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U.S. Department of Health and Human Services

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Enforcement Report for July 7, 2010

July 7, 2010                                                                                        10-26

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
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PRODUCT 
McCormick Fajitas Seasoning Mix, packaged in 1.12 oz foil packets, 12 packets/case and labeled in part *** UPC Code 5210002121. Recall # F-2242-2010
CODE
BEST BY Dates of JAN 16 12 AH and JAN 16 12 CH
RECALLING FIRM/MANUFACTURER
McCormick & Co Inc., Hunt Valley, MD, by press release, letter and e-mail on April 7, 2010. Firm initiated recall is ongoing.
REASON
Product contains undeclared wheat and milk ingredients.
VOLUME OF PRODUCT IN COMMERCE
7,200 cases
DISTRIBUTION
Nationwide, Belize and Bermuda
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PRODUCT 
1) Mexican bread PAN HUEVO, packaged six pieces in a clear plastic clam shell container. Product labeled in part: "PAN HUEVO JUANITA's 6 Count, UPC 048867002157". Recall # F-2243-2010;

2) Mexican bread PASTELES, packaged six pieces in a clear plastic clam shell container. Product labeled in part: "PASTELES JUANITA'S 6 Count, UPC 048867002300". Recall # F-2244-2010;

3) Mexican bread OJOS, packaged six pieces in a clear plastic clam shell container. Product labeled in part: "OJOS JUANITA'S 6 Count, UPC 048867002164". Recall # F-2245-2010;

4) Mexican bread CUERNOS, packaged six pieces in a clear plastic clam shell container. Product labeled in part: "CUERNOS JUANITA'S 6 Count, UPC 048867002225". Recall # F-2246-2010;

5) Cupcakes, packaged six pieces in a clear plastic clam shell container. Product labeled in part: "CUPCAKES JUANITA'S 6 Count, UPC 048867002249". Recall # F-2247-2010
CODE
BEST BY CODE DATE of 05/12/10 through 06/05/10
RECALLING FIRM/MANUFACTURER
Dominguez Family Enterprises, Inc., Hood River, OR, by e-mail and faxed letters on May 11, 2010, May 13, 2010 and by press release on May 18, 2010. Oregon initiated recall is complete.
REASON
Product declares whey on ingredient statement; however it does not declare milk.
VOLUME OF PRODUCT IN COMMERCE
31 pkgs of Pan Huevo; 25 pkgs Ojos; 10 pkgs Cuernos; 17 pkgs Cupcakes; 18 pkgs Pasteles
DISTRIBUTION
OR, WA, and Alaska
___________________________________
PRODUCT 
1) Garden Fresh Salad Chopped Romaine 6/2 Lb and 4/ 2.5 lb per master carton. Recall # F-2249-2010;

2) Garden Fresh Salad Romaine Blend 4 x 5 Lb master carton. Recall # F-2250-2010;

3) Garden Fresh Salad HR Salad 4 x 5 Lb master carton. Recall # F-2251-2010
CODE
Lot 35682 Use by Date 5/2/10
RECALLING FIRM/MANUFACTURER
Garden Fresh Salad Co., Inc., Chelsea, MA, by telephone and fax letter on May 8, 2010. Firm initiated recall is complete
REASON
Product was implicated an outbreak of E.Coli 0145.
VOLUME OF PRODUCT IN COMMERCE
520 cases
DISTRIBUTION
MA
___________________________________
PRODUCT 
1) TS-9, TS-OS, TS-7, TS-17, GL-RM, TS-14, TS-28 - Salad Mix (packaged in 4/2.5 lb bags, 6/3 lb bags, 4/5 lb bags, 4/3 lb bags); Item 20040162, 06429; Item 2003012, 06446; Item 2004047, 06451; All American Blend 07165, Item 2004006 06040/Item 2004018; and Ensalada, Item 06449 06449; Item 20040421 06454, and Item 6082275 0648. Recall # F-2252-2010;

2) TS-31 - Lettuce/Romaine w/Sep CA & RC, (4/5 lb bags), Item 4004034, 06441; and Item 235305, 07132. Recall # F-2253-2010;

3) TS-11, TS-5, CH-4, CH-5, TS-12, TS-2 and TS-29 Lettuce/Romaine Mix, (packaged in 1/5 lb bag, 4/5 lb bags, 8/2.5 lb bags, and 8/4 lb bags), Item 2004013, 06028; Item 5708308, 06037; Item 2002003, 06048; Item 2002004, 06049; Item 4004031, 06431; Item 4004030, 07138, Item 20020032, 06414, and Item 2004002P, 06032; Item 875697, 06417; Item 875748, 06435; and Item 931112/985824, 06436; Item 7663073, 06418; Item 1705821, 06423; Item 3523388, 06471, and Item 9197203, 06415; Item 4004032, 06434. Recall # F-2254-2010;

4) RM-1 Chopped Romaine, (package in 6/2 lb bags, 6/3 lb bags, 1/5 lb bag, 4/5 lb bags, 4/2.5 lb bags, 3/2 lb bags), Item 2003013, 06059; Item 20030138, 06355, Item 2003000, 06062, Item 2003002, 07123 and Item 2002999, 06356; Item 2273365D, 06367, Item 9363623, 06363, and Item 7021678, 06362; Item 2003014, 06357; and Item 880507, 06361. Recall # F-2255-2010;

5) RM-6, RM-4, and RM-2 Shredded Romaine, (packaged in 6/3 lb bags and 6/2 lb bags), Item 20030012, 06375, Item 20030011, 06374, Item 2003001, 06370, Item 20030015, 06371; and Item 30030010 06372. Recall # F-2256-2010;

6) TS-PP Piccolo Pezzo Mix, (4/5 lb bags), Item 20021111, 06452. Recall # F-2257-2010;

7) TS-33 Iceberg/Romaine/Green Leaf, (4/5 lb bags), Item 07109. Recall # F-2258-2010;

8) TS-34 and GL-RM Romaine/Green Leaf (packaged in 6/3 lb bags and 4/2.5 lb bags), Item 07110; and Item 0961557, 06421. Recall # F-2259-2010;

9) SH-3R Shredded Lettuce/Romaine, (packaged in 4/2.5 lb bags, and 4/5 lb bags), Item 07142, 07142,  Item 2001018, 06410, and Item 2001019, 06411. Recall # F-2260-2010;

10) TS-15 Summer Salad Blend, (6/2.25 lb bags), Item 07176, 07176. Recall # F-2261-2010;

11) TS-27 Culvers Salad, (4/5 lb bags), Item 07174, 07174. Recall # F-2262-2010;  

12) TS-13 Romaine/GL/Radicchio Mix 80/10/10, (2/5 lb bags), Item 6803965, 06014. Recall # F-2263-2010
CODE
Best By: 05/09/10 and 05/10/10
RECALLING FIRM/MANUFACTURER
Vaughan Foods, Moore, OK, by letter dated May 8, 2010 and by telephone on May 8, 2010. Firm initiated recall is ongoing.
REASON
Product has the potential to contain E. Coli 0145.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
OK, TX, LA, MS, AL, MO, IL, KS, CO, IA, OH, NE, TN

___________________________________
PRODUCT 
Tastefully Simple Toasted Garlic & Parmesan Cheese Ball Mix. Packaged into 2 consumer size packages: 1) 2-0.55 oz packets Net Wt. 101 oz (32 g). 2) Net Wt 0.3 oz (8g). Recall # F-2264-2010
CODE
1) Lots 9315, 9317, 0004; 2) Lots 9313, 9314, 0005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tastefully Simple, Inc., Alexandria, MN, by press release on March 12, 2010.
Manufacturer: Williams Foods, Lenexa, KS; Wind & Willow, Mount Vernon, MO. FDA initiated recall is ongoing.
REASON
The product was manufactured using black pepper recalled by Mincing Overseas Spice Company because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
48,144
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Frontier Natural Products Co-Op Coarse Grind Black Pepper, Piper nigrum, packaged in a) 16-oz. foil bags, Item 181, UPC 0-89836-00181-8; b) 1.76 glass bottles, Item 18381, UPC 0-89836-18381-1; and c) 400-oz. boxes, Item B600181, UPC 0-89836-80181-4. Recall # F-2265-2010;  

2) Frontier Natural Products Co-Op Whole Black Peppercorns, Piper nigrum, packaged in 16-oz. foil bags, Item 183, UPC 0-89836-00183-2. Recall # F-2266-2010;

3) Frontier Natural Products Co-Op Cracked Black Pepper, Piper nigrum, packaged in a) 16-oz. foil bags, Item 282, UPC 0-89836-00282-2, and b) 400-oz. boxes, Item B600282, UPC 0-89836-80282-8. Recall # F-2267-2010;

4) Frontier Natural Products Co-Op Fine Grind Black Pepper, Piper nigrum, packaged in a) 16-oz. foil bags, Item 298, UPC 0-89836-00298-3, and b) 1.76-oz. glass bottles, Item 18382, UPC 0-89836-18382-8. Recall # F-2268-2010;

5) Frontier Natural Products Co-Op Muchi Curry Powder, packaged in 16-oz. foil bags, Item 138, UPC 0-89836-00138-2. Recall # F-2269-2010;

6) Frontier Natural Products Co-Op Curry Powder, packaged in a) 16-oz. foil bags, Item 139, UPC 0-89836-00139-9, b) 2.19-oz. glass bottles, Item 18338, UPC 089836-18338-5, and c) 400-oz. boxes, Item B600139, UPC 0-89836-80139-5. Recall # F-2270-2010;

7) Frontier Natural Products Co-Op Herbs of Italy, Salt-Free Blend, packaged in .80-oz. glass bottles, Item 18446, UPC 0-89836-18446-7. Recall # F-2271-2010;

8) Frontier Natural Products Co-Op Salad Sprinkle, Salt-Free Blend, packaged in 1.23-oz. glass bottles, Item 18901, UPC 0-89836-18901-1. Recall # F-2272-2010;

9) Frontier Natural Products Co-Op Garlic 'N Herb, Salt-Free Blend, packaged in a)1.94-oz. glass bottles., Item 18908, UPC 0-89836-18908-0, b) 16-oz. foil bags, Item 295, UPC 0-89836-00295-2, and c) 400-oz. boxes, Item B600295, UPC 0-89836-80295-8. Recall # F-2273-2010;

10) Mediterranean Seafood Seasoning packaged under the following labels: (1) Frontier Natural Products Co-Op Mediterranean Seafood Seasoning, a) 16-oz. foil bags, Item 2834, UPC 0-89836-02834-1. The firm name on the label is Frontier; (2) Whole Foods Market 365 Mediterranean Seafood Seasoning, packaged in 4.23-oz. plastic bottles, Item CO18125, UPC 0-99482-72687-4, and c) 4-oz. plastic bottles, Item WO18125, UPC 0-99482-40687-5. Recall # F-2274-2010;

11) Toronto Steak & Chicken Rub, packaged under the following labels: (1) Frontier Natural Products Co-Op Toronto Steak & Chicken Rub, a) 16-oz. foil bags, Item 2835, UPC 0-89836-02835-8; and (2) Whole Foods Market 365, packaged in b) 4.76-oz. plastic bottles, Item C018124, UPC 0-99482-72686-7, and c) 5-oz. plastic bottles, Item W018124, UPC 0-99482-40686-8, Recall # F-2275-2010;

12) Frontier Natural Products Co-Op Cajun Blackened Fish/Meat Seasoning, packaged in 16-oz. foil bags, Item 351, UPC 0-89836-00351. Recall # F-2276-2010;

13) Frontier Natural Products Co-Op Greek Seasoning, packaged in 16-oz. foil bags, Item 353, UPC 0-89836-00353-9. Recall # F-2277-2010;

14) Frontier Natural Products Co-Op Oriental Seasoning, packaged in 16-oz. foil bags, Item 360, UPC 0-89836-00360-7. Recall # F-2278-2010;

