FDA

Enforcement Report

CODE
None. The recalled product represented invoiced shipments from 5/28/98 to 6/4/98.

MANUFACTURER
C.I. Oceanos S.A.. Colombia.

RECALLED BY
Interamerican Trading and Products Corporation, Medley (repacker/distributor), by letter on July 29, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Florida, Ohio, Georgia, Pennsylvania, Alabama, North Carolina, South Carolina, Maryland, Wisconsin.

QUANTITY
782 10-pound cases were distributed.

REASON
Product may Be Contaminated with Salmonella.

F-617-8 Group 1:  Autumn Honey Wheat (Item No. 209), Autumn
        Honey Wheat 32 oz. (Item No. 210), and Shurfresh 20 oz.
        Wheat(Item No. 1095).
F-618-8 Group 2:  Golden Soft 16 oz.(Item No. 215) and 
        F-O-RGoldW (Item No. 984).
F-619-8 Group 3:  Cot Autumn Grain 100% (Item No. 212).
F-620-8 Group 4:  GH Stone Ground White (Item No. 204).
F-621-8 Group 5:  Buttermilk (Item No. 225). 
F-622-8 Group 6:  Holsum Sm A (Item No. 102), Wonder White 16 oz.
        A (Item No. 103), Blue Seal A (Item No. 947), Great Value
        16 oz.(Item No. 1000), and Price Saver 16 oz. A (Item No.
        1070).
F-623-8 Group 7:  Holsum Thin 20 oz. A (Item No. 108), Holsum 
        Twin 40 oz. A (Item No. 113), Holsum Extra 
        Thin A (Item No. 120), Wonder White 24 oz. A              
       (Item No. 130), Big Value 20 SD (Item No. 944),  
        Butterkrust 20 SD (Item No. 953), F-O-R   
        20 Sandwich (Item No. 985), Great Value 24 oz. 
        A (Item No. 1002), Best Yet 20SD (Item No. 1016), IGA 20 
        SD (Item No. 1026), Oven Gold 20 SD (Item No. 1045), 
        Piggly Wiggly 20 SD (Item No. 1055), Real Value 20 SD 
        (Item No. 1073), Sally Sandwich 20 oz.(Item No. 1086), 
        Shur Fresh 20 TS A (Item No. 1088), Super Value 20 SD 
       (Item No. 2806), and Parade T Sand White (Item No. 2850).
F-624-8 Group 8:  HP Buttertop Wheat (Item No. 213), Albertson  
        BT Wheat (Item No. 904), Cof Split Wheat  
       (Item No. 920), Country Market Split (Item No. 963),  
        Great Value Split Wheat (Item No. 1009), Piggly    
        Wiggly Splittop Wheat (Item No. 1054), Price Low Wheat 
        (Item No. 1067), and Parade Wheat OT (Item No.  2854).
F-625-8 Group 9:  Wonder 24 oz. Family Wheat (Item No. 219),    
        Albertson Lee Wheat 24 oz.(Item No. 909),     
        Goodday Wheat (Item No. 911), and Great Value 
        Wheat 24 oz. (Item No. 1006).
F-626-8 Group 10:   Wonder OT White A (Item No. 121) and Holsum   
        Large 24 oz. A (Item No. 122).
F-627-8 Group 11:   HP Buttertop White (Item No. 218).
F-628-8 Group 12:   HP Butter Wheat 24 (Item No. 216).

CODE
See item numbers listed above. All bread produced at the Alexandria bakery involved in the product recall would have a white twist tie on each bag with the number 47 printed on it.

MANUFACTURER
Interstate Brands Corporation, doing business as Cotton's Holsum Bakery, Alexandria, Louisiana.

RECALLED BY
Manufacturer, by letter dated July 31, 1998., Firm-initiated recall complete.

DISTRIBUTION
Arkansas, Louisiana, Mississippi, Texas.

QUANTITY
103,590 loaves were distributed.

