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U.S. Department of Health and Human Services

Safety

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Enforcement Report for May 5, 2010

May 5, 2010                                                                                        10-17

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
Old Apple Tree Tomme cheese in paper with label affixed stating Old Apple Tree Tomme Cheese Estrella Family Creamery. Product size varies - product was cut to order. Recall # F-1931-2010
CODE
No code
RECALLING FIRM/MANUFACTURER
Estrella Family Creamery, Montesano, WA, by press release and telephone on March 5, 2010. Firm initiated recall is complete.
REASON
Product contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Approx. 3 1/2 wheels
DISTRIBUTION
WA
___________________________________
PRODUCT
Glutino Raisin Bread, Gluten Free in 22.6 oz. bags (Frozen) UPC 6 78523 03015 8 Product of Canada. Recall # F-1932-2010
CODE
Use By: 08OCT10
RECALLING FIRM/MANUFACTURER
Glutino, Laval, Canada, by telephone and letter on March 31, 2010 and press release on April 1, 2010. Firm initiated recall is ongoing.
REASON
Product contains undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
261 cases (1566 units)
DISTRIBUTION
CA, CO, IL, IN, FL, NH, WA
___________________________________
PRODUCT
1) Vic's Seasoning; 582 Steak Seasoning; packaged in 16.0 oz. pouches, 40 pouches per case; product 582T-T0751. Recall # F-1933-2010;

2) TUF Poultry Gravy Mix; packaged in 14.1 oz. pouches, 6 pouches per case; product 217T-T0700. Recall # F-1934-2010;
CODE
1) Lot number C0046I96;
2) Lot number C0043C44 and C0046C44
RECALLING FIRM/MANUFACTURER
Recalling Firm: Precision Foods, Inc., Bolingbrook, IL, by letters dated March 1, 2010.
Manufacturer: Precision Foods Inc., Columbus, OH. Firm initiated recall is ongoing.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
96 cases
DISTRIBUTION
KY, OH, SC
___________________________________
PRODUCT
Chick Pea Salad, Wt: 5 Lbs., Exp. Date: 04/07/10. The product is packaged in a hard plastic container. Recall # F-1935-2010
CODE
Exp. Date: 04/07/10
RECALLING FIRM/MANUFACTURER
NY Gourmet Salads, Inc., Brooklyn, NY, by telephone and press release on April 2, 2010. Firm initiated recall is ongoing.
REASON
The product was found to be contaminated with Listeria monocytogenes based on FDA sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
60 lbs. (12 - 5 lb. containers)
DISTRIBUTION
NY City
___________________________________
PRODUCT
1) Soup Base Beef Style: Farmer Brothers Brand, Item Number 040022, 5 lb, 6 units/case; Sierra Brand, Item Number 040030, 25 lb. Recall # F-1936-2010;

2) Soup Base Beef Special: Sierra Brand, Item Number 040071, 5 lb, 6 units/case; Sierra Brand, Item Number 040089, 20 lb. Recall # F-1937-2010;

3) Soup Base Beef Special No MSG: Sierra Brand, Item Number 040096, 5 lb, 6 units/case; Sierra Brand, Item Number 0400979, 20 lb. Recall # F-1938-2010;

4) Soup Mix Cream: Farmer Brothers Brand, Item Number 040410, 1 lb 12 oz, 12 units/case. Recall# F-1939-2010;

5) Soup Base Chicken Special No MSG: Sierra Brand, Item Number 041116, 5 lb, 6 units/case; Sierra Brand, Item Number 041117, 20 lb. Recall # F-1940-2010;

6) Soup Base Chicken Los Lupes Sierra Brand, Item Number 041138, 30 lb. Recall # F-1941-2010;

7) Gravy Mix Beef Instant: Farmer Brothers Brand, Item Number 042079, 15 oz, 18 units/case. Recall # F-1942-2010;

8) Gravy Mix Poultry Instant: Farmer Brothers Brand, Item Number 042079, 15 oz, 18 units/case. Recall # F-1943-2010;

9) AU JUS MIX: Farmer Brothers Brand, Item Number 042119, 6 oz, 36 units/case; Farmer Brothers Brand, Item Number 042127, 4 lb, 6 units/case. Recall # F-1944-2010
CODE
1) Julian Code Dates:Z288, Z289, Z292,Z293, Z294 Z295, Z296, Z289, Z292, Z 294, Z295, Z 296, Z299, Z300, A035, A 036, A040, A041;

2) Julian Code Dates:Z320, Z321, Z322, Z 323, Z 324, Z327, Z316, Z317, Z320, Z322, Z324, Z327, Z328, Z329, Z335, Z336, Z337;

3) Julian Code Dates: Z302, Z303, Z 306, Z307, Z301, Z303, Z306, Z307, Z313, Z314;

4) Julian Code Dates: Z349, Z350, Z351, Z352, Z354, Z355, Z356,Z357, Z358, Z362, Z363, Z364, Z365, A004, A005,A006,A007, A008;

5) Julian Code Dates: Z300, Z301, A005, Z300, Z301, Z302, Z365 A004, A005;

6) Julian Code Dates: A048, A049;

7) Julian Code Dates: Z260, Z261, Z264, Z265, Z266,Z267, Z357, Z358, Z362, Z363, Z364, A004, A005, A006, A007, A008, A011, A012, A013, A014, A015, A018, A019, A020;

8) Julian Code Dates: Z344, Z345, Z346, Z348, Z349, Z350, Z351, Z352, Z353, Z355, Z356;

9) Julian Code Dates: Z273, Z274, Z275, Z278, Z279, Z280, Z281, A026, A027, A028, A029, A032, A033, A034, Z268, Z271, Z280, Z281, Z282, Z285, Z286, Z287, A025, A026, A027, A028, A029, A032, A033, A034, A035
RECALLING FIRM/MANUFACTURER
Farmer Brothers Company Inc., Torrance, CA, by letter on February 28, 2010. Firm initiated recall is ongoing.
REASON
The recall was initiated because the products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
128,975 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Whole Black Pepper. Recall # F-1952-2010
CODE
Lot # 3258, 3258B, 3258D, 3258G, 3258P, 3258Q, 3258R, 3258T, 3258X and Lot # 3309, 3309B, 3309F, 3309G, 3309K, 3309P and 3309T.
RECALLING FIRM/MANUFACTURER
Mincing Trading Corp., Dayton, NJ, by press release on March 5, 2010.  Firm initiated recall is ongoing.
REASON
Two lots of black pepper may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
FL, IA, IL, IN, MA, OH, NJ, NY, PA, RI, TX, MI, NC, OK and WI
___________________________________
PRODUCT
Quaker Crispy Minis Rice Cakes, Savoury Tomato & Basil; 14 rice cakes per 173 g plastic bag; UPC 0 55577 10790 4. Recall # F-1953-2010
CODE
0211CZ013E, 0211CZ013W, 0212CZ013E, 0212CZ013W
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pepsi-QTG, Chicago, IL, by letters dated March 5, 2010 and press release on March 8, 2010.
Manufacturer: Quaker Oats Co., Columbia, MO. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
49 cases
DISTRIBUTION
Canada
___________________________________
PRODUCT
1) Sharp Cheddar Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce, 12 ounce, and 16 ounce round or square plastic containers (tub with snap on lid), 5 lb., 5.5 lb., 10 lb., and 30 lb. white tub with snap on lid; 2. Happy Farms label in 16 ounce round plastic container (tub with snap on lid); 3. Kroger label in 8 ounce round plastic container (tub with snap on lid); 4. Central Markets label in 8 ounce round plastic container (tub with snap on lid); 5. Dutch Farms label in 8 ounce round plastic container (tub with snap on lid); 6. Crystal Farms label in 8 ounce round plastic container (tub with snap on lid); 7. Helluva Good label in 8 ounce round plastic container (tub with snap on lid); 8. Amish Classic label in 8 ounce round plastic container (tub with snap on lid); 9. Century Resources label in 12 ounce tub with snap on lid; 10, Block & Barrel label in 4 lb. and 5.5 lb. white tub with snap on lid, and 30 lb. white pail with snap on lid; 11. Cobblestone label in 5 lb. and 30 lb. white pail with snap on lid; 12. Biery label in 5 lb. white tub with snap on lid; 13. Dierks Waukesha label in 5 lb. white tub with snap on lid. Recall # F-1954-2010;