15) Frontier Natural Products Co-Op Veggie Pepper, packaged in 16-oz. foil bags, Item 366, UPC 0-89836-00366. Recall # F-2279-2010;

16) Frontier Natural Products Co-Op Salad Sprinkle, packaged in 16-oz. foil bags, Item 367, UPC 0-89836-00367-6. Recall # F-2280-2010;

17) Frontier Natural Products Co-Op Spaghetti Seasoning, packaged in 16-oz. foil bags, Item 384, UPC 0-89836-00384-3. Recall # F-2281-2010;

18) Frontier Natural Products Co-Op Thai Seasoning, packaged in 16-oz. foil bags, Item 387, UPC 0-89836-00387-4. Recall # F-2282-2010;

19) Whole Foods Market 365 Asian Seafood Seasoning, packaged in 5-oz. plastic btls, Item W018121, UPC 99482-40683-7. Recall # F-2283-2010;

20) Whole Foods Market 365 Mediterranean Rotisserie Seasoning, packaged in a) 4.73-oz. plastic bottles, Item C018122, UPC 0-99482-72684-3, and b) 5-oz. plastic bottles, Item W018122, UPC 0-99482-40684-4. Recall # F-2284-2010;

21) 365 Southwestern Grille seasoning, packaged in 6-oz. plastic bottles, Item W018120, UPC 99482-40682-0. Recall # F-2285-2010

22) Whole Pantry Muchi Curry packaged in 1.41-oz. glass bottles, Item W041956, UPC 0-99482-41956-1. Recall # F-2286-2010
CODE
1) a) Lots 9327 and 9357; b) Lot 9339; c) Lots 0019 and 0032;

2) Lots 9299, 9306, and 9357;

3) a) Lots 9321 and 9349; b) Lots 0004 and 0021;

4) a) Lot 0008; b) Lot 0020;

5) Lots 0004 and 9350;

6) a) Lots 0007, 0029, 9350, and 9351; b) Lots 0042 and 9352; c) Lots 0029 and 9351;

7) Lot 9355;

8) Lot 0005;

9) a) Lots 0005 and 9351; b) Lots 0035, 9324, 9334, 9344, and 9363; c) Lots 0033 and 9335;

10) a) Lot 9351; b) Lot 0029;  c) Lots 0029, 9316, and 9321;

11) a) Lots 0028 and 9342; b) Lots 0028, 9338, and 9356; c) Lots 0025, 0026, 0028, 9310, 9321, 9362, and 9363;

12) Lot 0011

13) Lots 0032 and 9310;

14) Lots 0061, 9363, and 9356;

15) Lots 0034 and 9352;

16) Lot 0022;

17) Lot 9341;

18) Lot 0015;

19) Lot 0029;

20) a) Lots 0021, 0029, and 9362; b) 0026 and 0029;

21) Lots 0019, 0026, and 0028;

22) Lots 0014, 9355, and 9364
RECALLING FIRM/MANUFACTURER
Frontier Natural Products Co-op, Norway, IA, by letters dated March 8, 2010 and by press release on March 9, 2010. FDA initiated recall is ongoing.
REASON
The product was manufactured using black pepper recalled by Mincing Overseas Spice Company because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approximately 57,363 units (approx. 28,564 lbs)
DISTRIBUTION
Nationwide, Canada, West Indies, and the Cayman Islands
___________________________________
PRODUCT 
1) Smoked Chicken Apple seas Aidells - S109, item number PS109.02. Net. Wt. 14.91 lbs bag. Ingredients: Bag - 1 - 13.41 lb) Salt, and Spices Bag 2 - 1.5 lb) Vegetable Stabilizer (Celery Powder, Sea Salt). Recall # F-2287-2010;

2) Natural Fresh C - A Mango spice S101-N, item number PS101N.02. Net. Wt. 48.24 lb case. Ingredients: Salt, Natural Spices and not more than 2% Vegetable Oil added as a processing aid. Recall # F-2288-2010;

3) Lemon Pepper #51-0363, item number PK0555.01. Net. Wt. 50 lb (22.68 kg) carton. Ingredients: Black Pepper, Salt, Modified Tapioca Starch, Citric Acid, Lemon Peel, sugar, Garlic, Onion, Natural Flavor, Riboflavin and not more than 2% Vegetable Oil and Silicon Dioxide added as processing aids. Recall # F-2289-2010;

4) BK Patty Breader, item number G5835.49.01. Net. Wt. 50 lb (22.6799 kg) bag. Ingredients: Bleached wheat Flour, Salt, spices, Partially Hydrogenated Vegetable Oil (Soybean and/or Cottonseed), Whey, Monosodium Glutamate, Yeast, Sweet Pepper, Onion Powder, Garlic Powder, Dextrose, and Leavening (Monocalcium Phosphate, Sodium Bicarbonate). Recall #
F-2290-2010;

5) Breader, item number G5092.49, Net. Wt. 50 lb (22.6799 kg) bag. Ingredients: Wheat Flour, Salt, Spice, Paprika, and Extractives of Paprika. Recall # F-2291-2010;

6) Breader, item number G4340.49, Net. Wt. 50 lb (22.6799 kg) bag. Ingredients: Enriched Wheat Flour (enriched with Niacin, Reduced Iron, Thiamine Mononitrate, Riboflavin, folic Acid), Salt, Spices, Yellow Corn flour, Maltodextrin, Caramel Color, Onion Powder, Paprika, Extractives of Paprika, and Turmeric. Recall # F-2292-2010;

7) Seasoned Breader, item number G2259.B3. Recall # F-2293-2010;

8) Link's Original Canadian 30152, item number CS401560.01, Net Wt. 25.56 lb (11.59 kg) bag. Ingredients: Spices, Dextrose, Salt, Sugar, flavoring, Sodium Erythorbate. Recall # F-2294-2010;

9) Pork Sausage Link Spice, item number CS401965.01, Net Wt. 8.26 lb bag. Recall # F-2295-2010;

10) Italian Chicken Rub Predust, R7103, item numberB20392.01, Net Wt. 50 lb (22.68kg) case Ingredients: Sugar, Yellow Corn Flour, Wheat Flour, Salt, Garlic Powder, Romano Cheese (Part Skim Cow's Milk, Cheese Cultures, Salt, enzymes), Dehydrated Onions, Corn Starch, Spices, Maltodextrin, Paprika, Caramel Color, Soybean Oil, Sodium Alginate, Defatted Soy Flour, Baking Powder (Baking Soda, Corn Starch, Sodium Aluminum Sulfate, Calcium Sulfate, Monocalcium Phosphate), Calcium Silicate (anticaking Agent), autolyzed Yeast Extract, Dextrose, Grill Flavor (from partially Hydrogenated Cottonseed and Soybean Oils), Wheat Starch, Honey Solids, Beef and Beef Fat . Recall # F-2296-2010;

11) Roast Flavored Chicken Glaze, item number B20184.01, Net Wt. 50 lb (22.68 Kg) bag. Ingredients: Modified Corn Starch, Whey Powder, Maltodextrin, Chicken Flavor (Chicken, Chicken Skin, Chicken Broth, Salt, Natural Flavoring), Chicken Flavor (Hydrolyzed Chicken, Maltodextrin, Autolyzed Yeast, Natural Flavoring), Chicken Fat, Salt, Onion Powder, Spices, Dehydrated Garlic, Paprika, Xanthan Gum, Flavorings and Oleoresin Turmeric. Recall # F-2297-2010;

12) All American Seasoning, 1505046, item number B20140.01, Net Wt. 50 lb (22.68 Kg) bag. Ingredients: Salt, Modified Food Starch, Dehydrated Garlic, Spices, Sugar, Dehydrated Onion, Dehydrated Red Bell Peppers, Autolyzed Yeast Extract, Paprika, Canola Oil. Recall # F-2298-2010;

13) Salsa Enchilada Seasoning, item number B18942.01, Net Wt. 50 lb (22.68 Kg) bag. Ingredients: Modified Corn Starch, Spices, Salt, Sugar, Dried Tomato, Dried Onion, Dextrose, Maltodextrin, Dried Garlic, Dried Red and Green Bell Pepper, Hydroxypropyl Methylcellulose, Guar Gum, Autolyzed Yeast Extract, Vinegar, Caramel Color, Citric Acid, Soybean Oil, Cilantro, Natural Flavor, and less than 2% Silicon Dioxide (to prevent caking). Recall # F-2299-2010;

14) Apple Bourbon Spice, item number B18895.01, Net Wt. 49.00 lbs (22.22 KG) bag. Ingredients: Brown Sugar, Modified Corn Starch, Salt, natural Bourbon Flavor (maltodextrin, Natural Flavor, Bourbon Maple Syrup), Freeze Dried Molasses Powder, Autolyzed Yeast Extract, Maltodextrin, Hydrolyzed Soy Protein, Spices, Garlic Powder, Onion Powder, Citric Acid, Dried Parsley, Soybean Oil, Natural Flavor, Malted Barley Flour, Paprika Extract, Apple Cider Vinegar, Natural Smoke Flavor. Recall # F-2300-2010;

15) Fajita Rub, item number B18853.01, Net Wt. 50 lb (22.68 Kg) bag. Ingredients: Spices, Salt, Dried Onion, Dried Garlic, Lemon Juice Powder (Corn Syrup Solids, Lemon Juice Solids, Lemon Oil), Citric Acid, Grill Flavor (from partially hydrogenated soybean/Cottonseed Oil), Natural Smoke flavor, Turmeric Extract, and less than 2% Silicon Dioxide (to prevent caking). Recall # F-2301-2010;

16) Cedar Rub, item number B18852.02, Net Wt. 5.00 lb (2.26 Kg) bag. Ingredients: Brown Sugar, Maltodextrin, Sugar, Dried Garlic, Modified Corn Starch, Salt, Spices, Dried Onion, Hydrolyzed Soy Protein, Caramel Color, Molasses, Citric Acid, Vinegar, Onion Powder, Sodium Diacetate, Garlic Powder, Soybean Oil, Paprika Extract (color), Natural Flavor (including Smoke), Worcestershire Sauce (Distilled Vinegar, Molasses, Corn Syrup, Salt, Caramel Color, Garlic Powder, Sugar, Spices, Tamarind, Natural Flavor, Sulfiting Agents), Polysorbate 80, and less than 2% Silicon Dioxide (to prevent caking). Recall # F-2302-2010;

17) Tomato Florentine Seasoning, 18784, item number B18784.03, Net Wt. 24.10 lb (10.93 Kg) bag. Ingredients: Modified Corn Starch, Spices, Sugar, Salt. Recall # F-2303-2010;

18) Zesty Seasoning, 96001699, item number B18530.01, Net Wt. 40.0 lb (18.14 Kg) bag. Ingredients: salt, Spices, Paprika, Dextrose, Sodium Phosphate, Dried Garlic, Garlic Powder, Soybean Oil, Spice Extract, Citric Acid. Recall # F-2304-2010;

19) All American Seasoning, 1518498, item number B18498.01, Net Wt. 50 lb (22.68 Kg) bag. Ingredients: Modified Corn Starch, Dehydrated Garlic, Salt, Black Pepper, Dehydrated Red Bell Peppers, Autolyzed Yeast Extract, Dehydrated Onion, Paprika, Thyme, Rosemary, Celery Seed, Red Pepper, Soybean Oil (processing aid). Recall # F-2305-2010;

20) Scampi Seasoning, item number B18471.01, Net Wt. 50 lb (22.68 Kg) bag. Ingredients: Modified Corn Starch, Maltodextrin, Salt, Garlic Powder, Monosodium Glutamate, Sugar, Whey, Spices, Natural Flavors, Onion Powder, Autolyzed Yeast Extract, Dried Parsley, Dried Vinegar, Citric Acid, Butterfat, Sauterne Wine Solids (prepared with Sulfur Dioxide), Dried Red Bell Pepper, Dried Green Bell Pepper, Disodium Inosinate and Disodium guanylate, Garlic Extract, Tapioca Dextrin, Grill Flavor, Paprika Extract (color), Turmeric Extract (color), Spice Extract. Recall # F-2306-2010;

