1044978P1,
DYK1047595A, DYK1057519A, DYK1057519G, DYK1062678H,
DYK1065831A1, DYK1066128A, DYK1066646A, DYK1066646A1,
DYK1066658A, DYK1066666A, DYK1069400M, DYK1073114A,
DYK1077038A, DYK1077038A1, DYK1077257A, DYK1082600A,
DYK1088656A, DYK1090570W, DYK1100748A, DYK11199A2,
DYK1150235A, DYK1160184M, DYK1166218A, DYK1171804A1,
DYK1172636A, DYK1177716A, DYK1183936A, DYK1194815A,
DYKD1000841A, DYKD1000858A, DYKD1000907A, DYKD1000923A,
DYKD1001437A, DYKD1001650A, DYKD1001695A, DYKD1001793A,
DYKD1001808A, DYKD1001808A1, DYKD1001899M, DYKD1001A,
DYKD1002169T, DYKD1002348A, DYKD1002373A, DYKD1002375A,
DYKD1002907A, DYKD1002907A1, DYKD1002986M, DYKD1002A,
DYKD10030070A, DYKD1003070A, DYKD1003094, DYKD1003094A,
DYKD1003212A, DYKD1003632A, DYKD1003928G, DYKD1003938A,
DYKD1003938C, DYKD1003996A, DYKD1004094A, DYKD1004206F,
DYKD1004206M, DYKD1004212A, DYKD1004458A, DYKD1004506A,
DYKD1004577A, DYKD1004946A, DYKD1005411A, DYKD1005472A,
DYKD1005474A, DYKD1005478P, DYKD1005483A, DYKD1005941P,
DYKD1006085A1, DYKD1006110A, DYKD1006200A,
DYKD1006230A1, DYKD1006230M, DYKD1006372A, DYKD1006789M,
DYKD1006989P1, DYKD1007893A2, DYKD1008367A,
DYKD1008403A, DYKD1008744A, DYKD1008771A, DYKD1008817A,
DYKD1008830A, DYKD1008847A, DYKD1008852A, DYKD1008929A,
DYKD1008988A, DYKD1008988A1, DYKD1008988A2,
DYKD1008993A, DYKD1008993A1, DYKD1009018A,
DYKD1009018A1, DYKD1009081A, DYKD1009223A, DYKD1009309A,
DYKD1009309A1, DYKD1010115A, DYKD1010404C,
DYKD1010986P1, DYKD1011014A, DYKD1011054A, DYKD1011059A,
DYKD1011136F, DYKD1011136M, DYKD1011563M, DYKD1011563M1,
DYKD1011585A, DYKD1011671A, DYKD1011726A, DYKD1011885A,
DYKD1011909A, DYKD1011935A, DYKD1011945B, DYKD1012057A,
DYKD1012095A, DYKD1012163A, DYKD1012163A1, DYKD1012183P,
DYKD1012232A, DYKD1012288A, DYKD1012422H, DYKD1012726A,
DYKD1012728P, DYKD1013765A, DYKD1013770A, DYKD1014057A,
DYKD1014477A, DYKD1014534D1, DYKD1014894A2,
DYKD1014985A, DYKD1015077A, DYKD1015233A, DYKD1015595A2,
DYKD1015791B, DYKD1016104A, DYKD1016104A1, DYKD1016164M,
DYKD1016165A, DYKD1016469A, DYKD1017104M, DYKD1017362A,
DYKD1017362A1, DYKD1017362A2, DYKD1017488A,
DYKD1017488A1, DYKD1017493A, DYKD1017502A, DYKD1017518A,
DYKD1017922A, DYKD1017922A1, DYKD1018205A,
DYKD1018205A1, DYKD1018533A, DYKD1018541A,
DYKD1018541A1, DYKD1018542A, DYKD1018568A, DYKD1018585A,
DYKD1018732A, DYKD1018992A, DYKD1019268A, DYKD1019890A,
DYKD1020631A, DYKD1020880A, DYKD1021268P4,
DYKD1021278M, DYKD1021411A, DYKD1021834A,
DYKD1022207A1, DYKD1022117A, DYKD1022207M,
DYKD1022211A, DYKD1022397A, DYKD1022440A,
DYKD1022486A, DYKD1022486A1, DYKD1022597A, DYKD1022610A,
DYKD1022643P, DYKD1022868A, DYKD1023535M1,
