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U.S. Department of Health and Human Services

Safety

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Enforcement Report for July 22, 2009

July 22, 2009
09-29

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

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PRODUCT 
1) Peanut Butter Blast Pie, 65 oz., UPC # 0 24916 20052. Recall # F-479-9;

2) Red Robin 10 inch DD Peanut Butter Ice Cream Cake (Mountain High Mudd Pie), Net Wt 10.8 Lbs (4.76kg), Keep Frozen, UPC # 10049800629.  Recall # F-480-9
CODE
1) Product Code 01279;
2) Product Code 62902
RECALLING FIRM/MANUFACTURER
Rich Products Corp., Buffalo, NY, by letter on January 29, 2009 and by press release on February 4, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
PB Blast Pie: 1421 cases (2 pies per case); Red Robin PB Ice Cream Cake: 57,994 cases (2 per case)
DISTRIBUTION
Nationwide
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PRODUCT 
1)  Decadent Deserts 6712 Double Fudge Peanut Butter Brownie, U.S. Foods Number 5627104, Net 7.2 lbs.; a frozen food service 1/2 sheet brownie in a box inside a master case, which is thawed and served. Recall # F-481-9;

2) 3212 Peanut Butter Cookie Gourmet 3 oz.; Net Weight 27 Pounds, 3 oz. frozen peanut butter cookie pucs, 144 per bulk puc case. Recall # F-482-9;

3) 8104 Ida's Peanut Butter Cookies; 3 oz. baked, individually wrapped cookies, then frozen, 12 cookies per tray, 48 per master case; the cookies are labeled as follows: Ida's Gourmet Cookies, Peanut Butter Home Made Cookies, Net Wt. 3 Oz.(88g), UPC 8 55094 00132 3. Recall # F-483-9
CODE
1) Lots: 6712082180035, 6712082260036, 6712082460037, 6712082681, 6712083111 and 6712083271;

2) Lots: 3121081281, 3121081621, 3121081821 and 3121082231;

3) Lot: 8104083411
RECALLING FIRM/MANUFACTURER
T.F. Processors Inc, Elk Grove Village, IL, by letter and e-mail on January 29, 2009 and by press release on February 3, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
131 cases of brownies; 5,231 cases of cookies
DISTRIBUTION
IL
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PRODUCT 
1) KARMA brand BAR -- ALL NATURAL SNACK BAR -- Orange Cranberry Almond -- Net Wt. 1.76 oz. (50 g) -- UPC 49826 17041 (individual bar); each box contains 9 - 1.76 oz. (50 g) bars, Net Wt. 15.87 oz. (450 g) -- UPC 49826 17042. Recall # F-484-9; 

2) Karma brand Bar -- All Natural Snack Bar -- Double Chocolate -- Net Wt. 1.76 oz. (50 g) -- UPC 49826 17035 (individual bar); each box contains 9 x 1.76 oz. (50 g) bars, Net wt. 15.87 oz. (450 g), UPC 49826 17036. Recall # F-485-9
CODE
1) Individual Bar: Lot # EM1818F82, Best By June 29, 2009, UPC 49826 17041; Box: Lot # EM1818F82, Best By June 29, 2009, UPC 49826 17042;

2) Individual Bar: Lot # EM1818F81, Best By June 29, 2009, UPC 49826 17035; Box: Lot # EM1818F81, Best By June 29, 2009, UPC 49826 17036
RECALLING FIRM/MANUFACTURER
Recalling Firm: U.S. Nutrition, Ronkonkoma, NY, by press release and letters dated February 3, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Orange Cranberry Almond Bars: 1750 boxes (9 bars per box), 61 boxes were samples; Double Chocolate Bars: 2409 boxes (9 bars per box), 60 boxes were samples
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Laxmi Peanuts Hot & Spicy, Net Wt 30 lb, Item Code NUPEHLXICS. Recall # F-486-9
CODE
NUPEHLXICS
RECALLING FIRM/MANUFACTURER
House of Spice India, Inc, Flushing, NY, by letters dated February 4, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
41 – 30 lbs. cases
DISTRIBUTION
NY, NJ, MA, MD, PA, and CA
___________________________________
PRODUCT 
1) American Almond brand Roasted Granulated Nuts Peanuts in various sizes and containers: Net Weight 4 Lbs. in cans - UPC 717740505350, 5 Lb. in cartons - UPC 717740505275, Net Weight 10 Lbs. in cartons - UPC 717740505381, Net Weight 30 Lbs. in cartons - UPC 717740505312. Recall # F-487-9;

2) American Almond brand Peanut Brittle Crunch in various sizes: a) 5 Lb. cartons - UPC 717740806075, b) 10 Lb. cartons - UPC 717740806037, and Net Weight 30 Lbs. in cartons - UPC 717740806020. Recall # F-488-9;

3) American Almond brand Chunky Pure Peanut Butter, Net Weight 40 Lbs. in pails, UPC 717740303093. Recall # F-489-9;

4) Fresh direct brand Honey-Roasted Peanut Butter in hard plastic containers, net wt. 16 oz (453.6g), 24 units per case, UPC FD0300777433. Recall # F-490-9;

5) Fresh direct brand Chunky Peanut Butter in hard plastic containers, net wt. 16 oz (453.6g), 24 units per case, UPC FD0300777435. Recall # F-491-9
CODE
1) 4 Lb cans: Lot Nos. 031307-529001 through 082108-529001 (9 lots total: 032907-529001, 032408-529001, 031307-529001, 042307-529001, 092407-529001, 012908-529001, 032408-529001, 073108-529001, 082108-592001), UPC 717740505350; -- 5 LB. cartons: Lot No.050708-525001, UPC 717740505275; -- 10 LB. cartons: Lot Nos.031307-523001 through 010609-523001 9 (18 lots total: 031307-523001, 031407-523001, 040907-523001, 070307-523001, 070507-523001, 090507-523001, 102207-523001, 102907-523001, 121207-523001, 012808-523001, 040108-523001, 052708-523001, 072108-523001, 090408-523001, 091708-523001, 102908-523001, 122908-523001, 010609-523001), UPC 717740505381; -- 30 LB. cartons: Lot Nos. 041807-521001 through 011409-521001 (32 lots total: 041807-521001, 081307-521001, 081407-521001, 090507-521001, 092407-521001, 100907-521001, 110107-521001, 120507-521001, 121207-521001, 121907-521001, 010208-521001, 010908-521001, 012408-521001, 012808-521001, 030308-521001, 032408-521001, 041408-521001, 052108-521001, 052908-521001, 062508-521001, 072808-521001, 081108-521001, 082108-521001, 090208-521001, 090308-521001, 092408-521001, 102808-521001, 110408-521001, 112008-521001, 112408-521001, 122208-521001, 011409-521001), UPC 717740505312;

2) a) Lot Nos. 091508-590001 through 120408-590001 (4 lots: 091508-590001, 092408-590001, 102908-590001, 120408-590001); b) Lot No. 101007-594001; c) Lot Nos. 031207-590001 through 010809-590001 (9 lots total: 031207-590001, 031307-590001, 071807-590001, 080907-590001, 101507-590001, 020408-590001, 073108-590001, 090508-590001, 010809-590001);

3) Lot Nos. 032907-586001 through 102308-586001(8 lots total: 032907-586001, 080607-586001, 111207-586001, 111607-586001, 060408-586001, 061708-586001, 102108-586001, 102308-586001);

4) Lot Nos. 091808-588001 through 010509-588001(3 lots total: 091808-588001, 120208-588001, 010509-58801);

5) Lot Nos. 091708-586001 through 010509-586001 (4 lots total: 091708-586001, 110408-586001, 120308-586001, 010509-586001)
RECALLING FIRM/MANUFACTURER
American Almond Products Co., Inc., Brooklyn, NY, by letter on January 30, 2009 and by press release on February 12, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1) 4lbs - 8 cans & 340 cases (6 cans per case); 5 lbs - 1 carton; 10 lbs - 3,829 cartons; 30 lbs - 2839 cartons
2) 5 lbs - 4 cartons; 10 lbs - 1 carton; 30 lbs - 189 cartons
3) 86 pails
4)133 cases (24 units per case)
5) 120 cases (24 units per sale)
DISTRIBUTION
NY, NJ, CT, PA, WA, IL, RI, and PR
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PRODUCT 
1) French Burnt Peanuts, Net Wt. 21 lbs. (9.53 kg); sugar coated peanuts packaged in bulk poly-lined boxes; Item No. 0000140021 The French Burnt Peanuts were also contract manufactured and packaged under the following label: Brach's French Burnt Peanuts, Net Wt. 7 Oz. (198 g) plastic bags, 12 bags per case; UPC 0 11300 38119 5. Recall # F-492-9; 

2) Boston Baked Beans, Net Wt. 25 lbs. (11.3 kg); candy coated peanuts packaged in bulk poly-lined boxes; Item No. 0000150025; Red Boston Baked Beans, Net Wt. 25 lbs. (11.3 kg); candy coated peanuts packaged in bulk poly-lined boxes; Item No. 0000150025R. Recall # F-493-9 
CODE
All lots that begin with “7” or “8”
RECALLING FIRM/MANUFACTURER
Primrose Candy Co., Chicago, IL, by letter dated January 30, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
55,690 cases
DISTRIBUTION
FL, IL, IN, IA, MD, MI, MO, MN, NY, OH, OK, OR, PA, TX, VA and WI
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PRODUCT 
8" Peanut Butter Chocolate Chip Cookie Dough Cheesecake -- Net Wt.: 3 Lbs (1361g), Item # M18011-- UPC 7 48924 60860 4 -- Sold Exclusively Through QVC. Recall # F-494-9
CODE
Batches 0218 and 0278
RECALLING FIRM/MANUFACTURER
Recalling Firm: Junior’s Cheesecakes & Desserts, Brooklyn, NY, by telephone on/about January 29, 2009 and by press release on February 17, 2009.
Manufacturer: Junior’s Cheesecakes & Desserts / G.A.D. Company, LLC, Maspeth, NY. Firm initiated recall is complete.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,143 units
DISTRIBUTION
Nationwide
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PRODUCT 
Diabetic Emporium & Confectionery Shoppe Ltd. -- Chocolate Covered Peanuts -- Net Weight-8 oz (263 gm) -- Product # 1168 and Net Weight-16 oz (454 gm) -- Product # 1169. Recall # F-495-9
CODE
Product codes only
RECALLING FIRM/MANUFACTURER
Diabetic Emporium and Confectionary Shoppe, Ltd, Bainbridge, NY, by telephone on March 11, 2009 and by press release on March 13, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
966 bags of 8 oz. and 466 bags of 16 oz
DISTRIBUTION
NY, NJ, OH, and PA
___________________________________
PRODUCT 
La Bella Romana French Burnt Peanuts; sugar coated peanuts packaged in variable weight (approx. 1 lb) clear plastic clam shell containers; UPC 299667 501610. Recall # F-496-9
CODE
Lot numbers 80310 through 90182
RECALLING FIRM/MANUFACTURER
Caputo’s New Farm Produce, Addison, IL, by press release on February 18, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella
VOLUME OF PRODUCT IN COMMERCE
630 packages
DISTRIBUTION
IL
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PRODUCT 
Balance Nutrition Energy Bar/High Protein/Honey Peanut; 1.76 oz bars, 15 bars per display carton, 8 cartons per case; bar UPC 7 50049 00010 2, carton UPC 7 50049 00110 9, case UPC 7 50049 00110 0. Recall # F-497-9
CODE
All code dates
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kraft Foods, Inc. Northfield, IL, by press release on February 13, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
24,462 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Taylors Chocolate Peanuts, double dipped chocolate covered peanuts; 4.5 oz plastic bags, 12 bags per case; UPC 7 43779 20898 6. Recall # F-498-9
CODE
Lot 3508
RECALLING FIRM/MANUFACTURER
Taylor’s Candy, Inc., Alsip, IL, by telephone and letter on February 4, 2009 and by letter on February 13, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
92 cases
DISTRIBUTION
IL, IN
___________________________________
PRODUCT 
1) Sisler's Taffy Apple Ice Cream; Apple flavored Ice Cream with a Caramel Swirl and Chopped Peanuts; gallon plastic tubs; UPC 44417 00012. Recall # F-499-9;

2) Sisler's Chunky Peanut Butter Ice Cream; creamy peanut butter Ice cream with loads of granulated peanuts; gallon plastic tubs; UPC 44417 00012. Recall # F-500-9
CODE
1) Lot 100860;
2) Lot 000874
RECALLING FIRM/MANUFACTURER
Sisler’s Dairy Products Co. Inc., Ohio, IL, by telephone on February 4, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
200 gallons
DISTRIBUTION
IL
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PRODUCT 
Honey Roasted Peanuts, Net Wt. 30 lbs; Ingredients: Peanuts, Sugar, Honey, Sunflower Oil, Salt and Gum Arabic; Item #N8100. Both whole and granulated honey roasted peanuts were packaged with the Item #N8100. Recall # F-501-9
CODE
Lot 147163
RECALLING FIRM/MANUFACTURER
Baldi Candy Company dba Arway Confections, Inc, Chicago, IL, by letters dated February 3, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
24 cases
DISTRIBUTION
IL, MO, TX
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PRODUCT 
MET-Rx ProteinPlus Protein Bar Chocolate Roasted Peanut with Caramel, bar - Net Wt. 1.76 oz. (50 g) bar - UPC 86560 15125; box - Net Wt. 15.87 oz. (450 g) - UPC 86560 15126 ; bar - Net Wt. 3.0 oz. (85 g) - UPC 86560 01651; box -Net Wt. 36 oz. (12 - 3 oz. bars) - UPC 86560 01652. Recall # F-502-9
CODE
Best By January 1, 2008 through January 1, 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: U.S. Nutrition, Ronkonkoma, NY, by press release on March 5, 2009.
Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
76 oz. (50 g) bars: 932,760 bars; 3 oz. (85 g) bars: 4,785,696 bars
DISTRIBUTION
Nationwide, Korea, Kuwait, Bahrain, Bosnia, Germany, Guam, Europe, Honduras
___________________________________
PRODUCT 
1 Liquid Pasteurized Salted Egg Yolks, Approximately 10% Salt Added, Keep Refrigerated 40F or Less; USDA Inspected Egg Products P1141; shipped in 2000 lb. totes and insulated tanker trucks. Recall # F-503-9;

2) Frozen Pasteurized Salted Egg Yolks, Approximately 10% Salt Added, Keep Frozen; USDA Inspected Egg Products P1141; shipped in 30 lb. plastic pails. Recall # F-504-9    
CODE
Lot #082-09 (March 23, 2009)
RECALLING FIRM/MANUFACTURER
Brown Produce Company, Farina, IL, by telephone on March 30, 2009. Firm initiated recall is ongoing.
REASON
The pasteurized salted egg yolks were found to be contaminated with Salmonella Heidelberg.
VOLUME OF PRODUCT IN COMMERCE
117,886 lbs
DISTRIBUTION
GA, IL, MA, and OH
___________________________________
PRODUCT 
Carol’s Cookies Peanut Butter Combo Cookie, 7 oz. cookies; baked natural peanut butter mixed with double-chocolate brownie dough cookies; individually wrapped cookies are packed 36 per case and frozen. Recall # F-517-9
CODE
Manufacture dates 9/8/08 through 9/15/08
RECALLING FIRM/MANUFACTURER
Carol’s Cookies, Inc., Highland Park, IL, by telephone on January 26, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
20 cases
DISTRIBUTION
TX

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PRODUCT 
1) Weis Quality Premium Ice Cream Nutty Cone Sundae in 56 ounce cartons with UPC 041497-01238. The product is shipped in cases containing 6 cartons. Recall # F-520-9;

2) Weis Quality Light Ice Cream Nutty Cone Sundae in 56 ounce cartons with UPC 041497-01386. The product is shipped in cases containing 6 cartons. Recall # F-521-9;

3) Weis Quality Monkey Business Premium Ice Cream in 56 ounce cartons with UPC 041497-01223.The product is shipped in cases containing 6 cartons. Recall # F-522-9;

4) Weis Quality Light Ice Cream Tin Roof Sundae in 56 ounce cartons with UPC 041497-01385. The product is shipped in cases containing 6 cartons. This product was discontinued and out of stock since the end of September. Recall # F-523-9;

5) Weis Quality Premium Ice Cream Peanut Perfection in 56 ounce cartons with UPC 041497-01236. The product is shipped in cases containing 6 cartons. This product was discontinued and out of stock since the end of August. Recall # F-524-9;