REASON
Products may have contained pieces of metal.

PRODUCT
Mae Tu brand Shrimp Paste, in 3.5 ounce plastic jars. Recall #F-632-8.

CODE
None.

MANUFACTURER
Mae Tu Company, Ltd., Bangkok, Thailand.

RECALLED BY
Summit Import Corporation, New York, New York, by letter dated September 5, 1997. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
Florida, Maryland, Pennsylvania, New York.

QUANTITY
Undetermined.

REASON
Product was contaminated with filth.

PRODUCT
Blue Ribbon Brand "Nova Salmon Bits" (Hickory Smoked) in Rigid Plastic Tubs with Lids, Net Wt. 8 oz. (227g). Recall #F-649-8.

CODE
11/30/97.

MANUFACTURER
Blue Ribbon Smoked Fish Co., Inc., Brooklyn, New York.

RECALLED BY
Manufacturer, by telephone on November 25, 1997. Completed recall resulted from sample analysis and follow-up by the New York Department of Agriculture and Markets.

DISTRIBUTION
New Jersey and New York.

QUANTITY
21 units were distributed.

REASON
Product contains undeclared nitrites.

CODE
S:Lots 17775 and 17776 of 60-tablet bottles; and lot 17790 of unit dose packets.

MANUFACTURER
Upsher-Smith Laboratories, Inc., Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by telephone beginning on August 21, 1998, and by letter dated August 25, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
27,062 60-tablet bottles and 1,240 unit dose, 100-tablet cartons were distributed.

REASON
Superpotency.

PRODUCT
Fluoride Toothpaste/gel (Colgate/Aim), Regular/Winterfresh/Mint Flavors, OTC, in 75 ml (3.7 ounce) and 100 ml tubes, product of Canada. Recall #D-241-8.

CODE
All lots.

MANUFACTURER
Spain's Gifts & Cards, Philadelphia, Pennsylvania.

RECALLED BY
Manufacturer, by fax on or about July 17, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Pennsylvania, Delaware, Maryland, New Jersey.

QUANTITY
Undetermined.

REASON
Product may contain cyclamates.

CODE
Lot numbers: 00447F EXP 4/99, 02818F EXP 1/00, 00367F EXP 7/99, 02887F EXP 7/99.

MANUFACTURER
Warner Lambert Company, Fajardo, Puerto Rico.

RECALLED BY
Parke-Davis, Division of Warner Lambert Company, Morris Plains, New Jersey, by letter on August 12, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
95,658 units were distributed.

REASON
In-process blend specification failure; loss on drying.

CODE
Unit numbers: a) X68040, X69364, M24522, X71255, X72786, M30179, M30857, X85826; b) X69364, X72786, M30179; c) X68040; d) X68040, X69364.

MANUFACTURER
Central California Blood Center, Fresno, California.

RECALLED BY
Manufacturer, by letter dated either December 18 or 20, 1995. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
a) 8 units; b) 3 units; c) 1 unit; d) 2 units were distributed.

REASON
Blood products tested non-reactive for the antibody to the Hepatitis B core antigen (anti-HBc), but were collected from a donor who was previously repeatedly reactive for anti-HBc on two separate donations.

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1593/1594-8.

CODE
Unit #47G94206.

MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.

RECALLED BY
Manufacturer, by letter dated May 12, 1998, by telephone on June 2 and 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois and California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products tested negative for the Hepatitis B Surface Antigen, (HBsAg), but were collected from a donor who previously tested repeat reactive for HBsAg, with no confirmatory testing.

CODE
Unit #4113263.

MANUFACTURER
Department of the Navy, Naval Hospital, Bremerton, Washington.

RECALLED BY
Manufacturer, by letters dated December 4 and 10, 1997. Firm-initiated recall complete.

DISTRIBUTION
California, Florida, Washington state.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who exceeded the donation acceptance criteria for body temperature.

PRODUCT
Source Plasma. Recall #B-1591-8.

