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U.S. Department of Health and Human Services

Safety

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Enforcement Report for November 25, 2009

November 25, 2009
09-47

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

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PRODUCT 
1) Blue Bunny No Sugar Added Reduced Fat Bunny Tracks ice cream in 1.75 qt plastic containers, UPC 70640 03434. Recall # F-0065-2010;

2) Blue Bunny Hot Fudge Sundae original packaged ice cream square paperboard, package 1.75 quarts, UPC 70640 05056. Recall # F-0066-2010;

3) Blue Bunny Caramel Lovers Champ Cone, 2 Dozen, UPC 70640 40075 and 6-pack, UPC 70640 40080. Recall # F-0067-2010;

4) Blue Bunny Vanilla Champ Cone, 2 Dozen, UPC 70640 40072, and 6-Pack, UPC 70640 40074. Recall # F-0068-2010;

5) Blue Bunny Big Dipper Vanilla Cone, 2 Dozen, UPC 70640 40110. Recall # F-0069-2010;

6) Blue Bunny Champ Variety Pack, 2 Dozen, Vanilla UPC 70640 40072, Hot Fudge UPC 70640 40073, Caramel Lovers UPC 70640 40075, and 6-Pack, UPC 70640 40076. Recall # F-0070-2010;

7) Blue Bunny Vanilla Nutty Sundae Cone, 2 Dozen, UPC 70640 63007. Recall # F-0071-2010;

8) Blue Bunny Classic Vanilla Sundae Cone, 8-Pack, UPC 70640 63023. Recall # F-0072-2010;

9) Blue Bunny Sweet Freedom Vanilla Sundae Cone, 6-Pack, UPC 70640 63021. Recall # F-0073-2010;

10) Blue Bunny Light Cone, Variety Pack, 6-Pack, UPC 70640 30112. Recall # F-0074-2010;

11) Sysco Cool N' Classy Sundae Cone, 2 Dozen, UPC 74865 46248. Recall # F-0075-2010;

12) Great Value Nutty Caramel Cone, 6-Pack, UPC 05388 18855. Recall # F-0076-2010;

13) Great Value Chocolate Dipped Vanilla Sundae Cone, 8-Pack, UPC 78742 14223. Recall # F-0077-2010;

14) Fastco Vanilla Sundae Cone, 6-Pack, UPC 21333 99237. Recall #F-0078-2010;

15) Hy-Vee Sundae Cone, 6-Pack, UPC 75450 06150. Recall # F-0079-2010;

16) Hy-Vee Variety Pack Cone, 6-Pack, UPC 75450 06151. Recall # F-0080-2010;

17) Shurfresh Sundae Cone, 6-Pack, UPC 11161 45053. Recall # F-0081-2010;

18) Country Rich Vanilla Cone, 6-Pack, UPC 70640 30086. Recall # F-0082-2010;

19) Blue Bunny Personals Bunny Tracks, 8 fl oz, UPC 70640 45121. Recall # F-0083-2010
CODE
1) All codes displaying “Best Used By” dates prior to January 29, 2010;
2) through 18) Best used by dates prior to 2/4/2010 (all lot numbers);
19) Lot No. 80024 D19114 "Best Used By" date 9/11/09 and Lot No. 80030 D19114 "Best Used By" date 11/17/09
RECALLING FIRM/MANUFACTURER
Wells Dairy Inc., Le Mars, IA, by press releases on January 29 & 30, 2009, and on February 23, 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
Approximately 2,973,510 cases
DISTRIBUTION
Nationwide
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PRODUCT 
Baba Joon's Peanut Chocolate Chewie cookies. The product was packaged in either heat-sealed cello bags, 5 cookies per bag, or in transparent plastic boxes containing 20-25 loose cookies. The products do not have a UPC or lot codes. Recall # F-0088-2010
CODE
None 
RECALLING FIRM/MANUFACTURER
Chocolate Chewies, Eugene, OR, by telephone on March 4, 2009 and by press release on March 12, 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
Unknown
DISTRIBUTION
OR, CT, NY, FL
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PRODUCT 
1) Bulk Peanuts. Peanuts and bulk ground peanut butter made from Conventional Split Peanuts Dry-Roasted (non-salted) sold in Bulk Foods section. Recall # F-0089-2010;