6) Food City Premium Tin Roof Sundae Ice Cream in 56 ounce cartons with UPC 87848-10231. The product is shipped in cases containing 6 cartons. Recall # F-525-9
CODE
1), 2), 3), 6) Codes 010910 or earlier;
4), 5) All codes (product discontinued)
RECALLING FIRM/MANUFACTURER
Weis Markets, Inc., Sunbury, PA, by telephone press release and e-mails on January 29, 2009 and by e-mail on January 30, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
32,000 units
DISTRIBUTION
PA, NY, NJ, MD, WV, KY, VA, and TN
___________________________________
PRODUCT 
1) Archer Farms Brand Milk Chocolate Monster Chewy Soft Baked Cookies, 8.6 oz.; UPC #85239 09156. Recall # F-526-9;

2) Archer Farms Brand Double Peanut Butter Chewy Soft Baked Cookies, 8.6 oz.; UPC #85239 09811; Recall # F-527-9;

3) Sam's Choice Brand Peanut Butter Milk Chocolate Cookies, 7.2 oz; UPC #81131 89490. Recall # F-528-9 
CODE
1) Date codes: 26Jan2009A, 31Jan2009A, 09Feb2009B, 09Feb2009A, 14Feb2009B2, 17Feb2009B2, 08Mar2009B2, 15Mar2009B2, 21Mar2009A2, 12Apr2009A2, 21Apr2009A2, 16May2009B2, 23May2009A2, and 31May2009B2;

2) Date codes: 01Feb2009, 07Feb2009A, 14Feb2009B2, 17Feb2009B2, 16Mar2009A2, 22Mar2009A2, 12Apr2009A2, Apr 18 2009, 06May2009B2, 19May2009B2, 25May2009A2, 02Jun2009A2, 13Jun2009B2;

3) Date codes: A517Jan09, A5Jan242009
RECALLING FIRM/MANUFACTURER
Brent & Sam’s, North Little Rock, AR, by press release on January 21, 2009 and January 23, 2009 and by letter on January 23, 2009.  Firm initiated recall is complete.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
10,460 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Peanut Butter Precut Frozen Cookie Dough, 1.25 oz. packaged in 22.5-lb case, 288 cookies per case with Best Brands code #1003-01 and also packaged in 18-lb pail with Best Brands Code 5201-67. Case UPC Code 10035074520175. Recall # F-529-9; 

2) Custom Peanut Butter Precut Frozen cookie Dough, Best Brands, BB, 1.5-oz packaged in 20.25-lb case, 216 cookies per case with code #1046-01, 1.25-oz packaged in 18.75 cases of 240 cookies per case with item code #1046-02, 2-oz packaged in 25-lb case of 200 cookies per case with item code #1046-05. 1.5 oz. Case UPC code 10035074104610; 1.25 oz. UPC Code 10035074104627; 2 oz. 10035074104658. Recall # F-530-9; 

3) Custom Peanut Butter Chocolate Chip Precut Frozen Cookie Dough, Best Brands, BB, 1.5-oz packaged in 20.25-lb case of 216 cookies per case with item code #1047-01. Case UPC Code 10035074104719. Recall # F-531-9; 

4) Custom Reese's Peanut Butter Precut Frozen Cookie Dough, Best Brands, BB, 1.5-oz packaged in 20.25 cased of 216 cookies per case with item code #1048-01. Case UPC code 10035074104818. Recall # F-532-9;

5) Original Peanut Butter Precut Frozen Cookie Dough, 3-oz, packaged in 21-lb case with 112 cookies per case with item code #1610-12. Case UPC Code 10035074161026. Recall # F-533-9;

6) ZT Custom Peanut Butter Frozen Cookie Dough, Best Brands, BB, 1.5-oz packaged in 20.25 case of 216 cookies per case with item code #4367-01, case UPC code 10035074436711. Recall # F-534-9;

7) Gourmet Peanut Butter Frozen Cookie Dough, Best Brands, BB, 18-lb pail with Best Brands code 1659-66, Case UPC code 10098086165963. Expanded recall on January 30, 2009. Recall # F-535-9;

8) Gourmet Peanut Butter and Chocolate Chunk Frozen Cookie Dough, Best Brands, BB, 18-lb pail with Best Brands code 1665-98, case UPC code 10098086166595. Recall # F-536-9;

9) ZT Custom Reese's Peanut Butter Precut Frozen Cookie Dough, Best Brands, BB, 1.5-oz packaged in 20.25-lb case of 216 cookies per case with Item code #4369-01, Case UPC code 10035074436919. Recall # F-537-9;

10) Peanut Brittle, Best Brands, BB, Net Wt. 20 LB, 1700-01. Recall # F-538-9
CODE
All products recalled with lot codes between 0017-1and 0139-1;
RECALLING FIRM/MANUFACTURER
Best Brands Corporation, Minnetonka, MN, by letter dated January 19, 2009, by press release on January 21, 2009, by press release and letters on January 30, 2009 and February 13, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
6,441 cases of frozen cookie dough; 195 cases of peanut brittle
DISTRIBUTION
AR, CA, FL, GA, IA, IL, IN, KS, LA MI, MN, MO, NC, ND, NB, OH, OK, SD, TX, WI, WY
___________________________________
PRODUCT 
Golden Temple Wha Guru Chew Peanut Cashew Candy Smothered in Nutty Caramel. Individually wrapped in red and black plastic, 1.13 oz. First three ingredients include: Honey, Peanuts, Brown Rice Syrup. Product is sold 24 chew bars per sleeve and 6 sleeves per case with UPC code 0 75070 00101 1 on sleeves. Individual bars are not stamped with any code. Item code 450001. Recall # F-539-9
CODE
Lot codes 040909, 041509. 2/20/2009 expanded recall of lot numbers 050109, 052909, 061709, and 061809. Lot codes are read: MMDDYY and corresponds to the expiration date of the lot and can be found on the bottom of each display sleeve.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Golden Temple of Oregon LLC, Eugene, OR, by press release on February 10, 2009 and February 20, 2009 and by e-mails on February 11, February 12 and February 23, 2009.  
Manufacturer: The Candy Basket Inc., Portland, OR. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
38,376 bars
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Granulated Peanuts, packed in 30 lb (13.61 kg) corrugated cardboard cases with an inner plastic lining and/or 2 & 1/2 lb. poly bags. The labeling of the granulated peanuts reads either: Granulated Peanuts Net Wt 30 lbs (13.61 kg) Ingredients: Dry Roasted Peanuts; or Granulated Peanuts Net Wt. 2.5 Lbs Ingredients: Dry Roasted Peanuts. No UPC code. Recall # F-540-9;

2) Dry Roast Split Peanuts packed in 30 lb. (13.61 kg) cases made of corrugated card board with an inner plastic liner. The product label reads: Dry Roast Split Peanuts Net Wt 30 lbs (13.61 kg) Ingredients: Dry Roasted Peanuts. Also called Peanut Butter Stock. No UPC code. Recall # F-541-9;

3) Chopped Mixed Nuts packed in 30 lb. (13.61 kg) corrugated card board cases with an inner plastic liner. The label reads: Chopped Mixed Nuts Net Wt 30 Lbs. (13.61 KG) Ingredients: Peanuts, Cashews, Almonds, Peanut Oil, or Granulated Peanuts Net Wt. 2.5 Lbs Ingredients: Dry Roasted Peanuts, UPC 1367102288. Recall # F-542-9
CODE
1) Lot Numbers: 7080, 7103, 7122, 7136, 7138, 7207, 7241, 8018, 8135, 8136, 8137, 8140, 8141, 8182, 8184, 8189, 8190, 8191, 8281, 8285, 8287, 8341, 8343, and 8344;

2) Lot Numbers: 7065, 7120, 7197, 7201, 7218, 8017, 8141, and 8287;

3) Manufacturing dates prior to: 1/30/2008
RECALLING FIRM/MANUFACTURER
CJ Dannemiller Company, Inc., Norton, OH, by letter on January 31, 2009 and by press release on February 3, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
5,515 cases
DISTRIBUTION
OH, PA, TN, NC, NY, NJ, NH, VA, SD, TX, WI, OK, FL, CT, AZ, IL, IN, KS, KY, MD, MN, and MO

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT 
Bella Cucina Artful Food, Porcini and Parmesan Pesto, Net Wt 6 oz (169g). The product is packed in glass jars. SKU #146, Product Code: 0081028 and 0081018; UPC #61919301468. Recall # F-464-9
CODE
No lot #’s
RECALLING FIRM/MANUFACTURER
Bella Cucina Artful Food, Atlanta, GA, by press release on/about April 28, 2008, by telephone starting April 9, 2008 with a follow-up letter on/about April 9 and 11, 2008. Firm initiated recall is ongoing.
REASON
Product is inadequately processed to prevent the outgrowth and toxin production of pathogens of public health concern, particularly Clostridium botulinum.
VOLUME OF PRODUCT IN COMMERCE
97 cases/12 jars per case
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Olivier brand Parmesan & Asiago Dip with Garlic & Basil in 11.76 oz. glass jars, 12 units per case. Recall # F-465-9
CODE
All codes. The following codes have been identified: OPA 34171, OPA 23471, OAP 17271, OAP 17671, OAP 36061, OAP36161, OPA 33961
RECALLING FIRM/MANUFACTURER
Oliver Napa Valley, Inc., Saint Helena, CA, by press release on January 31, 2008. Firm initiated recall is ongoing.
REASON
Product is inadequately processed to prevent the outgrowth and toxin production of pathogens of public health concern, particularly Clostridium botulinum.
VOLUME OF PRODUCT IN COMMERCE
12,437 units
DISTRIBUTION
Nationwide, Canada and British Columbia

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III

___________________________________
PRODUCT 
Maine Wild Blueberry Company Frozen Wild Blueberries, Poly Bags 8 x 3 lbs. (10.9 kgs) USDA Food Contract #120295240v02/2009. Recall # F-509-9
CODE
Case code: May 7 and 8
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cherryfield Foods, Inc., Cherryfield, ME, by telephone and letter on May 27, 2009.
Manufacturer: Maine Wild Blueberry Company, Machias, ME. Firm initiated recall is ongoing.
REASON
Product contains metal fragments.
VOLUME OF PRODUCT IN COMMERCE
420 cases
DISTRIBUTION
GA

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I

___________________________________
PRODUCT 
LIBIMAX All Natural Herbal Extract Capsules, 430 mg herbal blend, sold in 1-capsule individual packs and 10-capsule or 20-capsule plastic bottles, Libido Enhancer, Rev Up Your Sex Drive, Recall # D-1499-2009
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nature & Health Company, Brea, CA, by telephone on April 25, 2009 and by letters beginning April 27, 2009.
Manufacturer: Shenyang Green Near Health Food CO., LTD, Shenyang, China. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product contained undeclared active pharmaceutical ingredient tadalafil.
VOLUME OF PRODUCT IN COMMERCE
Approximately 400 cases/720 individual packets per case; 1,000 bottles of 10 capsule bottle; 300 bottles of the 20 capsule bottle
DISTRIBUTION
CA, GA, IL, TX, OH
___________________________________
PRODUCT
Zencore Plus, Natural Male Enhancement Dietary Supplement, 275mg proprietary blend of herbal ingredients, supplied in 2 capsule blister packs and 10 capsule blister packs, labeled...It's Natural And It Works, For Male Sexual Performance, UPC for 10 Capsule box: 8 5919700106 8; UPC Code for Individual 2 Capsule Packet: 8 5919700102 0; UPC Code for Display Box 8 5919700103 7. Recall # D-1500-2009
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Hi Tech Pharmaceuticals, Norcross, GA, by press release and letters dated March 11, 2009. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product found to contain benzamidenafil which is a newly discovered PDE-5 inhibitor similar to FDA approved drugs to treat erectile dysfunction.
VOLUME OF PRODUCT IN COMMERCE
1,500,000 capsules
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Digoxin, 0.25 mg, packaged in 30 tablet bottles, NDC 57664-441-04, part #5758-0; Rx only. Recall # D-1530-2009
CODE
Lot numbers 9023045, 8350165, 8325065, 8294169, 8291068, 8086157, 8045070, 7334139 and 7218363
RECALLING FIRM/MANUFACTURER
A-S Medication Solutions LLC, Libertyville, IL, by letters dated April 2, 2009. Firm initiated recall is ongoing.
REASON
Some of the tablets are over sized or undersized, which will result in the patient not receiving the expected dose of medication.
VOLUME OF PRODUCT IN COMMERCE
670 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
1) Amicar, Aminocaproic Acid, 500MG Tablet, Mfg. XAN, NDC 66479-0021-82, Rx Only. Recall # D-1338-2009; 

2) Methimazole, 5MG TAB, Mfg. PAR, NDC 49884-0640-01, Rx Only. Recall # D-1339-2009; 

3) Levothyroxine, 137MCF TAB, Mfg. MYL, NDC 00378-1823-01, Rx Only. Recall # D-1340-2009; 

4) Cerovite, sub: Centrum Liquid, 15ML, Mfg. RUG, NDC 00536-2790-59, OTC. Recall # D-1341-2009; 

5) Azilect, Rasagiline Mesylate, 1MG TAB, Mfg. TNE, NDC 68546-0229-56, Rx Only. Recall # D-1342-2009;

6) Durahist, P-Ephedr/CPM/Methscop, 60/8/1.25MG TAB, Mfg. PEL, NDC 66869-0424-10, Rx Only. Recall # D-1343-2009;

7) Ferrex-150 Plus, CAP, Mfg. Brk, NDC 51991-0703-90, OTC. Recall # D-1344-2009;

8) Propylthiouracil, 50MG TAB, Mfg. W-W, NDC 00143-1480-01, Rx Only. Recall # D-1345-2009;

9) Acetaminophen, sub: Tylenol, 325MG TAB, Mfg. IVX, NDC 00182-1000-10, OTC. Recall # D-1346-2009;

10) Isoniazid, 100MG TAB, Mfg. BAR, NDC 00555-006-02, Rx Only. Recall # D-1347-2009;

11) Vitamin D, Cholcalciferol, 400IU TAB, Mfg. NVC, NDC 79854-0011-62, OTC. Recall # D-1348-2009;

12) Phillips, Magnesium Hydroxide, 311MG, Chew Tab, Mfg. BAY, NDC 31284-3373-12, OTC. Recall # D-1349-2009;

13) Thyroid, gr, 15MG TAB, Mfg. FOR, NDC 00456-0457-01, Rx Only. Recall # D-1350-2009;

14) Terazosin HCL, 10MG CAP, Mfg. A-C, NDC 60505-0118-00, Rx Only. Recall # D-1351-2009;

15) Razadyne, Galantamine HBr, 8Mg TAB, Mfg. JOM, Rx Only. Recall # D-1352-2009;

16) Nephro-Vite, TAB, Mfg R&D, NDC 00536-7300-01, OTC. Recall # D-1353-2009;

17) Docusate Calcium, 240MG CAP, Mfg. RUG, NDC 00536-3755-05, OTC. Recall # D-1354-2009;

18) Glyburide/Metformin, sub: Glucovance, 1.25/250MG TAB, Mfg. TEV, NDC 00093-5710-01, Rx Only. Recall # D-1355-2009;

19) Diltiazem, HCL ER, Extended-Release, 240MG CAP, Mfg. MYL, Rx Only. Recall # D-1356-2009;

20) Gerivite, Multivits W-Fe & Min, LIQ, 15ML, Mfg. GDL, NDC 00182-6054-40, OTC. Recall # D-1357-2009;

21) Demeclocycline, 150MG TAB, Mfg. GLO, NDC 00115-2111-01, Rx Only. Recall # D-1358-2009;

22) Nortriptyline, sub: Pamelor, 25MG CAP, Mfg. TEV, NDC 00093-0811-01, Rx Only. Recall # D-1359-2009;

23) Nabumetone, 750MG TABLET, Mfg. SDZ, NDC 00185-0146-01, Rx Only. Recall # D-1360-2009;

24) Ethosuximide, sub: Zarontin, 250MG CAP, Mfg. PLV, NDC 50111-0901-01, Rx Only. Recall # D-1361-2009;

25) Sotalol HCl, 80MG TABLET, Mfg. A-C, NDC 60505-0090-11, Rx Only. Recall # D-1362-2009;

26) Glybutide/Metformin sub: Glucovance, 5/500MG TAB, Mfg. TEV, NDC 00093-5712-01, Rx Only. Recall # D-1363-2009;

27) Potassium Citrate ER, sub: Urocit-K. 5MEQ TAB, Mfg. RIS, NDC 64980-0137-01, Rx Only. Recall # D-1364-2009;

28) Lexapro, Escitalopram, 5MG TAB, Mfg. FOR, NDC 00456-2005-01, Rx Only. Recall # D-1365-2009;

29) Tylenol Arthritis, Acetaminophen E-R, 650MG TAB, Mfg. MCN, NDC 00045-0838-50, OTC. Recall # D-1366-2009;

30) Omega-3, Fish Oil, 1000MG SOFGELS, Mfg. N-B, NDC 74312-0278-11, OTC. Recall # D-1367-2009;

31) Calcitriol, 0.25MCG CAP, Mfg. TEV, NDC 00093-1657-01, Rx Only. Recall # D-1368-2009;