21) Roasted Garlic Rosemary Seasoning, item number B18473.01, Net Wt. 50 lb (22.68 Kg) bag. Recall # F-2307-2010;

22) Citric Beef Stick 30495, item number B18102.01, Net Wt. 25.62 lb bag. Recall # F-2308-2010;

23) Italian Seasoning, item number B17805.02, Net Wt. 45.5 lb bag. Recall # F-2309-2010;

24) Savory Spiced Rub, item number B17577.01, Net Wt. 50 lb bag (22.68 Kg). Ingredients: Salt, Spices, Sugar, Dried Garlic, Modified Corn Starch, Corn Syrup Solids, Died Onion, Turmeric, Lemon Juice Solids, Dried Parsley, Citric Acid, Lemon Oil Spice Extracts, and less than 2% Silicon Dioxide and Soybean Oil (processing aids). Recall # F-2310-2010;

25) Squash Casserole Seas 17367, item number B17367.01, Net Wt. 30.5 lb bag (13.83kg). Ingredients: Salt, Spices, and Soybean Oil. Recall # F-2311-2010;

26) Alfredo Sauce Seasoning 17101, item number B17101.02, Net Wt. 48.0 lb (21.77kg) bag. Ingredients: Modified Corn Starch, Salt, Soy Mono and Diglycerides, Spice, Soybean Oil, Xanthan Gum, Guar Gum, Caramel Color, and Turmeric. Recall # F-2312-2010;

27) Beef Marinade 16584, item number B16584.01, Net Wt. 50 lb (22.68 kg) carton. Ingredients: Salt, Dextrose, Hydrolyzed Soy Protein, Sugar, Monosodium Glutamate, Maltodextrin, Spices, Autolyzed Yeast Extract, Caramel Color, Lemon Juice Powder (Corn Syrup, Lemon Juice, Lemon Oil), Disodium Inosinate and Disodium Guanylate, Citric Acid, Dried Vinegar, Dried Parsley, Soybean Oil, Garlic Extract, Onion Extract, Spice Extracts, Soy Lecithin, and less than 2% silicon Dioxide (to prevent caking). Recall # F-2313-2010;

28) Italian Rub 15539, item number B15539.01, Net Wt. 50 lb (22.68 kg) bag. Ingredients: Sugar, Spices (including Basil and Oregano), Dextrose, Dried Garlic, Salt, Maltodextrin, Dried Onion, Dried Red Bell Pepper, Brown Sugar, Dried Tomato, Corn Syrup Solids, Citric Acid, Sherry Wine solids (prepared with sulfur Dioxide), Modified corn Starch, Vinegar, Natural Tomato Flavor (Natural Flavor, Maltodextrin, Salt, Gum Arabic, Sunflower Oil), and less than 2% Silicone Dioxide (anti-caking agent). Recall # F-2314-2010;

29) Italian Seasoning Salt, item number B01966.01, Net Wt. 50 lb (22.68 kg) bag. Ingredients: Salt, Sugar, Spices, Dehydrated Garlic & Onion, Dehydrated Bell peppers. Recall # F-2315-2010;

30) SUNDRD Tom #81023, item number 01008.01, Net Wt. 50 lb bag. Recall # F-2316-2010;

31) Domino's Cooked Beef Seasoning, item number 01003.01, Net Wt. 21.0 lb (9.5kg) bag. Ingredients: Spices, Disodium Inosinate, Disodium Guanylate, Soybean Oil (processing aid), BHA (1.057%) BHT (1.057%), Citric Acid (1.057%), and not more than 2% Silicone Dioxide added to prevent caking. Recall # F-2317-2010;

32) Pastrami Rub S14122, item number 00996.01, Net Wt. 50 lb (22.68 kg) bag. Ingredients: Salt, Spices, Caramel Color, Dehydrated Garlic, Corn Oil (processing aid), Natural Smoke Flavor, and Spice Extractives. Not more than 2% Silicone Dioxide added to prevent caking. Recall # F-2318-2010;

33) Italian Rub / PREDST #R7050, item number B00914.01, Net Wt. 50 lb (22.68 kg) bag. Ingredients: Corn Flour, Wheat Flour, Salt, Corn Starch, Spices, Paprika, Maltodextrin, Caramel Color, Defatted Soy flour, Sodium Alginate, Baking Powder (Baking Soda, Corn Starch, Sodium Aluminum Sulfate, Calcium Sulfate, Calcium Acid Phosphate), and Extractives of Paprika with not more than 2% each Soybean Oil and

Calcium Silicate added to prevent caking. Recall # F-2319-2010;

34) PRK SAU SEA #03250, item number B00886.01, Net Wt. 26.59 lb bag. Recall # F-2320-2010;

35) 96058243 JS 243, item number B00868.01, Net Wt. 28.36 lb (12.9 Kg) bag. Ingredients: Spices, Sugar, Caramel Color, Soybean Oil (processing aid), and less than 2% Silicon Dioxide added to prevent caking. Recall # F-2321-2010;

36) Show Biz Pork Seasoning, item number B00604.01, Net Wt. 35.5 lb (16.1kg) case. Ingredients: Spices, Salt, Sugar, Paprika, Dehydrated Onion, Dehydrated Garlic, Oleoresin Paprika, Caramel Color, Disodium Inosinate, and Disodium Guanylate. Recall # F-2322-2010;

37) Show Biz Beef Seasoning, item number B00603.01, Net Wt. 35.36 lb (16.04kg) case. Ingredients: Salt, Spices, Disodium Inosinate, Disodium Guanylate, BHA (0.305%), BHT (0.305%), and Citric Acid (0.306%). Not more than 2% Soybean Oil and/or Silicon Dioxide added to prevent caking. Recall # F-2323-2010;

38) Cajun Rub #80087, item number B00371.01, Net Wt. 50 lb (22.68 Kg) bag. Ingredients: Spices, Salt, Dehydrated Onion, Natural Smoke flavor, Dehydrated Garlic, Oleoresin Paprika, Flavoring, and not more than 2% Silicon Dioxide to prevent caking. Recall # F-2324-2010;

39) Italian Blend with Predust #R7048, item number B00194.01, Net Wt. 50 lb (22.68kg) bag. Ingredients: Sugar, Corn Flour, Wheat Flour, Salt, Garlic Powder, Romano Cheese (Part - Skim Cow's Milk, Cheese Culture, Salt, Enzymes, Calcium Chloride), Dehydrated Onion, Paprika, Corn Starch, Spices, Maltodextrin, Soy Flour, Sodium Alginate, Baking Powder (Baking Soda, Corn Starch, Sodium Aluminum Sulfate, Calcium Sulfate, Calcium Acid Phosphate), Caramel Color, Dextrose, Honey Powder (Honey, Maltodextrin), Wheat Starch, and Extractive of Paprika. Not more than 2% Calcium Silicate and Soybean Oil added to help prevent caking. Recall # F-2325-2010;

40) Chili Con Queso Seasoning, 96054355, item number 35105.PM5 Net Wt. 52.5 lb (23.81 kg) bag. Ingredients: Chili Pepper, Spices, Salt, Paprika, Maltodextrin, Dehydrated Garlic, Soy Sauce Solids (Wheat, Soybeans, Salt), less than 2% Silicon Dioxide to prevent caking. Recall # F-2326-2010;

41) Lemon Pepper Seasoning 96002457, item number 717429.01 Net Wt. 50 lb (22.68 Kg) bag. Ingredients: Onion*, Spices, Carrots,*, Maltodextrin, Orange Peel*, Corn Syrup Solids*, Bell Pepper*, Lemon Peel*, Partially Hydrogenated Cottonseed and Soybean Oil, Lemon Oil, and Turmeric*. *Dehydrated. Recall # F-2327-2010;

42) Nat Spicy Caribbean Jerk Seas, S702, item number 717371.01 Net Wt. 14.84 lbs (6.737 Kgs) bag. Ingredients: Salt and Spices. Recall # F-2328-2010;

43) Peppercorn Parmesan Seasoning, item number 717248.01 Net Wt. 15 lbs bag. Ingredients: Monosodium Glutamate, Dextrose, Salt, Parmesan Cheese (Cultured Milk, Salt, Enzymes), Maltodextrin, Cultured Nonfat Milk, Onion Powder, Partially Hydrogenated Soybean Oil, Modified Corn Starch, Spices, Whey, Natural Flavors, Citric Acid, Lactic Acid, Garlic Powder, Cheddar Cheese (Pasteurized Milk, Cheese Cultures, Salt, Enzymes), Autolyzed yeast Extract, Sodium Citrate, Calcium Lactate, Vinegar, Paprika Extract (color), Annatto Extract (color), and less than 2% Silicon Dioxide (to prevent caking). Recall # F-2329-2010;

44) Potato Soup Seasoning, item number 40029.465 Net Wt. 50 lbs (22.68 Kg) bag. Ingredients: Modified Food Starch (Corn, Tapioca, Potato), Cream Solids, Enriched Bleached Wheat Flour (Bleached Wheat Flour, Malted Barley Flour, Niacin, Reduced Iron, Thiamine Mononitrate, Riboflavin, Folic Acid), Sugar, Natural Flavor, Dehydrated Garlic, Spices, Skim Milk Solids, Butter Solids, Mono and Diglycerides Soy Lecithin Xanthan Gum. Recall # F-2330-2010;

45) French Onion Soup Seasoning, 96053504, item number 35204.01. Net Wt. 10.0 lbs (4.54kg) bag. Ingredients: Sugar, Salt, Spice, Caramel Color. Recall # F-2331-2010
CODE

1) Lot number: 1104976802;

2) Lot number: 1103977201;

3) Lot numbers: 111976603, 1022976702;

4) Lot numbers: 1118932314, 1111932311-14, 1112932301, 1118932307-13, 1111932309-10,  1118932306;

5) Lot number: 1118932303-04;

6) Lot numbers: 1209916102, 1209916103, 1209916104, 1209916105, 1209916106, 1209916107, 1209916108, 1021916103;

7) Lot number: 1211947001;

8) Lot number: 1211947001;

9) Lot number: 0106060107;

10) Lot number: 1015960107;

11) Lot number: 1014924107;

12) Lot numbers: 1013960202, 1119960105, 0118060004;

13) Lot number: 1116960203;

14) Lot number: 1105960005;

15) Lot number: 1028960203;

16) Lot number: 1110982111;

17) Lot numbers: 1027942504, 1029942501, 103094260;

18) Lot number: 1216942501;

19) Lot number: 1013960101;

20) Lot numbers: 1116960105, 0113024101;

21) Lot number: 0106060203;

22) Lot number: 1202960106;

23) Lot number: 1208960001;

24) Lot number: 1112960003;

25) Lot number: 1104942505;

26) Lot numbers: 1111942401, 1111942402, 1111942403, 1111942404, 1111942405, 1119942402, 1119942403, 1119942404, 1119942405, 1119942406, 1202942401, 1202942402, 1202942403;

27) Lot numbers: 1105960006, 1217923805;

28) Lot numbers: 1112960002, 0113060201;

29) Lot numbers: 1112960001, 0120024107;

30) Lot numbers: 1124923805, 0113060203;

31) Lot number: 1119960205;

32) Lot number: 1027960203;

33) Lot numbers: 1023960101, 0114024301, 1109924304, 1109924305;

34) Lot number: 1014923806;

35) Lot numbers: 1014960102, 1102960204, 1209923905;

36) Lot numbers: 0114042407-8, 1201942403-4;

37) Lot number: 1105942404;

38) Lot number: 1103960003;

39) Lot number: 1015960106;

40) Lot numbers: 1203942408-12, 1209942404-5, 1222942402-6;

41) Lot numbers: 1123960203, 1203924108;

42) Lot number: 1023976701;

43) Lot number: 1202924102;

44) Lot number: 1216942408;