CODE
XU44955, XU45572, XU50832, XU56257, XY04174.

MANUFACTURER
Plasma Center - Tyler, Inc., Austin, Texas.

RECALLED BY
Community Bio-Resources, Inc., Hoover, Alabama, by fax dated March 18 and 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
Austria.

QUANTITY
5 units were distributed.

REASON
Blood products were collected from donors who were not tested for syphilis.

PRODUCT
Red Blood Cells. Recall #B-1596-8.

CODE
Unit #12430-2715.

MANUFACTURER
United Blood Services, Albuquerque, New Mexico.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on May 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
Colorado.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

PRODUCT
a) RAD-Sure Blood Irradiation Labels, 15GY b) RAD-Sure Blood Irradiation Labels, 25GY, distributed by ISP, Huntsville, Huntsville, Alabama. Recall #B-1597/1598.

CODE
a) All identification codes beginning with the following lot numbers: F40___, F47___, F48___, F50___. b) All identification codes beginning with the following lot numbers: F44___, F45___, F46___, F49___, F51A36, F51B44.

MANUFACTURER
KAPCO, Kent, Ohio.

RECALLED BY
International Specialty Products, Wayne, New Jersey, by letter dated January 12, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
14,508 boxes (200 units per box)of indicators were distributed.

REASON
Blood irradiation labels may not perform as intended throughout their labeled expiration dates.

a) Product No. 2051-2048; b) Product No. 2051-2052; c) Product No. 2051-2056; d) Product No. 2051-2060; e) Product No. 2051-3052; f) Product No. 2051-3056; g) Product No. 2051-3060; h) Product No. 2051-2044P; i) Product No. 2051-2066P; j) Product No. 2051-2068P; k) Product No. 2051-2070P; l) Product No. 2051-2072P. Recall #Z-851/862-8.

CODE

Lot numbers:  a) Nos. 28026701, 28128401
b) 28077703, 28353902, 28353903
c) 28335401, 28335402, 28355001, 28355002, 28159101, 
d) 27617807,  28198201; e) 27987801, 28221701;
f) 28221901; g) 28159201; h) 28476201; i) 28477601
j) 28477801; k) 28478001; l) 28478101.

MANUFACTURER
Osteonics Corporation, Allendale, New Jersey.

RECALLED BY
Manufacturer, by telephone, followed by letter on August 22, 1997. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
162 units were distributed.

REASON
The multilingual side of the outer carton has incorrect size information, while the English side of the outer carton has the correct size information.

PRODUCT
Horizon Pump IV Administration Set. Recall #Z-869-8.

CODE

LOT#       CATALOG#  
F8C393       NF3116  
F8C404       V7410   
F8C405       V7410   
F8C406       V7410   
F8C407       NF3140  
F8C494       V7410   
F8C495       CC3131  
F8C496       NF3160  
F8C497       NF3141  
F8C498       V7430   
F8C499       V7410   
F8C500       CC3130  
F8C501       NF3150  
F8C503       NF3140  
F8C504       V7410-SPO2 
F8C508       CC3120     
F8C509       NF3121     
F8C540       V7460      
F8C617       V7410      
F8C619       NF3140     
F8C622       V7425      
F8C624       NF3140-10  
F8C625       V7410    
F8C626       V7490    
F8C627       NF3120   
F8D040       V7421    
F8D087       V7410    
F8D089       CC3130   
F8D090       CC3130-SPO1  
F8D091       NF3140    
F8D099       CC3150    
F8D124       V7423     
F8D220       V7410-10  
F8D222       V7413     
F8D223       NF3140    
F8D224       CC3130-SPO1 
F8D225       V7425     
F8D226       V7410     
F8D227       CC3130    
F8D228       CC3131    
F8D349       V7410     
F8D350       V7413     
F8D351       V7425     
F8D352       NF3140    
F8D353       V7410     
F8D355       V7490     
F8D467       NF3141    
F8D468       V7430     
F8D469       V7410     
F8D470       CC3130    
F8D471       NF3140    
F8D473       CC3131    
F8D474       CC3130-SPO1 
F8D475       V7410       
F8D476       NF3120    
F8D477       V7490     
F8E123       V7425     
F8E126       V7410     
F8E128       CC3130    
F8E145       V7460     
F8E282       NF3116.