32) Wellbutrin XL, Buproprion HCl ER, 150MG TAB, Mfg. BPC, NDC 00173-0730-02, Rx Only. Recall # D-1369-2009;

33) Carbamide Peroxide, Ear Wax Removal, 6.5% Ear Drops, 15ML, Mfg. MAJ, NDC 00901-3220-35, OTC.  Recall # D-1370-2009;

34) Theophylline, Extended-Release, 300MG TAB, Mfg. PLV, NDC 50111-0459-01, Rx Only. Recall # D-1371-2009;

35) Mirapex, Pramipexole, 0.5MG TAB, Mfg. BOE, Rx Only. Recall # D-1372-2009;

36) Multivitamin W/MIN, ONE-TAB-DAILY W/MIN, SF TAB, Mfg. GDL, OTC.  Recall # D-1373-2009;

37) Glyburide/Metformin, 5MG/500MG TAB, Mfg. APH, NDC 00228-2753-11, Rx Only. Recall # D-1374-2009;

38) Thermotabs, Salt Supplement, Buffered TAB, Mfg. NUM, NDC 38485-0863-35, OTC. Recall # D-1375-2009;

39) Sotalol HCl, 240MG TABLET, Mfg. SDZ, Rx Only, Recall # D-1376-2009;

40) Venlafaxine HCl, 37.5MG TAB, Mfg. RED, Rx Only. Recall # D-1377-2009;

41) Simethicone, sub: GAS-X EXTRA STR, 125MG CHEW TAB, Mfg. RUG, NDC 00536-4534-08, OTC. Recall # D-1378-2009;

42) Amlodipine/Benazepril, 10/20MG CAP, Mfg. SNZ, NDC 00781-1174-01, Rx Only. Recall # D-1379-2009;

43) Armour Thyroid, 60MG (1 gr) TAB, Mfg. FOR, NDC 00456-0459-01, Rx Only. Recall # D-1380-2009;

44) Neomycin Sulf, 500MG TAB, Mfg. TEV, Rx Only. Recall # D-1381-2009;

45) Rocaltrol, Calcitriol, 0.25 MCG CAP, Mfg. FON, NDC 42559-0143-23, Rx Only. Recall # D-1382-2009;

46) Glycerin, 82.5% Suppository, Mfg. G&W, OTC. Recall # D-1383-2009;  

47) Bromocriptine, 2.5MG TAB, Mfg. SNZ, NDC 00781-5325-31, Rx Only. Recall # D-1384-2009;

48) Fluoxetine HCL, 10MG TAB, Mfg. PAR, NDC 49884-0734-11, Rx Only. Recall # D-1385-2009;

49) Fluconazole, 100MG TAB, Mfg. R/P, NDC 63304-0804-01, Rx Only. Recall # D-1386-2009;

50) Rowasa, Mesalamine, 4G/60ML Enema, 60ML, Mfg. ALA, Rx Only. Recall # D-1387-2009;

51) Uroxatral ER, Alfuzosin ER, 10MG TAB, Mfg. AVE, NDC 00024-4200-10, Rx Only. Recall # D-1388-2009;

52) Ultram ER, Tramadol ER, 100MG TAB, Mfg. BPC, NDC 00062-0653-30, Rx Only. Recall # D-1389-2009;

53) Docusate Calcuim, 240MG, CAP, Mfg. GDL, NDC 0018-1302-05, OTC. Recall # D-1390-2009;

54) Sensipar, Cinacalcet, 60MG TABLET, Mfg. AMG, Rx Only. Recall # D-1391-2009;

55) Avalide, Irbesartan/HCTZ, 150/12.5MG TAB, Mfg. BRI, NDC 00087-2775-31, Rx Only. Recall # D-1392-2009;

56) Selegiline HCl, 5MG TAB, Mfg. A-C, NDC 60505-3438-03, Rx Only. Recall # D-1393-2009;

57) Risperidone, 3MG TAB, Mfg. TEV, NED 00093-7242-06, Rx Only. Recall # D-1394-2009;

58) Fleet Pedia-Lax, Liquid Glycerine Suppository, 4ML, Mfg. CBF, NDC 00132-0190-1, OTC. Recall # D-1395-2009;

59) Chantix, Varenicline, 0.5MG TAB, Mfg. PFZ, NDC 00069-0468-56, Rx Only. Recall # D-1396-2009;

60) Mesalamine, 4G/60ML, Enema, 60ML, Mfg. PRS, Rx Only. Recall # D-1397-2009;

61) Prempro, Conj. Estrog/M-Progest, 0.3/1.5MG TAB, Mfg. WYEm BDC 00046-0938-09, Rx Only. Recall # D-1398-2009;

62) Meclizine HCL, 12.5 MG TAB, Mfg. RUG, NDC 00536-3985-01, Rx Only.  
Recall # D-1399-2009;

63) Venlafaxine HCl, 100MG TAB, Mfg. TEV, NDC 0093-7383-01, Rx Only. Recall # D-1400-2009;

64) Capsaicin, 0.025% Topical Cream, Mfg, SLI, OTC. Recall # D-1401-2009;

65) Claritin-D, Loratadine/P Ephed, 10/240MG TAB, Mfg. SPH, OTC. Recall # D-1402-2009;

66)  Glyburide, Micronized, sub: Glynase, 3MG TAB, Mfg. MPI, NDC 67253-0462-10, Rx Only. Recall # D-1403-2009;

67) Levothroid, Levothyroxine Sodium, 137MCG TAB, Mfg. FOR, NDC 00456-1331-01, Rx Only. Recall # D-1404-2009;

68) Levsin, Hyoscyamine, 0.5MG/ML, AMP, Mfg. SWZ, Rx Only. Recall # D-1405-2009;   

69) Flavoxate HCl, 100MG TAB, Mfg. GLO, NDC 00115-1811-72, Rx Only. Recall # D-1406-2009;

70) Midodrine, 2.5MG TAB, Mfg. MYL, NDC 00378-1901-01, Rx Only. Recall # D-1407-2009;

71) Primidone, 50MG Tablet, Mfg. QLT, Rx Only. Recall # D-1408-2009;

72) Actos, Pioglitazone HCl, 30MG Tablet, Mfg. TPA, NDC 64764-0301-48, Rx Only. Recall # D-1409-2009;

73) Prochlorperazine Suppository, 25MG, Mfg. PAD, Rx Only. Recall # D-1410-2009;

74) Vitamin E, 400IU CAP, Mfg. MAJ, NDC 00904-0274-72, OTC. Recall # D-1411-2009;

75) Diltiazem ER, ONCE-A- DAY DOSAGE, 180MG CAP, Mfg. TEV, NDC 0093-5117-98, Rx Only. Recall # D-1412-2009;

76) Pancrease MT-4, Pancrelipase CAP, Mfg. JOM, Rx Only. Recall # D-1413-2009;

77) Accolate, Zafirlukast, 10MG TAB, Mfg. ZNC, NDC 00310-0401-60, Rx Only. Recall # D-1414-2009;

78) Avapro, Irbesartan, 300MG TAB, Mfg. BRI, NDC 00087-2773-32, Rx Only. Recall # D-1415-2009;

79) Declofenac DR, sub: Voltaren, 50MG EC TAB, Mfg. APH. NDC 00228-2550-11, Rx Only. Recall # D-1416-2009;

80) Nitroglycerin, Extended-Release, 2.5MG CAP, Mfg. ETH, NDC 58199-0004-03, Rx Only. Recall # D-1417-2009;

81) Synthroid, Levothyroxine Sod, 112MCG TAB, Mfg. ABB, NDC 00074-9296-13, Rx Only. Recall # D-1418-2009;

82) Cimetidine HCl, 300Mg/5ML SOLUTION, 5ML, Mfg. MGP, NDC 60432-0007-08, Rx Only. Recall # D-1419-2009;

83) Carbamazepine, sub: Tegretol, 200MG TAB, Mfg. TAR, NDC 51672-4005-01, Rx Only. Recall # D-1420-2009;

84) Venlafaxine HCl, 25MG, TAB, Mfg. TEV, NDC 00093-0199-01, Rx Only. Recall #
D-1421-2009;

85) L-Arginine, 500MG TAB, Mfg. MAJ, NDC 00904-4215-51, OTC. Recall # D-1422-2009;

86) Etodolac, 400MG RAB, Mfg. SDZ, NDC 00185-0140-01, Rx Only. Recall # D-1423-2009;

87) Mephyton, Phytonadione, 5MG TAB, Mfg. MER, NDC 25010-0405-15, Rx Only
Recall # D-1424-2009;

88) Sulfasalazine, 500Mg TAB, Mfg. WAT, NDC 00591-0786-01, Rx Only. Recall # D-1425-2009;
 
89) Culturelle, Lactobacillus GG, CAP, Mfg AMF, OTC. Recall # D-1426-2009;

90) Aspirin, Enteric Coated, 325MG TAB, Mfg. S/B, NDC 15127-0000-04, OTC. Recall # D-1427-2009;

91) Misoprostol, 100MCG TAB, Mfg. IVX, MDC 00172-4430-59, Rx Only. Recall # D-1428-2009;

92) Phenazopyridine, 100MG TAB, Mfg. BRK, NDC 51991-0520-01, Rx Only. Recall # D-1429-2009;

93) Coreg CR, Carvedilol E-R, 40MG CAP, Mfg. SKB, NDC 00007-0072-13, Rx Only. Recall # D-1430-2009;

94) Levothroxine, sub Synthroid, 175MCG (0.175MG) TAB, Mfg. LAN, NDC 00527-1350-01, Rx Only. Recall # D-1431-2009;

95) Nepho-Vite RX, TAB, Mfg. NEX, NDC 52544-0977-01, Rx Only. Recall # D-1432-2009;

96) Januvia, Sitagliptin Phos, 50MG TAB, Mfg. MSD, NDC 0006-112-21, Rx Only. Recall # D-1433-2009;

97) Sulfamethoxazole/TMP, SMZ/Trimethoprim, 800/160MG TAB, Mfg. MUT, NDC 53489-0146-01, Rx Only. Recall # D-1434-2009;

98) Calcium Citrate, Sugar/Dye Free, 950MG CAPLET, Mfg. GDL, NDC 00182-4151-01, OTC. Recall # D-1435-2009;

99) Metanx, TAB, Mfg. PAN, NDC 00525-8019-90, OTC. Recall # D-1436-2009;

100) Benazepril HCl, sub: Lotensin, 5MG TAB, Mfg. A-C, NDC 60505-0265-01, Rx Only. Recall # D-1437-2009;

101) Avodart, Dutasteride, 0.5MG CAP, Mfg. GSK, NDC 00173-0712-04, Rx Only. Recall # D-1438-2009;

102) Rifampin, 150MG CAP, Mfg. SNZ, NDC 00185-0801-30, Rx Only. Recall # D-1439-2009;

103) Nephrocap, CAP, Mfg. FLE, NDC 00256-0185-04, Rx Only. Recall # D-1440-2009;

104) Aspirin, 81MG TAB, Mfg. GDD, NDC 00113-0274-68, OTC. Recall # D-1441-2009;

105) Potassium Gluconate, (Potassium=99MG), 595MG TAB, Mfg. N-B, NDC 74312-0011-10, OTC. Recall # D-1442-2009;

106) Prednisolone, sub: Prelone, 5MG/5ML, LIQUID, Qty 5ML, Mfg. ETH, Rx Only. Recall # D-1443-2009;

107) Domeboro Powder, Mfg BAY, OTC. Recall # D-1444-2009;

108) Prednisolone, 15MG/5ML SYRUP, 5ML, Mfg. HTP, NDC 50383-0042-24, Rx Only. Recall # D-1445-2009;

109) Sensipar, Cinaclacet, 30MG Tablet, Mfg. AMG, NDC 55513-0073-30, Rx Only. D-1446-2009;

110) Requip, Ropinirole HCl, 4MG TAB, Mfg. GSK, Rx Only. Recall # D-1447-2009;

111) Risperidone, 0.25MG TAB, Mfg. TEV, NDC 00093-0221-06, Rx Only. Recall # D-1448-2009;

112) Lipitor, Atorvastatin, 80MG TAB, Mfg. PFZ, Rx Only. Recall # D-1449-2009;

113) Welchol, Colesevelam HCl, 625MG Tablet, Mfg. DSI, NDC 65597-0701-18, Rx Only. Recall # D-1450-2009;

114) Actonel, Risedronate Sod, 35MG TAB, Mfg. P&G, NDC 00149-0472-01, Rx Only. Recall # D-1451-2009;

115) Nitro-Dur, Nitroglycerin, 0.3MG/HR PATCH, Mfg. KEY, Rx Only. Recall # Recall # D-1452-2009;

116) Calcium Polycarbphl, sub: Fibercon, 625MG TAB, Mfg, G-S, NDC 00113-0477-75, OTC. Recall # D-1453-2009; 

117) Butalbital/APAP/CAF, 50/325/40MG TAB, Mfg. MAJ, NDC00904-3280-60, Rx Only. Recall # D-1454-2009

118) Sulfamethox/TMP, sub: Septra, 200/40MG/5ML SUSP, 5ML, Mfg. HTP, NDC 50383-0824-16, Rx Only. Recall # D-1455-2009;

119) OYS Shell Calcium+D, 500MG/400IU TAB, Mfg. NVC, NDC 79854-0016-80, Rx Only. Recall # D-1456-2009; 

120) Quinapril HCl, 40MG TAB, Mfg. A-C, NDC 60505-0175-00, Rx Only. Recall # D-1457-2009;

121) Mirapex, Pramipexole DHCL, 0.125MG TAB, Mfg. BOE, NDC 00597-0183-90, Rx Only. Recall # D-1458-2009;

122) Nifedipine, Extended-Release, 30MG TAB, Mfg. MYL, NDC 00378-3475-01, Rx Only. Recall # D-1459-2009; 

123) Levothyroxine Sodium, sub: Synthroid TAB, 112MCG (0.112MG), Mfg. LAN, NDC 00527-1346-01, Rx Only. Recall # D-1460-2009;

124) Synthroid, Levothyroxine, 137MCG TAB, Mfg. ABB, NDC 00074-3727-13, Rx Only. Recall # D-1461-2009;

125) Guaifenesin/DM SF, sub: Robitussin DM SF, 200/20/10ML, SYR, 10ML, Mfg. GDD, NDC 00113-0578-26, OTC. Recall # D-1462-2009;

126) Kaopectate, Bismuth Subsalicylate, 262MG/15ML LIQ, 15ML, Mfg. CHA, NDC 04116-7605-02, OTC. Recall # D-1463-2009;

127) Meclizine HCl, 25MG TAB, Mfg. PAR, NDC 49884-0035-01, Rx Only. Recall # D-1464-2009;

128) Imitrex Nasal Spray, Sumatriptan, 20MG SPRAY, Mfg. GSK, Rx Only. Recall # D-1465-2009;

129) Enablex ER, Darifenacin ER, 7.5MG TAB, Mfg. NVT, NDC 00078-0419-15, Rx Only. Recall # D-1466-2009;

130) Glimepiride, 1MG Tablet, Mfg. PRS, Rx Only. Recall # D-1467-2009;

131) Famciclovir, 500MG Tablet, Mfg. TEV, NDC 00093-8119-56, Rx Only. Recall # D-1468-2009;

132) Tandem OB, Prenatal VIT W/FE, Capsule, Mfg. USP, NDC 52747-0903-60, Rx Only. Recall # D-1469-2009;

133) Glycopyrrolate, sub: Robinul, 1MG TAB, Mfg. RIS, NDC 64980-0131-01, Rx Only. Recall # D-1470-2009;

134) Tegretol-XR, Carbamazepine E-R, 200MG TAB, Mfg. NVT, Rx Only. Recall # D-1471-2009;

135) Feosol TAB, Ferrous Sulfate, 325MG (65MG FE), Mfg. GSK, NDC 49692-0942-25, OTC. Recall # D-1472-2009;

136) Actos, Pioglitazone, 30MG Tablet, Mfg. TPA, NDC 64764-0301-14, Rx Only. Recall # D-1473-2009;

137) Simethicone, Infants, 40MG/0.6ML DROP, 30ML, Mfg. MAJ, OTC. Recall # D-1474-2009;

138) Lansinoh, Lanolin, 1/4oz, Mfg. LLI, OTC. Recall # D-1475-2009;

139) Pangestyme CN-10, Pancrelipase CAP, Mfg. KVP, NDC 58177-0029-04, Rx Only. Recall # D-1476-2009;

140) Vitamin B Complex, Timed Release, B-100 TAB, Mfg NVC, NDC 79854-0200-96, OTC. Recall # D-1477-2009;

141) Levothroid, Levothyroxine, 80MDG Tablet, Mfg. FOR, NDC 00456-1329-01, Rx Only. Recall # D-1478-2009;

142) Diltiazem SDV, INJECTION, 50MG/10ML VIAL, 10ML, Mfg. BED, Rx Only. Recall # D-1479-2009;