45) Lot numbers: 112042401, 1209942406
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kerry, Inc., Beloit, WI, by letters via e-mail the week of March 7, 2010 and March 14, 2010.
Manufacturers: Kerry Ingredients & Flavours, Sturtevant, WI;
Kerry Ingredients and Flavours, Irving, TX; 
Kerry Inc., Evansville, IN;  
Kerry Ingredients & Flavours Inc., Calhoun, GA; 
Kerry Ingredients & Flavours, Flemington, NJ. FDA initiated recall is ongoing.
REASON
The products were manufactured using black pepper recalled by Mincing Overseas Spice Company because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
7847,157.32 lbs
DISTRIBUTION
AL, AR, CA, IA, IL, IN, KS, MD, MN, MO, MS, NC, NE, OH, SC, TX, WI and Mexico

___________________________________
PRODUCT 
1) KIT CHEF SALAD SMALL BOWLS sold under the following brand names: a) Imperial Sysco,  Item #74875, 5.5 lb, b) Freshway, Item # 74839, 5.5 lb. Recall # F-2332-2010;

2) KIT CHICKEN CAESAR SMALL BOWLS under the following brand names: a) Imperial Sysco, Item #74876, 4.5 lb, b) Freshway, Item # 74840, 4.5 lb. Recall # F-2333-2010;

3) LETTUCE CHOP ROMAINE sold under the following brand names: Imperial Sysco, 4/5#, Item #, 73621, 4/5 lb bags; Imperial Sysco Branded, 5/4#, Item #, 73620, 5/4 lb bags; Imperial Sysco Branded, 5/4 #, Item #, 73622, 5/4 lb bags; Imperial Sysco Branded, LETTUCE CHOP W/50% ROMAINE 4/2.5 #, Item #, 73617, 4/2.5 lb bags; Freshway Branded, CHOP LETTUCE W/ ROMAINE, Item #73604, 4/2.5 lb bags; Freshway Branded, CHOP LETTUCE W/30% ROMAINE, Item #73607, 4/5 lb bags; Freshway Branded, CHOP LETTUCE W/30% ROMAINE, Item #73615, 4/5 lb bags; & Freshway Branded, CHOP LETTUCE W/ROMAINE, Item #73602, 4/5 lb bags; CHOP LETTUCE W/ROMAINE, Item #73602, 4/5 lb bags; LETTUCE CHOP W/20% ROMAINE, item #73612, 4/5 lb. bags; LETTUCE CHOP W70% ROMAINE, item #73624, 6/3 lb. bags; CHOP LETTUCE W/ 50% ROMAINE, Item #73625, 5/4 lb bags; CHOP LETTUCE W/ 40% ROMAINE, Item #73626, 4/ lb bags; CHOP LETTUCE W/ 40% ROMAINE, Item #73626, 5/4 lb bags; Lettuce Blend W/20% ROMAINE, item #73627. Recall # F-2334-2010;

4) Romaine Chop sold under the following brand names: Imperial Sysco, 2/2.5#, Item #74035, 2/2.5 lb bags, Use by 05/11/2010; Imperial Sysco Branded, Romaine Chop 4/2.5# , Item #74034, 4/2.5 lb bags, Use by 05/11/2010; Imperial Sysco Branded, ROMAINE CHOP 6/2#, Item #74033, 6/2 lb bags, Use by 05/11/2010 & Imperial Sysco Branded, Romaine Chop 6/2#, Item #74036, 6/2 lb bags, Use by 05/11/2010; 31, Freshway Branded, ROMAINE CHOP 2" x 2" 3/2#, Item #74038, 3/2 lb bags, Use by 05/12/2010; Freshway Branded, ROMAINE CHOP 6/2#, Item #74013, 6/2 lb bags, Use by 05/12/2010; Freshway Branded, ROMAINE CHOPPED 6/2#, Item #74001, 6/2 lb bags, Use by 05/12/2010; Freshway Branded, ROMAINE CHOPPED 6/2#, Item #74009, 6/2 lb bags, Use by 05/11/2010; Freshway Branded, ROMAINE CHOPPED 6/2#, Item #74018, 6/2 lb bags, Use by 05/12/2010; Freshway Branded, ROMAINE CHOPPED 1" X 2" 6/2#, Item #74016, 6/2 lb bags, Use by 05/12/2010; Freshway Branded, ROMAINE CHOPPED 1X1 6/2#, Item #74019, 6/2 lb bags, Use by 05/12/2010; Freshway Branded, ROMAINE CHOPPED 9/2#, Item #74006, 9/2 lb bags, Use by 05/11/2010; Freshway Branded, ROMAINE CHOPPED 6/2#, Item #74007, 6/2 lb bags, Use by 05/10/2010; & Freshway Branded, ROMAINE CHOPPED 6/2#, Item #74027, 6/2 lb bags, Use by 05/10/2010. Recall # F-2335-2010;

5) ROMAINE SHRED sold under the following brand names: Imperial Sysco, 1/4" x 2" 6/2 #, Item #74037, 6/2 lb bags; Freshway Branded, 1/8", Item #74003, 6/2 lb bags; Freshway Branded,1/4" 6/2#, Item #74011, 6/2 lb bags; Freshway Branded, 6/2#, Item #74002, 6/2 lb bags; & Freshway Branded,1" 6/2#, Item #74010, 6/2 lb bags. Recall # F-2336-2010;

6) Imperial Sysco Branded, SALAD ALL AMERICAN LETTUCE 1/5#, Item #73857, 1/5 lb bag; Imperial Sysco Branded, SALAD ALL AMERICAN LETTUCE 4/5#, Item #73843, 4/5 lb bags; & Imperial Sysco Branded, SALAD ALL AMERICAN LETTUCE 4/5#, Item #73856, 4/5 lb bags. Recall # F-2337-2010;

7) Imperial Sysco Branded, SALAD CALIFORNIA BLEND 4/5#, Item #73849, 4/5 lb bags.
Recall # F-2338-2010;

8) Imperial Sysco Branded, SALAD MIX W/ 50% ROMAINE 1/5#, Item #73864, 1/5 lb bag; Imperial Sysco Branded, SALAD MIX W/ 50% ROMAINE 4/5#, Item #73863, 4/5 lb bags; Imperial Sysco Branded, SALAD MIX W/ROMAINE LCR 4/5#, Item #73861, 4/5 lb bags; & Imperial Sysco Branded, SALAD MIX W/ROMAINE 4/5#, Item #73847, 4/5 lb bags. Recall # F-2339-2010;

9) Imperial Sysco Branded, SALAD SUPERIOR BLEND 2/5#, Item #73844, 2/5 lb bags. Recall # F-2340-2010;

10) 20% ROMAINE SALAD MIX sold under the following name brands: Freshway, 4/5, Item #73804, 4/5 lb bags; Freshway, 2/5 # 1.5 x 2, Item #73627, 2/5 lb bags; Freshway, Item #73829, 4/5 lb bags; & Freshway, 6/3 #, Item #73842, 6/3 lb bags. Recall # F-2341-2010;

11) Freshway Branded, CAESAR SALAD KIT, Item #74810, 5.56 lb kit; Freshway, 3.81#, Item #74873, 3.81 lb kit. Recall # F-2342-2010;

12) Freshway Branded, GREEK SALAD KIT, Item #74806, 6.13 lb kit. Recall # F-2343-2010;

13) 16, Freshway Branded, ITALIAN LETTUCE BLEND, Item #73811, 6/2 lb bags. Recall # F-2344-2010;

14) Freshway Branded, KIT - APPLE WALNUT 5.8# 8 bowls, Item #74842, 5.8 lb kit. Recall # F-2345-2010;

15) Freshway Branded, KIT - HARVEST BLEND 5.875#, Item #74871, 5.875 lb kit. Recall # F-2346-2010;

16) KIT GARDEN SALAD SMALL BOWLS sold under the following brand names: Freshway 5 lb Item # 74838; Imperial Sysco 5 lb, Item # 74874. Recall # F-2347-2010;

17) Fresh way Branded, KIT-GREEK 8 SALAD BOWLS, Item #74843, 5.8 lb kit. Recall # F-2348-2010;

18) Freshway Branded, LETTUCE BLEND W/SEP COLOR, Item #73809, 4/5 lb bags. Recall # F-2349-2010;

19) Freshway Branded, LETTUCE CHOP W/20% ROMAINE 1/2" 4/5#, Item #73612, 4/5 lb bags; Freshway Branded, LETTUCE CHOP W/40% ROMAINE 1.5" x 2" 4/5#, Item #73626, 4/5 lb bags; Freshway Branded, LETTUCE CHOP W/50% ROMAINE 1" x 1" 5/4#, Item #73625, 5/4 lb bags; Freshway Branded, LETTUCE CHOP W/70% ROMAINE 6/3#, Item #73624, 6/3 lb bags. Recall # F-2350-2010;

20) Freshway Branded, ORIENTAL SALAD KIT 20#, Item #73830, 20 lb kit, Use by 05/12/2010; Freshway Branded, ORIENTAL SALAD MIX 4/3#, Item #73831, 4/3 lb bags. Recall # F-2351-2010;

21) Freshway Branded, PICCOLO PEZZO, Item #73603, 4/5 lb bags. Recall # F-2352-2010;

22) Freshway Branded, ROMAINE BLEND 50-50, Item #73605, 4/5 lb bags. Recall # F-2353-2010;

23) Freshway Branded, ROMAINE BLEND MIXED, Item #73822, 4/5 lb bags. Recall # F-2354-2010;

24) Freshway Branded, ROMAINE LETTUCE BLEND SMALL CHOP 3/4" 4/5#, Item #73609, 4/5 lb bags. Recall # F-2355-2010;

25) Freshway Branded, ROMAINE SALAD W/15% RAD, 10% CAR 10% ENDIVE 4/2.5#, Item #73865, 4/2.5 lb bags. Recall # F-2356-2010;

26) Freshway Branded, ROMAINE SLICED 1/2" 9/2#, Item #74025, 9/2 lb bags. Recall # F-2357-2010;

27) Freshway Branded, SALAD MIX STONEY RIVER 4/5#, Item #73855, 4/5 lb bags. Recall # F-2358-2010;

28) Freshway Branded, SALAD ROMAINE BLEND W/SEP 4/5#, Item #73821, 4/5 lb bags, Use by 05/11/2010. Recall # F-2359-2010;

29) Freshway Branded, SALAD W/30% ROMAINE 5% RC 5% CARROT 4/5#, Item #73854, 4/5 lb bags, & Freshway Branded, SALAD W/35% ROMAINE 5% RC & 5% CARROT, Item #73827, 4/5 lb bags. Recall #F-2360-2010;

30) Imperial Sysco Branded, SALAD MIX CHARTHOUSE 4/2.5#, Item #73850, 4/2.5 lb bags.  
Recall # F-2361-2010;