MANUFACTURER
B. Braun Medical, Inc., Bethlehem, Pennsylvania.

RECALLED BY
B. Braun/McGaw, Sabana Grande, Puerto Rico, by letters on May 19, 1998, and July 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and Canada.

QUANTITY
560,642 units were distributed.

REASON
Non-conforming Horizon IV Sets due to a defective component (cassette) assembled into the IV line.

PRODUCT
Biopak for Windows Software, Versions 1.33 and 1.5, for the BioPak Measurement System, designed to help the physician obtain a comprehensive evaluation of the entire oral system. Recall #Z-870/871-8.

CODE
Software Version 1.33 and 1.5 are being replaced.

MANUFACTURER
Bio-Research, Inc., Milwaukee, Wisconsin.

RECALLED BY
Manufacturer, by letter on September 24, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
280 software disk sets (7 disks per set) were distributed.

REASON
The firm did not get premarket approval (PMA) or 510(k) clearance for significant changes to their BioPak Occlusal Measurement System.

PRODUCT
Baxter Minicap Disconnect Cap with Povidone-Iodine Solution, Catalog number 5C4466P, a plastic cap containing povidone-iodine, designed to isolate the Easy-Lock connector of the solution transfer set during peritoneal dialysis. Recall #Z-876-8.

CODE
Lot number GD630590.

MANUFACTURER
Baxter Healthcare Corporation, Cleveland, Mississippi.

RECALLED BY
Baxter Healthcare Corporation, McGaw Park, Illinois, by letter dated September 16, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
207,940 units were distributed.

REASON
Some of the caps do not contain povidone iodine. Use of the caps with no povidone iodine poses a risk of peritonitis.

PRODUCT
Alcon Surgical Custom Paks containing Devon Needle Counters. Recall #Z-877/957-8.