143) Hydroxychloroquine, sub: Plaquenil, 200MG TAB, Mfg. TEV, NDC 00093-9774-01, Rx Only. Recall # D-1480-2009;

144) Pindolol, 5MG TAB, Mfg. MYL, NDC 00378-0052-01, Rx Only. Recall # D-1481-2009;

145) Antacid E/S TABS, Calcium 300MG, CAL CARB 750MG, Mfg. GDL, NDC 00182-1136-94, OTC. Recall # D-1482-2009;

146) Digoxin, 250MCG TAB, Mfg. LAN, NDC 00527-1325-01, Rx Only. Recall # D-1483-2009;

147) Vitamin D3, Cholecalciferol, 400IU TAB, Mfg. N-B, NDC 74312-0011-40, OTC. Recall # D-1484-2009;

148) Prednisolone, 15MG/5ML SOL, 5ML. Mfg. MGP, NDC 60432-0212-08, Rx Only. Recall # D-1485-2009;

149) Flavoxate HCL, 100MG TAB, Mfg. PAD, NDC 00574-0155-01, Rx Only. Recall # D-1486-200;

150) Moexipril HCl, 7.5MG TABLET, Mfg. PAD, NDC 00574-0110-01, Rx Only. Recall # D-1487-2009;

151) Docusate Calcium, 240MG CAP, Mfg. RUG, NDC 00536-3755-01, OTC. Recall # D-1488-2009;

152) Stuart Prenatal, Multi Vitamin/Min TAB, Mfg. XAN, NDC 64731-0795-01, Rx Only. Recall # D-1489-2009;

153) Felodipine ER, 5MG ER, Mfg. MUT, NDC 53489-0369-01, Rx Only. Recall # D-1490-2009;

154) B Complex and B-12, TAB, Mfg N-B, NDC 74312-0001-90, OTC. Recall # D-1491-2009;

155) Vitamin E, Softgels, 400 IUNIT CAP, Mfg. NVC, NDC 79854-0900-25, OTC. Recall # D-1492-2009;

156) Vit B Complex w/C, sub: Nephro-Vite, TAB, Mfg. NVC, NDC 79854-0012-69, OTC. Recall # D-1493-2009;

157) Methergine, Methergonovine, 0.2MG TAB, Mfg. NVT, NDC 00078-0054-05, Rx Only. Recall # D-1494-2009 
CODE
1) Mfg. Lot A080036A, Exp. 09/23/09;
2) Mfg. Lot 21017301, Exp, 09/24/09;
3) Mfg. Lot 3004309, Exp. 09/24/09;
4) Mfg. Lot 801796, Exp. 09/24/09;
5) Mfg. Lot R14068, Exp. 09/23/09;
6) Mfg. Lot 324005, Exp. 09/24/09;
7) Mfg. Lot 081425, Exp. 09/23/09;
8) Mfg. Lot 64735A, Exp. 09/24/09;
9) Mfg. Lot P50438, Exp. 09/24/09;
10) Mfg. Lot 306856, Exp. 09/24/09;
11) Mfg. Lot 8FB53, Exp. 09/24/09;
12) Mfg. Lot 266068C, Exp. 09/24/09;
13) Mfg. Lot 070823, Exp. 09/24/09;
14) Mfg. Lot HR6800, Exp. 09/24/09;
15) Mfg. Lot 8HG745, Exp. 09/24/09;
16) Mfg. Lot 6718010, Exp. 09/24/09;
17) Mfg. Lot 13118050, Exp. 09/24/09;
18) Mfg. Lot 14G004, Exp. 08/01/09;
19) Mfg. Lot 3004643, Exp 09/24/09;
20) Mfg. Lot 701120, Ex. 09/30/09;
21) Mfg. Lot 8010591, Exp 10/01/09;
22) Mfg. Lot 29730, Exp. 09/30/09;
23) Mfg. Lot 175717, Exp. 10/01/09;
24) Mfg. Lot 307476, Exp. 10/01/09;
25) Mfg. Lot HW0613, Exp. 10/01/09;
26) Mfg. Lot 16G147, Exp. 10/01/09;
27) Mfg. Lot CPD890, Exp. 10/01/09;
28) Mfg. Lot. P14294, Exp. 09/30/09;
29) Mfg. Lot 24880, Exp. 10/01/09;
30) Mfg. Lot 18315301, Exp. 09/30/09;
31) Mfg. Lot 269133, Exp. 10/01/09;
32) Mfg. Lot P08D012, Exp 09/01/09;
33) Mfg. Lot 8G13, Exp.07/01/10;
34) Mfg. Lot 307517, Exp. 09/29/09;
35) Mfg. Lot 8570121A, Exp. 09/30/09;
36) Mfg. Lot 8723521506, Exp. 09/26/09
37) Mfg. Lot 738F81, Exp. 09/29/09;
38) Mfg. Lot 08F001, Exp. 09/29/09;
39) Mfg. Lot 174841, Exp. 09/30/09;
40) Mfg. Lot C81308, Exp. 09/26/09;
41) Mfg. Lot 08E259, Exp. 09/29/09;
42) Mfg. Lot F1009UI, Exp. 09/29/09;
43) Mfg. Lot 080842, Exp. 09/30/09;
44) Mfg. Lot 000029752. Exp. 09/26/09;
45) Mfg. Lot U305901, Exp. 09/29/09;
46) Mfg. Lot 210108001, Exp 01/01/11;
47) Mfg. Lot AA3256, Exp 09/30/09;
48) Mfg. Lot 21587801. Exp. 09/29/08;
49) Mfg. Lot 1835095, Exp. 09/29/09;
50) Mfg. Lot 500156, Exp. 02/01/11;
51) Mfg. Lot ZH27, Exp. 09/30/09;
52) Mfg. Lot P08E025, Exp. 09/29/09;
53) Mfg. Lot 27040587A, Exp. 09/29/09;
54) Mfg. Lot D1033277, Exp. 09/30/09;
55) Mfg. Lot 8G2081A, Exp 09/30/09;
56) Mfg. Lot HP0077, Exp. 10/01/09;
57) Mfg. Lot R46015, Exp. 10/23/09;
58) Mfg. Lot 0800710, Exp. 07/01/09;
59) Mfg. Lot 710285831, Exp. 08/01/09;
60) Mfg. Lot 500159, Exp. 02/01/10;
61) Mfg. Lot C75299, Exp. 09/01/09;
62) Mfg. Lot 08H468, Exp. 10/22/09;
63) Mfg. Lot 05W014, Exp. 10/22/09;
64) Mfg. Lot 1003208, Exp. 03/01/09;
65) Mfg. Lot 8DCS48, Exp. 02/01/11;
66) Mfg. Lot 08T7611A, Exp. 10/22/09;
67) Mfg. Lot 050823, Exp. 10/01/09;
68) 11028, Exp. 01/01/10;
69) Mfg. Lot 8010201, Exp. 10/22/09;
70) Mfg. Lot 3002280, Exp. 10/22/09;
71) Mfg. Lot T107D08A, Exp. 10/23/09;
72) Mfg. Lot A14215, Exp. 10/22/09;
73) Mfg. Lot 8253344, Exp. 05/01/10;
74) Mfg. Lot 66527, Exp. 10/01/09;
75) Mfg. Lot P0805T05, Exp. 10/22/09;
76) Mfg. Lot 8HG774, Exp. 10/23/09;
77) Mfg. Lot 107608, Exp. 10/23/09;
78) Mfg. Lot 8G2010A, Exp. 10/22/09;
79) Mfg. Lot 187H81, Exp. 10/29/09
80) Mfg. Lot M110TA, Exp. 10/29/09;
81) Mfg. Lot 67158A8, Exp 04/22/09;
82) Mfg. Lot 29369A, Exp. 10/29/09;
83) Mfg. Lot 089804, Exp. 10/29/09;
84) Mfg. Lot 01V009, Exp. 10/29/09;
85) Mfg. Lot 12145702, Exp. 10/28/09;
86) Mfg. Lot ML080544, Exp 10/29/09;
87) Mfg. Lot 7N526, Exp 10/29/09;
88) Mfg. Lot 3065430, Exp. 10/29/09;
89) Mfg. Lot 0349B8, Exp. 09/30/09;
90) Mfg. Lot 8F22525, Exp. 10/29/09;
91) Mfg. Lot BEF38A, Exp. 10/29/09;
92) Mfg. Lot 082587, Exp 10/29/09;
93) Mfg. Lot X5783, Exp. 10/28/09;
94) Mfg. Lot 024608, Exp. 10/29/09;
95) Mfg. Lot 325079, Exp. 10/29/09;
96) Mfg. Lot X4599, Exp. 10/29/09;
97) Mfg. Lot 62055, Exp. 10/28/09;
98) Mfg. Lot 8741450911, Exp. 10/29/09;
99) Mfg. Lot 0608004, Exp 10/29/09;
100) Mfg. Lot HX5819, Exp. 10/28/09;
101) Mfg. Lot 131615, Exp. 10/28/09;
102) Mfg. Lot ML080531, Exp, 10/29/09;
103) Mfg. Lot 0801902, Exp. 10/02/09;
104) Mfg. Lot 8DE0795, Exp. 10/28/09;
105) Mfg. Lot 17675308, Exp. 10/28/09;
106) Mfg. Lot 91554, Ex. 10/29/09;
107) Mfg. Lot 272568J, Exp. 07/31/11;
108) Mfg. Lot 818042, Exp. 10/27/09;
109) Mfg. Lot D092757, Exp. 10/27/09;
109) Mfg. Lot D092757, Exp. 10/27/09;
110) Mfg. Lot X7825A, Exp. 10/28/09;
111) Mfg. Lot R43014, Exp. 10/27/09;
112) Mfg. Lot 13398V, Exp. 10/28/09;
113) Mfg. Lot JW59, Exp. 10/27/09
114) Mfg. Lot 329232, Exp. 10/27/09;
115) Mfg. Lot DCBU2311, Exp. 09/30/09;
116) Mfg. Lot 7KE0198, Exp. 10/27/09;
117) Mfg. Lot F080234B, Exp. 10/27/09;
118) Mfg. Lot 832824, Exp. 10/28/09;
119) Mfg. Lot 10099, Exp. 10/28/09;
120) Mfg. Lot HY4738, Exp. 10/28/09;
121) Mfg. Lot 856580C, Exp. 10/27/09
122) Mfg. Lot 05218V, Exp. 10/28/09;
123) Mfg. Lot 013808, Exp. 10/28/09;
124) Mfg. Lot 66318A8, Exp. 03/14/09;
125) Mfg. Lot 8GK0379, Exp. 10/28/09;
126) Mfg. Lot 0AHX6, Exp. 09/30/09;
127) Mfg. Lot 21082801, Exp 10/27/09;
128) Mfg. Lot D474, Exp. 04/30/10;
129) Mfg. Lot F0066, Exp. 10/28/09;
130) Mfg Lot 1117140, Exp. 10/27/09;
131) Mfg. Lot 35304265A, Exp. 10/24/09;
132) Mfg. Lot 07121202, Exp. 10/01/09;
133) Mfg. Lot CPD886, Exp. 10/23/09;
134) Mfg. Lot F0016, Exp. 10/27/09;
135) Mfg. Lot 8F05, Exp. 10/24/09;
136) Mfg. Lot A14457, Exp. 10/24/09;
137) Mfg. Lot H810, Exp. 08/01/10;
138) Mfg. Lot 32270, Exp 07/31/11;
139) Mfg. Lot 90110, Exp. 10/24/09;
140) Mfg. Lot 8FB42, Exp 10/24/09;
141) Mfg. Lot 080819, Exp. 07/01/09;
142) Mfg. Lot 1156424, Exp. 10/27/09;
143) Mfg. Lot 30200262A, Exp. 10/24/09;
144) Mfg. Lot 3T0065, Exp. 10/24/09;
145) Mfg. Lot 1279004, Exp. 10/23/09;
146) Mfg. Lot 017308, Exp. 10/24/09;
147) Mfg. Lot 18025503, Exp. 10/24/09;
148) Mfg. Lot 29451A, Exp. 10/24/09;
149) Mfg. Lot E080179A, Exp. 10/23/09;
150) Mfg. Lot 8223126, Exp. 10/23/09;
151) Mfg. Lot 09418060, Exp. 10/24/09;
152) Mfg. Lot 08D027, Exp. 10/24/09;
153) Mfg. Lot 61403, Exp. 10/24/09;
154) Mfg. Lot 17303302, Exp. 10/24/09;
155) Mfg. Lot 8DB29, Exp. 10/24/09;
156) Mfg. Lot 8FB43, Exp. 10/23/09;
157) Mfg. Lot F0117, Exp. 10/23/09
RECALLING FIRM/MANUFACTURER
Advantage Dose LLC, Shreveport, LA, by telephone, electronic mail, and letter beginning November 26, 2008. Firm initiated recall is ongoing.
REASON
Non-Compliance with current Good Manufacturing Practices (GMPs).
VOLUME OF PRODUCT IN COMMERCE
2,635,663 unit doses
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) BD Glucose, Dextrose, 5GM TAB, Mfg. B-D, Recall # D-1531-2009;

2) Benazepril HCl, 10 MG TAB, Mfg. A-C, NDC 60505-0266-01. Recall # D-1532-2009;

3) Certavite SR W/LUT, Multivit. U/MIN/LUT TAB, Mfg. MAJ, NDC 00904-5486-52. Recall # D-1533-2009;

4) Ferrlecit, 62.5MG/5ML AMP, 5ML, Mfg. WAT, NDC 2544-922-26. Recall # D-1534-2009;

5) Lipitor, Atorvastatis Ca, 40 MG TAB, Mfg. PFZ, NDC 00071-0157-23. Recall # D-1535-2009;

6) Sotalol HCl, sub: BETAPACE, 80MG TAB, Mfg. SDZ, NDC 00185-171-01. Recall # D-1536-2009;

7) Isopto Homatropine, 5% OPHTH DROP, 5ML, Mfg. ALC. Recall # D-1537-2009;

8) Hydralazine HCl, 25 MG TAB, Mfg. HPI, NDC 23155-0002-01. Recall # D-1538-2009;

9) Prandin, Repaglinide, 1MG TAB, Mfg. NPH, NDC 00169-0082-81. Recall # D-1539-2009;

10) Medroxyprogesterone Injection, 150MG/ML Vial, Advantage Dose not on label. Recall # D-1540-2009;

11) Metoprolol Succinate, Extended-Release, 50 MG TAB; Mfg. PAR, NDC 49884-0405-01. Recall # D-1541-2009;

12) Phenazopyridine Plus Tab, Mfg. BRK, NDC 51991-0255-33. Recall # D-1542-2009;

13) Calcium Acetate, 667 MG CAP, Mfg. ROX, NDC 00054-0088-26. Recall # D-1543-2009;

14) Avitene, 1 GM JAR, Mfg. DAV. Recall # D-1544-2009;

15) Prenate Elite, Prenatal Vitamins TAB, Mfg. SPI. Recall # D-1545-2009;  

16) Orphenadrine ER, Orphenadrine Citrate, 100MG TAB, Mfg. GLO, NDC 00115-2011-01. Recall # D-1546-2009;

17) Chromagen Caplet, Mfg. TRC, NDC 64011-0198-26.  Recall # D-1547-2009;

18) Revatio, Sildenafil Citr, 20 MG TAB, Mfg. PFZ, NDC 00069-4190-68. Recall # D-1548-2009;

19) Actos, Pioglitazone, 45 MG TAB, Mfg TPA, NDC 64764-0451-24. Recall # D-1549-2009;

20) Colestipol HCl, Tablet 1G, Mfg. GLO, NDC 00115-5211-15. Recall # D-1550-2009;

21)Thermazene, Silver Sulfadiazine, 1% 20GM Cream, Mfg. KEN. Recall # D-1551-2009;

22) Acetaminophen Suppository, 325 MG, Mfg. GDL, 00182-7001-11. Recall # D-1552-2009;

23) Lamictal, Lamorigine, 25 MG Tablet, Mfg. GSK, NDC 00173-0633-02. Recall # D-1553-2009;

24) Glipizide ER, Sub: Glucotrol XL, 5 MG TAB, Mfg. GRN, NDC 59762-5032-01. Recall # D-1554-2009;

25) Acetaminophen Rectal Suppository, Mfg. G&W. Recall # D-1555-2009;

26) Levothyroxine Tab, 175 MCG (0.175 MG), Mfg. MYL, NDC 00378-1817-01. Recall # D-1556-2009;

27) Commit Lozenge, Nicotine Polarcrilex, 4 MG LOZ, Mfg. SKB, NDC 00766-1500-20. Recall # D-1557-2009;

28) Belladonna Alk W/PB, Sub: Donnatal Elixir, Mfg. QLT, NDC 00603-1030-58, 15 ML. Recall # D-1558-2009;