2) Organic Split Peanuts and Peanut Butter from Dry-Roasted (non-salted) peanuts sold in Bulk Foods section. Recall # F-0090-2010
CODE
1) Bulk Bin # 2201;
2) Bulk Bin # 2200
RECALLING FIRM/MANUFACTURER
Community Food Co. Op. Inc., Bellingham, WA, by press release on March 6, 2009. Firm initiated recall is complete.  
REASON
The products were manufactured using peanut product recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
6,810 lb containers
DISTRIBUTION
WA
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PRODUCT 
Milk Chocolate with Peanut Butter Candy, packaged as .5 oz, 2 oz, 2.25 oz, 2.55 oz, 3.5 oz, and 6 oz. bars and novelty shapes and further packaged as 40 ct, 48 ct, 24 ct, and 192 ct cartons under the following labels: Mr. Chocolate, Old Fashion Candy Company, The Kidz Kompany, 4-H Fundraising, Wilson Candies, Penhurst Candy Co., Taufelen Candy Co., Fortune Fundraising, Heart and Soul Candies, S & S Candies, The Candy Lady, The Foreign Candy Co., and Dazzling Delicacies. Brand Item: a) Mr. Chocolate, Milk Chocolate with Peanut Butter Bar; b) Old Fashion Candy Company, Milk Chocolate with Peanut Butter Bar; c) Mr. Chocolate: Peanut Butter Paws; d) The Kidz Kompany: Milk Chocolate with Peanut Butter Bar; e) The Kidz Kompany :Peanut Butter Paws; f) The Kidz Kompany: Peanut Butter Bears; g) 4-H Fundraising: Milk Chocolate with Peanut Butter Bar; g) Wilson Candies: Milk Chocolate with Peanut Butter Bar; h) Penhurst Candy Co.: Milk Chocolate with Peanut Butter Bar; i) Taufelen Candy Co.: Milk Chocolate with Peanut Butter Bar; j) Fortune Fundraising: Milk Chocolate with Peanut Butter Bar; l) Heart and Soul Candies: Peanut Butter Meltaway Hearts; m) S & S Candies: Overload King Size Peanut Butter Cups; n)The Candy Lady: Milk Chocolate with Peanut Butter Bar. Recall # F-0106-2010
CODE
a) Lots: 8044 and 8056; b) lots 7300 to 7365, 8001 to 8365 and 9001 to 9008; c) lot 8315;  d) lots 8033 to 8316; e) lot 8315 f) lot 8315; g) lots 8029,8014,8070,8071, and 8281;  h) lots 8028 to 8365; i) lots 7300 to 7365, 8001 to 8365, and 9001 to 9008 j) lots 7300 to 7365, and 8001 to 8365; k) lots 8200 to 8303; l) lots 7300 to 7365, and 8001 to 8325; m) lots 7304 to 7365, and 8001 to 8319; n) lots 8056, 8059, and 8071
RECALLING FIRM/MANUFACTURER
The Annapolis Chocolate Co. Inc., Hanover, MD, by letter on January 16-19, 2009 and press release on February 13, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
321.462 pieces
DISTRIBUTION
Nationwide
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PRODUCT 
1) Premium Orchard Rainbow Trail Mix packaged and labeled into two different sizes: 28 oz and 6 oz. The two different size packages are labeled as the following: Premium Orchard Rainbow Trail Mix A Delicious Energy Source. Great for Snacking. a) Oven Roasted Peanuts & Cashews Net Wt 28 oz. (1.75 lb) 794g with UPC 7 67000 18916 5. Product is packaged in a stand up plastic zip lock style bag. b) Premium Orchard Rainbow Trail Mix Combinacion Rastro deArco Iris Dry Roasted Peanuts & Cashews Net Wt 6 oz. 170g with UPC 7 67000 18912 7. Product is packaged in a stand up plastic zip lock style bag. Recall # F-0107-2010;