CODE

1.  Catalog No. 2028-09, Lot Nos. WB76149, WB78362;
2.  Catalog No. 3010-08, Lot Nos. WB75782, WB78115;
3.  Catalog No. 3073-09, Lot Nos. WB77182, WB79509;
4.  Catalog No. 3282-03, Lot Nos. WB79840, WB81469;
5.  Catalog No. 3381-09, Lot No. WB75406;
6.  Catalog No. 3542-12, Lot Nos. WB73914, WB75299, WB77222,
    WB78583, WB79534;
7.  Catalog No. 3825-12, Lot No. WB75813;
8.  Catalog No. 3911-09, Lot No. WB78040;
9.  Catalog No. 3972-05, Lot No. WB77135;
10. Catalog No. 4073-08, Lot Nos. WB76413, WB80829;
11. Catalog No. 4075-12, Lot Nos. WB77140, WB82392;
12. Catalog No. 4081-02, Lot No. WB78047;
13. Catalog No. 4188-17, Lot No. WB78053;
14. Catalog No. 4212-08, Lot No. WB79726;
15. Catalog No. 4287-04, Lot Nos. WB76188, WB77898;
16. Catalog No. 4388-04, Lot Nos. WB78628, WB79620;
17. Catalog No. 4389-11, Lot Nos. WB75562, WB79989;
18. Catalog No. 4473-03, Lot Nos. WB75435, WB81017;
19. Catalog No. 4652-04, Lot Nos. WB77165, WB79998;
20. Catalog No. 4654-05, Lot Nos. WB76874, WB79751, WB78400;
21. Catalog No. 4654-06, Lot No. WB81980;
22. Catalog No. 4894-06, Lot Nos. WB76887, WB81244;
23. Catalog No. 4893-08, Lot Nos. WB76212, WB77922;
24. Catalog No. 4893-09, Lot No. WB79768;
25. Catalog No. 4934-03, Lot No. WB76216;
26. Catalog No. 4973-04, Lot Nos. WB68067, WB72101, WB75888,
    WB81332, WB83302, WB85694;
27. Catalog No. 4893-09, Lot No. WB79768;
28. Catalog No. 5094-12, Lot Nos. WB77350, WB79673;
29. Catalog No. 5100-05, Lot Nos. WB78655, WB79627;
30. Catalog No. 5101-04, Lot No. WB78656;
31. Catalog No. 5180-03, Lot No. WB81335;
32. Catalog No. 5250-06, Lot Nos. WB73979, WB75898, WB82383;
33. Catalog No. 5251-11, Lot Nos. WB68793, WB71818, WB73980,
    WB77357, WB79713, WB82384, WB84403, WB86116;
34. Catalog No. 5294-08, Lot Nos. WB71896, WB73394, WB74839;
35. Catalog No. 5252-09, Lot No. WB71258;
36. Catalog No. 5402-13, Lot No. WB78120;
37. Catalog No. 5415-03, Lot Nos. WB68507, WB69799, WB71113;
38. Catalog No. 5573-01, Lot Nos. WB76920, WB79843;
39. Catalog No. 5551-06, Lot No. WB78668;
40. Catalog No. 5631-04, Lot No. WB78127;
41. Catalog No. 5663-05, Lot Nos. WB78917, WB80878;
42. Catalog No. 5846-03, Lot No. WB78282;
43. Catalog No. 5859-03, Lot Nos. WB67984, WB78671, WB74703,
    WB83777, WB86429;
44. Catalog No. 5877-04, Lot Nos. WB77410;
45. Catalog No. 6011-04, Lot No. WB80720;
46. Catalog No. 6221-04, Lot No. WB77970;
47. Catalog No. 6222-07, Lot Nos. WB76951, WB82046;
48. Catalog No. 6223-07, Lot Nos. WB76952, WB81262;
49. Catalog No. 6297-03, Lot No. WB76475;
50. Catalog No. 6333-02, Lot No. WB79919;
51. Catalog No. 6420-02, Lot Nos. WB76282, WB81074;
52. Catalog No. 6457-02, Lot No. WB78305;
53. Catalog No. 6496-02, Lot No. WB67256;
54. Catalog No. 6621-02, Lot Nos. WB76485, WB80907;
55. Catalog No. 6658-05, Lot No. WB80204;
56. Catalog No. 6707-04, Lot No. WB77980;
57. Catalog No. 6738-01, Lot Nos. WB74933, WB79928;
58. Catalog No. 6828-02, Lot No. WB81081;
59. Catalog No. 6886-04, Lot No. WB76693;
60. Catalog No. 6985-01, Lot No. WB79118;
61. Catalog No. 6987-02, Lot No. WB78196;
62. Catalog No. 8008-01, Lot Nos. WB76085, WB78704;
63. Catalog No. 8109-01, Lot No. WB78232;
64. Catalog No. 8139-01, Lot No. WB80066;
65. Catalog No. 8807-11, Lot Nos. WB76577, WB80091;
66. Catalog No. 8808-12, Lot No. WB77493;
67. Catalog No. 8938-04, Lot Nos. WB74081, WB78800;
68. Catalog No. 9364-13, Lot No. WB80117;
69. Catalog No. 9379-17, Lot Nos. WB66937, WB68609, WB72711,
    WB75023, WB76334, WB77031, WB78477, WB80006;
70. Catalog No. 9452-14, Lot No. WB80123;
71. Catalog No. 9521-23, Lot No. WB76532, WB78266, WB80263;
72. Catalog No. 9593-08, Lot No. WB76071;
73. Catalog No. 9610-09, Lot Nos. WB78831, WB80773, WB74968,
    WB77528;
74. Catalog No. 9611-13, Lot Nos. WB77529, WB80141;
75. Catalog No. 9710-12, Lot No. WB69145;
76. Catalog No. 9710-13, Lot Nos. WB72868, WB80027, WB84739;
77. Catalog No. 9853-23, Lot Nos. WB76545, WB77477, WB78969,
    WB80277;
78. Catalog No. 9890-07, Lot Nos. WB76093, WB80784;
79. Catalog No. Q21624C, Lot No. P13750;
80. Catalog No. Q22446A, Lot No. P13897;
81. Catalog No. Q22658, Lot No. P13947.