DYKD1023550L, DYKD1023560P, DYKD1023658A1,
DYKD1028626A, DYKD1035A, DYKD1040139A,
DYKD1040139A1, DYKD1044978P, DYKD1045425A,
DYKD1045457A, DYKD1045954A, DYKD1046741A1,
DYKD1047792A, DYKD10513A, DYKD10513I, DYKD1051400M,
DYKD1055671A, DYKD1057519A, DYKD1058363A1,
DYKD1059923A, DYKD1062084A, DYKD1062861A, DYKD1064832A,
DYKD1065503A, DYKD1065831A, DYKD1066473A,
DYKD1066637PY, DYKD1067490A, DYKD1067490A1,
DYKD1069268A, DYKD1069439A, DYKD1069585A,
DYKD1081765D, DYKD1081765P, DYKD1083475A, DYKD1084904A,
DYKD10914A, DYKD1094391A, DYKD11199A1, DYKD1157310A,
DYKD1157310A1, DYKD1159847M, DYKD11623A, DYKD1165052A,
DYKD11685A, DYKD1171804A, DYKD12311A1, DYKD14135AX,
DYKD14169A1, DYKD14184A, DYKD14613A1, DYKD151317A,
DYKD152249H, DYKD15278PSY, DYKD15630A1, DYKD15792A,
DYKD162S1, DYKD17190A1, DYKD21124A, DYKD21366A1,
DYKD22038A, DYKD23290A, DYKD2540A, DYKD29085A,
DYKD29395A, DYKD3009AP1, DYKD31095A, DYKD31453A,
DYKD32847A, DYKD33118A1, DYKD33160A1, DYKD406281A,
DYKD41512A1, DYKD42378A, DYKD43240A1, DYKD43387A2,
DYKD44302A2, DYKD494806A, DYKD500318AX, DYKD5048A,
DYKD520276A, DYKD53139A, DYKD5627A, DYKD56443A,
DYKD57117M, DYKD58922A, DYKD61586B, DYKD63249A,
DYKD64737A, DYKD64737AM, DYKD6719A, DYKD711091AX,
DYKD712608A1, DYKD712608A2, DYKD715748A, DYKD715990A,
DYKD7263A1, DYKD7323A, DYKD744274A, DYKD748223P,
DYKD753049AX1, DYKD805002A, DYKD832499A, DYKD90814A,
DYKG1407A, DYKN1000883A, DYKN1000927A, DYKN1001450A,
DYKN1005518S, DYKN1005518S1, DYKN1007881A,
DYKN1007881A1, DYKN1008608A, DYKN1010991A, DYKN1011935A,
DYKN1012025A, DYKN1012379A, DYKN1013490A, DYKN1013493A,
DYKN1016652A, DYKN1020908A, DYKN1034127A, DYKN1044932I,
DYKN1044978P, DYKN1066481A, DYKN1070589A, DYKN1070589A1,
DYKN1070841A, DYKN1078288A, DYKN1097943A
and MSC095004H;
c) All bottle lots beginning with a "3" or 4001,
4002, 4003, 4004, 4005, 4006, 4007, 4008,
or have no lot number. The following kit reorder
numbers contain the 3.5 oz bottles: DYKD1013275A2,
MSC090472H and MSC090474H;
d) All bottle lots beginning with a "3" or 4001,
4002, 4003, 4004, 4005, 4006, 4007, 4008, or
have no lot number. The following kit reorder
numbers contain 2 oz. bottles of baby oil:
DYK1004385B, DYK10223668B, DYK1022368B,
DYK1082407I1, DYKD1005919B2, DYKD1006195N1,
DYKD1006948B, DYKD1011944BC, DYKD1021267H,
DYKD1022BW, DYKD1070118I, DYKD1082407I,
DYKD1166040N, DYKN1015466N, DYK1005919B3 and
DYK1022368B1

The following kit reorder numbers
contain 4 oz. bottles of baby oil: DYKD1023674B,
DYKD1034163N, DYKD1046741A, DYKD1046741A1,
DYKD1074113N, DYKD1084904A, DYKD1087914A,
DYKD15278P, DYKD39254B1, DYKD55021B and MSC095052H.