2) Port Wine Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce, 12 ounce, and 16 ounce round or square plastic containers (tub with snap on lid), 5 lb., 5.5 lb., 10 lb., and 30 lb. white tub with snap on lid; 2. Happy Farms label in 16 ounce round plastic container (tub with snap on lid); 3. Kroger label in 8 ounce round plastic container (tub with snap on lid); 4. Central Markets label in 8 ounce round plastic container (tub with snap on lid); 5. Dutch Farms label in 8 ounce round plastic container (tub with snap on lid); 6. Crystal Farms label in 8 ounce round plastic container (tub with snap on lid); 7. Helluva Good label in 8 ounce round plastic container (tub with snap on lid); 8. Amish Classic label in 8 ounce round plastic container (tub with snap on lid); 9, Block & Barrel label in 4 lb. and 5.5 lb. white tub with snap on lid; 10. Cobblestone label in 5 lb. white pail with snap on lid; 11. Biery label in 5 lb. white tub with snap on lid; 12. Dierks Waukesha label in 5 lb. white tub with snap on lid. Recall # F-1955-2010;

3) Swiss Almond Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce, 12 ounce, and 16 ounce round or square plastic containers (tub with snap on lid), 5 lb., 5.5 lb., 10 lb., and 30 lb. white tub with snap on lid; 2. Happy Farms label in 16 ounce round plastic container (tub with snap on lid); 3. Kroger label in 8 ounce round plastic container (tub with snap on lid); 4. Central Markets label in 8 ounce round plastic container (tub with snap on lid); 5. Dutch Farms label in 8 ounce round plastic container (tub with snap on lid); 6. Crystal Farms label in 8 ounce round plastic container (tub with snap on lid); 7. Amish Classic label in 8 ounce round plastic container (tub with snap on lid); 8. Block & Barrel label in 4 lb. and 5.5 lb. white tub with snap on lid; 9. Cobblestone label in 5 lb. white pail with snap on lid; 10. Dierks Waukesha label in 5 lb. white tub with snap on lid. Recall # F-1956-2010;

4) Horseradish Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce, 12 ounce, and 16 ounce round or square plastic containers (tub with snap on lid), 5 lb., 5.5 lb., 10 lb., and 30 lb. white tub with snap on lid; 2. Central Markets label in 8 ounce round plastic container (tub with snap on lid); 3. Dutch Farms label in 8 ounce round plastic container (tub with snap on lid); 4. Helluva Good label in 8 ounce round plastic container (tub with snap on lid); 5. Amish Classic label in 8 ounce round plastic container (tub with snap on lid); 6. Century Resources label in 12 ounce tub with snap on lid; 7, Block & Barrel label in 4 lb. and 5.5 lb. white tub with snap on lid; 8. Cobblestone label in 5 lb. white pail with snap on lid; 9. Dierks Waukesha label in 5 lb. white tub with snap on lid. Recall # F-1957-2010;

5) Bacon Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce, 12 ounce, and 16 ounce round or square plastic containers (tub with snap on lid), 5 lb., 5.5 lb., 10 lb., and 30 lb. white tub with snap on lid; 2. Crystal Farms label in 8 ounce round plastic container (tub with snap on lid); 3. Century Resources label in 12 ounce tub with snap on lid. Recall # F-1958-2010;

6) Swiss & Cheddar Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce, 12 ounce, and 16 ounce round or square plastic containers (tub with snap on lid), 5 lb., 5.5 lb., 10 lb., and 30 lb. white tub with snap on lid; 2. Dutch Farms label in 8 ounce round plastic container (tub with snap on lid). Recall # F-1959-2010;

7) Onion Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce, 12 ounce, and 16 ounce round or square plastic containers (tub with snap on lid), 5 lb., 5.5 lb., 10 lb., and 30 lb. white tub with snap on lid. Recall # F-1960-2010;

8) Smoked Cheddar Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce, 12 ounce, and 16 ounce round or square plastic containers (tub with snap on lid), 5 lb., 5.5 lb., 10 lb., and 30 lb. white tub with snap on lid. Recall # F-1961-2010;

9) Garlic Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce, 12 ounce, and 16 ounce round or square plastic containers (tub with snap on lid), 5 lb., 5.5 lb., 10 lb., and 30 lb. white tub with snap on lid. Recall # F-1962-2010;

10) Jalapeno Cheddar Cold Pack Cheese sold under the following sizes and brands: Crystal Farms label in 8 ounce round plastic container (tub with snap on lid). Recall # F-1963-2010;

11) Pimento Spread Cold Pack Cheese sold under the following sizes and brands: 1. Block & Barrel label in 4 lb. and 5.5 lb. white tub with snap on lid. Recall # F-1964-2010;

12) Sharp Cheddar cheese ball and logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce, 9 ounce and 10 ounce, logs and balls in film overwrap; 2. Amish Classic label in 10 ounce balls and logs in film overwrap; 3. Century Resources in 8 ounce and 12 ounce cheese balls and logs in film overwrap. Recall # F-1965-2010;

13) Port Wine cheese ball and logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce, 9 ounce and 10 ounce, logs and balls in film overwrap; 2. Amish Classic label in 10 ounce balls and logs in film overwrap. Recall # F-1966-2010;

14) Ranch cheese ball and logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce, 9 ounce and 10 ounce, logs and balls in film overwrap; 2. Amish Classic label in 10 ounce balls and logs in film overwrap. Recall # F-1967-2010;

15) Smokey Bacon cheese ball and logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce, 9 ounce and 10 ounce, logs and balls in film overwrap; 2. Amish Classic label in 10 ounce balls and logs in film overwrap. Recall # F-1968-2010;

16) Beef and Onion cheese ball and logs sold under the following sizes and brands: Amish Classic label in 10 ounce balls and logs in film overwrap. Recall # F-1969-2010;

17) Garlic cheese ball and logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce, 9 ounce and 10 ounce, logs and balls in film overwrap. Recall # F-1970-2010;

18) Jalapeno cheese ball and logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce, 9 ounce and 10 ounce, logs and balls in film overwrap. Recall # F-1971-2010;

19) Pimento cheese ball and logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce, 9 ounce and 10 ounce, logs and balls in film overwrap. Recall # F-1972-2010;

20) Spinach cheese ball and logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce, 9 ounce and 10 ounce, logs and balls in film overwrap. Recall # F-1973-2010;

21) Jajik cheese ball and logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce, 9 ounce and 10 ounce, logs and balls in film overwrap.  Recall # F-1974-2010;

22) Beer and Chorizo cheese ball and logs sold under the following sizes and brands: 1. Parkers Farm and Parkers label in 8 ounce, 9 ounce and 10 ounce, logs and balls in film overwrap. Recall # F-1975-2010;

23) Century Resources Pimento Spread, 12 ounce, tub with snap on lid. Recall # F-1976-2010;