MANUFACTURER
Graphic Controls Corporation, Chatsworth, California (Devon Needle Counters).

RECALLED BY
Alcon Laboratories, Inc., Houston, Texas (kit assembler), by telephone on August 24, 1998, followed by letter on August 28, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Canada.

QUANTITY
3,996 kits were distributed.

REASON
The kits contain Devon needle counters recalled by Graphic Control Corp., Buffalo, New York, because the foam strip used to secure suture needles was detaching from the needle counter box.

a) Solid Phase No Boil Folic Acid Kit, Catalog No. KDSP1, 100
Test Kit Size;
b) Solid Phase No Boil Folic Acid Kit, Catalog No. KDSP2, 200
Test Kit Size; 
c) Solid Phase No Boil Folic Acid Kit, Catalog No. KDSP5, 500
Test Kit Size; 
d) Dualcount Solid Phase No Boil Folic Acid/Vitamin B12 Kit,
Catalog No. KFSP1, 100 Test Kit Size;
e) Dualcount Solid Phase No Boil Folic Acid/Vitamin B12 Kit,
Catalog No. KFSP2, 200 Test Kit Size;
f) Dualcount Solid Phase No Boil Folic acid/vitamin B12 Kit,
Catalog No. KFSP5, 500 Test Kit Size.  Recall
#Z-828/833-8.

CODE
Lot numbers: a) 674 and 675; b) 527; c) 517; d)457 and 458; e)438; f)418 and 419.

MANUFACTURER
Diagnostic Products Corporation (DPC), Los Angeles, California.

RECALLED BY
Manufacturer, by telephone between June 12 and 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona, California, Connecticut, Indiana, Massachusetts, Maryland, Michigan, New York, Wisconsin, Wyoming, Florida, international.

QUANTITY
1,100 kits were distributed; firm estimates none remains on the market.

REASON
The folate control values are elevated and exceed the limits of acceptability.

PRODUCT
Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens Buttons, Catalog #2600-B. Recall #Z-874-8.

CODE
Lot #0035951.

MANUFACTURER
Polymer Technology, a division of Wilmington Partners, LP, Wilmington, Massachusetts.

RECALLED BY
Polymer Technology, a division of Wilmington Partners, LP (subsidiary of Bausch & Lomb, Inc.), Rochester, New York, by letters dated August 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
15,297 buttons were distributed.

REASON
Particulate matter has been found in some lens buttons.

PRODUCT
Navarre 6 French Locking Pigtail Universal Drainage Catheter, Product NUD6LPT, used only in non-vascular drainage procedures, for abscess, cyst, and other general purpose drainage applications. Recall #Z-875-8.

CODE
Lot #980540, Use by 2001-07.

MANUFACTURER
Navarre Biomedical, Ltd., Plymouth, Minnesota.

RECALLED BY
Manufacturer, by telephone starting on September 1, 1998. Firm-initiated field correction complete.

DISTRIBUTION
California, Florida, Massachusetts, Minnesota, Missouri, Nevada, New York, Oklahoma, Pennsylvania, Texas.

QUANTITY
100 catheters were distributed.

REASON
The recommended guidewire size on the product labels was incorrect.

END OF ENFORCEMENT REPORT FOR SEPTEMBER 30, 1998. BLANK PAGES MAY FOLLOW. ####