RECALLING FIRM/MANUFACTURER
Medline Industries, Inc., Mundelein, IL, by letters dated March 29, 2004. Firm initiated recall is complete.
REASON
Lotions and oils are contaminated with Burkholderia cepacia, and fungus respectively.
VOLUME OF PRODUCT IN COMMERCE
2,443,750 bottles, 1,461,300 kits.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Ground M&M's Candies (Plain), packed in 19.1 lbs, plastic lined bulk cardboard containers. Recall # F-217-5.
CODE
GC Lot Code: #536 = Manufacturer Code: 424DLHKP41,
GC Lot Code: #601 = Manufacturer Code: 444FLHKP41.
RECALLING FIRM/MANUFACTURER
Glass City Food Services Co., Inc., Holland, OH, by telephone on February 7, 2005 and by letters on February 11, 2005. Firm initiated recall is ongoing.
REASON
Repacked candies contain undeclared colors including FD&C Red #40 Lake, Blue #2 Lake, Red #40, Blue # 1 Lake, Blue #1, and Blue #2.
VOLUME OF PRODUCT IN COMMERCE
325 cartons.
DISTRIBUTION
OH and MI.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I

_______________________________
PRODUCT
a) Health & Herbs Eye Rinse Concentrate Formula
1036 Herbal Tincture in 2 fl. oz. amber bottles
with black glass dropper. Recall # D-143-5;
b) White Willow Bark (3193) Herbal Tincture in 2 fl.
oz. amber bottles with black glass dropper.
Recall # D-144-5;
c) Fennel Seed 3126 Herbal Tincture in 2 fl.
oz. amber bottles with black glass dropper
and 8 oz. bottles. Recall # D-145-5;
d) Elderberry Flower 3247 Herbal Tincture in 2 fl.
oz. amber bottles with black glass dropper and
32 oz glass bottle. Recall # D-146-5.
CODE
Not all bottles are coded. Some of the bottles have fill dates on them, however the dating system used by each employee was not systematic.
RECALLING FIRM/MANUFACTURER
Alternative Health & Herbs Remedies, Albany, OR, by press releaseon December 2, 2004, by telephone on December 3, 2004, and by letter beginning on December 6, 2004. Firm initiated recall is ongoing.
REASON
Non-Sterility.
VOLUME OF PRODUCT IN COMMERCE
a) 87/2 oz. bottles;
b) 41/2 oz. bottles;
c) 35/2 oz. bottles and 1/8 oz bottle;
d) 8/2 oz. and 1/32 oz. bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
BioTouch Instant Numb Topical Anesthetic Ointment, 12 grams, labeled to contain 4% Lidocaine and 15% Benzocaine. Recall # D-142-5.
CODE
Lot numbers 95396 and 95393.
RECALLING FIRM/MANUFACTURER
Coats Aloe International, Inc, Garland, TX, by letter on November 3, 2004. Firm initiated recall is ongoing.
REASON
Potency: Super-potent for Lidocaine and sub-potent for benzocaine based on labeled quantities.
VOLUME OF PRODUCT IN COMMERCE
3,381 bottles.
DISTRIBUTION
CA.
______________________________
PRODUCT
Ibuprofen Tablets USP, 400mg, 500 ct bottles, NDC # 0591-4010-05 and 100 ct bottles, NDC # 0591-4010-01, Rx only. Recall # D-147-5.
CODE
Lot # 23248, Exp. 8-2007;
Lot # 23045, Exp. 8-2007.
RECALLING FIRM/MANUFACTURER
BASF Corporation, Shreveport, LA, by telephone and email on February 18, 2005, and by letter dated February 23, 2005. Firm initiated recall is ongoing.
REASON
Adulterated; Foreign tablets co-mingled in a package lot of ibuprofen tablets.