24) Strawberry Cream Cheese Bagel Spread sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 7 ounce in white plastic container tub with snap on lid); 2. Dutch Farms label in 7 ounce round plastic container (tub with snap on lid). Recall # F-1977-2010;

25) Wildberry Cream Cheese Bagel Spread sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 7 ounce in white plastic container tub with snap on lid). Recall # F-1978-2010;

26) Apple Cinnamon Cream Cheese Bagel Spread sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 7 ounce in white plastic container tub with snap on lid); 2. Dutch Farms label in 7 ounce round plastic container (tub with snap on lid). Recall # F-1979-2010;

27) Honey Walnut Cream Cheese Bagel Spread sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 7 ounce in white plastic container tub with snap on lid). Recall # F-1980-2010;

28) Garden Veggie Cream Cheese Bagel Spread sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 7 ounce in white plastic container tub with snap on lid). Recall # F-1981-2010;

29) Parkers Farm and Parkers label Jalapeno Nacho Dips and Spreads, 12 and 14 ounce, in square plastic container (tub with snap on lid)
 Recall # F-1982-2010;

30) Parkers Farm and Parkers label Pimento Dips and Spreads, 12 and 14 ounce, in square plastic container (tub with snap on lid)
Recall # F-1983-2010;

31) Salsa Con Queso Dips and Spreads under the following sizes and brands: 1. Parkers Farm and Parkers label, 12 and 14 ounce, in square plastic container (tub with snap on lid); 2. Century Resources label in 12 ounce tub with snap on lid. Recall # F-1984-2010;

32) Parkers and Parkers Farm label All Natural Peanut Butter Creamy, in 12 ounce and 16 ounce square plastic containers (tub with snap on lid) and 34 ounce Round plastic containers (tub with snap on lid). Recall # F-1985-2010;

33) Parkers and Parkers Farm label All Natural Peanut Butter Crunchy, in 12 ounce and 16 ounce square plastic containers (tub with snap on lid) and 34 ounce Round plastic containers (tub with snap on lid). Recall # F-1986-2010;

34) Parkers and Parkers Farm label All Natural Peanut Butter Honey Creamy, in 12 ounce and 16 ounce square plastic containers (tub with snap on lid). Recall # F-1987-2010;

35) Parkers and Parkers Farm label All Natural Peanut Butter Honey Crunchy, in 12 ounce and 16 ounce square plastic containers (tub with snap on lid). Recall # F-1988-2010;

36) Hot Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce square plastic containers (tub with snap on lid), 32 and 128 ounce plastic jugs (clear jug with screw cap); 2. Central Market label in 16 ounce round plastic containers (tub with snap on lid); Recall # F-1989-2010;

37) Mild Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce square plastic containers (tub with snap on lid), 32 and 128 ounce plastic jugs (clear jug with screw cap); 2. Central Market label in 16 ounce round plastic containers (tub with snap on lid); 3. San Pablo label in 128 ounce plastic jug (clear jug with screw cap). Recall # F-1990-2010;

38) Garlic Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce square plastic containers (tub with snap on lid), 32 and 128 ounce plastic jugs (clear jug with screw cap); 2. Central Market label in 16 ounce round plastic containers (tub with snap on lid). Recall # F-1991-2010;

39) Fire Roasted Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce square plastic containers (tub with snap on lid), and 128 ounce plastic jugs (clear jug with screw cap); 2. San Pablo label in 128 ounce plastic jug (clear jug with screw cap); Recall # F-1992-2010;

40) Black Bean Salsa sold under the following sizes and brands: Parkers Farm or Parkers label in 16 ounce square plastic containers (tub with snap on lid), and 32 ounce plastic jugs (clear jug with screw cap). Recall # F-1993-2010;

41) Medium Salsa sold under the following sizes and brands: Central Markets label in 16 ounce round plastic containers (tub with snap on lid). Recall # F-1994-2010
CODE
1) 1. Parkers Farm or Parkers label Sell by Dates on or before 12/31/2010; 2. Happy Farms label Sell by Dates on or before 12/31/2010; 3. Kroger label Sell by Dates on or before 12/31/2010; 4. Central Markets label Sell by Dates on or before 12/31/2010; 5. Dutch Farms label Sell by Dates on or before 12/31/2010; 6. Crystal Farms label Sell by Dates on or before 12/31/2010; 7. Helluva Good label in Sell by Dates on or before 12/31/2010; 8. Amish Classic label Sell by Dates on or before 12/31/2010; 9. Century Resources label with a sell by date of XXX9, (the last digit must be a 9); 10, Block & Barrel label Packed On Dates on or before 12/31/2010; 11. Cobblestone label Sell by Dates on or before 06/30/2010; 12. Biery label Sell by Dates on or before 09/30/2010; 13. Dierks Waukesha label Sell by Dates on or before 09/30/2010;

2) 1. Parkers Farm or Parkers label Sell by Dates on or before 12/31/2010; 2. Happy Farms label Sell by Dates on or before 12/31/2010; 3. Kroger label Sell by Dates on or before 12/31/2010; 4. Central Markets label Sell by Dates on or before 12/31/2010; 5. Dutch Farms label Sell by Dates on or before 12/31/2010; 6. Crystal Farms label Sell by Dates on or before 12/31/2010; 7. Helluva Good label in Sell by Dates on or before 12/31/2010; 8. Amish Classic label Sell by Dates on or before 12/31/2010; 9. Block & Barrel label Packed On Dates on or before 12/31/2010; 10. Cobblestone label Sell by Dates on or before 06/30/2010; 11. Biery label Sell by Dates on or before 09/30/2010; 12. Dierks Waukesha label Sell by Dates on or before 09/30/2010;
 
3) 1. Parkers Farm or Parkers label Sell by Dates on or before 12/31/2010; 2. Happy Farms label Sell by Dates on or before 12/31/2010; 3. Kroger label Sell by Dates on or before 12/31/2010; 4. Central Markets label Sell by Dates on or before 12/31/2010; 5. Dutch Farms label Sell by Dates on or before 12/31/2010; 6. Crystal Farms label Sell by Dates on or before 12/31/2010; 7. Amish Classic label Sell by Dates on or before 12/31/2010; 8. Block & Barrel label Packed on Dates on or before 12/31/2010; 9. Cobblestone label Sell by Dates on or before 06/30/2010; 10. Dierks Waukesha label Sell by Dates on or before 09/30/2010;

4) 1. Parkers Farm or Parkers label Sell by Dates on or before 12/31/2010; 2. Central Markets label Sell by Dates on or before 12/31/2010; 3. Dutch Farms label Sell by Dates on or before 12/31/2010; 4. Helluva Good label in Sell by Dates on or before 12/31/2010; 5. Amish Classic label Sell by Dates on or before 12/31/2010; 6. Century Resources label with a sell by date of XXX9, (the last digit must be a 9); 7, Block & Barrel label Packed On Dates on or before 12/31/2010; 8. Cobblestone label Sell by Dates on or before 06/30/2010; 9. Dierks Waukesha label Sell by Dates on or before 09/30/2010;

5) 1. Parkers Farm or Parkers label Sell by Dates on or before 12/31/2010; 2. Crystal Farms label Sell by Dates on or before 12/31/2010; 3. Century Resources label with a sell by date of XXX9, (the last digit must be a 9);

6) 1. Parkers Farm or Parkers label Sell by Dates on or before 12/31/2010; 2. Dutch Farms label Sell by Dates on or before 12/31/2010;

7) Parkers Farm or Parkers label Sell by Dates on or before 12/31/2010;

8) Parkers Farm or Parkers label Sell by Dates on or before 12/31/2010;

9) Parkers Farm or Parkers label Sell by Dates on or before 12/31/2010;