2) Premium Orchard Fruit Nut Mix packaged and labeled into two different sizes: 28 oz and 6 oz. The two different size packages are labeled as the following: a) Premium Orchard Fruit Nut Mix A Delicious Energy Source. Great for Snacking. Net Wt. 28 oz. (794g) with UPC 7 67000 18706 2. Product is packaged in a stand up plastic zip lock style bag; 6 oz. UPC 767000-187024. b) Premium Orchard Fruit Nut Mix Combinacion de Fruta Seca y Nueces Net Wt. 6 oz. 170g with UPC 7 67000 18702 4. Product is packaged in a stand up plastic zip lock style bag. Recall # F-0108-2010;

3) Yogurt Trail Mix packaged and labeled under two brand names: Snack'rs and Premium Orchard. The two different brands and size packages are labeled as the following: a) Snack'rs Yogurt Trail Mix Net Wt 28 oz (1 lb 12 oz) 794 g with UPC 0 41512 01196 2. Product is packaged in a stand up plastic zip lock style bag. b) Premium Orchard Yogurt Trail Mix Combinacion Rastro de Yogur Net Wt. 24 oz. (1 lb 8 oz) 680g with UPC 7 67000 18806 9 and 6 oz. 170g with UPC 7 67000 18802 1. Product is packaged in a stand up plastic zip lock style bag. Recall # F-0109-2010;

4) Tropical Island Mix packaged and labeled into two different sizes: 28 oz and 6 oz. The two different size packages are labeled as the following: Premium Orchard Tropical Island Mix A Delicious Energy Source. Great for Snacking, Net Wt. 28 oz. (794g) with UPC 7 67000 18906 6. Product is packaged in a stand up plastic zip lock style bag. Premium Orchard Tropical Island Mix Combinacion Isla Tropical Net Wt. 6 oz. 170g with UPC 7 67000 18902 8. Product is packaged in a stand up plastic zip lock style bag. Recall # F-0110-2010;

5) Snack'rs Tropical Trail Mix NET WT 28 OZ (1 lb 12 oz) 794 g with UPC 0 41512 01198 6. Product is packaged in a stand up plastic zip lock style bag. Recall # F-0111-2010;

6) Snack'rs Trail Mix NET WT 26 oz (1 lb 10 oz) 737 g with UPC 0 41512 01197 9. Product is packaged in a stand up plastic zip lock style bag. Recall # F-0112-2010;

7) Snack'rs Mixed Nuts with Peanuts NET WT 28 oz (1 lb 12 oz) 794 g with UPC 04 512 01337 9. Product is packaged in a stand up plastic zip lock style bag. Recall # F-0113-2010
CODE
1) a) Lot codes: 2 to 343; b) Lot codes: 20 to 193;

2) a) Lot Codes: 7 to 200 and 315 to 359; b) Lot codes: 217 to 261;

3) a) Lot Codes: 4 to 261 and 343 to 364; b) Lot Codes: 217 to 261; c) Lot Codes 8 to 199 and 315 to 357;

4) Lot Codes: 18 to 200 and 315 to 364;

5) Lot Codes: 8 to 199 and 308 to 358;

6) Lot Codes: 7 to 253 and 323 to 358;

7) Lot Codes: 18 to 255 and 297 to 364
RECALLING FIRM/MANUFACTURER
Mixed Nuts Inc., Pacoima, CA, by e-mail on February 3, 2009 and press release on February 20, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approximately 521, 402 bags
DISTRIBUTION
CA, WI
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PRODUCT 
1) Milk Chocolate Peanut Clusters, 4 lb bulk box of individually enrobed peanut clusters, packed in single layers. Box labeled with the product name and Julian date on the end of the stock box. Recall # F-0114-2010;

2) Dark Chocolate Peanut Clusters, 4 lb bulk box of individually enrobed peanut clusters, packed in single layers. Box labeled with the product name and Julian date on the end of the stock box. Recall # F-0115-2010;

3) White Chocolate Peanut Clusters, 4 lb bulk box of individually enrobed peanut clusters, packed in single layers. Box labeled with the product name and Julian date on the end of the stock box. Recall # F-0116-2010;