VOLUME OF PRODUCT IN COMMERCE
20,124 bottles of 500 ct;
13,056 bottles of 100 ct.
DISTRIBUTION
CA.
______________________________
PRODUCT
APRI (desogestrel and ethinyl estradiol) Tablets, 0.15 mg/0.03 mg, 28 Day Regimen, Oral Contraceptive. Rx only. NDC # 0555-9043-58. Recall # D-149-5.
CODE
Lot #590434045, Exp. date: 12/06.
RECALLING FIRM/MANUFACTURER
Barr Pharmaceuticals, Inc., Cincinnati, OH, by letter dated February 15, 2005. Firm initiated recall is ongoing.
REASON
The individual 28 count tablet blister pack may be packaged upside down in the printed card package that is placed over the blister pack. The "start" row contains white placebo tablets instead of rose colored active tablets.
VOLUME OF PRODUCT IN COMMERCE
67,512 blister cards.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

______________________________
PRODUCT
Pfizer brand Dalacin T Gel 1%, clindamycin phosphate, in tubes 10g X 10, Rx only, Product is labeled in Japanese. Recall # D-148-5.
CODE
Lots 27MCC and 14MCM; Exp. April 2006.
RECALLING FIRM/MANUFACTURER
Pfizer, Inc., Kalamazoo, MI, by email on February 7, 2005. Firm initiated recall is ongoing.
REASON
Presence of foreign substance: Insect contamination.
VOLUME OF PRODUCT IN COMMERCE
14,090 tubes.
DISTRIBUTION
Japan.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Source Plasma, Recall # B-0614-5.
CODE
Units G72559117, G72126117, G70835117, G70524117, G69393117, G67174117, G66751117, G64384117, G58195117, G58036117, G57443117, G57316117, G51231117, G50957117, G48228117, G45951117, G45056117, G44656117, N05199117, and N05179117.
RECALLING FIRM/MANUFACTURER
DCI Biologicals, LLC, Lubbock, TX, by facsimile on December 18, 2001. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV), but were collected from a donor who previously tested repeatedly reactive for anti-HIV and indeterminate by the Western Blot test , were distributed.          
VOLUME OF PRODUCT IN COMMERCE
20 units.
DISTRIBUTION
NC, and Switzerland.

_______________________________
PRODUCT
Platelets. Recall # B-0764-5.
CODE
Units 7041761, 7041762.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on June 7, 2004, and by facsimile dated June 7, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0765-5.
CODE
Units 53LT83790, 53LT82919, 53LT80882.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD, by facsimile dated August 31, 2004, and by letter dated October 4, 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
3 units.
DISTRIBUTION
MD.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0766-5.
CODE
Units 53LT83003, 53LT83316.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD, by letter dated August 2, 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
MD, and DC.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0799-5.
CODE
Unit 53R23481.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on May 17, 2004 and by letter dated May 18, 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
MD.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0800-5.
CODE
Unit 7080624.
RECALLING FIRM/MANUFACTURER
Department of the Air Force, 81st Medical Group/SGSC, Keesler AFB, MS, by letter dated September 21, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Africa.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0801-5.
CODE
Units W001703000744, W001703000748.
RECALLING FIRM/MANUFACTURER
Department of the Air Force, 81st Medical Group/SGSC, Keesler AFB, MS, by facsimile on August 6, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested repeatedly reactive for the antibody to the human t-lymphotropic virus type I/II (antiHTLV-I/II) but tested negative by confirmatory test, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0802-5.
CODE
Units 53P95098 (Part 1 and Part 2).
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on May 7, 2004 and by letter dated May 7, 2004. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Bacillus subtilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall #-B0803-5;
b) Platelets. Recall # B-0804-5;
c) Recovered Plasma. Recall # B-0805-5.
CODE
a), b), and c) Unit 53GM53124.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated September 30, 2004, and electronic notification on September 30, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MD, DC, and CA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0811-5.
CODE
Unit 7220341.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on September 30, 2004. Firm initiated recall is complete.
REASON
Blood product, which was not properly quarantined after receiving post donation information concerning high-risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0812-5;
b) Red Blood Cells, Leukocytes Reduced.