10) Crystal Farms label Sell by Dates on or before 12/31/2010;

11) Block & Barrel label Packed On Dates on or before 12/31/2010;

12) Parkers Farm and Parkers label with sell by dates on or before 01/05/2011; 2. Amish Classic with sell by dates on or before 01/05/2011. 3. Century Resources with a sell by date of XXX9 (the last digit must be a 9);

13) 1. Parkers Farm and Parkers label with sell by dates on or before 01/05/2011; 2. Amish Classic with sell by dates on or before 01/05/2011;

14) 1. Parkers Farm and Parkers label with sell by dates on or before 01/05/2011; 2. Amish Classic with sell by dates on or before 01/05/2011;

15)  1. Parkers Farm and Parkers label with sell by dates on or before 01/05/2011; 2. Amish Classic with sell by dates on or before 01/05/2011;

16) Amish Classic with sell by dates on or before 01/05/2011;

17) 1. Parkers Farm and Parkers label with sell by dates on or before 01/05/2011;

18) 1. Parkers Farm and Parkers label with sell by dates on or before 01/05/2011;

19) 1. Parkers Farm and Parkers label with sell by dates on or before 01/05/2011;

20) Parkers Farm and Parkers label with sell by dates on or before 01/05/2011;

21) Parkers Farm and Parkers label with sell by dates on or before 01/05/2011;

22) 1. Parkers Farm and Parkers label with sell by dates on or before 01/05/2011;

23) Sell by date of XXX9 (last digit must be a 9);

24) 1. Sell by Dates on or before 06/30/2010; 2. Sell by Dates on or before 06/30/2010;

25) 1. Parkers Farm or Parkers label Sell by Dates on or before 06/30/2010; 2. Dutch Farms label Sell by Dates on or before 06/30/2010;

26) 1. Parkers Farm or Parkers label Sell by Dates on or before 06/30/2010; 2. Dutch Farms label Sell by Dates on or before 06/30/2010;

27) 1. Parkers Farm or Parkers label Sell by Dates on or before 06/30/2010; 2. Dutch 27) Farms label Sell by Dates on or before 06/30/2010;

28) Parkers Farm or Parkers label Sell by Dates on or before 06/30/2010;

29) Sell by dates on or before 09/30/2010;

30) Sell by Dates on or before 09/30/2010;

31) 1. Sell by dates on or before 09/30/2010 2. Sell by date of XXX9 (the last digit must be a 9);

32) 12 & 16 ounce containers with sell by dates on or before 12/31/2010. 34 ounce containers with sell by dates on or before 09/30/2010;

33) 12 & 16 ounce containers with sell by dates on or before 12/31/2010. 34 ounce containers with sell by dates on or before 09/30/2010;

34) 12 & 16 ounce containers with sell by dates on or before 12/31/2010;

35) 12 & 16 ounce containers with sell by dates on or before 12/31/2010;

36) 1. Parkers Farm or Parkers label Sell by dates o or before 04/30/2010; 2. Central Market label Sell by dates on or before 04/30/2010

37) 1. Parkers Farm or Parkers label Sell by dates o or before 04/30/2010; 2. Central Market label Sell by dates on or before 04/30/2010; 3. San Pablo label Sell by dates on or before 04/30/2010;

38) 1. Parkers Farm or Parkers label Sell by dates o or before 04/30/2010; 2. Central Market label Sell by dates on or before 04/30/2010

39) 1. Parkers Farm or Parkers label Sell by dates on or before 04/30/2010; 2. San Pablo label Sell by dates on or before 04/30/2010;

40) Parkers Farm or Parkers label Sell by dates on or before 04/30/2010;

41) Central Market label Sell by dates o or before 04/30/2010
RECALLING FIRM/MANUFACTURER
Parkers Farm Inc., Coon Rapids, MN, by press release, telephone and e-mail on January 8, 2010 and January 14, 2010. Firm initiated recall is ongoing.
REASON
Parkers Farm, Inc. is recalling certain products because they have the potential to be contaminated with Listeria monocytogenes. EXPANDED: On 01/14/2010 Parkers Farm expanded their recall to include all date codes of all products made at their facility because they have the potential to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
491,287 cases total
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
Bull Dawg Concentrate 1+ 5, 3 gallon bag in a box. There is a white label with black print on box, No UPC. Recall # F-1929-2010
CODE
Code date: 3/30/10 to 5/17/10
RECALLING FIRM/MANUFACTURER
Penguin Juice Company, Inc., Westland, MI, by voicemail on March 23, 2010 and verbally on March 24, 2010. Firm initiated recall is ongoing.
REASON
The product contains FD&C yellow # 5 and yellow # 6 which are not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
30 3 gallon bag in a box containers
DISTRIBUTION
MI and GA
___________________________________
PRODUCT
Delicias del Mar, 6 pieces, net wt. 16 oz. Four packs/6 pieces per box. Total of 24 per box. Recall # F-1930-2010
CODE
C1034C
RECALLING FIRM/MANUFACTURER
Delicias del Mar, Vega Baja, PR, by visit on April 5, 2010. Firm initiated recall is complete.
REASON
The original packaging of the shrimp (raw material), lists sodium bisulfite as a preservative. The label of the product Empanadillas de camarones "Turnover filled with shrimp" does not declare sodium bisulfite. For a person who is sensitive to sulfites, a reaction can be mild to life threatening.
VOLUME OF PRODUCT IN COMMERCE
7 boxes
DISTRIBUTION
PR
___________________________________
PRODUCT
1) Product label reads in part: "Kirkman Zinc Liquid***Dietary Supplement***Each Serving Contains***Zinc (from Zinc Alpha Ketoglutarate) 20 mg***Ingredients: Distilled Water, Sorbitol, Glycerine, Citric Acid, Zinc Alpha Ketoglutarate, Natural Raspberry Flavor, Potassium Sorbate, Stevia Leaf Extract. The product is available in 8 and 16 fluid ounce sizes and a 60 ml trial size. Recall # F-1945-2010;

2) Product label reads in part: "Kirkman Vitamin C Chewable Tablets 250mg***Dietary Supplement***Each Serving Contains Vitamin C 250mg***Ingredients: Sorbitol, Sodium Ascorbate, Ascorbic Acid, Natural Passion Fruit Flavor, Stearic Acid (Vegetable), Magnesium Stearate (Vegetable), Stevia Leaf Extract. The product is available in bottles of 100 or 250 tablets and a 15 tablet trial size bottle. Recall # F-1946-2010;

3) Product label reads in part: "Kirkman B-Complex with CoEnzymes Pro-Support Powder200 gm/7oz***Dietary Supplement***Ingredients: Fructose, Choline Citrate, Citric Acid, Thiamine Mononitrate, Natural Tropical Punch Flavor, Riboflavin 5 Phosphate, Niacinamide, Di-Calcium Phosphate, Silicon Dioxide, Pyridoxal 5 Phosphate, Biotin, Cyanocobalamin, d-Calcium Pantothenate, Stevia Leaf Extract, Folic Acid. Product is in powder form in a white plastic tub. Recall # F-1947-2010;

4) Product label reads in part: "Kirkman TMG (Trimethylglycine) with Folic Acid & B-12 Powder 227 gm/8 oz***Dietary Supplement***Ingredients Trimethylglycine, Mannitol, Natural Berry Flavor, Citric Acid, Silicon Dioxide, Stevia Leaf Extract, Vitamin B-12 (Cyanacobalamin), Folic Acid. Product is in powdered form in an 8oz white plastic tub. Recall # F-1948-2010;