29) Bismuth Subsalicylate, 262 MG/15 ML Oral, Mfg. GDD, NDC 00113-0302-34, 30 ML. Recall # D-1559-2009;

30) Levothyroxine Tab, 200 MCG (0.2MG), Mfg. MYL, NDC 00378-1819-01. Recall # D-1560-2009;

31) Sular, Nisoldipine, 8.5MG ER-TAB, MFG. SPP, NDC 39630-0500-10. Recall # D-1561-2009;

32) Centrum Multivitamin/Min TAB, Mfg. W-R, NDC 00005-4239-36. Recall # D-1562-2009;

33) Nephplex Rx, Tab, Mfg. N-T, NDC 59528-0317-01. Recall # D-1563-2009;

34) Trazodone, Sub: Desyrel, 150 MG TAB, Mfg. A-C, NDC 60505-2655-01. Recall # D-1564-2009;

35) Tekturna, Aliskiren, 150MG TAB, Mfg. NVT, NDC 00078-0485-15. Recall # D-1565-2009;

36) Aspirin, 325 MG TAB, Mfg. MAJ, NDC 00904-2009-60. Recall # D-1566-2009;

37) Prograf, Tacrolimus Anhydrous, 0.5 MG CAP, Mfg. ASE, NDC 00469-0607-73. Recall # D-1567-2009;

38) Tizanidine HCl, sub: Zanaflex, 2 MG TAB, Mfg. SDZ, NDC 00185-0034-51. Recall # D-1568-2009;

39) HydroOXYzine HCl, Sub: Atarax Tab, 25 MG TABLET, Mfg. PLU, NDC 50111-0308-01. Recall # D-1569-2009;

40) Mucinex, Guaifenesin ER, 600 MG TAB, Mfg. ADA, NDC 63824-0008-40.  Recall # D-1570-2009;

41) Cellcept, Mycophenolate, 500 MG TAB, Mfg. ROC, NDC 00004-0260-01. Recall # D-1571-2009;

42) Naproxen Sod, Sup: Anaprox DS, 550 MG TAB, Mfg. W-W, NDC 00143-9908-01. Recall # D-1572-2009;

43) Diamox Seq ER, Acetazolamide, 500 MG CAP, Mfg. DMD, NDC 51285-0754-02. Recall # D-1573-2009;

44) Estradiol, Sub: Estrace, 2MG TAB, Mfg. WAT, NDC 00591-0488-01. Recall # D-1574-2009;

45) Megace ES, Megestrol Acetate, 625 MG/5 ML SUSP, Qty 5 ML, Mfg. PAR, NDC 49884-0949-69. Recall # D-1575-2009;

46) Ondansetron ODT, 4 MG TAB, Mfg. GPI, NDC 68462-0157-13. Recall # D-1576-2009;

47) Commit Lozenge, Nicotine Polacrilex, 2 MG LOZ, Mfg. SKB, NDC 00766-1500-10. Recall # D-1577-2009;

48) Trandolapril, Sub: MAVIK, 2 MG TAB, Mfg. TEV, NDC 00093-7326-01. Recall # D-1578-2009;

49) Bisac - Evac Bisacodyl, 10 MG Rectal Suppository, Mfg. G&W, 99086. Recall # D-1579-2009;

50) Levothyroxine Sod Tab, 50 MCG (0.05 MG), Mfg. MYL, NDC 00378-1803-01. Recall # D-1580-2009;

51) Cellcept, Mycophenolate, 250 MG CAP, Mfg. ROC, NDC 00004-0259-01. Recall # D-1581-2009;

52) Warfarin Sodium, 6 MG TAB, Mfg. BAR, NDC 00555-0926-02. Recall # D-1582-2009;

53) Levothyroxine Sod Tab, 25 MCG (0.025MG), Mfg. MYL, NDC 00378-1800-01. Recall # D-1583-2009;

54) Zinc Sulfate, (Zinc 50 MG), 220 MG CAPSULE, Mfg. MAJ, NDC 00904-5332-60. Recall # D-1584-2009;

55) Lamictal, Lamotrigine, 200 MG TAB, Mfg. SKB, NDC 00173-0644-60. Recall # D-1585-2009;

56) Levothyroxine Sod Tab, 75 MCG (0.075MG), Mfg. MYL, NDC 00378-1805-01. Recall # D-1586-2009;

57) Isosorbide Mono, 20 MG TAB, Mfg. ACT, NDC 00228-2620-11. Recall # D-1587-2009;

58) Topamax, Topiramate, 200 MG TAB, Mfg. JOM, NDC 00045-0642-65. Recall # D-1588-2009;

59) Ticlopidine HCl, 250 MG TAB, Mfg. A-C. Recall # D-1589-2009;

60) Levothyroxine Sod Tab, 125 MCG (0.125MG), Mfg. MYL, NDC 00378-1813-01. Recall # D-1590-2009;

61) NAC, N-Acetyl-Cysteine, 600 MG CAP, Mfg. TWI, NDC 02743-4002-11. Recall # D-1591-2009;

62) Isosorbide Mono, 10 MG TAB, Mfg. ACT, NDC 00228-2631-11. Recall # D-1592-2009;

63) Vistide SDV, Cidofovir, 75 MG/ML Vial, 5 ML, Mfg. GSI. Recall # D-1593-2009;

64) Levothyroxine Sod Tab, 100 MCG (0.1 MG), Mfg. MYL. Recall # D-1594-2009;

65) Levothyroxine Tablet, 300 MCG (0.3MG), Mfg. MYL, NDC 00378-1821-01. Recall # D-1595-2009;

66) Keppra, Levetiracetam, 750 MG TAB, Mfg. UCB, NDC 50474-0596-40. Recall # D-1596-2009;

67) Carvedilol, 6.25 MG TAB, Mfg. AUP, NDC 65862-0143-01. Recall # D-1597-2009;

68) Vfend, Voriconazole, 200 MG TABLET, Mfg. PFZ, NDC 00049-3180-30. Recall # D-1598-2009;

69) Levothyroxine Sod Tab, 150 MCG (0.15MG), Mfg. MYL, NDC 00378-1815-01. Recall # D-1599-2009;

70) Valcyte, Valganciclovir, 450 MG TABLET, Mfg. ROC, NDC 00004-0038-22. Recall # D-1600-2009;

71) Midazolam HCL, Oral Syrup, 2MG/ML CIV, Qty 5 ML, Mfg. ROX, NDC 00054-3566-99. Recall # D-1601-2009;

72) Kaletra, Ritonavir/Lopinavir Tab, 50 MG/200 MG, Mfg. ABB, NDC 00074-6799-22. Recall # D-1602-2009;

73) Cyclobenzaprine HCL, 5 MG TAB, Mfg. BRK, NDC 51991-0467-01. Recall # D-1603-2009;

74) Warfarin Sodium, 5 MG TAB, Mfg. BAR, NDC 00555-0833-02. Recall # D-1604-2009;

75) Amlodipine/Benazepril, 5/20 MG CAP, Mfg. SNZ, NDC 00781-2273-01. Recall # D-1605-2009;

76) Estradiol, 1 MG TAB, Mfg. WAT, NDC 00591-0487-01. Recall # D-1606-2009;

77) Zinc Gluconate Tab, 50 MG ZINC, Mfg. NVC, NDC 79854-0500-75. Recall # D-1607-2009;

78) Prednisolone Oral Solution, 15 MG/5ML, Mfg. TEV, NDC 00093-6118-16, 5ML. Recall # D-1608-2009;

79) Centrum Silver TAB, Mfg. Lot C76264A, Mfg. U-R, NDC 00005-4177-23. Recall # D-1609-2009;

80) Aspirin, Enteric Coated, 325 MG TAB, Mfg. MAJ, NDC 00904-2011-59. Recall # D-1610-2009;

81) Menest, Estrogens, Esterif, 0.625 MG TAB, Mfg. MNR, NDC 61570-0073-01. Recall # D-1611-2009;

82) Starlix, Nateglinide, 60 MG TAB, Mfg. NVT, 54523. Recall # D-1612-2009;

83) Balsalazide Disodium, 750 MG CAP, Mfg. WAT, NDC 00591-3570-35. Recall # D-1613-2009;

84) Albuterol Sulf, Strawberry, 2 MG/5ML Solution, Qty 5ML, Mfg. QLT, NDC 00603-1008-58. Recall # D-1614-2009;

85) Diclofenac Sod DR, Enteric Coated, 75 MG TAB, Mfg. ACT, NDC 00228-2551-06. Recall # D-1615-2009;

86) Reyataz, Atazanavir Sulf, 200 MG CAP, Mfg. BRI, 31247. Recall # D-1616-2009;

87) Metoprolol Tart, 25 MG TAB, Mfg. C-P, NDC 57664-0506-08. Recall # D-1617-2009;

88) Mexiletine HCl, 150 MG CAP, Mfg. TEV, NDC 00093-8739-01. Recall # D-1618-2009;

89) Gelfilm, Opth Film, Gelatin Film 2 sq in, Mfg. PFZ.  Recall # D-1619-2009;

90) Prednisolone SOL, Sub: Prelone, 15 MG/5ML ORAL, 5ML, Mfg. TEV, NDC 00093-6118-87. Recall # D-1620-2009;

91) Zinc Sulfate (Zinc 50 MG), 220 MG CAP, Mfg. CYP, NDC 60258-0131-01. Recall # D-1621-2009;

92) Amlodipine/Benazepril, 5/10 MG CAP, Mfg. SNZ, NDC 00781-22720-01. Recall # D-1622-2009;

93) Drisdol Cap, Ergocalciferol (Vit D), 50,000 IU (1.25MG), Mfg. RPS, 99607. Recall # D-1623-2009;

94) Nitroglycerin Extended Release, 9 MG CAP, Mfg. Lot L054T, Exp 11/10/09, Mfg. ETH, NDC 58177-0006-04. Recall # D-1624-2009;

95) Synthroid Tab, Levothyroxine, 0.088MG (88MCG), Mfg. ABB, NDC 00074-6594-13. Recall # D-1625-2009;  

96) Quinidine Sulf, 200 MG TABLET, Mfg. WAT, NDC 00591-5438-01. Recall # D-1626-2009;

97) Simethicone, 125 MG SOFTGEL, Mfg. GOD, NDC 00113-0428-65. Recall # D-1627-2009;

98) OS-CAL +D, Calcium + Vit D, 500MG/200IU TAB, Mfg. GSK. Recall # D-1628-2009;

99) Sudogest, Pseudoephedrine, 30 MG TAB, Mfg. MAJ, NDC 00904-5053-59. Recall # D-1629-2009;

100) Novolog, Insulin Aspart Inj., 100 U/ML Vial 10 ML, Mfg. NPH, NDC 00169-7501-11. Recall # D-1630-2009;

101) Lamotrigine, 100 MG TAB, Mfg. TEV, NDC 00093-0463-01. Recall # D-1631-2009;

102) Didronel, Etidronate Disodium, 400 MG TAB, Mfg. P&G, NDC 00149-0406-60. Recall # D-1632-2009;

103) Hyoscyamine ODT, 0.125 MG TAB, Mfg VPH, NDC 68013-0005-01. Recall # D-1633-2009;

104) Apidra, Insulin Glulisine, 100 Units/ML INJ 10 ML, Mfg. AVE, NDC 00088-2500-33. Recall # D-1634-2009;

105) Propantheline, Sub: Pro-Banthine, 15 MG TAB, Mfg. ROX, NDC 00054-4721-25. Recall # D-1635-2009;

106) Promethazine DM Syrup, 6.25 MG/15MG/5ML, Mfg. HTP, NDC 50383-0803-16, 10 ML. Recall # D-1636-2009;

107) Lantus Injection, 100 Units/ML, 10 ML, Mfg. AVE, NDC 00088-2220-33. Recall # D-1637-2009;

108) Cytomel, Liothyronine, 25 MCG TAB, Mfg. KPI, NDC 60793-0116-01. Recall # D-1638-2009;

109) Humalog Mix 75/25, INJ, 10 ML, Mfg. LIL, NDC 00002-7511-01. Recall # D-1639-2009;

110) Femara, Letrozole, 2.5 MG TAB, Mfg. NVT, NDC 00078-0248-15. Recall # D-1640-2009;

111) Didronel, Etidronate Disodium, 200 MG TAB, Mfg. P&G, NDC 00149-0405-60. Recall # D-1641-2009;

112) Nifedipine, 10 MG CAP, Mfg. ACT, NDC 00228-2497-10. Recall # D-1642-2009;

113) Meclofenamate Sod, 50 MG CAP, Mfg. MYL, NDC 00378-2150-01. Recall # D-1643-2009;

114) MAG 64, Sub: SLOW MAG, 64 MG TAB, Mfg RIS, NDC 68535-0005-75. Recall # D-1644-2009;

115) Vitamin C, Ascorbic Acid, 500 MG TAB, Mfg. MAJ, NDC 00904-0523-60. Recall # D-1645-2009;

116) Oxaprozin, 600 MG TAB, Mfg. RED, NDC 55111-0170-01. Recall # D-1646-2009;

117) Premarin, Conj. Estrogens, USP, 0.3MG TAB, Mfg. WYE, NDC 00046-1100-01. Recall # D-1647-2009;

118) Cytomel, Liothyronine Sod, 5MCG TAB, Mfg. KPI, NDC 60793-0115-01. Recall # D-1648-2009;

119) Acetazolamide, 250 MG TAB, Mfg TAR, NDC 51672-4023-01. Recall # D-1649-2009;

120) Novolog Mix 70/30 INJ, 10 ML, Mfg. NPH, NDC 00169-3685-12. Recall # D-1650-2009;

121) Mucinex, guaifenesin Oral, 100 MG/5ML Solution, Qty 5ML, Mfg. ADA, NDC 63824-0173-64. Recall # D-1651-2009;

122) Bisoprolol Fumarate, Sub: Zebeta, 5 MG TAB, Mfg. TEV, NDC 000935270-56. Recall # D-1652-2009;

123) Rozerem, Rameleon, 8MG TAB, Mfg. TPA, NDC 64764-0805-30. Recall D-1653-2009;

124) Levemir, Insulin Detemir, 100 UNITS/ML INJ, 10 ML, Mfg. NPH, NDC 00169-3687-12. Recall # D-1654-2009;

125) Keppra, Levetiracetam, 100 MG/ML Solution, 5ML, Mfg. UCB, NDC 50474-0001-48. Recall # D-1655-2009;