31) Imperial Sysco Branded, SALAD MIX SIGNATURE 4/2.5#, Item #73862, 4/2.5 lb bags.
Recall # F-2362-2010
CODE
1) Use by 05/11/2010; Use by 05/12/2010;
2) Use by 05/11/2010; Use by 05/12/2010;
3) Use by 05/11/2010; Use by, 05/12/2010;
4) Use by 05/10/2010; Use by 05/11/2010; Use by 05/12/2010;
5) Use by, 05/11/2010; and Use by 05/12/2010;
6) Use by 05/11/2010;
7) Use by 05/11/2010;
8) Use by 05/11/2010;
9) Use by 05/11/2010;
10) Use by 05/12/2010;
11) Use by, 05/11/2010; and Use by 05/12/2010;
12) Use by 05/12/2010;
13) Use by 05/12/2010;
14) Use by 05/12/2010;
15) Use by 05/12/2010;
16) Use by, 05/11/2010; and Use by 05/12/2010;
17) Use by 05/12/2010;
18) Use by 05/12/2010;
19) Use by 05/12/2010;
20) Use by 05/12/2010;
21) Use by 05/12/2010;
22) Use by 05/12/2010;
23) Use by 05/12/2010;
24) Use by 05/12/2010;
25) Use by 05/12/2010;
26) Use by 05/12/2010;
27) Use by 05/12/2010;
28) Use by 05/11/2010;
29) Use by 05/12/2010
30) Use by 05/11/2010;
31) Use by 05/11/2010
RECALLING FIRM/MANUFACTURER
Fresh Unlimited Inc., Sidney, OH, by letters on May 6, 2010. Firm initiated recall is ongoing.
REASON
Fresh way Foods has undertaken a recall regarding all Fresh way Foods products containing romaine lettuce with a USE BY date prior to or on May 12th because they have the potential to be contaminated with E. coli O145. During a conference call on May 5, 2010 evening around 6PM EST with the FDA Freshway Foods was notified that a lab in New York tested an unopened bag of romaine lettuce and it tested positive for STEC 2 O145.
VOLUME OF PRODUCT IN COMMERCE
52,272 cases
DISTRIBUTION
CT, FL, GA, IL, IN, KS, KY, MA, MD, MI, MO, NC, NJ, NY, OH, PA, SC, TN, VA & WV
___________________________________
PRODUCT 
Nut Tree Health Mix, Net Wt. 8 oz., PRODUCT OF U.S.A., Turkey and Philippine --- ING: Pecans, Cashew in Roasted Peanut Oil, Hazelnuts Raisin, Almond, Banana, Walnut, Apricot. The product is packaged in a square hard plastic tubs. Recall # F-2363-2010
CODE
DATE: SEP 28 10
RECALLING FIRM/MANUFACTURER
Green Land Natural Food, Oakland Gardens, NY, by telephone and visit beginning April 15, 2010 and by letter on April 16, 2010. NY State initiated recall is complete.
REASON
The product contained undeclared sulfites (347.9 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY
___________________________________
PRODUCT 
Baroody Dried Apricots, 14.1 oz/ 400 gr packaged in a clear plastic container with no manufacturer's code. Recall # F-2364-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baroody Imports, Inc., Clifton, NJ, by press release and letters on May 12, 2010.
Manufacturer: Mahmut Yarim Gida Ith. San. Ve. Tic. AS, Antakya, Turkey. Firm initiated recall is ongoing.
REASON
Baroody Dried Apricots are being recalled due to the presence of undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
15 cases
DISTRIBUTION
NJ, NY
___________________________________
PRODUCT 
Raw Shrimp Extra Jumbo E-Z Peel, 16 oz packages sold under a) Bloom Private Label, UPC 72543990374; and b) Hannaford brands; 16-20 shrimp per pound; UPC 04126813037. Product of Mexico. These brands may also be sold from the full service seafood cases, labeled as product of Mexico. Recall # F-2366-2010
CODE
a) Date codes: PGC33109, PGC22409, PGC33509; b) date codes PGC33509 PGC33609, PGC33709, PGC33809, PGC 34109 and PGC34209
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eastern Fish Company, Teaneck, NJ, by press release and letters on June 4, 2010.
Manufacturer: Granjas Santa Margarita, S.A. De C.V., Ciudad Obregon, Mexico. North Carolina initiated recall is ongoing.
REASON
Undeclared sulfites: The North Carolina Department of Agriculture tested raw shrimp and found it to declare an average of 247.64 ppm of sulfites, which are not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
a) 489 cases; b) 1,050 cases
DISTRIBUTION
NY, MA, NH, VT, ME, MC, SC, VA and MD

___________________________________
PRODUCT 
Sesame Seeds, hulled white in clear plastic jugs with label stating in part Acuna's Guadalajara Wholesale Mexican Products Ajonjoli Sesame Seed Net Wt 8 lb. (3.63 Kg). Recall # F-2367-2010
CODE
Not coded
RECALLING FIRM/MANUFACTURER
Guadalajara Wholesale Inc., Seattle, WA, by telephone on February 19, 2010. FDA initiated recall is complete.
REASON
Product potentially contaminated with Salmonella. Seeds used were recalled by Specialty Commodities due to potential Salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
7 containers
DISTRIBUTION
WA, OR
___________________________________
PRODUCT 
VALU TIME Ranch Dressing, 16 Fl oz (1 PT) 473mL (6 / 16 oz cases). Recall # F-2368-2010
CODE
Code Date of: Use by APR 21 11
RECALLING FIRM/MANUFACTURER
Vanlaw Food Products, Inc., Fullerton, CA, by e-mail on May 14, 2010 and by press release on May 20, 2010.  Firm initiated recall is ongoing.
REASON
The back label was mislabeled with VALU TIME Light Ranch Dressing and in particular the label is missing an egg allergen declaration.
VOLUME OF PRODUCT IN COMMERCE
788 cases
DISTRIBUTION
CA
___________________________________
PRODUCT 
Van Drunen Farms IQF/Frozen 3/8" Diced F/R Zucchini; individually quick frozen, fire roasted, 3/8" diced zucchini squash; packaged in 35 lb. poly lined bulk cartons; Product of Mexico. Recall # F-2369-2010
CODE
Lot number 18382177900, expiration date 02/JUL/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Van Drunen Farms, Momence, IL, by letters dated May 10, 2010 and by telephone on May 11, 2010 and May 18m 2010.
Manufacturer: Fruvemex Mexicali, S.A., Mexicali, Mexico. Firm initiated recall is ongoing.
REASON
The IQF Fire Roasted 3/8" Dices Zucchini was found to be contaminated with Listeria monocytogenes bacteria.
VOLUME OF PRODUCT IN COMMERCE
259 cartons
DISTRIBUTION
IL, MD, OH, PA and Canada
___________________________________
PRODUCT 
Black pepper packaged in 5 lb clear plastic bags. Recall # F-2370-2010
CODE
No code
RECALLING FIRM/MANUFACTURER
Recalling Firm: Grand Rapids Cheese, Grand Rapids, MI, by telephone on March 26, 2010.
Manufacturer: Mincing Trading Corporation, Dayton, NJ. FDA initiated recall is complete.
REASON
Pepper recalled due to product received from Mincing Overseas Spice Company due to potential salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
1-5 lb bag
DISTRIBUTION
MI

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT 
Stater Bros. Fruit on the Bottom Low Fat Yogurt, 6 oz size. Recall # F-2365-2010
CODE
JUN 01 10 UC, JUN 04 10 UC, JUN 29 10 UC, JUL 01 10 UC, JUL 13 10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Morningstar Foods LLC, Dallas, TX, by telephone on June 3, 2010.
Manufacturer: Morningstar Foods LLC, Fullerton, CA. Firm initiated recall is ongoing.
REASON
Product contains undeclared coconut.
VOLUME OF PRODUCT IN COMMERCE
1,436 cases (12 retail units per case = 17,232 retail units)
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) Chuck Evans" MONTEZUMA Brand 16 oz. glass bottle, Smokey Chipotle BBQ Sauce UPC 0 17667 16032 0 & Smokey Chipotle Habanero BBQ Sauce UPC 0 17667 16080 0. Note that products were combined because they contain the same formulation. Recall # F-2371-2010;

2) Chuck Evans" MONTEZUMA Brand 16 oz. glass bottle, Steak & Chicken Marinade UPC 0 17667 16008 4; Fajita Meat Marinade UPC 0 17667 16007 7. Note that products were combined because they contain the same formulation. Recall # F-2372-2010
CODE
All products
RECALLING FIRM/MANUFACTURER
C. Evans’ Montezuma Brand, Columbus, OH, by visit on May 10, 2010. Ohio initiated recall is ongoing.
REASON
On May 7, 2010, during an inspection by the Ohio Dept. of Agriculture the firm was notified that they did not have the Allergen Requirements on the label for soy and wheat.
VOLUME OF PRODUCT IN COMMERCE
Steak & Chicken Marinade 32 bottles; Fajita Meat Marinade 22 bottles; Smokey Chipotle BBQ Sauce 40 bottles; Smokey Chipotle Habanero BBQ Sauce 22 bottles 
DISTRIBUTION
OH

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
___________________________________
PRODUCT 
1) D-DROL capsules, D-Drol Complex 52.5 mg, (2a,17a-dimethyl-5a-androstane-3-one-17b-ol, Estra-4,9-diene-3,17-dione,17a-Methyl-etioallocholan-2-ene-17b-ol), Bergamottin (DHB) 25 mg, Liver Support Complex 300 mg, 60-count bottles, UPC 871938009560. Recall # D-623-2010;

2) DIENE DRONE capsules, (Estra-4, 9-diene-3, 17-dione) 50 mg, Enhancement Complex: Milk Thistle 100 mg, Piperine 5 mg, Luteolin 4 mg, 60-count bottle, UPC 893461001194. Recall # D-624-2010;

3) Liquid drone UTT anabolic suspension, (Estra-4, 9-diene-3, 17-dione) 12.5 mg, 60 mL bottle, UPC 893461001279. Recall # D-625-2010;

4) HYPERDROL X2 capsules, (6-BROMODIONE) 50 mg, X2 Support Matrix 260 mg, 120-count bottle, UPC 791851111266. Recall # D-626-2010;

5) MASTAVOL capsules, (2a-17a-DIMETHYL-5a-ANDROST 3-ONE-17b-OL) 10 mg, 90-count bottles, UPC 649241879732. Recall # D-627-2010;

6) REVAMP capsules, (Estra 4, 9-diene-3,17-dione) 30 mg, (2a, 3a-epithio-17a-methyl-5a-androstane-17b-ol) 10 mg, 90-count bottles, UPC 649241873501. Recall # D-628-2010;

7) ULTRA MASS STACK capsules, (19-NORANDROSTA-4,9 DIENE-3,17 DIONE) 40 mg, (17A-METHYL-ETIOALLOCHOLAN-2-ene-17b-ol) 10 mg, 90-count bottles, UPC 649241870913. Recall # D-629-2010;

8) ULTRA RIPPED STACK capsules, (19-norandrosta-4,9 diene-3,17 dione) 30 mg, (2a-17a-dimethyl-5a-androst-3-one-17b-ol) 10 mg, 90-count bottles, UPC 649241870906. Recall # D-630-2010;

9) Finadex capsules, Finadex Proprietary Blend 695 mg, 90-count bottle. Recall # D-631-2010;

10) STRAIGHT DROL capsules, (17a-Dimethyl-5a-Androst-3-One17b-Ol) 10 mg, 60-count bottles. Recall # D-632-2010;

11) STRAIGHT PHLEXED capsules, (17a-Methyl-etioallocholan-2-ene-17b-ol) 10 mg, 60-count bottles. Recall # D-633-2010;

12) TESTRA FLEX capsules, (Estra 4, 9-diene-3,17-dione) 25 mg, 90-count metal cans, UPC 689076771733. Recall # D-634-2010;

13) METHYLDROSTANOLONE tablets, (2a-17a-dimethyl-5a-androst 3-one) 10 mg, 3 x 10-count blister packs in a box, UPC 094922593658. Recall # D-635-2010;

14) EPI-TREN capsules, (Estra-4,9-diene-3, 17-dione) 30 mg, (2a, 3a,-epithio-17a-methyletioallocholanol) 10 mg, 90-count bottles. Recall # D-636-2010;

15) Magna Drol capsules, (3,2-c]pyrazole-5alpha-etioallocholane-17beta tetrahydropyranol) 30 mg, (17a-Methyl-etioallocholan-2ene 17b-ol) 10 mg, 90-count bottles. Recall # D-637-2010;

16) Epivol capsules, (Estra 4, 9-diene-3,17-dione) 30 mg, (2a,3a-epithio-17a-methyletioallocholanol) 10 mg, 90-count bottles. Recall # D-638-2010;

17) Pheravol-V capsules, (17a-Methyl-etioallocholan-2-ene-17b-ol) 10 mg, 90-count bottles. Recall # D-639-2010;