5) Product label reads in part: "Kirkman Dmae (Dimethylaminoethanol) 50 mg Chewable Wafers***Dietary Supplement***Ingredients: Sorbitol, Dimethylaminoethanol Bitartrate, Natural Tropical Fruit Punch Flavor, Citric Acid, Silicon Dioxide, Stearic Acid (Vegetable), Magnesium Stearate (Vegetable), Stevia Leaf Extract. Recall # F-1949-2010

6) Product label reads in part: "Kirkman Super Nu-Thera w/o Vitamins A & D Powder Flavored 454 gm/16 oz***Dietary Supplement***Ingredients: Fructose, Ascorbic Acid, Pyridoxine Hydrochloride, Magnesium Oxide, Magnesium Glycinate, Silicon Dioxide, Natural Orange Flavor, Vitamin E (Acetate dl), Maltodextrin, Starch, Magnesium Citrate, Zinc Citrate, Niacinamide, Natural Tangerine Flavor, d-Calcium Pantothenate, Thiamine Mononitrate, Riboflavin, Di-Calcium Phosphate, Biotin, Stevia Leaf Extract, Manganese Citrate, Selenium Chelate, Sodium Ascorbate, Cyanocobalamin, Calcium Folinate, Potassium Iodide. Recall # F-1950-2010;

7) Product label reads in part: "Kirkman Super Nu-Thera Powder Flavored 454 gm/16 oz***Dietary Supplement***Ingredients: Fructose, Ascorbic Acid, Vitamin B-6, Magnesium Oxide, Magnesium Glycinate, Silicon Dioxide, Natural Orange Flavor, Vitamin E Acetate (dl), Maltodextrin, Starch, Magnesium Citrate, Zinc Citrate, Niacinamide, Natural Tangerine Flavor, d-Calcium Pantothenate, Thiamine Mononitrate, Riboflavin, Vitamin A Acetate, Di-Calcium Phosphate, Stevia Leaf Extract, Biotin, Manganese Citrate, Selenium Chelate, Sodium Ascorbate, Vitamin D-3, Cyanocobalamin, Calcium Folinate, Potassium Iodide. Product is powdered and comes in 16 oz, 150gm and 2oz (trial) sizes. Recall # F-1951-2010;
CODE
1) Lot numbers: 413-001 Best Used By: 9/30/11 (lot dependent). Code Breakdown: First three numbers are product number; next 3 are sequential batches of that product. 001 was first batch produced, 002 was second produced etc;

2) Lot numbers: 389-001 through 389-004 Best Used By: 4/30/11 to 12/31/11 (lot dependent). Code Breakdown: First three numbers are product number; next 3 are sequential batches of that product. 001 was first batch produced, 002 was second produced etc;

3) Lot numbers: 399-001 through 399-003 Best Used By: 5/31/11 to 10/31/11 (lot dependent). Code Breakdown: First three numbers are product number; next 3 are sequential batches of that product. 001 was first batch produced, 002 was second produced etc;

4) Lot numbers: 387-001 through 387-014 Best Used By: 1/31/11 to 1/31/12 (lot dependent). Code Breakdown: First three numbers are product number; next 3 are sequential batches of that product. 001 was first batch produced, 002 was second produced etc;

5) Lot numbers: 489-001 through 489-003 Best Used By: 5/31/11 to 12/31/11 (lot dependent). Code Breakdown: First three numbers are product number; next 3 are sequential batches of that product. 001 was first batch produced, 002 was second produced etc;

6) Lot numbers: 447-001 and 447-002. Best Used By: 4/30/11 to 8/31/11 (lot dependent). Code Breakdown: First three numbers are product number; next 3 are sequential batches of that product. 001 was first batch produced, 002 was second produced etc;

7) Lot numbers: 410-001 and 410-002 Best Used By: 6/30/11 to 8/31/11(lot dependent). Code Breakdown: First three numbers are product number; next 3 are sequential batches of that product. 001 was first batch produced, 002 was second produced etc
RECALLING FIRM/MANUFACTURER
Kirkman Group Inc., DBA Kirkman Laboratories Inc., Lake Oswego, OR, by letter on December 30, 2009, email, telephone follow-up beginning January 6, 2010. Firm initiated recall is ongoing.
REASON
Products contain undeclared antimony.
VOLUME OF PRODUCT IN COMMERCE
15,061 bottles
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
1) Erythromycin Ophthalmic Ointment USP, 0.5% (5 mg/g), Net Wt 1 gram, Sterile tube, Rx only; NDC 0168-0070-11. Recall # D-504-2010;

2) Bacitracin Zinc and Polymyxin B Salfate Ophthalmic Ointment USP, 500 bacitracin units + 10,000 polymyxin B units per gram, Net Wt 3.5 g (1/8 oz), Sterile, tube, Rx only; NDC 0168-0273-38. Recall # D-505-2010;

3) Gentamicin Sulfate Ophthalmic Ointment USP, 3 mg/gram, Net Wt 3.5 g (1/8 0z), Sterile, tube, Rx only; NDC 0168-0044-38. Recall # D-506-2010;

4) Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP, 3.5mg Neomycin + 10,000 Polymyxin B units + 1mg Dexamethasone per gram; Net Wt 3.5 g (1/8 oz), Sterile, tube, Rx only; NDC 0168-0221-38. Recall # D-507-2010;

5) Puralube Ointment (Petrolatum Ophthalmic Ointment), Sterile Ocular Lubricant, Net Wt 1 gram, tube, OTC. NDC 0168-0150-11. Recall # D-508-2010
CODE
1) Lots R46 (exp. 03/10), R50 (exp. 04/10), R64 (exp. 05/10), R66 (exp. 06/10), R77 (exp. 07/10), R78 (exp. 09/10), R79 (exp. 10/10), R80 (exp. 10/10), R82 (exp. 12/10), 50A (exp. 03/11), 52A (exp. 04/11), 53A (exp. 05/11), 56A (exp. 06/11);

2) Lot 67A (exp. 01/11);

3) Lot 13A (exp. 10/10;

4) Lot 29A (exp. 11/10);

5) Lots R09 (exp. 11/10), R56 (exp. 04/11), R90 (exp. 06/11), 68A (exp. 01/12)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nycomed US, Inc.,  Melville, NY, by letters on March 19, 2010.
Manufacturer: Nycomed Us Inc., Hicksville, NY. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility. Potential bacterial contamination.
VOLUME OF PRODUCT IN COMMERCE
126,764 (for all 5 products)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Claritin Eye (ketotifen fumarate) ophthalmic solution, Antihistamine Eye Drops, sterile, 0.025%, 5 mL (0.17 FL OZ), dropper bottle, OTC. NDC# 11523-7235-1. Recall # D-509-2010
CODE
Lot Numbers: JH9861 (Exp Dec-11), JD2529V (Exp Jan-11), JD2532 (Exp Feb-11), JD2530 (Exp Feb-11), JD2531 (Exp Feb-11), JD2533 (Exp Feb-11), and JD3861 (Exp Feb-11). UPC code 0-41100-80586-7
RECALLING FIRM/MANUFACTURER
Apotex Corp.,Weston, FL, by letter on March 25, 2010. Firm initiated recall is ongoing.
REASON
Failed pH specifications.
VOLUME OF PRODUCT IN COMMERCE
906,926 bottles
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
1) Motrin IB (Ibuprofen) Tablets USP 200mg, Pain Reliever/Fever Reducer (NSAID), a) 24-count bottle , NDC 50580-109-02, UPC 300450463029; b) 50-count bottle , NDC50580-109-03, UPC 300450463036; c) 100-count bottle, NDC 50580-109-04, UPC 300450463043; d) 100+25-count bottle, NDC 50580-109-29, UPC 300450463296; e) 100+50-count bottle, NDC 50580-109-75, UPC 300450463753, OTC. Recall # D-510-2010;