126) Oxybutynin, Extended-Release, 15 MG TAB, Mfg. MYL, NDC 00378-6015-01. Recall # D-1656-2009
CODE
1) Mfg. Lot 1461C1230, Exp. 04/04/10;
2) Mfg. Lot HU7302, Exp. 11/07/09,
3) Mfg. Lot 27980, Exp. 11/07/09;
4) Mfg. Lot D7A342, Exp. 03/31/11;
5) Mfg. Lot 0627058, Exp. 11/07/09;
6) Mfg. Lot 177412, Exp 11/06/09;
7) Mfg. Lot 139296F, Exp. 02/28/10;
8) Mfg. Lot 6127005A, Exp 11/07/09;
9) Mfg. Lot 706756B, Exp. 11/06/09;
10) Mfg. SPI, Mfg. Lot 31302127B, Exp. 05/31/10;
11) Mfg. Lot PL0128, Exp 11/07/09;
12) Mfg. Lot PP00208, Exp. 11/07/09;
13) Mfg. Lot 856122A, Exp. 11/07/09;
14) Mfg. Lot WBSCFD12, Exp. 03/31/11;
15) Mfg. Lot ZC22, Exp. 01/31/10;  
16) Mfg. Lot 8022651, Exp 11/07/09;
17) Mfg. Lot 90806, Exp 11/07/09;
18) Mfg. Lot 8236805, Exp 11/06/09;
19) Mfg. Lot A14656, Exp 11/07/09;
20) Mfg. Lot 8090281, Exp. 11/07/09;
21) Mfg. Lot 820534, Exp. 08/31/11;
22) Mfg. Lot 016408002, Exp. 03/31/12;
23) Mfg. Lot 8ZP808, Exp. 11/07/09;
24) Mfg. Lot 10968V, Exp. 11/06/09;
25) Mfg. Lot 016408005, Exp. 05/31/12;
26) Mfg. Lot 3002998, Exp. 11/10/09;
27) Mfg. Lot 8B27, Exp 11/10/09;
28) Mfg. Lot L038G08A, Exp. 11/07/09;
29) Mfg. Lot 8AK0217, Exp. 11/07/09;
30) Mfg. Lot 3005319, Exp. 11/10/09;
31) Mfg. Lot 2017178, Exp. 09/30/09;
32) Mfg. Lot C23095, Exp. 11/07/09;
33) Mfg. Lot 0801, Exp. 11/10/09;
34) Mfg. Lot 306813, Exp. 11/07/09;
35) Mfg. Lot F0066, Exp. 11/07/09;
36) Mfg. Lot 3278, Exp. 11/07/09;
37) Mfg. Lot 034471, Exp. 11/07/09;
38) Mfg. Lot ME080083, Exp. 11/07/09;
39) Mfg. Lot 307300, Exp. 11/07/09;
40) Mfg. Lot PL00007951, Exp. 11/07/09;
41) Mfg. Lot U0979, Exp 11/10/09;
42) Mfg. Lot ND453B, Exp. 11/07/09;
43) Mfg. Lot 701367, Exp 11/07/09;
44) Mfg. Lot 48802M07, Exp. 11/07/09;
45) Mfg. Lot 19508101, Exp. 11/10/09;
46) Mfg. Lot Q10148018, Exp. 07/31/10;
47) Mfg. Lot 8B19, Exp. 11/10/09;
48) Mfg. Lot T22026, Exp. 11/07/09;
49) Mfg. Lot 010908006, Exp. 04/30/11;
50) Mfg. Lot 3003648, Exp. 11/10/09;
51) Mfg. Lot U1070, Exp. 11/10/09;
52) Mfg. Lot 701265, Exp. 11/10/09;
53) Mfg. Lot 3004424, Exp. 11/10/09;
54) Mfg. Lot 18029105, Exp. 11/10/09;
55) Mfg. Lot 8ZP7593, Exp. 11/10/09;
56) Mfg. Lot 3004069, Exp. 11/10/09;
57) Mfg. Lot 178H81, Exp. 11/10/09;
58) Mfg. Lot 8JG926, Exp. 11/10/09;
59) Mfg. Lot HN9113, Exp. 11/10/09;
60) Mfg Lot 3004586, Exp. 11/10/09;
61) Mfg. Lot 208471045, Exp. 11/10/09;
62) Mfg. Lot 475J81, Exp. 11/10/09;
63) Mfg. Lot 944279, Exp. 05/31/10;
64) Mfg. Lot 3004904, Exp. 11/10/09;
65) Mfg. Lot 3004664, Exp. 11/10/09;
66) Mfg. Lot 47908, Exp. 11/07/09;
67) Mfg. Lot CU0607008, Exp. 10/31/09;
68) Mfg. Lot 810312330, Exp. 11/10/09;
69) Mfg. Lot 3003210, Exp. 11/10/09;
70) Mfg. Lot B1049, Exp. 11/10/09;
71) Mfg. Lot 856964A, Exp. 11/10/09;
72) Mfg. Lot 64845AA40, Exp. 11/10/09;
73) Mfg. Lot AE060, Exp. 11/10/09;
74) Mfg. Lot 307460, Exp. 11/10/09;
75) Mfg. Lot F1015, Exp 11/10/09;
76) Mfg. Lot 48702K07, Exp. 10/31/09;
77) Mfg. Lot 7FC80, Exp. 11/10/09;
78) Mfg. Lot 30201673A, Exp. 11/11/09;
79) Mfg. Lot C76264A, Exp 11/10/09;
80) Mfg. Lot A194U, Exp 11/11/09;
81) Mfg. Lot 52693, Exp 11/10/09;
82) Mfg. Lot F0105, Exp. 11/10/09;
83) Mfg. Lot 320667, Exp 11/11/09;
84) Mfg. Lot L057G08A, Exp. 11/11/09;
85) Mfg. Lot 225H81, Exp 11/10/09;
86) Mfg. Lot 8C3048A, Exp 11/10/09;
87) Mfg. Lot 81739A, Exp 11/11/09;
88) Mfg. Lot 35303681A, Exp. 11/10/09;
89) Mfg. Lot 0APTY, Exp. 03/31/11;
90) Mfg. Lot 30202639A, Exp. 11/11/09;
91) Mfg. Lot 28104, Exp 11/10/09;
92) Mfg. Lot F1005, Exp 11/10/09;
93) Mfg. Lot 256797N, Exp 08/31/09;
94) Mfg. Lot L054T, Exp 11/10/09;
95) Mfg. Lot 69006A8, Exp. 05/26/09;
96) Mfg. Lot 90229A, Exp 11/10/09;
97) Mfg. Lot 8GEO110, Exp. 10/31/09;
98) Mfg. Lot 8A21, Exp. 11/10/09;
99) Mfg. Lot P50366, Exp 11/11/09;
100) Mfg. Lot VZF0216, Exp. 11/30/10;
101) Mfg. Lot 24L007, Exp. 11/11/09.
102) Mfg. Lot 435029, Exp. 11/11/09;  
103) Mfg. Lot C08013, Exp. 11/11/09;
104) Mfg. Lot 40U064, Exp. 06/30/10;
105) Mfg. Lot 857129A, Exp. 11/11/09;
106) Mfg. Lot 884803, Exp 1/11/09;
107) Mfg. Lot 40U339, Exp. 05/31/10;
108) Mfg. Lot 53179, Exp 11/11/09;
109) Mfg. Lot A477867C, Exp 01/31/10,
110) Mfg. Lot F4200, Exp. 11/11/09;
111) Mfg. Lot 430539, Exp. 11/11/09;
112) Mfg. Lot 279E81, Exp 11/11/09;
113) Mfg. Lot 3000913, Exp 11/11/09;
114) Mfg. Lot J058T, Exp 11/11/09;
115) Mfg. Lot 18282503, Exp 11/11/09;
116) Mfg. Lot C82088, Exp 11/11/09;
117) Mfg. Lot C88669, Exp 11/11/09;
118) Mfg. Lot 53178, Exp 11/11/09;
119) Mfg. Lot 080288, Exp 11/11/09;
120) Mfg. Lot VZF0225, Exp 06/30/10.
121) Mfg. Lot 804005, Exp 11/11/09.
122) Mfg. Lot 35304576A, Exp. 11/11/09;
123) Mfg. Lot C14058, Exp 11/10/09;
124) Mfg. Lot VZF0247, Exp. 06/30/10;
125) Mfg. Lot 47493, Exp 11/12/09;
126) Mfg. Lot 8DA580, Exp. 08/31/09
RECALLING FIRM/MANUFACTURER
Advantage Dose LLC, Shreveport, LA, by telephone, electronic mail, and letter beginning November 26, 2008. Firm initiated recall is ongoing.
REASON
Not in conformance with cGMPs.
VOLUME OF PRODUCT IN COMMERCE
2,635,663 unit doses
DISTRIBUTION
AR, GA, IL, LA, MS, MO, OK, TX

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
1) Allopurinol tablets, USP, 100 mg, Rx, 100 tablet bottles: NDC 57664-434-88 and 1000 tablet bottles: NDC 576644-434-18. Recall # D-1501-2009;

2) Allopurinol tablets, USP, 300 mg, Rx, 100 tablet bottles: NDC 57664-436-88 and 500 tablet bottles: NDC 576644-436-13. Recall # D-1502-2009;

3) Atenolol tablets, USP, 25 mg, 1000 tablet bottles, Rx, NDC 57664-264-18. Recall # D-1503-2009;

4) Carbamazepine tablets, USP, 200 mg, 500 tablet bottles, Rx, NDC 13668-268-05. Recall # D-1504-2009;

5) Carvedilol tablets, USP, 3.125 mg, Rx, 100 tablet bottles: NDC 57664-242-88, 500 tablet bottles: NDC 57664-242-13. 1000 tablets: NDC 57664-242-18. Recall # D-1505-2009;

6) Carvedilol tablets, USP, 6.25 mg, Rx, 100 tablet bottles: NDC 57664-244-88, 500 tablet bottles: NDC 57664-244-13. Recall # D-1506-2009;

7) Carvedilol tablets, USP, 25 mg, Rx, 500 tablet bottles: NDC 57664-247-13, 1000 tablet bottles: NDC 57664-247-18. Recall # D-1507-2009;

8) Choline Magnesium Trisalicylate tablets, 750 mg, 100 tablet bottles, Rx, NDC 57664-220-08. Recall # D-1508-2009;

9) Citalopram Hydrobromide tablets, 20 mg, Rx, 100 tablet bottles: NDC 57664-508-88, 500 tablet bottles: NDC 57664-508-13. 1000 tablets: NDC 57664-508-18. Recall # D-1509-2009;

10) Clonazepam tablets, USP, 0.5 mg, C IV, 500 tablet bottles, Rx, NDC 57664-273-13. Recall # D-1510-2009;

11) Clozapine tablets, USP, 25 mg, 500 tablet bottles, Rx, NDC 57664-345-13. Recall # D-1511-2009;

12) Flurbiprofen tablets, USP, 100 mg, 100 tablet bottles, Rx, NDC 57664-165-08. Recall # D-1512-2009;

13) Hydrochlorothiazide tablets, USP, 25 mg, 1000 tablet bottles, Rx, NDC 57664-428-18. Recall # D-1513-2009;

14) Hydrochlorothiazide tablets, USP, 50 mg, Rx, 100 tablet bottles: NDC 57664-429-88, 1000 tablet bottles: NDC 57664-429-18. Recall # D-1514-200;

15) Meloxicam tablets, 7.5 mg, Rx, 100 tablet bottles: NDC 57664-512-88, 1000 tablet bottles: NDC 57664-512-18. Recall # D-1515-2009;

16) Meloxicam tablets, 15 mg, Rx, 100 tablet bottles: NDC 57664-513-88, 500 tablet bottles: NDC 57664-513-13, 1000 tablet bottles: NDC 57664-513-18. Recall # D-1516-2009;

17) Metformin hydrochloride tablets, USP, 500 mg, 1000 tablet bottles, Rx, NDC 57664-397-18. Recall # D-1517-2009;

18) Metformin hydrochloride tablets, USP, 1000 mg, 1000 tablet bottles, Rx, NDC 57664-474-18. Recall # D-1518-2009;

19) Metoprolol Tartrate tablets, USP, 25 mg, 1000 tablet bottles, Rx, NDC 57664-506-18. Recall # D-1519-2009;

20) Metoprolol Tartrate tablets, USP, 50 mg, Rx, 1000 tablet bottles: NDC 57664-166-18, 1000 round tablet bottles: NDC 57664-477-18. Recall # D-1520-2009;

21) Metoprolol Tartrate tablets, USP, 100 mg, 1000 tablet bottles, Rx, NDC 57664-167-18.  Recall # D-1521-2009;

22) Paromomycin Sulfate capsules, USP, 250 mg, 100 capsule bottles, Rx, NDC 57664-175-08. Recall # D-1522-2009;

23) Paroxetine tablets, USP, 20 mg, Rx, 30 tablet bottles: NDC 57664-422-83, 90 tablet bottles: NDC 57664-422-99, 500 tablet bottles: NDC 57664-422-13. Recall # D-1523-2009;

24) Phentermine Hydrochloride tablets, USP, C IV, 37.5 mg, 100 tablet bottles, Rx, NDC 57664-504-88. Recall # D-1524-2009;

25) Tizanidine Hydrochloride tablets, USP, 4 mg, Rx, 150 tablet bottles: NDC 57664-503-89, 1000 tablet bottles: NDC 57664-503-18. Recall # D-1525-2009;

26) Tramadol Hydrochloride tablets, 50mg, Rx, 500 tablet bottles: NDC 57664-377-13, 1000 tablet bottles: NDC 57664-377-18. Recall # D-1526-2009;

27) Tramadol Hydrochloride and Acetaminophen tablets, 37.5 mg/325 mg, Rx, 100 tablet bottles: NDC 57664-537-88, 500 tablet bottles: NDC 57664-537-13. Recall # D-1527-200;

28) Zolpidem Tartrate tablets, 5 mg, C IV, Rx, 100 tablet bottles: NDC 57664-515-88, 500 tablet bottles: NDC 57664-515-13. Recall # D-1528-2009;

29) Zolpidem Tartrate tablets, 10 mg, C IV, Rx, 100 tablet bottles: NDC 57664-516-88, 500 tablets: NDC 57664-516-13. Recall # D-1529-2009
CODE
1) Lots 90260A, 90261A and 90262A;

2) Lots 90258A and 90259A;

3) Lot 82645A;

4) Lot 90008A;

5) Lots 90097A, 90098A and 90098B;

6) Lots 90099A, 90100A and 90101A;

7) Lots 90279A, 90278A and 90280A;

8) Lot 90135A;

9) Lots 82805A, 80806A and 80807A;

10) Lots 82797A, 82798A and 82799A;

11) Lot 90119A;

12) Lot 81844A and 82572A;

13) Lots 82830A, 82831A and 82832A;

14) Lot 90130B;

15) Lots 90081A, 90082A, 90083A, 90084A, 90330A and 90331A;

16) Lots 82596A, 82597A, 82597B, 90086A, 90087A, 90088A, 90250A, 90318A, 90320A and 90321A;

17) Lot 82740A;

18) Lots 82850A, 82689A, 90190A and 90191A;

19) Lots 90122A, 90123A and 90124A;

20) Lots 90027A, 90142A and 90210A;

21) Lot 82710A;

22) Lot 90242A;

23) Lots 90028A, 90028B and 90028C;

24) Lots 90089A and 90090A;

25) Lots 82684A, 90116A and 90017A;

26) Lots 82353A, 82355A, 82362A, 82624A, 82630A, 82631A, 82633A, 82634A, 82635A, 90071A, 90072A, 90073A, 90074A, 90075A, 90078A, 90079A and 90080A;

27) Lots 82603A, 82604A, 82820A and 82822A;

28) Lots 90167A, 90168A, 90168B and 90170A;

29) Lots 90030A, 90031A, 90032A, 90033A, 90034A and 90036A
RECALLING FIRM/MANUFACTURER
Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI, by letter dated April 17, 2009. Firm initiated recall is ongoing.
REASON
Lack of assurance products do not contain an additional drug ingredient.
VOLUME OF PRODUCT IN COMMERCE
410,033 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1171-09
CODE
Unit: 019GY53414
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by telephone, letter and electronic mail beginning on August 12, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
Platelets. Recall # B-1173-09
CODE
Unit: P14332
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc, Chattanooga, TN, by fax on September 12, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1176-09
CODE
Unit: W071208005381
RECALLING FIRM/MANUFACTURER
Medic, Inc, Knoxville, TN, by letter dated October 24, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
1) Source Plasma. Recall # B-1178-09;
2) Recovered Plasma. Recall # B-1179-09
CODE
1) Units: KZ009687, KP098310, KZ009543, KP097812, 06MTNA0146, 05MTNB3808, KP098130, KP098008;
2) Units: KP098130, KP098008
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc, Memphis, TN, by fax on August 29, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA, NC, Austria
___________________________________
PRODUCT 
1) Fresh Frozen Plasma (Apheresis). Recall # B-1230-09;
2) Platelets Pooled Leukocytes Reduced. Recall # B-1231-09;
3) Red Blood Cells Leukocytes Reduced. Recall # B-1232-09;
4) Fresh Frozen Plasma. Recall # B-1233-09
CODE
1) Unit: 9734652;
2) Units: 9734801, 9734652;
3) Units: 7332232, 7278160;
4) Unit: 7278160
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc, Orlando, FL, by telephone, letter and fax on October 31, 2008 and follow-up fax on November 14, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor previously deferred for exposure to hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1234-09
CODE
W0416080111604 (split product)
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on July 18, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1235-09;
2) Fresh Frozen Plasma. Recall # B-1236-09;
3) Red Blood Cells. Recall # B-1237-09
CODE
1) Unit: T80121;
2) Units: W127808104459; W127808100850; W127808102582;
3) Units: T77453; T78815; W127808100850; W127808102582; W127808104459
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone on February 3, 2009 and follow-up letter dated March 13, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
WA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1249-09
CODE
Unit: 9005982
RECALLING FIRM/MANUFACTURER
Atlanta Blood Services, Atlanta, GA, by letter dated December 31, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
1) Red Blood Cells. Recall # B-1250-09;
2) Fresh Frozen Plasma. Recall # B-1251-09
CODE
1) and 2) Unit: 4054709
RECALLING FIRM/MANUFACTURER
Wellmont Health System dba Marsh Regional Blood Center, Kingsport, TN, by letter dated October 4, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1252-09
CODE
Unit: 318647789
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Tupelo, MS, by electronic notification on November 1, 2005 or by letter dated December 9, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT 
Source Plasma. Recall # B-1254-09
CODE
Units: 363035924, 363035761, 363034642, 363034463, 363034153, 363033965, 363033670, 363033509, 363033093, 363032543, 363032383, 363032099, 363031873, 363031593, 363031321, 363031001, 363030738, 363030235, 363030057, 363029728, 363028978, 363028657, 363028438, 363028031, 363027863, 363027492, 363027314, 363026918, 363026688, 363026356, 363026123, 363025728, 363025483, 363025047, 363024873, 363024318, 363023960, 363023655, 363023279, 363022828, 363022612, 363020673, 363020392, 363021363, 363021144, 363019633, 363019419, 363018827, 363018647, 363016935, 363016561, 363016170, 363015723, 363014906, 363014413, 363014104, 363013235, 363012843, 363012402, 363011999, 363011601, 363011195, 363008854, 363008420, 363008054, 363007611, 363007268, 363006814, 363006486, 363006074, 363005753, 363005310, 363004961, 363004496, 363004188, 363003610, 363000147, I74029391, I74028830, I74028628, I74025361, I74024797, I74024560, I74024220, I74024002, I74023653, I74023404, I74023044, I74022854, I74022445, I74022288, I74021933, I74021763, I74021452, I74021274, I74020724, I74019586, I74025147, 363015212
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc, Fort Worth, TX, by facsimile on March 13, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
99 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1265-09
CODE
Unit: W040809103260
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center Inc, Jackson, TN, by letter dated April 15, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1266-09
CODE
W035209043436K
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on March 9, 2009 and by follow-up letter dated April 16, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a tattoo within 12 months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1267-09
CODE
Unit: 1096678
RECALLING FIRM/MANUFACTURER
West Tennessee Regional Blood Center Inc, Jackson, TN, by letter dated April 9, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1172-09
CODE
Unit: 019GY53414
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by telephone, letter and electronic mail beginning on August 12, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1225-09;
2) Fresh Frozen Plasma. Recall # B-1226-09;
3) Recovered Plasma. Recall # B-1227-09;
4) Plasma Frozen. Recall # B-1228-09
CODE
1) Units: W087608042113; W087608011029; W087608011025; W087608011024; W087608020997; W087608042120; W087608061050; W087608042116; W87608020294;