4) Sugar Free Milk Chocolate Peanut Clusters, 4 lb and 2 lb bulk boxes of individually enrobed peanut clusters, packed in single layers. Boxes labeled with the product name and Julian date on the end of the stock box. Recall # F-0117-2010;

5) Sugar Free Dark Chocolate Peanut Clusters, 4 lb and 2 lb bulk boxes of individually enrobed peanut clusters, packed in single layers. Boxes labeled with the product name and Julian date on the end of the stock box. Recall # F-0118-2010;

6) Sugar Free White Chocolate Peanut Clusters, 4 lb and 2 lb bulk boxes of individually enrobed peanut clusters, packed in single layers. Boxes labeled with the product name and Julian date on the end of the stock box. Recall # F-0119-2010
CODE
Julian Dates: 07001-07365, 08001-08365 and 09001 - 09047
RECALLING FIRM/MANUFACTURER
The Candy Basket, Inc., Portland, OR, by telephone on March 4, 2009 and by letter on March 9, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
3,184 lbs
DISTRIBUTION
OR, WA
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PRODUCT 
1) Cajun Hot Mix (containing roasted peanuts), 20 lb bags, Item #5400222. Recall # F-0120-2010; 

2) Dynamite Mix, containing roasted peanuts, 10 lb bags (Item #5400610) and 20 lb bags, Item #5400622. Recall # F-0121-2010;

3) Oriental Party Mix (containing roasted peanuts), 20 lb bags, Item #5401325. Recall # F-0122-2010; 

4) Mardi Gras Mix (containing roasted peanuts), 12 lb bags, Item #561212 and 25 lb bags, item #5601225. Recall # F-0123-2010;

5) Tropical Mix (containing roasted peanuts), 25 lb bags (Item #5602025. Recall # F-0124-2010
CODE
No lot codes
RECALLING FIRM/MANUFACTURER
Atlanta Nut Co., Atlanta, GA, by fax on January 30, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
60 lbs
DISTRIBUTION
AL, GA, NC
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PRODUCT 
1) ZT Butter Sauce Mix, 8/5 lb bags per case, Item Code: FA897701 and F6982101, (Net Weight 40 lbs), McCormicks. Recall # F-0125-2010;

2) Z-TF White Sauce Base, 30 lb bag, FA866501, McCormicks. Item Code: 43193253/D58278. Recall # F-0126-2010
CODE
All codes manufactured June 4, 2007 through June 24, 2009.
RECALLING FIRM/MANUFACTURER
Recalling Firm: McCormick & Co., Inc., Hunt Valley, MD, by letter on/about June 25, 2009.
Manufacturer: McCormick & Co., Inc., Atlanta Dist Center. Atlanta, GA. Firm initiated recall is complete.
REASON
The products were manufactured using an ingredient recalled by Plainview Milk Products Cooperative because it has the potential to be contaminated with Salmonella
VOLUME OF PRODUCT IN COMMERCE
2,492,850 pounds
DISTRIBUTION
AL, CA, CO, FL, IL, MD, NY, OH, OR and TX
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PRODUCT 
1) Instant Milk Protein Isolate "Instant MPI" Product Code: 100375, Net Wt. 20.00 kg (44.092 lbs). Made in USA. Recall # F-0127-2010;

2) Instant Milk Protein Concentrate 80%, Product Code 100955, New Wt: 20kg (44.092 lbs). Made in USA. Recall # F-0128-2010;

3) Instant Whey Protein Concentrate 80%, Product Code: 100283, New Wt. 20.00 kg (44.092 lbs). Made in USA. Recall # F-0129-2010;