2) Motrin IB (Ibuprofen) Tablets USP 200mg Coated Caplets, Pain Reliever/Fever Reducer (NSAID), a) 24-count bottles, NDC 50580-110-03, UPC 300450481030; b) 24+6-count bottle, NDC 50580-110-64, UPC 300450481641; c)50-count bottle, NDC 50580-110-02, UPC 300450481023; d) 100- count bottle, NDC 50580-110-01, UPC 3004850481016; e) 100+25-count bottle, NDC 50580-110-95, UPC 300450481955; f) 100+50-count bottle, NDC 50580-110-75, UPC 300450481757; g) 225-count bottle, NDC 50580-110-62, UPC 300450481627; h) 300-count bottle, NDC 50580-110-37, UPC 300450481375, OTC. Recall # D-511-2010;

3) Motrin Junior Strength for ages 6-11 (Ibuprofen ) Tablets, 100mg, Pain Reliever/Fever Reducer (NSAID), Grape Flavored Chewable Tablets, 24-count bottle, NDC 50580-909-24, UPC 300450909244, OTC. Recall # D-512-2010;

4) Motrin Junior Strength for ages 6-11 (Ibuprofen) Tablets, 100mg, Pain Reliever/Fever Reducer (NSAID), Easy-to-Swallow Caplets, 24-count bottle, NDC 50580-498-24, UPC 300450498243, OTC. Recall # D-513-2010;

5) Motrin Junior Strength for ages 6-11 (Ibuprofen) Tablets, 100mg, Pain Reliever/Fever Reducer (NSAID), Orange Flavored Chewable Tablets, 24-count bottle, NDC 50580-207-24, UPC 300450494245, OTC. Recall # D-514-2010
CODE
1) a) Lot # ABA003, Exp 11/30/2011; ADA258, Exp 2/28/2012; AFA309, Exp 3/31/2012; and AJA055, Exp 5/31/2012; b) Lot # ABA004, ABA152, Exp 11/30/2011; AFA228, Exp 3/31/2012; AHA024, Exp 4/30/2012; AJA007, Exp 5/31/2012; and AJA243 4/30/2012; c) Lot # AEA078, AEA261, Exp 3/31/2012 and AFA241, Exp 4/30/2012; d) Lot # AFA017 Exp 4/30/2012; and AJA168, Exp 1/31/2012; e) Lot # ALA109, Exp 7/31/2012;

2)  a) Lot # AAA435, ABA369, Exp 11/30/2011; ADA174, Exp 2/28/2012; AHA026, and AJA006, Exp 4/30/2012; b) Lot # ADA246, Exp 2/28/2012; c) Lot # ABA153, Exp 10/31/2011; ABA541, Exp 12/31/2011; ADA173, Exp 2/28/2012; and AHA025, Exp 4/30/2012; d) Lots # ABA019, Exp 11/30/2011; ACA469, Exp 12/31/2011; ADA245, Exp 2/28/2012; AEA260, Exp 3/31/2012; AFA015, Exp 4/30/2012; AJA049, and AJA186, Exp 6/30/2012; e) Lot # ADA287, Exp 2/28/2012; and AFA016, Exp 4/30/2012; f) Lot # ABA538, Exp 0/31/2011; AJA023 and AJA120, Exp 6/30/2012; g) Lot # 24526, Exp 12/31/2009; 24544 ,24604, Exp 1/31/2010; 24591, Exp 3/31/2010; 24634, Exp 5/31/2010; 24687, 24762, Exp 7/31/2010; 24795, Exp 9/30/2010; 24794, 24818, Exp 11/30/2010; 24864, Exp 1/31/2011; 24905, 24915, Exp 2/28/2011; 24935, 24939, Exp 3/31/2011; 25013, Exp 4/30/2011; 24977, Exp 5/31/2011; 25044, 25980, Exp 6/30/2011; 25996, 26051, Exp 8/31/2011; 26085, Exp 10/21/2011; 26134, 26192, Exp 11/30/2011; 26241, 26335, Exp 1/31/2012; 26423, 26455, Exp 4/30/2012; 26508, Exp 6/30/2012; 26533, Exp 8/31/2012; h) Lot # ACA442, ACA759, ADA018, Exp Date 1/31/2012; ADA419, Exp Date 2/28/2012; AFA098, AFA112, AHA034, AHA068, ALA359, Exp Date 4/30/2012; ALA254, AMA177, AMA350, Exp Date 8/31/2012; APA217, Exp Date 9/30/2012; SEA208, Exp Date 3/31/2011; SFA184, SFA259, SHA107, Exp Date 4/30/2011; SJA131, SLA162, Exp Date 6/30/2011; SLA049, SMA013, SMA082, Exp Date 7/31/2011; and SSA157 Exp Date 9/30/2011;

3) Lot # ADM006, Exp Date 2/28/2011; ADM052, Exp Date 3/31/2011; AFM016, AFM350, Exp Date 5/31/2011; AHM420, Exp Date 6/30/2011; AJM346, ALM344, Exp Date 7/31/2011; ALM399, AMM379, Exp Date 9/30/2011; APM303, APM418, Exp Date 10/31/2011; APM429, Exp Date 11/30/2011; and SLM084, Exp Date 8/31/2010;

4) Lot # AJM322, Exp Date 7/31/2012; and APM348, Exp Date 10/31/2012;

5) a) Lot # ADM013, AFM024, Exp Date 3/31/2011; AHM402, Exp Date 6/30/2011; AJM345, ALM326, Exp Date 7/31/2011; ALM456, AMM381, Exp Date 9/30/2011; APM306, Exp Date 10/31/2011; and APM421, Exp Date 11/30/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, by website posting on November 6, 2009, a press release on December 18, 2009 and letters on November 9, 2009, December 18, 2009 and January 15, 2010. 
Manufacturer:  McNeil Healthcare, LLC, Las Piedras, PR. Firm initiated recall is ongoing.
REASON
Chemical Contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2,4,6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
VOLUME OF PRODUCT IN COMMERCE
11,728,152 bottles
DISTRIBUTION
Nationwide, Puerto Rico, Canada, Uruguay, Fiji, Dominican Republic, Trinidad, Guatemala, Jamaica, Guam, and UAE
___________________________________
PRODUCT
Diflorasone Diacetate Cream, USP, 0.05%, a) 15 grams per tube (NDC 0168-0242-15) and b) 30 grams per tube (NDC 0168-0242-30), Rx only. The product is packaged in a tube which is packed inside a unit cardboard carton. Recall # D-515-2010
CODE
a) Lot# 976D, Exp 8/2011; b) Lot# 329D Exp 11/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nycomed US, Inc., Melville, NY, by letters and business reply cards dated March 30, 20103.  
Manufacturer: Nycomed Us Inc., Hicksville, NY. Firm initiated recall is ongoing.  
REASON
Superpotent (Single Ingredient) Drug: Out-of-specification (OOS) assay results both above and below the approved specification (90-110%) were found in the recalled lots.
VOLUME OF PRODUCT IN COMMERCE
22,779 tubes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1036-10
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1037-10 
CODE
1) Unit: W038309117129;
2) Unit: W038309084232 (2 units)
RECALLING FIRM/MANUFACTURER
Mississippi Valley Reg Building Center, Davenport, IA, by telephone and facsimile on November 4, 2009 and by letter dated November 6, 2009. Firm initiated Recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC, MO