Recall # B-0812-5;
c) Plasma, Frozen. Recall # B-0814-5.
CODE
a) Unit 53FR58273;
b) Unit 53GF55901;
c) Units 53GF55901, 53R87004.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated August 17, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor who disclosed a previous positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MD, and DC.

_______________________________
PRODUCT
Platelets Pheresis. Recall # B-0817-5.
CODE
Unit 0891494.
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Inc., Jackson, TN, by letter dated October 27, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm scrub was incorrectly performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0821-5.
CODE
Unit 9455421.
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center, Inc., Jackson, TN, by telephone on June 11, 2004. Firm initiated recall is complete.
REASON
Blood product, which tested positive for the hepatitis C virus (HCV), but was not labeled with a biohazard label, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Irradiated. Recall # B-0834-5;
b) Platelet Pheresis, Leukocytes Reduced
Irradiated. Recall # B-0835-5.
CODE
a) Units 22GW91209, 22GW91213, 22GW91214,
22KP91487, 22KT57446;
b) Units 22KG60174, 22KG69777, 22KG69778,
22KG74005, 22KG74499, 35P44389.
RECALLING FIRM/MANUFACTURER
American Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimiles dated March 10, 2004 and June 2, 2004, and by letters dated March 11, 2004, and June 3, 2004. Firm initiated recall is complete.
REASON
Blood products, lacking assurance of proper storage temperatures due to inaccurate documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units.
DISTRIBUTION
PA, and NJ.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0836-5.
CODE
Unit 4130363.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on April 20, 2004. Firm initiated recall is complete.
REASON
Blood product, not quarantined after receiving information concerning a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-0837-5;
b) Fresh Frozen Plasma. Recall # B-0838-5.
CODE
a) and b) Unit 22KW58193.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on July 21, 2004 and by letter dated July 22, 2004. Firm initiated recall is complete.
REASON
Blood products, in which the corresponding Platelets were possibly contaminated with coagulase-negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ and PA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0841-5;
b) Recovered Plasma. Recall # B-0842-5.
CODE
a) and b) Unit 53J92841.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone and electronic notification on September 15, 2004, and by letters dated September 20, 2004, October 14, 2004, and November 12, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who disclosed a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0859-5;
b) Red Blood Cells Pheresis, Leukocytes Reduced.
Recall # B-0860-5.
CODE
a) Unit 101860987;
b) Units 102989773 (split unit).
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on November 29, 2004, and by letters dated November 24, 2004 and December 23, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
AZ.

_______________________________
PRODUCT
Source Plasma. Recall # B-0862-5.
CODE
Unit 0490333812.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Grand Prarie, TX, by facsimile on May 14, 2003. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0767-5;
b) Fresh Frozen Plasma. Recall # B-0768-5.
CODE
a) and b) Unit 53GH61646.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD, by telephone on November 24, 2004, and by letter dated November 29, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD, and PA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0806-5;
b) Plasma, Frozen. Recall # B-0807-5.
CODE
a) Unit 53FL16859;
b) Units 53Q00247,53Q00243, 53Q00238, 53Q00241.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on February 7, 2003, and by letter dated August 11, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of whole blood more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MD, and DC.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0808-5.
CODE
Unit 22KW58201.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on August 3, 2004 and by letter dated August 12, 2004. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding Platelets were possibly contaminated with Propionibacterium acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
CryoVein, Saphenous Vein. Recall # B-0822-5.
CODE
Tissues 7192905, 7192875.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letter dated December 2, 2004. Firm initiated recall is complete.
REASON
Human tissues, possibly processed using an expired anti-microbial solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
MD.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0844-5;
b) Fresh Frozen Plasma. Recall # B-0845-5.
CODE
a) Units 22FN66880, 22LJ81445, 22LP03752;
b) Units 22KL10391, 22LJ81445.
RECALLING FIRM/MANUFACTURER
American Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on June 25, 2004 and by letter dated August 24, 2004. Firm initiated recall is complete.
REASON
Blood products, associated with a platelet pool implicated in a transfusion reaction and possibly contaminated with gram positive rods, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
PA, and NJ.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0850-5.