4) Instant Calcium Caseinate, Product Code 100771; Net Wt. 20 kg (44.092 LBS) Made in USA. Recall # F-0130-2010
CODE
1) Lot #'s ML9014A and ML9086A;
2) Lot # ML9100A;
3) Lot #’s ML9029A, ML9084A, ML9085A;
4) Lot # ML9099A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Milk Specialties Global, Carpentersville, IL, by telephone on June 25, 2009 and by letter on June 26, 2009.
Manufacturer: Plainview Milk Products Cooperative, Plainview, MN. Firm initiated recall is ongoing.
REASON
Since the products were agglomerated at Plainview Milk Products Cooperative, they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
161,707 lbs
DISTRIBUTION
CA, IL, MI, MN, MO, NY, PA
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PRODUCT 
Muranaka Farm, Inc. Fresh Bunched Parsley, 60 count. The bunches were banded using a red rubber band. Recall # F-0145-2010
CODE
Lot number: 0023909
RECALLING FIRM/MANUFACTURER
Muranaka Farm, Inc., Moorpark, CA, by letter on September 13, 2009. Firm initiated recall is ongoing.
REASON
Product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,005 cases/60 bundles in each case
DISTRIBUTION
AZ, CA, CO, FL, IA, IL, MO, TN, TX, WI
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PRODUCT 
1) Marin Brand Carob Energee Nuggets (10# UPC 0-74672-63513-6) and (7 oz UPC 0-74672-00092-7); Sunridge Farms Energy Nuggets. Frist 5 ingredients on label reads: "Honey, Sunflower Seeds, Carob Powder, Peanuts, Sesame Seeds". Snack Naturally (Whole Foods) Carob Energee Nuggets. First 5 ingredients on label read: "Honey, sunflower seeds, carob powder, peanuts, sesame seeds". Recall # F-0609-2010;

2) Dancing Star Chunks of Energy Carob Spirulina (10# UPC 7-69270-10001-7). First 5 ingredients on label read: "Sunflower seeds, honey, carob powder, sesame seeds, nutty rice cereal". Recall # F-0610-2010;

3) Sunridge Farms Candy Tropical Golden Nuggets. First 5 ingredients on label read: "Honey, tofu powder, sunflower seeds, peanuts, sesame seeds". Recall # F-0611-2010;

4) School Kine Cookies Peanut Butter Nibbles (9 oz UPC 0-34859-12007-7). First 3 ingredients on label read: "ENRICHED FLOUR..., BUTTER, SUGAR". Recall # F-0612-2010;

5) Marin Brand Cajun Snack Mix (12# UPC 0-74672-66624-6). First 5 ingredients on label reads: "Peanuts, sesame sticks..., chili bits..., spicy peanuts..., and pretzels". F-0613-2010;

6) Marin Brand Hong Kong Mix (10# UPC 0-74672-21502-4). First 5 ingredients on label read: "Sesame sticks..., Chinese noodles..., rice cracker mix...peanuts".  Recall # F-0614-2010;

7) Fred Meyer Happiness Oriental Mix (10# UPC 0-74672-66677-2). First 3 ingredients on label reads: "Sesame sticks..., chinese noodles..., rice cracker mix...peanuts...green peas". Recall # F-0615-2010;

8) Dancing Star Mixed Berry Blast Chunks of Energy (10# UPC 7-69270-10052-4). First 6 ingredients on label read: "Honey, sunflower seeds, peanuts, sesame seeds, GMO free tofu powder..., raisins". Recall # F-0616-2010;

9) Our Kitchen Just for You Trail Mix (12/11 oz UPC 8-26553-30515-3), First 5 ingredients on label reads: "Sunflower seeds, pumpkin seeds, peanuts..., raisins, papaya chunks". Recall # F-0617-2010;

10) Snack Naturally (Whole Foods) Honey Roasted Peanuts, (12/14 oz UPC 9-99482-00021-2). First 4 ingredients of label read: " Peanuts, sugar, honey, salt". Recall # F-0618-2010;

11) Snack Naturally (Whole Foods) Mojave Mix, (12/12 oz UPC 9-99482-00061-8). First 5 ingredients on label read: "...sesame sticks..., tamari almonds..., chili bits..., chili pepper". Recall # F-0619-2010;

12) Snack Naturally (Whole Foods) Goji Snack Mix (12/14 oz UPC 9-99482-00060-1). First 3 ingredients on label read: "Raisins, peanuts, yogurt raisins...". Recall # F-0620-2010;

13) Snack Naturally (Whole Foods) Politically Incorrect Mix (12.10 oz UPC 9-99482-00062-5). First 3 ingredients on label read: "Unbleached flour, sesame seeds, bulgur". Recall # F-0621-2010;