2) Units: W087608061050; W087608042120; W087608042116;

3) Units: W087608042113; W087608011029; W087608011025; W087608011023; W087608040764; W087608010854; W087608060878; W087608041744; W087608010850;

4) Units: W087608011024; W087608060433; W087608020294
RECALLING FIRM/MANUFACTURER
Virginia Blood Service Inc, Richmond, VA, by letter dated August 27, 2008 and by fax on September 4, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled with the incorrect anticoagulant and expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
VA, Austria
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1253-09;
CODE
Unit: 318647789
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Tupelo, MS, by electronic notification on November 1, 2005 or by letter dated December 9, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland 
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1264-09
CODE
Unit: W0410090590511
RECALLING FIRM/MANUFACTURER
Blood Systems Inc dba United Blood Services, Scottsdale, AZ, by telephone and fax on April 3, 2009. Firm initiated recall is complete.
REASON
Blood product, documented as being out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

___________________________________
PRODUCT 
Paradigm Quick-set Infusion Sets, Models MMT-396, MMT-397, MMT-398 and MMT-399. The Paradigm Quick-set infusion sets are intended for use in combination with Paradigm reservoirs (models MMT- 326 or MMT-332) and Paradigm external insulin infusion pumps to deliver insulin (subcutaneously) to patients who require exogenous insulin to maintain glycemic control. Recall # Z-1705-2009
CODE
Lot numbers starting with the Number 8
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic MiniMed, Northridge, CA, by letters dated July 6, 2009, July 7, 2009, July 8, 2009 and July 9, 2009 and by press release on July 10, 2009.
Manufacturer: Unomedical a/s, Lejre, Demark. Firm initiated recall is ongoing.
REASON
Approximately 2% of the infusion sets in the affected lots may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the syringe compartment with the surrounding atmosphere. If the vent does not work properly, this could potentially result in too much or too little insulin being delivered.
VOLUME OF PRODUCT IN COMMERCE
28,007,256 units
DISTRIBUTION
Nationwide, Canada, Mexico, Bermuda, Brazil, United Kingdom, Ecuador, Paraguay, Kuwait, Germany, El Salvador and Turkey

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
Hydration Station with Pedestal (Part # E30003-01), Hydration Station with Pedestal & DVD (Part # E30003-01D). Recall # Z-1245-2009
CODE
Serial Numbers: 206045779, SG2061042159, 206054856, 206054874, 205024943, 206055838, 206065900, 205086311, 205104399, 205044085, 205104389, SG2061052196, SG2061242331, 205026973, 205105418, 205124542, 205085303, 206045774, SG2061042139, 206025737, SG2061252335, SG2061042144, 205036004, 206054864, 206074978, SG2070142422, 206044815, 205114444, 206045777, 205106415, 205116435, 206064932, SG2070452617, 205026946, 205105397, 205044117, SG2070352558, 206055846, 205104413, 205114480, 205104402, 206034734, 206064954, 206045775, 206055872, 206065917, 2060742003, 205024996, 206024711, 206055879, 206064931, SG2070442571, SG2061242336, SG2061052167, SG2061252330, SG2061042152, 205016864, SG2070142362, 205114443, 205105419, 206044772, 206054883, SG2061252351, 205125523, 2060942089, SG2061142232, 206064949, 206065910, 205124550, 205115440, 206045781, 205085300, SG2061152280, 2060952083, 206075982, 206045773, 206064902, SG2070152435, 205016909, 206044770, 205114464, 206044801, 206075002, SG2061252339, 206035735, 205114456, 206045778, 206055860, 2060942063, 206054889, 206044814, SG2061152278, 205126569, 206075986, SG2070142383, SG2061052140 206054842, 206034728, SG2061042175, 206054854, SG2061152250, SG2061152223, 205024974, 205014893, 206045771, 205096337, 205105400, 205025988, SG2061042164, 205026938, 205046086, 205025939, 206065964, 205025978, SG2061252345, 205104390, 206044799, SG2061252338, SG2070152353, 206055855, SG2070442574, SG2070352513, SG2070452616, SG2070452610, 206045807, 206064965, 205114494, 205105408, 205015910, 206044802, SG2061242332, SG2070342501, 206044782, SG2070452608, SG2070152378, 205116476, 205104405, 205116431, 206074983, 206064938, 205116503, 206034730, SG2061242346, 206045767, 206035723, SG2061252341, 206045776, 206065945, SG2061252329, 204115767, 206064903, 205106395, 205106398, SG2060952114, 205116506, SG2070352490, SG2061142235, 206035729, 205016896, 204126827, 206044786, 206044783, 206064913, 206044812, 205105407, SG2060952109, SG2070242441, SG2070242446, 206065953, SG2070152389, 206054888, 205014920, SG2070442573, 206044818, 206045800, SG2061252347, 206064962, 206054880, 206045822, 206064946, 205034036, 205115495, 205115495, 206055885, 206065950, SG2070152391, 206055890, 2060952076, 206045787, SG2061052213, 206044823, SG2061242327, 206065942, SG2061052160, SG2060942123, 205094380, 205114468, 206035733, 205025976, SG2070152386, 206065936, SG2070142392, SG2061242344, 20634755, SG2061042204, 206054861, 206065901, SG2070452576, SG2070152382, SG2070452572, 205126515, 205125558, SG2061042205, SG2070142356, 206074994, 206034742, 205124565, 206045813, 205104428, 206044809, 206045808, SG2070252447, 205126527, 205024977, SG2060952113, 205105422, 206055868, SG2070242472, 205115460, SG2070142385, SG2070142385, SG2060942125, 206054891, SG2061052202, 206045824, 205105392, 205024984, 206075995, 206034732, 205026981, SG2061042199, SG2060952118, 205044116, 205016898, 205106393, 206045798, 205044087, 205096350, SG2061052177, SG2060952124, SG2070152417, SG2070342556, SG2070452622, SG2061252343, 204095524, SG2070142373, SG2070152407, SG2070142354, 206045817, 206065951, 206065963, SG2061242334, 205024937, 206045819, 2060655873, SG2070152364, SG2061042169, SG2060942119, SG2060952120, SG2061142269, SG2060942108, SG2060942105, 206054865, SG2070242440, 205114484, 205016923, SG2070142396, SG2070152399, 205084307, 206034721, SG2061042151, SG2061042171, SG2061152283, SG2061052168, 204095422, 206054850, 206065909, 206035724, 206045810, 205035068, SG2070142433, 206045784, 204125834, SG2070542669, 206055884, 206044820, SG2070152393, SG2061052161, 206055886, SG2061052172, SG2070152432, 206065944, 206034750, 206055859, SG2070142371, 205015895, 205024972, SG2070252454, SG2070252469, SG2070342551, SG2070352492, SG2070352552, 204096525, 204116734, SG2061252349, SG2070142355, 205106862, SG2060952115, 206074979, 206035727, 205114436, SG2061052141, 206064943, SG2070142411, SG2061252340, SG2070142434, SG2070352553, 206055858, SG2061042197, SG2061242350, 205046089, 205115493, 205014863, 206044785, SG2070152399, SG2070142394, SG2070252467, SG2070242481, SG2070342557, 205036066, SG2070152366, 205014894, SG2061052166, 2060942082, SG2070152395, SG2070152358, 206045805, SG2070442634, SG2070252444, SG2061042155, SG2061052176, 205116432, 205116511, 206026670, 206054887, 206075998, SG2060942104, SG2070252471, 206036720, SG2060942084, 205045088, 205124576, SG2061242333, 204116738, SG2061052150, SG2061052203, 205036042, SG2070152378, SG2070242482 and SG2070242488
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sybaritic, Inc., Bloomington, MN, by letter dated May 15, 2007.
Manufacturer: Sybaritic Spa Consulting OU, Marjamas, Estonia. Firm initiated recall is ongoing.
REASON
Sybaritic conducted a recall on the Hydration Station 806 because of the potential for hot water to spurt through steam ports into unit and cause burns. Also, potential for customers to inadvertently place their legs over the side wall of the unit directly onto the steam ports and cause burns. There were 18 injuries and 8 malfunctions reported.
VOLUME OF PRODUCT IN COMMERCE
370 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model #4550 116 02431 (TumorLoc). The BB is a CT X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. Recall # Z-1542-2009
CODE
Lot Numbers: 7001-7354 for BB; and 8222, 8270, 8709, 8838, 8841, 8862, 8986, 9014, 9019, 9127, 9166, 10331, 10348, 10364, 10402, 10705, 10827, 11002, 11047, 11055, 11096, 11362, 11588, and 11597, for EBW
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated January 28, 2009.
REASON
A software error in the TumorLoc software was discovered upon receipt of a customer complaint. There is the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.
VOLUME OF PRODUCT IN COMMERCE
356 units
DISTRIBUTION
Nationwide, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Jordan, Libyan Arab Jamahiriya, Lithuania, Malaysia, Netherlands Antilles, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Tahiti, Taiwan, Thailand, United Kingdom and Venezuela
___________________________________
PRODUCT 
GE Centricity PACS RA1000 Workstation software (for diagnostic image analysis); The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure. Recall # Z-1543-2009
CODE
Software Versions: Centricity 1.X, 2.0.X, 2.1.X and 3.0.X and PathSpeed 7.X and 8.X
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letter dated March 2, 2009. Firm initiated recall is ongoing.
REASON
Software anomalies may allow the image orientation to be misinterpreted, posing a potential patient safety issue.
VOLUME OF PRODUCT IN COMMERCE
984 units
DISTRIBUTION
Nationwide and countries of Brazil, Canada, Chile, Ecuador, Mexico, Australia, China, Hong Kong, Japan, Korea, Malaysia, New Zealand, Singapore, Taiwan, Austria, Belgium, Switzerland, Germany, Denmark, Egypt, Spain, France, Great Britain, Ireland, Israel, Italy, Kuwait, Lebanon, Malta, Netherlands, Portugal, Saudi Arabia, Sweden and Turkey
___________________________________
PRODUCT 
Gendex VixWin Platinum Imaging Software, Versions 1.0, 1.1 and 1.2; Intended for use of the software is to control capture, display, treatments, analysis and saving of x-ray digital images. Recall # Z-1548-2009  
CODE
Software versions 1.0, 1.1 and 1.2
RECALLING FIRM/MANUFACTURER
Gendex Dental Systems, Des Plaines, IL, by letter dated March 6, 2009. Firm initiated recall is ongoing.
REASON
There is a compatibility issue when the VixWin Platinum versions 1.0/1.1/1.2 software is used in conjunction with Easy Dental, PracticeWorks, EagleSoft and SoftDent practice management software, resulting in patient files that may contain images that are mixed between patients.
VOLUME OF PRODUCT IN COMMERCE
1,256 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
1) Medtronic One Source Pack, Catalog Numbers: ATLS21, ATLS24, ATLS2469, EC1S24, EC2S00, EC2S24, EE1S048 and EE2S21. Kits are packaging convenience kits containing previously released sterile-pack products and accessories. Recall # Z-1550-2009;

2) Medtronic One Source Pack Magellan, Catalog Number: COS310. Kits are packaging convenience kits containing previously released sterile-pack products and accessories. Medtronic Ideal MAXPAC Total System. Recall # Z-1551-2009;

3) Medtronic Ideal MAXPAC Total System, Catalog Numbers: TS1262R6, TS1262R7, TS1420R, TS1420R1, TS1442R, TS1446R, TS1464T, TS1470R, TS1470T1, TS1480R3, TS1480R5, TS1480R6, TS1487R, TS1487R2, TS8040R28, TS8108R6, TS8163R10, TS8387R5, TS9412R3, TS9453R28, TS9764R9, TS9800R28, TS9800R29, TS9800R31, TS9987R33 and TS9987R34. Sterile and nonpyrogenic, EtO or Gamma Sterilized. Medtronic Purfusion Systems. Kits are packaging convenience kits containing previously released sterile-pack products and accessories. Recall # Z-1552-2009
CODE
1) Lot Numbers: 0000574290, 0000574314, 0000574316, 0000580205, 0000608559, 0000618615, 0000640122, 0000640634, 0000771456, 0000772227, 0000777567, 0000780964, 0000781651, 0000800394, 0000920163 and 0000950662;

2) Lot Numbers: 0000567714, 0000569193, 0000569453, 0000571627, 0000574238, 0000579154, 0000579157 and 0000580322;

3) Lot Numbers: 0000570577, 0000574333, 0000597907, 0000597954, 0000603799, 0000603854, 0000604000, 0000604584, 0000604619, 0000607627, 0000611283, 0000617833, 0000624995, 0000628687, 0000641735, 0000644599, 0000645307, 0000648997, 0000653336, 0000654111, 000065606, 0000662898, 0000666630, 0000666650, 0000676750, 0000680771, 0000682337, 0000697089, 0000699592, 0000708267, 0000708363, 0000712299, 0000721526, 0000727448, 0000738389, 0000756494, 0000762708, 0000797022, 0000805167, 0000805376, 0000806225, 0000806808, 0000812913, 0000838110, 0000846202, 0000849687, 0000850497, 0000854152, 0000854999, 0000856172 and 0000969188
RECALLING FIRM/MANUFACTURER
Medtronic Cardiovascular Revascularization & Surgical Therap, Brooklyn Park, MN, by letter dated March 23, 2009. Firm initiated recall is ongoing.  
REASON
Medtronic has identified a small number of One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates on the outer kit package label. The Use Before Date on the outer label of the kit/pack does not accurately reflect the Use Before Date of the components within the kit/pack. For affected product, the outer label lists a date which exceeds the earliest Use Before Date of the components included in the kit/pack. Medtronic requests that you immediately quarantine this product. Affected product should be returned to Medtronic.
VOLUME OF PRODUCT IN COMMERCE
1363 kits
DISTRIBUTION
AZ, CA, CO, CT, DE, FL, HI, IL, IN, LA, MI, MN, NC, NJ, NM, NV, NY,OH, OK, PA, TN, TX, and WI and countries of Australia, Japan and Venezuela
___________________________________
PRODUCT 
Waste bottles Part Numbers/Article Numbers: a) 905-590/D512 and b) 905-802/D513. The waste bottles are used to collect waste from the ABL7XX and the ABL8XX blood gas analyzer after rinsing. Recall # Z-1554-2009
CODE
a) Lot Numbers: WR-01, WR-02, WR-03, WS-01, WS-02, WS-03, WU-01, WU-02 and WU-03; b) Lot Numbers: WR-01, WR-02, WR-03, WR-04, WS-01, WS-02, WS-03, WS-04, WU-01, WU-02, WU-03, WU-04, WU-05, WU-06 and WY-01
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America Inc., Westlake, OH, by letter dated May 5, 2009.  
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON
When removing the waste bottle from the analyzer waste material may leak both from the analyzer and from the waste bottle.
VOLUME OF PRODUCT IN COMMERCE
905-590 (D512): 35,552 bottles; 905-802 (D513): 45,240 bottles
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Siemens Stratus CS Acute Care Troponin I CalPak. In vitro product intended to be used for calibration of the cardiac troponin I method on the Stratus CS analyzer. Recall # Z-1555-2009
CODE
Lot Numbers: 637218002 (expired immediately), 637281002 (expired immediately), 637350002 (expired immediately), 638035002 (expired June 4, 2008); and 638105002 (expired August 14, 2008)
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated April 29, 2008. Firm initiated recall is complete.
REASON
The firm received and confirmed that some lots of Cardiac Troponin I (cTnl) CalPaks (CCTNI-CR) may exhibit calibration issues that cause lower than typical signal during calibration with the current population of cTnl TestPaks (CCTNI). This issue may result in failed calibrations due to "Slope Error" messages or falsely elevated patient sample and quality control (QC) results on calibrations that are within the calibration guidelines (no Slope Errors).
VOLUME OF PRODUCT IN COMMERCE
3,257 cartons
DISTRIBUTION
Nationwide and United Arab Emirates, Austria, Bermuda, Belize, Canada, Germany, Egypt, India, Japan, Saudi Arabia and Bengal
___________________________________
PRODUCT 
1) Smith & Nephew Endoscopic Disposable Blades: Full Radius Blade, 5.5MM, SER 3000 Part #: 7206010. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1560-2009;