___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1038-10 
CODE
Unit: W041509040925S
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc - Lubbock Center, Lubbock, TX, by letter dated December 16, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who lived in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1039-10
CODE
Unit: 2008353
RECALLING FIRM/MANUFACTURER
Upstate New York Transplant Services, Inc., Buffalo, NY, by telephone and facsimile on November 12, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of hepatitis B, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Source plasma. Recall # B-1068-10
CODE
Units 0411156741, 0411149824, 0411147516, 0411146603, 0411132985, 0411122483, 0411121510, 0411121015, 0411119855, 0411119141, 0411117883, 0411117172, 0411115511, 0411113286, 0411112530, 0411098824, 0411091243, 0411090486, 0411088698, 0411088255, 0411086884, 0411085937, 0411085285, 0411075986, 0411098014, 0411097229, 0411096314, 0411095439, 0411094704, 0411093698, 0411092841 and 0411092039
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Oak Park, MI, by facsimile on or about March 18, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD) were distributed.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION
NC, Germany and Switzerland
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1116-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1117-10;

3) Platelets Pheresis Leukocytes Reduced. Recall # B-1118-10;

4) Fresh Frozen Plasma Pheresis. Recall # B-1120-10;

5) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1121-10; 

6) Red Blood Cells Pheresis Leukocytes Reduced. Recall # B-1122-10; 

7) Plasma Frozen Within 24 hours (FP24). Recall # B-1123-10 
CODE
1) Units: 158322668, 158326591, 158326705, 158327268;

2) Units: Units: 157031049, 157031052, 157031057, 157031134, 157031135, 157035112, 157035172, 157035178, 157035185, 157035192, 157035194, 157035241, 157035247, 157035318, 157035328, 157035437, 157035438, 157035440, 157035445, 157035446, 157035449, 157035452, 157037094, 157037097, 157037109, 157037115, 157037177, 157037181, 157037183, 157037189, 157037194, 157037275, 157037277, 157037281, 157037540, 157040402, 157040409, 157040412, 157040414, 157040415, 157040681, 157040697, 157040703, 157041436, 157041479, 157041481, 157041525, 157041546, 157041748, 157041752, 157041756, 157043405, 157043409, 157043416, 157043468, 157043470, 157043486, 157043623, 157043631, 157043633, 157043634, 157043849, 157043870, 157045495, 157045543, 157045546, 157046225, 157046230, 157046233, 157046236, 157046240, 157046243, 157047055, 158327342, 158327347, 158327348, 158327350, 158327352, 158327354, 158327356, 157031202, 157031204, 157031213, 157031214, 157031215, 157031216, 157031261, 157031275, 158322668, 158322761, 158322762, 158325111, 158325116, 158325122, 158325124, 158325126, 158325128, 158325367, 158325368, 158325380, 158325382, 158325860, 158325868, 158325878, 158325890, 158326251, 158326264, 158326277, 158326282, 158326451, 158326517, 158326528, 158326531, 158326537, 158326539, 158326544, 158326546, 158326591, 158326705, 158326719, 158326722, 158326758, 158327017, 158327070, 158327077, 158327080, 158327081, 158327220, 158327225, 158327240, 158327241, 158327244, 158327247, 158327249, 158327255, 158327262, 158327265, 158327268, 157035026, 157035137, 157035182, 157040671, 157040684, 157040689, 157045412, 158327079, 158327132;

3) Units: 157031040, 157031082, 157031139 (2 units), 157037262, 157040661 (2 units), 157040695 (2 units), 157041634, 157041649 (3 units), 157041650 (2 units), 157043841 (3 units), 158322607, 158322621 (2 units), 158322736, 158327012, 158327014 (2 units), 158327124 (2 units), 158327131 (2 units), 158327179, 158327180, 157043838, 158322677;

4) Units: 157037254 (2 units), 157031055, 157035031, 157041634, 158327012, 158327179, 158327180;

5) Units: 157035031, 157043838, 158322677;

6) Units: 157035323 (2 units), 157035329 (2 units), 157035433 (2 units), 157035441 (2 units), 157037254, 157037576 (2 units), 157037591 (2 units), 157040404 (2 units), 157041421 (2 units), 157043403 (2 units), 157043625 (2 units), 157043698 (2 units), 158325370 (2 units), 158326252 (2 units), 158326446 (2 units), 158326513 (2 units), 158326714 (2 units), 157035026, 157035137, 157035182, 157040661, 157040671, 157040684, 157040689, 157045412, 158327014, 158327079, 158327124, 158327126, 158327132, 158327179, 158327180;

7) Units: 157035241, 157037094, 157037097, 157037109, 157037115, 157043409, 157043416, 157043633, 157043634
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on April 18, 2007 and by letter dated May 18, 2007.  
Manufacturer: United Blood Services - San Angelo, San Angelo, TX. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
252 units

DISTRIBUTION
NY, NM, TX, MS, AR, England, Switzerland
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1131-10; 
2) Fresh Frozen Plasma. Recall # B-1132-10  
CODE
1) and 2) Unit: W04190902807D
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by facsimile on November 2, 2009 and by letter dated December 14, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UK, NV
___________________________________
PRODUCT
Source Plasma. Recall # B-1133-10
CODE
Unit: 09SWIG2570
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LLC, Sheboygan, WI, by facsimile on November 20, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a physical exam, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-1134-10
CODE
Unit: 09FNCE8448
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Fayetteville, NC, by facsimile on October 23, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a physical exam, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1135-10
CODE
Unit: 09SWIA2419
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LLC, Sheboygan, WI, by facsimile on October 27, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a physical exam, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1051-10 
CODE
53GK51109 (Parts 1, 2, and 3), 53GK51106 (Parts 1, 2, and 3), 53GK51103 (Part 3)
RECALLING FIRM/MANUFACTURER
America National Red Cross-Greater Chesapeake & Potomac Reg., Baltimore, MD, by telephone on September 4, 2007 and by letter dated November 5, 2007. Firm initiated recall is complete.
REASON
Blood products, which were not tested for platelet yield, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MD
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1119-10;
CODE
Units: 157031134, 157031135, 157031202, 157031204, 157031213, 157031214, 157031215, 157031216, 157035318, 157037275, 157037277, 157037281, 157037540, 157040402, 157040409, 157040412, 157040415, 157040681, 157041479, 157043405, 157043486, 157043870, 158322762, 158325111, 158325116, 158325122, 158325124, 158325126, 158325128, 158325367, 158325368, 158325380, 158325382, 158325860, 158325868, 158325878, 158325890, 158326251, 158326264, 158326277, 158326282, 158326451, 158326517, 158326528, 158326531, 158326537, 158326539, 158326544, 158326546, 158326719, 158326722, 158326758, 158327017, 158327070, 158327077, 158327080, 158327081, 158327220, 158327225, 158327240, 158327241, 158327244, 158327247, 158327249, 158327255, 158327350, 158327352, 158327354, 157031049, 157031052, 157031057, 157035112, 157035172, 157035178, 157035185, 157035192, 157035194, 157035437, 157035438, 157035440, 157035445, 157035446, 157035449, 157035452, 157037177, 157037181, 157037183, 157037189, 157037194, 157041525, 157041748, 157041752, 157041756, 158327342, 158327347, 158327348, 158327356
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on April 18, 2007 and by letter dated May 18, 2007.  
Manufacturer: United Blood Services - San Angelo, San Angelo, TX. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
97 units
DISTRIBUTION
NY, NM, TX, MS, AR, England, Switzerland

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

___________________________________
PRODUCT
1) Orthofix US XCaliber Meta-Diaphyseal Complete Kit, Sterile. 99-91600. Intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality. Recall # Z-1434-2010;