18) M-DROL capsules, (2a 17a di methyl etiocholan 3-one. 17b-ol) 10 mg, 90-count bottles, UPC 891192002015. Recall # D-640-2010;

19) P-PLEX capsules, (17a-Methyl-etioallocholan-2-ene-17b-ol) 10 mg, 90-count bottles, UPC 891192002046. Recall # D-641-2010;

20) X-TREN capsules, (19-Noradrosta-4,9 diene-3,17 dione) 30 mg, 90-count bottles, UPC 891192002091. Recall # D-642-2010;

21) EPIO-PLEX capsules, (2,3A-EPITHIO-17A-METHYLETIOALLOCHOLAN-17B-OL) 10 mg, (17A-METHYL-ETIOALLOCHOLAN-2-ENE-17B-OL) 10 mg, Milk Thistle 70 mg, AAKG 350 mg, Uva Ursi 125 mg, 90-count bottles. Recall # D-643-2010;

22) FINABOLIC 50 capsules, (19 NORANDROSTA 4,9 DIENE 3, 17 DIONE) 50 mg, 90-count bottles. Recall # D-644-2010;

23) REVENGE capsules, (2A, 17A DIMETHYLETIOCHOLAN 3-ONE, 17B-OL) 15 mg, (2-ENE (17A-METHYL-ETIOALLOCHOLAN-2-ENE-17B-OL)) 10 mg, (ESTRA-4, 9-DIENE-3, 17DIONE) 40 mg, 60-count bottles. Recall # D-645-2010;

24) MethAnstane capsules, (2-alpha-17 alpha-dimethyl-5 alpha-androst-3-one), Proprietary Blend: 62.5 mg (5a-Etioallocholan[2,3-C]furazan-17b-Tetrahydropyranol Ether), (2-alpha-17 alpha-dimethyl-5alpha-androst-3-one), 60-count bottles, UPC 895524000793. Recall # D-646-2010;

25) Susto-Test Depot capsules, (17a-Methyl-Androst-1 4-Diene-3-17b-Diol) 100 mg, (Estra-4 9-Diene-3 17-Dione) 75 mg, (6,7 Dihydroxybergamottin) (DHB) 155 mg, (13-Ethyl-emethyl-Gona-Diene-17) 75 mg, (6,17 Dito-Etiocholene-4-Ol) 75 mg, Magnesium 100 mg, Zinc 10 mg, Bioperine 10 mg, 90-count bottle. Recall # D-647-2010;

26) ON CYCLE II HARDCORE capsules, 80% Milk Thistle Extract 100 mg, (4-Chloro-17a-methyl-androst-1,4-diene-3,17b-diol) 25 mg, Lecithin (LPC) 20 mg, (Estra 4,9 Diene 3,17 Dione) 10 mg, (2a,17a-dimethyl-etiocholan 3-one, 17b-Ol) 5 mg, Bioperine 5 mg, 30-count bottle, UPC 876436000637. Recall # D-648-2010;

27) SUS500 softgels, Active Ingredients: Estra-4 9-Diene-3 17-Dione, 13-Ethyl-3-Methoxy-Gona2, 5(10)-Diene-17-One, 3, 17 Ketoetiochol-Triene, Silymarin Extract, TPGS (Advanced Delivery System), In A Base of Safflower Oil, Geletin, 60-count bottles. Recall # D-649-2010;

28) TREN-250 softgels, Active Ingredients: Estra-4, 9-Diene, TPGS 78 mg Safe Methyl Process, Vitamin E 1mg. In A Base Of 267 mg Safflower Oil, Geletin, 25 mg, 60-count bottles. Recall # D-650-2010;

29) T-ROID capsules, (19-Norandrosta 4,9 Diene 3,17 Dione) 30 mg, 90-count bottles, Hardcore Forumlations. Recall # D-651-2010;

30) 1,4 AD BOLD 200 capsules, (1,4 Androstadiene-3, 17-dione) 200 mg, 60-count bottles, UPC 854503001145. Recall # D-652-2010;

31) 17a PheraFLEX capsules, (17a-Methyl-Etioallocholan-2-ene-17b-OL) 15 mg, 90-count bottles, UPC 854503001176. Recall # D-653-2010;

32) DYMETHAZINE capsules, 15 mg, 60-count box, UPC 854503001206. Recall # D-654-2010;

33) 2a,17a Methadrol capsules, (2a 17a di methyl etiocholan 3-one, 17b-ol) 10 mg, 90-count bottles, UPC 854503001152. Recall # D-655-2010;

34) BROMODROL tablets, Bromodrol Growth Complex 531 mg (Green Tea, Hoelene, Bergamottin, Bupleurum, 6 Bromo 3, 17 dioxoetioallocholane, Nettle Root, Chrysin, Saw Palmetto, Schizandra Berry, Wild Yam, Safed Musli), 60-count foil packed tablets in a box, UPC 675941002507. Recall # D-656-2010;

35) GROW TABS capsules, 582 mg, Proprietary Testopen Blend (Kudzu root, Green Tea, Zinc aspartate, Pygeum africanum extract, Stinging nettle leaf extract, 17 alpha methyl 17 beta hydroxyl 5 alpha androst 2 ene, 4 Androstene 4 chloro 17 alpha methyl 3 beta 17 beta diol, Urtica Dioica, Tongkat Ali (malaysian Eurycoma Longifolia Jack), Dodder Seed) 250 mg, Bergamottin 50 mg, Bupleurum 50 mg, Hoelen 50 mg, 60-count foil packed capsules in a box, UPC 675941002521. Recall # D-657-2010;

36) MASS TABS capsules, Proprietary Mass Tabs Blend 87,000 mcg (Kudzo Extract 40%, Trifolium Pratense Extract 8%, Fenugreek Seed Powder, Tribulus Terrestris Extract 40%, MethylSten, Avena Sativa Extract 10:1, Pygeum Africanum Bark Extract 4:1, Milk Thistle, Maca Powder Extract .6%, Epimedium Leaf, Bacopa Monniera Extract 4:1, Rhodiola Rosea 3%, Nettle Leaf Powder), 30-count bottles, UPC 675941001494. Recall # D-658-2010;

37) OXODROL PRO tablets, Supplement Facts: Hoenelen 100 mg, Bupleurium 100 mg, Bergamottin 100 mg, Green Tea 100 mg, Proprietary Blend 150 mg (Nettle Leaf Powder, Maca Powder Extract, Avena Sativa Extract, Fenugreek Seed Powder, Tribulus Terrestris Extract), (2alpha, 3alpha-epithio-17alpha-methyletioallocholanol) 10 mg, 60-count foil packed tablets in a box, IDS. Recall # D-659-2010;

38) RIPPED TABS TR capsules, Anabolic AmplifierTM Proprietary Blend (Hoenelen, Buplurium, Bergamottin) 300 mg; Energy XT Proprietary Blend (Green Tea, Caffeine USP, Mateine) 500 mg; Anabolic Cutter Blend (1,3,7-trimethyl-1H-purine-2,6 (3H,7H) dione, 19 Norandrosta 4, 9 diene 3, 17 dione) 257 mg; 60-count bottle, UPC 675941001623. Recall # D-660-2010;

39) Massdrol capsules, (2a, 17a-Dimethyl-5a-Androst-3-One, 17B-0l) 10 mg, 60-count bottles. Recall # D-661-2010;

40) Phera-Mass capsules, (17a-Methyl-Eticoallocholan-2-Ene-17b-Ol) 10 mg, 60-count bottles, KiloSports. Recall # D-662-2010;

41) Trenadrol capsules, (17b-Methoxy-Trienbolonein) 30 mg, 60-count bottles, KiloSports.
Recall # D-663-2010;

42) MONSTER CAPS capsules, Milk Thistle 150 mg, Proprietary Blend (4-chloro-17a-methyl-etioallocholan-1, 4-diene-3, 17-diol 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one 2a,17a di-methyl etiocholan 3-one, 17b-ol 6,7 Dihydroxybergamottin) 60 mg, 60-count bottles, UPC 689076956505. Recall # D-664-201;

43) Spawn capsules, (Estra-4 9-Diene-3 17 Dione ) 30 mg, (2a, 3a-Epithio-17a-Methyletioallocholanol) 8 mg, 90-count bottles, Myogenix Products. Recall # D-665-2010;

44) D-STiANOZOL tablets, (17a-Methyl-etioallocholan-2-ene-17b-ol) 10mg, 60-count bottles,  UPC 8272386000284. Recall # D-666-2010;

45) H-DROL tablets, (polydehydrogenated, polydehydroxylated halomethetioallocholane) 25 mg, 60-count bottle, UPC 8272386000369. Recall # D-667-2010;

46) MD1T capsules, L-Arginine Alpha-Ketoglutarate (AAKG) 1000 mg, Uva Ursi (Leaf) (Arctostaphylos Uva-Ursi) 400 mg, Milk Thistle (80% Silymarin) 200 mg, (19-Norandrosta 4, 9 Diene 3, 17 Dione) 50 mg, (17a-Methyl-Etioallocholan-2-Ene- 17b-01) 20 mg, 90-count bottle, Nutracoastal. Recall # D-668-2010;

47) Nutracoastal S-Drol tablets, (2a, 17a-Dimethyl-5a-Androst-3-One, 17b-OI) 10 mg, 60-count bottles, Nutrcoastal. Recall # D-669-2010;

48) TRENA tablets, (19-norandrosta-4,9-diene-3,17-dione) 25 mg, 90-count bottles, UPC 8272386000383. Recall # D-670-2010;

49) 2a, 17a METHASTADROL capsules, (2a, 17a di methyl etiocholan 3-one, 17b-ol) 10 mg, 90-count bottles, UPC 089935100207. Recall # D-671-2010;

50) TRI-METHYL X capsules, vitamin C 60 mg, Vitamin B-12 24 mcg, (2a, 17a di-methyl etiocholan 3-one, 17b-ol) 10mg, (17a-Methyl-etioallocholan -2-ene-17b-ol) 10 mg, (4 chloro17amethylandrost-1,4diene-3-17b-diol) 20 mg, 60-count bottles, UPC 089935100214. Recall # D-672-2010;

51) e-pol capsules, (2a,17a-dimethyl-5a-androstane-3-one-17b-ol) 15 mg, (Estra-4,9-diene-3,17-dione) 30 mg, InSLINsified Proprietary Insulin Mimetic 250.5 mg, 60-count bottles, UPC 855279025144. Recall # D-673-201;

52) Nasty mass capsules, (13-ethyl-3-methoxy-gona-2,5(10) dien-17-one) 25 mg, (17a-Methyl-etioallocholan-2-ene-17b-ol) 10 mg, InSLINsified Proprietary Insulin Mimetic 250.5 mg, 60-count bottles, UPC 793214256904. Recall # D-674-2010;

53) RAGE RV2 capsules, (1,4-androstadiene-3,17-dione) 150 mg, (Estra-4,9-diene-3, 17-dione) 30 mg, 90-count bottles, UPC 718122731350. Recall # D-675-2010;

54) RAGE RV3 capsules, (17a-methyl-1,4-androstadiene-3,17-diol) 26 mg, (Estra-4,9-diene-3, 17-dione) 26 mg, (13-ethyl-3-methoxy-gona-2,5(10) dien-17-one) 20 mg, (1,4,6-androstatriene-3,17-dione) 20 mg, 60-count bottles, UPC 718122747122. Recall # D-676-2010;

55) RAGE RV4 capsules, (17a-methyl-1,4-androstadiene-3,17-diol) 25 mg, (Estra-4,9-diene-3, 17-dione) 20 mg, (2a, 3a-epithio-17a-methyl-5a-androstan-17b-ol) 8 mg, 60-count bottle, UPC 718122747320. Recall # D-677-2010;

56) RAGE RV5 capsules, (4 chloro17amethylandrost-1,4diene 17b-ol) 25 mg, (2a,17a di methyl etiocholan 3-one, 17b-ol) 10 mg, (17a-Methyl-etioallocholan-2-ene-17b-ol) 10 mg, 60-count bottles, UPC 718122747221. Recall # D-678-2010;