CODE
Units 7056018 (split unit).
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on June 6, 2004. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Diptheroid bacilli, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA, and NY.

_______________________________
PRODUCT
Human Tissue For Transplantation. Recall # B-0855-5.
a) Patellar Ligament Hemi Frozen Aseptic;
b) Achilles Tendon Frozen Aseptic;
c) Tibialis Tendon Anterior Frozen Aseptic;
d) Tibialis Tendon Posterior Frozen Aseptic;
e) Patellar Ligament Whole Frozen Aseptic.
CODE
a) Tissues 045679-105, 045679-106;
b) Tissue 045063-102;
c) Tissue 045063-103;
d) Tissue 045063-104;
e) Tissue 045707-102.

RECALLING FIRM/MANUFACTURER
Allo Source, Inc., Centennial, CO, by letters dated December 8, 2004. Firm initiated recall is complete.
REASON
Human tissues, in which sterility testing may not have been valid, were distributed.          
VOLUME OF PRODUCT IN COMMERCE
6 tissues.
DISTRIBUTION
CO, and IL.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0861-5.
CODE
Unit 101860987.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by electronic notification December 9, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from donors who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
a) Angiographic Syringe, 10 cc Thumb Ring
with Rotator Reservoir. Recall # Z-0617-05;
b) Angiographic Syringe, 12 cc Thumb Ring
with Rotator Reservoir. Recall # Z-0618-05;
c) Angiographic Syringe, 12 cc Thumb Ring
with Rotator Non-Reservoir. Recall # Z-0619-05;
d) Angiographic Syringe, 12 cc Palm Pad with
Rotator Reservoir. Recall # Z-0620-05;
e) Catheterization Kits containing Angiographic
Syringes with Rotator Connector.
Recall # Z-0621-05.
CODE
a) List Numbers: 4204004 Lot Numbers: 15173SN, 19104SN;
b) List Numbers: 4204201 Lot Numbers: 13193SN, 15171SN;
17151SN;
c) List Numbers: 4204401 Lot Numbers: 17149SN;
d) List Numbers: 4204801 Lot Numbers: 14182SN;
e) List Numbers: 460690403; 460690469; 460710409;
460710468; 460730411; 460730412; 460730414;
460730455; 460730470; 460730472; 460750442;
460750461; 460780417; 460780453; 460790418;
460830405; 460830411; 460830431; 460830470;
460830471; 460830473; 460840444; 460840454;
460840463; 460840475; 460870444; 460870455;
460870464; 460870467; 460870471; 460880477;
460890413; 460890419; 460890456; 460890461;
460890465; 460890471; 460890478; 460900407;
460900420; 460900465; 460900473; 460920412;
460920422; 460920431; 460920454; 460920455;
460920470; 460930404; 460930418; 460930419;
460930426; 460930468; 460930478; 460950404;
460950405; 460950417; 460950426; 460950429;
460950433; 460950436; 460950437; 460950439;
460950443; 460950444. Lot Numbers: 09284SN;
10004SN; 10019SN; 10026SN; 10042SN; 11007SN;
10008SN; 11081SN; 11085SN; 11122SN; 11182SN;
11225SN; 11228SN; 11245SN; 11272SN; 11295SN;
11313SN; 12022SN; 12039SN; 12074SN; 12075SN;
12091SN; 12116SN; 12128SN; 12131SN; 12250SN;
12253SN; 12281SN; 12282SN; 12284SN; 13016SN;
13033SN; 13060SN; 13096SN; 13123SN; 13189SN;
13193SN; 13271SN; 13275SN; 13283SN; 13285SN;
13292SN; 13294SN; 13296SN; 14018SN; 14107SN;
14128SN; 14129SN; 14141SN; 14144SN; 14182SN;
14232SN; 14236SN; 14242SN; 14249SN; 14269SN;
14298SN; 14302SN; 14306SN; 14309SN; 15020SN;
15036SN; 15061SN; 15123SN; 15126SN; 15149SN;
14161SN; 15162SN; 15163SN; 15164SN; 15171SN;
15173SN; 15224SN; 15241SN; 15245SN; 15250SN;
15253SN; 15257SN; 16007SN; 16013SN; 16032SN;
16045SN; 16052SN; 16084SN; 16088SN; 16137SN;
16213SN; 16227SN; 16235SN; 16273SN; 16274SN;
16279SN; 16287SN; 17019SN; 17084SN; 17086SN;
17105SN; 17106SN; 17116SN; 17133SN; 17149SN;
17151SN; 17204SN; 17211SN; 17220SN; 18004SN;
18008SN; 18021SN; 18022SN; 18045SN; 18055SN;
18066SN; 18116SN; 18118SN; 18127SN; 18128SN;
18134SN; 18147SN; 18156SN; 18161SN; 18239SN;
18249SN; 18250SN; 18284SN; 18290SN; 19010SN;
19074SN; 19090SN; 19104SN; 19156SN; 19182SN;
20024SN; 20064SN; 20065SN; 20067SN; 20069SN;
20073SN; 20082SN; 20085SN; 20171SN; 20174SN;
20224SN; 20225SN; 21137SN; 21209SN; 21218SN;
22213SN.