2) Orthofix US XCaliber Ankle Complete Kit, Sterile, 99-91647. Intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality. Recall # Z-1435-2010
CODE
1) Lot Numbers: IT965408;
2) Lot Numbers: IT956155 and IT967331
RECALLING FIRM/MANUFACTURER
Orthofix Srl, Bussolengo (Verona), Italy, by Field Safety Notice, dated February 22, 2010. Firm initiated recall is completed.
REASON
During standard quality controls, firm identified a potential for breakage of the XCaliber clamp when locking the cam.
VOLUME OF PRODUCT IN COMMERCE
34 units
DISTRIBUTION
TX, ND, NY, FL and CA
___________________________________
PRODUCT
Elekta Synergy Intended to be used for radiation therapy treatment of malignant neoplastic diseases. Recall # Z-1441-2010
CODE
Lots 135003, 135013, 135015, 135020, 135022, 135023, 135024, 135025, 135028, 135035, 135036, 135037, 135038, 135042, 135046, 135047, 135055, 135056, 135058, 135061, 135062, 135063, 135065, 135068, 135071, 135072, 135073, 135076, 135079, 135085, 135087, 135090, 135093, 135096, 135100, 135101, 135103, 135105, 135110, 135111, 135113, 135118, 135119, 135121, 135122, 135124, 135125, 135126, 135144, 135150, 135151, 135157, 135158, 135163, 135164, 135167, 135168, 135170, 135172, 137173, 135175, 135177, 135181, 135182, 135184, 135189, 135191, 135190, 135192, 135195, 135196, 135199, 135200, 135206, 135207, 135208, 135209, 135210, 135211, 135215, 135216, 135224, 135225, 135226, 135227, 135230, 135233, 135237, 135241, 135247, 135251, 135256, 135258, 135262, 135271, 135272, 135274, 135277, 135278, 135282, 135285, 135296, 135298, 135303, 135306, 135313,135323, 135324, 151008, 151024, 151033, 151038, 151051, 151053, 151055, 151059, 151073, 151074, 151076, 151080, 151084, 151093, 151104, 151110, 151130, 151134, 151141, 151143, 151151, 151154, 151155, 151156, 151157, 151160, 151167, 151168, 151173, 151176, 151178, 151216, 151228, 151229, 151238, 151245, 151250, 151253, 151256, 151259, 151260, 151266, 151267, 151269, 151298, 151301, 151305, 151309, 151317, 151325, 151326, 151327, 151328, 151340, 151352, 151359, 151360, 151362, 151363, 151369, 151371, 151387, 151390, 151394, 151398, 151411, 151416, 151421, 151422, 151423, 151430, 151433, 151435, 151441, 151446, and 151479
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcros, GA, by letters on March 13, 2008 and October 17, 2008.
Manufacturer: Elekta Oncology Systems (Fmrl Philipps), Crawley, West Sussex, United Kingdom. Firm initiated recall is ongoing.
REASON
Installation of a touchguard to prevent injury to patients or staff by stopping machine movements in the case of accidental collision.
VOLUME OF PRODUCT IN COMMERCE
184 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Literature for Implant Extraction Set - Implant Extraction Guide Module One & Two. Lists and describes the instruments which are in the Implant Extraction Set and the general application of these instruments for hardware removal. Recall # Z-1443-2010
CODE
LIES-OT
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on March 2, 2010.
Manufacturer: Stryker Trauma GmbH, Schonkirchen, Germany. Firm initiated recall is ongoing.
REASON
Literature did not include the design change to a smaller cannulation diameter.
VOLUME OF PRODUCT IN COMMERCE
790 pieces
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Baxter RenAmin (Amino Acid) Injection; Pharmacy Bulk Package Not for Direct Infusion, Rx Only, 250 mL type II glass bottles; Made in USA; product code 2A6222. Recall # Z-1528-2010;

2) Baxter Evacuated Container, 250 mL, Sterile, non pyrogenic, Rx Only. Made in USA, product code 1A8502. Recall # Z-1529-2010;

3) Baxter Evacuated Container, 500 mL, Sterile, non pyrogenic, Rx Only. Made in USA, product code 1A8503. Recall # Z-1530-2010
CODE
1) Lot number: G076802;
2) Lot numbers: G075531, G076937, and G076794;
3) Lot numbers: G075770, G075788, and G075796
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated February 15, 2010. Manufacturer: Baxter Healthcare Corp., Cleveland, MS. Firm initiated recall is ongoing.
REASON
Routine stability testing of the evacuated container product, along with trending of results, indicates that the pH will exceed the upper specification limit prior to the expiration date of this product.
VOLUME OF PRODUCT IN COMMERCE
148,032 units
DISTRIBUTION
Nationwide, Puerto Rico, Canada and Saudi Arabia
___________________________________
PRODUCT
Medtronic HMS PLUS, Hemostasis Management System. A microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations. HMS Plus Catalog Number: 30514. Recall # Z-1537-2010
CODE
Heparin Assay Controls: 306-01POR, 306-02POR, 306-03POR, 306-04POR, 306-05POR and 306-09POR
RECALLING FIRM/MANUFACTURE
Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, by letter dated March 8, 2010.  
Manufacturer: Medtronic Cardiovascular Revascularization & Surgical Therap
Brooklyn Park, MN; Medtronic Blood Management, Parker, CO. Firm initiated recallis ongoing.
REASON
The heparin assay controls may run longer than normal and in some cases; fail to give an acceptable result.
VOLUME OF PRODUCT IN COMMERCE
508 Nationwide, 36 Internationally
DISTRIBUTION
Nationwide, Western Europe and the Middle East, Australia and Canada
___________________________________
PRODUCT
Leksell Gamma Knife C. Recall # Z-1533-2010
CODE
Lot 4149, 4150, 4151, 4157, 4158, 4160, 4151, 4165, 4168, 4171, 4175, 4176, 4178, 4183, 4187, 4189, 4191, 4193, 4194, 4195, 4196, 4197, 4199, 4201, 4202, 4204, 4207, 4208, 4212, 4300, 4302, 4303, 4306, 4307, 4308, 4309, 4313, 4314, 4315, 4318, 4319, 4321, 4322, 4326, 4328, 4329, 4334, 4337, 4802, 4809, 4816, 4817, 4818, 4824, 4828, 4830, 5000, 5003, 5006, 5009, 5010, 5001, 4803, 4310, 4210, 4311, 4330, 5004, 5014, 4305, 4320, 4317, 4324, 4325, 5011, 5012, 4304, 4316, 5002, 5007, 5008, 5013, 4819, 4806, 5005, 4301, 4323, 4312
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by Technical Note – dated July 2006 and Aug. 28, 2006.
Manufacturer: Elekta Instrument AB, Stockholm, Sweden. Firm initiated recall is complete.
REASON
Leksell Gamma Knife C 1.2 with MCU version 4.0.0.6 improperly adjusted trolley for 4mm helmet caused jamming when helmet changer attempted to lock helmet. Lock did not fully engage and could still be raised. When the lock does not engage, then when the helmet changer rises, the helmet could disengage from the helmet changer and fall back onto the helmet trolley.
VOLUME OF PRODUCT IN COMMERCE
88 units
DISTRIBUTION
Nationwide, Austria, Belgium, Canada, China, Croatsia, Italy, Japan, Korea, Norway, Spain, Sweden, Taiwan and Turkey
___________________________________
PRODUCT
Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation. Catalog number: ASK-09903-CMC. Recall # Z-1538-2010
CODE
Lot number RF9060715
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc., Reading, PA, by letter on/about December 15, 2009.
Manufacturer: Arrow International Inc., Asheboro, NC. Firm initiated recall is ongoing.  
REASON
Some central venous catheter sets had the incorrect lid stock.
VOLUME OF PRODUCT IN COMMERCE
295 kits
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR MAY 5, 2010

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