57) FINAFLEX 550-XD capsules, (2a, 17a-Di-methyl-etiocholan-3-one, 17B-ol) 10 mg, (Estra-4,9-diene-3,17-dione) 25 mg, (3, 17 ketoetiochol-triene) 10 mg, Milk Thistle (80% Silymarin) 120 mg, NAC (N-Acetyl Cysteine) 250 mg, Vitamin C (ascorbic acid) 50 mg, 60-count bottles, rd labs, UPC 689466048865. Recall # D-679-2010;

58) FINAFLEX RIPPED capsules, (1,4Androstadiene-3,17-dione) 100 mg, (Estra-4,9-diene-3,17-dione) 30 mg, Caffeine Anhydrous 100 mg, Dandelion Root 200 mg, Green Tea Extract (60% EGCG) 200 mg, Vitamin B6 100 mg, 60-count bottles, UPC 689466130577. Recall # D-680-2010;

59) FORGED EXTREME MASS capsules, Proprietary Blend (17a-methyl-etioallocholan-2-ene-17b-o 4 chloro 17a methyl androst-1,4 diene-3-17b-diol Estra-4,9-diene-3) 65 mg, 60-count bottles, transform Supplements, UPC 788903093748. Recall # D-681-2010;

60) FORGED LEAN MASS capsules, Proprietary Blend (2a,17a-dimethyl-17b-hydroxy-5a-androstane-3-one 17a-methyl-etioallocholan-2-ene-17b-ol 3,17- keto-etiochol-triene) 55 mg, 60-count metal cans, transform Supplements, UPC 788903057924. Recall # D-682-2010;

61) RIPPED TABS TR tablets, Anabolic Amplifier Proprietary Blend (Hoenelen, Buplurium, Bergamottin) 300 mg, Energy XT Proprietary Blend (Green Tea, Caffeine USP, Mateine) 425 mg, Anabolic Cutter Blend (1,3,7-trimethyl-1H-purine-2,5 (3H,7H) dione, 19 Norandrosta 4, 9 diene 3, 17 dione, Juniper Berry, Cornsilk Stylus, Bulgarian Tribulus Terrestris (Standardized at a 25% saponin content), Fenugreek seed, Theine, Acetyl-L Carnatine, Zinc (as zinc aspartate), Stinging nettle leaf, Maca Root, Eurycoma Longifolia, Couchgrass Rhizome) 234 mg, 60-count foil packed blisters per box, UPC 675941001623. Recall # D-683-2010;

62) IForce Dymethazine/Reversitol Combo Pack. Recall # D-684-2010
CODE
All lots and codes.
RECALLING FIRM/MANUFACTURER
Bodybuilding.Com, Meridian, ID, by press release on November 3, 1009 and by e-mail on November 20, 2009. Firm initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA: 62 products marketed as dietary supplements have been found to contain steroid or steroid-like substances, making them unapproved new drugs.
VOLUME OF PRODUCT IN COMMERCE
48,890 bottles   
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT 
Metronidazole Injection, USP, 500 mg/100 mL (5 mg/mL), Single Dose Premix Bag, Rx only, 24 bags per case; NDC 25021-131-82, UPC 3 25021 13182 4. Recall # D-687-2010
CODE
Lot #: A090742, A090743, A090744, A090745, A090746, A090769, A090770, A090771, A090772, A090773, A090774, Exp 09/11; A090775, A090776, Exp 10/11; A090968, A091014, Exp 11/11; A000013, A000016 and A000019, Exp 12/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sagent Pharmaceuticals, Inc., Schaumburg, IL, by letters dated May 13, 2010.
Manufacturer:  Claris LifeSciences Limited, Ahmadabad, India. Firm initiated recall is ongoing.
REASON
Non-Sterility: This product is being recalled because of two complaints of a white feathery substance floating inside the IV bag which was identified as Mucor spp. fungus.
VOLUME OF PRODUCT IN COMMERCE
142,176 bags
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT 
Isosorbide Mononitrate Extended-Release Tablets, 30 mg, Rx only, 100 and 1000 count bottles. Recall # D-686-2010
CODE
Lot 0913001 (100) and 0913002 (1000)
RECALLING FIRM/MANUFACTURER
Schwarz Pharma Manufacturing, Inc., Seymour, IN, by letter on June 1, 2010. Firm initiated recall is ongoing.
REASON
Tablet Thickness; presence of thicker, overweight tablets due to presence of start-up waste in acceptable product.
VOLUME OF PRODUCT IN COMMERCE
28543 bottles (100 count tablets); and 1082 bottles (1000 count tablets)
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT 
ISMO Tablets (Isosorbide mononitrate) 20 mg, Rx only, 100 count bottles, Scored,
NDC: 67857-702-01. Recall # D-685-2010
CODE
Lot number 62519A, Exp 10/2010; Lot 66948A, Exp 6/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Promius Pharma, LLC, Bridgewater, NJ, by letters on April 29, 2010.
Manufacturer: West-ward Pharmaceutical Corp., Eatontown, NJ. Firm initiated recall is on going.
REASON
Failed Dissolution Specification; 44 month time point.
VOLUME OF PRODUCT IN COMMERCE
19,476 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0836-10
CODE
Unit: 72J389876
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on December 8, 2009. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-1521-10
CODE
Unit: 3157921
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter dated November 4, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the medication Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1650-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1651-10;
CODE
1) Unit: W068509030122;
2) Unit: W068509353543
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by letter on February 1, 2010. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA, ID
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1652-10
CODE
Unit: 2567416
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter on February 3, 2010. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1653-10
CODE
Unit: 20M58459
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by fax on December 11, 2009. 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) Platelets. Recall # B-1654-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1655-10
CODE
1) and 2) Unit: 2470663
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter on January 5, 2010. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY

___________________________________
PRODUCT 
1) Platelets. Recall # B-1656-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1657-10
CODE
1) Unit: 2489635,
2) Units: 2430587,2434419, 2489635, 2512191
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter on December 31, 2009. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-1658-10
CODE
Unit: W020009100984
RECALLING FIRM/MANUFACTURER
National Naval Medical Center Bb, Bethesda, MD, by fax on August 7, 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
District of Columbia
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-1659-10
CODE
Unit: W020408002137
RECALLING FIRM/MANUFACTURER
Naval Hospital, Camp Lejeune, NC, by fax on December 11 and 23, 2008 and February 6, 2009. 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
NC
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-1661-10
CODE
Units: 4818826, 4821498
RECALLING FIRM/MANUFACTURER
National Naval Medical Center Bb, Bethesda, MD, by fax on September 3, 2008, January 13, 2009, April 21, 2009 and June 30, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Afghanistan, Bahrain
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B- 1662-10
CODE
Unit: W03509005931
RECALLING FIRM/MANUFACTURER
Community Blood Center dba Community Tissue Services, Dayton, OH, by telephone on January 18, 2010 and letter dated January 19, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT 
Source Plasma. Recall # B-1663-10
CODE
Units: AU0049555; AU0048602; AU0048243; AU0049918
RECALLING FIRM/MANUFACTURER
DCI Biologicals Austin, LLC, Austin, TX, by fax on January 28, 2010 and e-mail on March 19, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1664-10
CODE
Unit: 06GS20840
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by fax and letter on December 20, 1009. 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 
Source Plasma. Recall # B-1665-10
CODE
Units: SS0035343; SS0039872; SS0059043
RECALLING FIRM/MANUFACTURER
DCI Biologicals San Marcos, LLC, San Marcos, TX, by fax on January 14, 2010 and e-mail on March 8, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1666-10
CODE
Units: W043210001777; W043210001777
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on February 11, 2010. Firm initiated recall is complete.
REASON
Blood products, with unacceptably high platelet yields, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1667-10
CODE
Units: 024FH67277; 024FH67277
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by telephone on December 11, 2009 and fax on December 16, 2009. Firm initiated recall is complete.
REASON
Blood products, processed from an apheresis unit with platelet yield below the specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1670-10
CODE
Unit: 007GJ36609
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tucson, AZ, by fax and the LOGIC system on January 27, 2010. 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
AZ  
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1672-10
CODE
Unit: W0407099030265
RECALLING FIRM/MANUFACTURER
Indiana Blood Center, Indianapolis, IN, by telephone on December 28, 1009 and follow up letter dated February 17, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1673-10
CODE
Unit: W0419090486672
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by telephone on December 27, 2009. Firm initiated recall is complete.
REASON
Blood product, with insufficient plasma to support the platelet concentration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NV
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1674-10
CODE
Unit: 2907576
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated November 17, 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
OH

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________
PRODUCT 
Platelets Leukocytes Reduced. Recall # B-1562-10
CODE
Units: 6735905; 0817396
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter dated October 9, 2006. Firm initiated recall is complete.
REASON
Blood products, which may have been stored under unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1571-10
CODE
Units: W086509002348, W086309005244, W086209006280, W086209009277, W086109006758, W085009002221, W084909004377, W084609002631, W084709000910, W086209006293, W085009002222, W085909006739, W086009006304, W086309005193, W086909000848, W085609002200, W085809004665, W086509002364, W087009002641, W084609002630, W085409001195, W085609002203, W086109006735, W086509002385, W084109001855, W086009006374
RECALLING FIRM/MANUFACTURER
ITXM Clinical Services, Pittsburgh, PA, by facsimile on August 31, 2009. Firm initiated recall is complete.
REASON
Blood products, leukodepleted greater than five days after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
PA
___________________________________
PRODUCT 
Whole Blood. Recall # B-1623-10
CODE
Unit: 0822633; 0822638; 0822670; 0822708
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter on November 17, 2008. Firm initiated recall is complete.
REASON
Blood products, collected in 500 mL bags but labeled as 450 mL, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OH
___________________________________
PRODUCT 
Liquid Plasma. Recall # B-1660-10
CODE
Unit: W020408002137
RECALLING FIRM/MANUFACTURER
Naval Hospital, Camp Lejeune, NC, by fax on December 11 and 23, 2008 and February 6, 2009. 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
NC