2) Smith & Nephew Endoscopic Disposable Blades: Stonecutter ACR, 4.0, EP-1, DSP Part #: 7205330. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1561-2009;

3) Smith & Nephew Endoscopic Disposable Blades: Notchblaster ABR, EP-1,5.5 DSPL Part #: 7205329. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1562-2009;

4) Smith & Nephew Endoscopic Disposable Blades: Incisor, 5.5mm, EP-1, DSPL Blade Product #: 7205314. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1563-2009;

5) Smith & Nephew Endoscopic Disposable Blades: Disposable BL, 4.5MM FR Elite Part #: 7210499. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1564-2009;

6) Smith & Nephew Endoscopic Disposable Blades: Boxed F/R, BL, 4.5MM, Series 3000 /6 Product #: 7206011. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1565-2009;  

7) Smith & Nephew Endoscopic Disposable Blades: Incisor Blade, 3.5MM DSPL, EP-1 Part #: 7205312. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1566-2009;

8) Smith & Nephew Endoscopic Disposable Blades: Turbowhisker BLD, EP-1, 4.5MM (6) Part #: 7205316. Dyonics Series 3000 Bonecutter Disposable Arthroscopic Surgery Blades are indicated for resection of soft and osseous tissues in large and small articular cavities. Specific applications may include knee and shoulder reconstructive procedures such as notchplasty and acromioplasty. Recall # Z-1567-2009
CODE
1) Lot #: 20154971 and 20148707;
2) Lot #: 20153856;
3) Lot #: 20153855;
4) Lot #: 20153878;
5) Lot #: 20153865;
6) Lot #: 20148714 and 20153849;
7) Lot #: 20153858;
8) Lot #: 20153874
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc. Endoscopy Division, Andover MA, by letter dated May 5, 2009 and/or by e-mail on May 7, 2009.
Manufacturer: Avail Medical, Juarez Chih, Mexico. Firm initiated recall is ongoing.
REASON
Product sterility is compromised due to breach in the sterile packaging.
VOLUME OF PRODUCT IN COMMERCE
13,638 units
DISTRIBUTION
Nationwide, and Switzerland, Canada, United Arab Emeritus, Belgium, Mexico, South Africa, Great Britain, Australia, Korea, Japan, Germany, Israel, India, Taiwan, Greece, Italy, Turkey and Chile
___________________________________
PRODUCT 
Sterrad 50 Sterilizer, Product Code 10050. Low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. Recall # Z-1570-2009
CODE
Affected units in the US: 10050000502, 10050000505, 10050000509, 10050000510 10050000513, 10050000516, 10050000517, 10050000532, 10050000534, 10050000545, 10050000548, 10050000549, 10050000551, 10050000552, 10050000554, 10050000564, 10050000567, 10050000570, 10050000574, 10050000576, 10050000588, 10050000597, 10050000606, 10050000609, 10050000613, 10050000614, 10050000615, 10050000616, 10050000617, 10050000618, 10050000621, 10050000624, 10050000625, 10050000627, 10050000635, 10050000644, 10050000648, 10050000653, 10050000662, 10050000673, 10050000676, 10050000680, 10050000686, 10050000692, 10050000694, 10050000705, 10050000710, 10050000712, 10050000713, 10050000714, 10050000717, 10050000725, 10050000727, 10050000728, 10050000729, 10050000730, 10050000739, 10050000745, 10050000756, 10050000759, 10050000760, 10050000762, 10050000767, 10050000768, 10050000773, 10050000774, 10050000779, 10050000782, 10050000784, 10050000800, 10050000801, 10050000803, 10050000804, 10050000806, 10050000813, 10050000815, 10050000822, 10050000832, 10050000834, 10050000835, 10050000837, 10050000840, 10050000844, 10050000849, 10050000850, 10050000852, 10050000855, 10050000857, 10050000858, 10050000863, 10050000864, 10050000866, 10050000867, 10050000868, 10050000869, 10050000872, 10050000873, 10050000874, 10050000877, 10050000895, 10050000897, 10050010911, 10050010916, 10050010918, 10050010922, 10050010941, 10050010945, 10050010948, 10050010952, 10050021012, 10050021013, 10050021016, 10050021022, 10050021029, 10050021030, 10050021031, 10050021032, 10050021033, 10050021034, 10050021036, 10050021037, 10050021038, 10050021041, 10050021042, 10050021043, 10050021045, 10050021046, 10050021049, 10050021050, 10050021054, 10050021059, 10050021060, 10050021064, 10050021069, 10050021087, 10050021092, 10050021094, 10050021095, 10050021097, 10050021099, 10050021100, 10050021103, 10050021104, 10050021106, 10050021110, 10050021111, 10050021112, 10050021116, 10050021136, 10050021137, 10050021139, 10050021140, 10050021142, 10050021145, 10050021146, 10050021147, 10050021148, 10050021149, 10050021150, 10050035004, 10050035006, 10050035008, 10050035011, 10050035013, 10050035014, 10050035015, 10050035022, 10050035023, 10050035027, 10050035028, 10050035030, 10050035034, 10050035035, 10050035036, 10050035037, 10050035039, 10050035041, 10050035042, 10050035044, 10050035046, 10050035050, 10050035051, 10050035054, 10050035055, 10050035059, 10050035060, 10050035061, 10050035063, 10050035065, 10050035066, 10050035067, 10050035070, 10050035071, 10050035074, 10050035075, 10050035076, 10050035077, 10050035078, 10050035086, 10050035094, 10050035100, 10050035101, 10050035103, 10050035104, 10050035105, 10050035106, 10050035111, 10050035116, 10050035117, 10050035118, 10050035119, 10050035121, 10050035124, 10050035126, 10050035127, 10050035128, 10050035129, 10050035130, 10050035131, 10050035132, 10050035134, 10050035135, 10050035136, 10050035137, 10050035139, 10050035140, 10050035141, 10050035142, 10050035143, 10050035144, 10050035148, 10050035149, 10050035153, 10050035154, 10050035155, 10050035156, 10050035157, 10050035158, 10050035160, 10050035162, 10050035164, 10050035166, 10050035167, 10050035170, 10050035171, 10050035172, 10050035173, 10050035174, 10050035175, 10050035179, 10050035181, 10050035182, 10050035184, 10050035185, 10050035188, 10050035196, 10050035204, 10050035205, 10050035321, 10050035323, 10050035324, 10050035385, 10050970298, 10050970344, 10050980382, 10050980383, 10050980478, 10050980356, 10050980408, 10050980434, 10050980450, 10050980452, 10050980464, 10050970312 and 10050000500 and Affected units distributed internationally : 10050021141, 10050035146, 10050960065, 10050970149, 10050970201, 10050970253, 10050980089, 10050021143, 10050035161, 10050960066, 10050970150, 10050970202, 10050970254, 10050980345, 10050021144, 10050035163, 10050960067, 10050970151, 10050970203, 10050970255, 10050980346, 10050027061, 10050035165, 10050960068, 10050970152, 10050970204, 10050970256, 10050980347, 10050035001, 10050035168, 10050960069, 10050970153, 10050970205, 10050970257, 10050980348, 10050035003, 10050035176, 10050960070, 10050970154, 10050970206, 10050970258, 10050980351, 10050035005, 10050035177, 10050960071, 10050970155, 10050970207, 10050970259, 10050980353, 10050035007, 10050035178, 10050960072, 10050970156, 10050970208, 10050970260, 10050980354, 10050035009, 10050035180, 10050960073, 10050970157, 10050970209, 10050970261, 10050980357, 10050035010, 10050035183, 10050960075, 10050970158, 10050970210, 10050970262, 10050980358, 10050035016, 10050035186, 10050960076, 10050970159, 10050970211, 10050970263, 10050980363, 10050035017, 10050035187, 10050960078, 10050970160, 10050970212, 10050970264, 10050980381, 10050035018, 10050035189, 10050960080, 10050970161, 10050970213, 10050970265, 10050980384, 10050035019, 10050035190, 10050960083, 10050970162, 10050970214, 10050970269, 10050980385, 10050035020, 10050035191, 10050960086, 10050970163, 10050970215, 10050970270, 10050980391, 10050035021, 10050035192, 10050960087, 10050970164, 10050970216, 10050970271, 10050980393, 10050035024, 10050035193, 10050960088, 10050970165, 10050970217, 10050970272, 10050980396, 10050035026, 10050035194, 10050960092, 10050970166, 10050970218, 10050970273, 10050980398, 10050035031, 10050035195, 10050960096, 10050970167, 10050970219, 10050970276, 10050980399, 10050035038, 10050035197, 10050960098, 10050970168, 10050970220, 10050970277, 10050980400, 10050035040, 10050035198, 10050960099, 10050970169, 10050970221, 10050970278, 10050980402, 10050035043, 10050035199, 10050960101, 10050970170, 10050970222, 10050970279, 10050980403, 10050035045, 10050035200, 10050960103, 10050970171, 10050970223, 10050970280, 10050980405, 10050035047, 10050035202, 10050960104, 10050970172, 10050970224, 10050970283, 10050980413, 10050035048, 10050035203, 10050960105, 10050970173, 10050970225, 10050970287, 10050980414, 10050035052, 10050035206, 10050960106, 10050970174, 10050970226, 10050970288, 10050980415, 10050035056, 10050035349, 10050960111, 10050970176, 10050970227, 10050970289, 10050980417, 10050035057, 10050035357, 10050960117, 10050970177, 10050970228, 10050970290, 10050980424, 10050035058, 10050038295, 10050960118, 10050970178, 10050970229, 10050970292, 10050980425, 10050035072, 10050096063, 10050960119, 10050970179, 10050970230, 10050970293, 10050980426, 10050035073, 10050098041, 10050960314, 10050970180, 10050970232, 10050970300, 10050980427, 10050035080, 10050960028, 10050960322, 10050970181, 10050970233, 10050970301, 10050980436, 10050035081, 10050960030, 10050970120, 10050970182, 10050970234, 10050970302, 10050980437, 10050035082, 10050960036, 10050970121, 10050970183, 10050970235, 10050970306, 10050980438, 10050035083, 10050960041, 10050970123, 10050970184, 10050970236, 10050970311, 10050980439, 10050035085, 10050960046, 10050970124, 10050970185, 10050970237, 10050970313, 10050980441, 10050035088, 10050960050, 10050970128, 10050970186, 10050970238, 10050970321, 10050980442, 10050035090, 10050960051, 10050970130, 10050970187, 10050970239, 10050970323, 10050980443, 10050035095, 10050960052, 10050970131, 10050970188, 10050970240, 10050970324, 10050980444, 10050035096, 10050960053, 10050970134, 10050970189, 10050970241, 10050970325, 10050980446, 10050035097, 10050960054, 10050970136, 10050970190, 10050970242, 10050970326, 10050980447, 10050035098, 10050960055, 10050970138, 10050970191, 10050970243, 10050970327, 10050980448, 10050035099, 10050960056, 10050970140, 10050970192, 10050970244, 10050970329, 10050980449, 10050035102, 10050960057, 10050970141, 10050970193, 10050970245, 10050970329, 10050980453, 10050035108, 10050960058, 10050970142, 10050970194, 10050970246, 10050970330, 10050980461, 10050035112, 10050960059, 10050970143, 10050970195, 10050970247, 10050970331, 10050980462, 10050035113, 10050960060, 10050970144, 10050970196, 10050970248, 10050970332, 10050980469, 10050035114, 10050960061, 10050970145, 10050970197, 10050970249, 10050970333, 10050980470, 10050035122, 10050960062, 10050970146, 10050970198, 10050970250, 10050970338, 10050980471, 10050035125, 10050960063, 10050970147, 10050970199, 10050970251, 10050970339, 10050980475, 10050035145, 10050960064, 10050970148, 10050970200, 10050970252, 10050970340 and 10050980480
RECALLING FIRM/MANUFACTURER
Advanced Sterilization Products, Irvine, CA, by letter dated January 12, 2009. Firm initiated recall is ongoing.
REASON
The capacitor in the vacuum pump component within the Sterrad 50 System could overheat and potentially create a hazardous condition inside the system, resulting in smoke and/or fire.
VOLUME OF PRODUCT IN COMMERCE
1,151 units
DISTRIBUTION
Nationwide and Germany, Italy, France, United Kingdom, Switzerland, Benelex, Uruguay, Venezuela, Argentina, Chile, Columbia, Belgium, Puerto Rico, Mexico, Philippines, Australia, Japan, Korea, Malaysia, Taiwan, Middle East, Peru, Canada, Czech Republic, Portugal, Spain, Sweden, Hungary, Poland, Brazil, Russia, Finland, Norway, Panama and Switzerland

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

___________________________________
PRODUCT 
Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010. Recall # Z-1576-2009
CODE
Lot Number: 060713-244
RECALLING FIRM/MANUFACTURER
Recalling Firm: Inovel LLC, Culver City, CA, by letter on July 23, 2007. Firm initiated recall is complete.
REASON
Display boxes labeled as FRN95-MLEZ, Medium/Large Size Respirators were inadvertently mixed with Display Boxes labeled for FRN95-SEZ Small Size Respirators.
VOLUME OF PRODUCT IN COMMERCE
80 cases
DISTRIBUTION
IL

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II

___________________________________
PRODUCT
1) Woodpecker Blend, Wild Bird Food packed in 20 lb. bags, MFG. #81132200 2921 008124. Recall # V-236-2009;

2) Woodpecker Wise, Wild Bird Food packed in 20 lb. bags. Recall # V-236-2009;

3) Choice Harvest Blend, Wild Bird Food packed in 20 lb. bags, MFG. #81132200 2930 06275. Recall # V-237-2009;

4) No-Mess, Wild Bird Food packed in 20 lb. bags, MFG. #81132200 2918 08024. Recall # V-238-2009;

5) No Mess Harvest Blend, Wild Bird Food packed in 20 lb. bags, MFG. #81132200 2915 05115. Recall # V-239-2009;

6) Choice Blend, Wild Bird Food packed in 20 lb. bags, MFG. #81132200 2912 08024. Recall # V-240-2009;

7) Shelled Peanuts, Wild Bird Food packed in 20 lb. bags. The recalled product was distributed under the Song of America (SOA) and Wild Birds Unlimited (WBU) brand labels. The WBU product is labeled as follows: Shelled Peanuts, MFG. #81132200 2956 08124. The SOA product is labeled: Song Of America Shelled Peanuts. Recall # V-241-2009;

8) Roasted Peanut Splits, Wild Bird Food packed in 20 lb. bags. Recall # V-242-2009;

9) Deluxe Songbird Mix, Wild Bird Food packed in 20 lb. bags. Recall # V-243-2009;

10) Nut & Berry Buffet, Wild Bird Food packed in 20 lb. bags. Recall # V-244-2009;

11) Critterwise, Wild Bird Food packed in 20 lb. bags. Recall # V-245-2009;

12) Hopper Mix, Wild Bird Food packed in 20 lb. bags. Recall # V-246-2009;

13) Patio Mix, Wild Bird Food packed in 20 lb. bags. Recall # V-247-2009;

14) Southeast No-Mess, Wild Bird Food packed in 20 lb. bags, MFG. #81132200 2920 1116. Recall # V-248-2009;
CODE
All wild bird food products distributed by the recalling firm from 2/01/2008 through 4/01/2008 were subject to recall:
1) Code #2921;
2) Code #4936;
3) Code #2930;
4) Code #2918; 
5) Code #2915; 
6) Code #2912; 
7) Code #2956; 
8) Code SKU #4937:
9) Code SKU #4906; 
10) Code SKU #4932; 
11) Code SKU #4931; 
12) Code SKU #4913;
13) Code SKU #4909;
14) Code #2920
RECALLING FIRM/MANUFACTURER
Burkmann Feeds LLC, Glasgow, KY, by telephone on February 9, 2009. Firm initiated recall is ongoing.
REASON
The recalling firm repackaged and distributed wild bird food mixes which contained peanuts that were produced by Peanut Corporation of America in Blakely, GA. Peanuts and /or peanut products produced by PCA were implicated in an outbreak of Salmonellosis and these products may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
259 tons of multiple bird food products
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR JULY 22, 2009

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