RECALLING FIRM/MANUFACTURER
Hospira, Inc., Lake Forest, IL, by letter on November 10, 2004 or by telephone on November 11, 2004. Firm initiated recall is ongoing.
REASON
Syringes could possibly allow air to enter the patient's vascular system.
VOLUME OF PRODUCT IN COMMERCE
72,555 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
a) MurphyScope, Bayonet, Malleable,
Catalog # 2121-157. Recall # Z-0615-05;
b) MurphyScope, Curved, Malleable,
Catalog # 2125-163. Recall # Z-0616-05.
CODE
a) Lot A52300;
b) Lot A57384.
RECALLING FIRM/MANUFACTURER
Medtronic Neurosurgery, Goleta, CA, by letters on February 28, 2005. Firm initiated recall is ongoing.
REASON
Products are mislabeled. Each designated lot contains the other model. Bayonet type contains Curved and vice versa.
VOLUME OF PRODUCT IN COMMERCE
4 devices.
DISTRIBUTION
NJ and India.

_______________________________
PRODUCT
a) LICOX Complete Brain IMC Probe Kit,
Model IM3.ST C. Recall # Z-0622-05;
b) LICOX temperature probe, Model C8.B.
Recall # Z-0623-05.
CODE
a) Lot numbers: 2506, 3904, 04779, 04795,
04835, 14716, 18141, 19059, 21044, 28800,
28806, 28806A, 47814, 050105, 619202,
619406, 619419, 619466, 619536, 619593,
619632, 619675, 619733, 619886, 619999,
620331/1;
b) Lot numbers: 160504 and 240604.
RECALLING FIRM/MANUFACTURER
Integra Neuro Sciences, San Diego, CA, by letter on January 21, 2005. Firm initiated recall is ongoing.
REASON
LICOX Model C8.B temperature probes may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.
VOLUME OF PRODUCT IN COMMERCE
842 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360),
catalog number 66009585 Dental impression material.
Recall # Z-0624-05;
b) Heraeus Kulzer brand P2 Magnum 360 Trial Kit,
Heavy+Light, catalog number 66009583. Recall
# Z-0625-05;
c) Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360),
catalog number 66009584. Recall # Z-0626-05;
d) Heraeus Kulzer brand P2 Magnum 360 Trial Kit
Monophase, catalog number 66009582. Recall # Z-0627-05.
CODE
a) Lots 190429,190438, 190519, 190521, 190522,
190524, 190535, 190545, 190547, 190554 and 190560;
b) Lots 195402, 195404, 195405, 195411, 195412
and 195420;
c) Lot 190416;
d) Lots 195417 and 195418.
RECALLING FIRM/MANUFACTURER
Heraeus Kulzer Inc., South Bend, IN, by letter on or about November 1, 2003. Firm initiated recall is complete.
REASON
Packaging defects could result in improper mixing ratios and unusable impressions.
VOLUME OF PRODUCT IN COMMERCE
2,672 bags.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR MARCH 23, 2005

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