___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # 1668-10;
2) Recovered Plasma. Recall # 1669-10
CODE
1) and 2) Unit: W221609400615
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by telephone on December 7, 2009 and e-mail and fax on December 8, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a bone graft within one year of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, TX
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1671-10
CODE
Unit: 007GJ36609
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tucson, AZ, by fax and the LOGIC system on January 27, 2010. 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 
Source Plasma. Recall # B-1694-10
CODE
Unit: AQ030475
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Asheville, NC, by facsimile on October 1, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma. Recall # B-1696-10
CODE
Unit: AQ030614
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plasma Biological Services, Memphis, TN, by facsimile on September 20, 2007.
Manufacturer: Plasma Biological Services, Asheville, NC. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma. Recall # B-1697-10
CODE
Unit: AQ030654
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plasma Biological Services, Inc., Memphis, TN, by facsimile on September 28, 2007.
Manufacturer: Plasma Biological Services, Asheville, NC. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma. Recall # B-1698-10
CODE
Unit: AQ030467
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plasma Biological Services, Inc., Memphis, TN, by facsimile on October 2, 2007.
Manufacturer: Plasma Biological Services, Asheville, NC. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1813-10
CODE
Units: 7164980, 7131248, 7131274, 7164847, 7131800, 7131665, 7131673, 7131538, 7131348, 7131712
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by fax on October 18, 2007. Firm initiated recall is complete.
REASON
Blood products, for which Quality Control was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
Source Plasma. Recall # B-1860-10
CODE
Unit: 05ANCA1760
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plasma Biological Services, Memphis, TN, by facsimile on February 22, 2008.
Manufacturer: Plasma Biological Services, Asheville, NC. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT 
Platelet Pheresis Leukocyte Reduced-7 day. Recall # B-1861-10
CODE
Unit: 4761440
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL, by telephone on July 18, 2007 and fax on July 19, 2007. Firm initiated recall is complete.
REASON
Blood product, with positive bacterial detection testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Fresh Frozen Plasma (Apheresis). Recall # B-1863-10
CODE
Units: KF41050 Part B; KF41050 Part C
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by fax on December 28, 2006. Firm initiated recall is complete.
REASON
Blood products, which may have reached an unacceptable temperature during storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT 
Boston ES Rigid Gas Permeable Contact lens manufactured with Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material. Indicated for daily wear for the correction of refractive ametropia in aphakic and/or not-aphakic persons with non-diseased eyes. Recall # Z-1705-2010
CODE
Lot Number: 156PTC05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb, Inc., Rochester, NY, by letter dated April 20, 2010.
Manufacturer: Bausch & Lomb, Inc., Wilmington, MA. Firm initiated recall is ongoing.
REASON
The amount of D&C #6 Dye added to the formulation exceeded specified amounts.
VOLUME OF PRODUCT IN COMMERCE
2,572 units
DISTRIBUTION
TX, IN, WI
___________________________________
PRODUCT 
AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. a) Label Power: -0.50, Cylinder: -1.75, Axis: 180; b) Label Power: -2.50, Cylinder -1.75, Axis 180. Toric lenses approved for daily wear and extended wear up to 6 nights. Recall # Z-1706-2010
CODE
a) Lot Number: 8717082, Exp. 10/2013 and b) Lot Number: 8717066, Exp. 10/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ciba Vision Corp., Duluth, GA, by letter beginning April 15, 2010.
Manufacturer: Pt Ciba Vision Batam, Batam Island, Indonesia. Firm initiated recall is ongoing.
REASON
The lenses inside the package do not match the prescription information for power labeled on the primary package.
VOLUME OF PRODUCT IN COMMERCE
10,434 lenses
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
PulseSpray Infusion System, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, Sterile, EO; Infusion Catheter. Recall # Z-1707-2010
CODE
Lot number: 991437
RECALLING FIRM/MANUFACTURER
Angiodynamics, Inc., Queensbury, NY, by letter dated May 11, 2010. Firm initiated recall is ongoing. 
REASON
This lot was packaged with the wrong occluding ball guidewire. The PulseSpray Catheter is 90 cm in length and requires a 109 cm occluding ball guidewire; however this lot was packaged with a 60 cm occluding ball guidewire.
VOLUME OF PRODUCT IN COMMERCE
20 catheters
DISTRIBUTION
AR, NY, PA, MI, MN, LA, WA, Spain, Austria and Denmark
___________________________________
PRODUCT 
Axiom Artis systems with Motor Controller Unit. Intended for x-ray, angiographic use. Model Numbers: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717 and 7728392. Recall # Z-1732-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter April 12, 2010.
Manufacturer:  Siemens Medical Solutions, Inc., Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Sporadic malfunctions of the Artis Systems with Motor Controller caused by tolerances on electronic parts that might increase during the lifetime of the system.
VOLUME OF PRODUCT IN COMMERCE
83 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) ANGIODYNAMICS BENEPHIT(TM) XT Infusion System, 35 cm, Targeted Renal Therapy Infusion system, Model/REF Number 70035, Sterile, EO, Intended for Single Use Only. Recall # Z-1733-2010;

2) ANGIODYNAMICS BENEPHIT(TM) CV Infusion System, 35 cm, Targeted Renal Therapy Infusion system, Catalog/Model/REF Number 60035, Sterile, EO, Intended for Single Use Only. Recall # Z-1734-2010
CODE
1) Batch Numbers: P909081, P909291, P910092, P910262, P911053, P911163, P911243, P912083, P912293 and P001203;

2) Batch Number: P909231
RECALLING FIRM/MANUFACTURER
Angiodynamics, Inc., Queensbury, NY, by letter dated April 28, 2010. Firm initiated recall is ongoing. 
REASON
Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile product, which could potentially cause a patient infection which is a serious medical condition.
VOLUME OF PRODUCT IN COMMERCE
763 units
DISTRIBUTION
Nationwide and Italy
___________________________________
PRODUCT 
1) ARTERIAL LINE KIT Arterial Line Kit #2 20ga X 3" REF/REORDER NO. 194284 Labeled Sterile, Rx. Recall # Z-1737-2010;

2) CATHETER INTRODUCER KIT PCI KIT/5 REF/REORDER NO. 496185. Disposable Single Use, Rx. Recall # Z-1738-2010;

3) CATHETER INTRODUCER KIT SPECIAL RIGHT HEART KIT REF/REORDER NO. 496413Y. Disposable Single Use, Rx. Recall # Z-1739-2010

4) ARTERIAL LINE KIT REF/REORDER NO. 498104 DISPOSABLE SINGLE USE, Rx. Recall # Z-1740-2010;

5) ARTERIAL LINE KIT REF/REORDER NO. 498410B DISPOSABLE, SINGLE USE, Rx. Recall # Z-1741-2010;

6) ARTERIAL LINE KIT REF/REORDER NO. 498411B DISPOSABLE SINGLE USE, Rx. Recall # Z-1742-2010;

7) ARTERIAL LINE KIT REF/REORDER NO. 498412B DISPOSABLE SINGLE USE, Rx. Recall # Z-1743-2010;

8) ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498439 DISPOSABLE SINGLE, Rx. Recall # Z-1744-2010;

9) ARTERIAL LINE KIT, Custom Arterial Kit REF/REORDER NO. 498447 DISPOSABLE SINGLE USE, Rx. Recall # Z-1745-2010
CODE
1) Lot Number: 99737820, Expiration Date: 2015-03;

2) Lot Number: 99738261, Expiration Date: 2014-07;

3) Lot Number: 99737884, Expiration Date: 2014-06;

4) Lot Number: 99737777, Expiration Date: 2014-12;

5) Lot Number: 99737665, Expiration Date: 2012-10;

6) Lot Number: 99736745, Expiration Date: 2012-10;

7) Lot Number: 99716572, Expiration Date: 2011-12 and Lot Number: 99738188, Expiration Date: 2012-10;

8) Lot Number: 99734514, Expiration Date: 2015-02;

9) Lot Number: 99738189, Expiration Date: 2014-06
RECALLING FIRM/MANUFACTURER
Argon Medical Devices, Inc., Athens, TX, letters dated March 29, 2010. Firm initiated recall is ongoing.   
REASON
There are 1-2 places on some of the multi-purpose kit blisters/trays in which there are holes and/or the material is so thin that holes are easily created. This would potentially cause the sterility of the products to be compromised.
VOLUME OF PRODUCT IN COMMERCE
675 trays
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in February 2003. The cords are a detachable unit, supplied with the instruments listed below: Medtronic Bio-Console 550 centrifugal pump console, Model #95180, Catalogue # 95180, E95180, R95180. Medtronic Bio-Console 560 centrifugal pump consoles Model # 560BC, Catalogue # 560BC, 560BCS, 560BCS1. Medtronic autoLog, Model # ATLG110, Catalogue # ATLG110, ATLG110E ATLG110R. Medtronic Sequestra 1000, Model #SEQ1000, Catalogue # SEQ1000, SEQ1000E, SEQ1000R. Recall # Z-1939-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Medtronic Cardiovascular Revascularization & Surgical Therapy, Brooklyn Park, MN, by letter dated April 19, 2010. Firm initiated recall is ongoing.
REASON
The power cord's prongs may crack and fail at/or inside the plug.
VOLUME OF PRODUCT IN COMMERCE
699 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis. Sample Probe Catalog Numbers 337170, 333494, 333485, 339118, 647768, 647769. Recall # Z-1940-2010
CODE
Lot numbers: 92035 and 92036
RECALLING FIRM/MANUFACTURER
BD Biosciences, Systems and Reagents, San Jose, CA, by letter of February 2010. Firm initiated recall is ongoing.
REASON
Samples prepared on the BD SPA II, SN T0076 produced inaccurate sample results due to inaccurate sample dispensed as a result of the cap piercing probe.
VOLUME OF PRODUCT IN COMMERCE
349 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT 
STERIS 4085, 5085 & 5085SRT Surgical Tables. Model #: 4085, 5085 & 5085SRT.  Recall # Z-1941-2010
CODE
Serial Numbers: 0400710041, 0400710042, 0400710043, 0400710044, 0401510077, 0401510080, 0401510081, 0401510082, 0401510086, 0401510087, 0401510088, 0401510089, 0401510090, 0401510092, 0401910133, 0402010001, 0402010002, 0402010003, 0403210095, 0403210096, 0403210096, 0403210097, 0403210098, 0403610046, 0403610047, 0403610048, 0403610049, 0403610050, 0403610053, 0403610054, 0403610055, 0403610057, 0403610061, 0403610062, 0403610063, 0404610061, 0404610062, 0404610063, 0404610063, 0404610064, 0404610064, 0404610065, 0404610065, 0404610070, 0404610070, 0404610071, 0404610071, 0404610072, 0404610072, 0405410037, 0405410038, 0405410039, 0432709078, 0432709079, 0432709079, 0432709080, 0432709081, 0432709082, 0432709083, 0432709083, 0432709084, 0432709084, 0433609001, 0433609001, 0433609002, 0433609002, 0433609005, 0433609005, 0433609062, 0434309100, 0434309101, 0434309103, 0434809001, 0434809003, 0434809004, 0434809005, 0434809006, 0434809007, 0434809007, 0434809008, 0434809008, 0434809012, 0434809013, 0434809014, 0434809014, 0434809015, 0434809015, 0434809016, 0434809016, 0434809017, 0434809017, 0434809018, 0434809018, 0434809019, 0434809019, 0436309084, 0436309085, 0436509122, 0436509123, 0436509124 & 0436509124
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corporation, Mentor, OH, by letters on May 14, 2010.
Manufacturer: Steris Corporation, Montgomery, AL. Firm initiated recall is ongoing.
REASON
STERIS has learned that a limited quantity of manifold assemblies were manufactured by our supplier with incorrect washers and springs in the valves of the manifold. This supplier error has the potential to cause: a) an inability to articulate/move a table section when commanded by the operator; b) two different articulations occurring when a single articulation is commanded, or c) that the table sections move slowly or drift without prompting by an operator.
VOLUME OF PRODUCT IN COMMERCE
79 units
DISTRIBUTION
Nationwide, Australia, India, Korea & New Zealand

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III
___________________________________
PRODUCT 
Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021. Recall # Z-1942-2010
CODE
Lot numbers: 273005A, 273005B, 273005C, and 273005D
RECALLING FIRM/MANUFACTURER
Recalling Firm: Inova Diagnostics Inc., San Diego, CA, by letters on October 30, 2009.  
Manufacturer: The Binding Site, Ltd., Birmingham, United Kingdom. Firm initiated recall is complete.
REASON
The affected Bindazyme Human C1q binding Circulating Immune Complex EIA Kits may contain an ELISA plate labeled as "tissue Transglutaminase Coated Wells" instead of "C1q Coated Wells".
VOLUME OF PRODUCT IN COMMERCE
700 units
DISTRIBUTION
Nationwide, Germany, Italy, Belgium, Romania, Portugal, Argentina, Spain, Sweden, and India
___________________________________
PRODUCT 
Biomet Microfixation Ref: 91-6103 "1.5MM" System High Torque (HT), SD, X-DR, Screw 1.5MM X 3.5MM (WXL) Titanium, Non Sterile Product. Bone screws used along with implantable bone plates for oral, cranio-maxillofacial procedures. Recall # Z-1943-2010
CODE
Lot 829760
RECALLING FIRM/MANUFACTURER
Biomet Microfixation, Inc., Jacksonville, FL, by e-mail and fax on October 5, 2009. Firm initiated recall is complete.
REASON
Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw.
VOLUME OF PRODUCT IN COMMERCE
91 units
DISTRIBUTION
CA, CO, MI, and MO

END OF ENFORCEMENT REPORT FOR JULY 7, 2010

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