14) Snack Naturally (Whole Foods) Nutty Delight Mix (12/16 oz UPC 9-99482-00059-5). First 2 ingredients on label read: "Sundrops..., pure natural vanilla". Recall # F-0622-2010;

15) Snack Naturally (Whole Foods) On the Trail Mix, (12/14 oz UPC 9-99482-00013-7). First 3 ingredients on label reads: "Raisins, peanuts..., tamari almonds...".  Recall # F-0623-2010;

16) Marin brand Tofu Energee Nugget (10# UPC 0-74672-63426-9) and (7 oz UPC 0-74672-00099-6). First 5 ingredients on label reads: "Sunflower Seeds, Honey, Tofu Powder, Peanuts, Sesame Seeds". Recall # F-0624-2010;

17) Marin brand Cranberry Energee Nuggets (10# UPC 0-74672-63450-4) and (7 oz UPC 0-74672-00097-2). Frist 4 ingredients on label reads: "Dried Cranberries, Honey, Tofu Powder, Sunflower Seeds, Peanuts". Recall # F-0625-2010;

18) Marin brand Chocolate Energee Nuggets (10# UPC 0-74672-63430-6). Frist 5 ingredients on label reads: "Honey, sunflower seeds, peanuts, tofu powder..., sesame seeds". Recall # F-0626-2010;

19) Dancing Star High Country GORP Chunks of Energy (10# UPC 7-69270-10011-6). First 5 ingredients on label read: "Peanuts, honey, sunflower seeds, sunspire sundrops". Recall # F-0627-2010;

20) Marin brand Apple Energee Nuggets (10# UPC 0-74672-6514-3) and (7 oz UPC 0-74672-00092-7). First 6 ingredients on label read: "Sunflower seeds, honey, tofu powder, peanuts, sesame seeds, dried apples". Recall # F-0628-2010;

21) Sunridge Farms Chocolate Nuggets. First 5 ingredients on label read: "Honey, tofu powder, sunflower seeds, raisins, brown rice cereal". Recall # F-0629-2010;

22) Snack Naturally (Whole Foods) Spicy Cajun Mix (12/10 oz UPC 9-99482-00014-4), Our Kitchen Cajun Mix (12/10 oz UPC 8-26553-30516-0). First 5 ingredients on labels reads: "Peanuts, sesame sticks..., chili bits..., pretzels, cajun spice blend". Recall # F-0630-2010;

23) Fred Meyer Cajun Mix (10# UPC 0-74672-66650-5). First 6 ingredients on label reads: "Peanuts, sesame sticks..., chili bits..., chili pepper, spicy peanuts..., pumpkin seeds". Recall # F-0631-2010;

24) Our Kitchen Classic Trail Mix (12/11 oz UPC 8-26553-30522-1). First 3 ingredients on label read: "M&Ms, raisins, peanuts". Recall # F-0632-2010;

25) Dancing Star Chunks of Energy Organic Wild Cranberry with Apricot (10# UPC 7-69270-20011-3). First 3 ingredients on label read: "Organic honey, organic sunflower seeds". Recall # F-0633-2010
CODE
1) Marin lots (0017 through 3657), (0018 through 2248) and (2258, 2318, 2358, 2408, 2468, 2498, 2558, 2668, 2838, 2878, 2888, 2908, 2968, 2978, 2988, 3048, 3058, 3088, 3098, 3128, 3268, 3298, 3308, 3378, 3388, 3408, 3438, 3578, 3588, 3658, 0069, 0099). Sunridge lots (2468, 2708, 2748, 2948, 3098, 3108, 3388, 3398), (all lots 0017 through 3657) and all lots 0018 through 2458. Snack Naturally, Sell by (12-28-08, 1-12-09, 1-17-09, 1-26-09, 2-24-09, 3-14-09, 4-5-09, 4-12-09). Any sell by prior to 12-28-08;

2) Lots (2268, 2278, 2288, 2318, 2358, 2388, 2398, 2408, 2468, 2468, 2488, 2498, 2558, 2568, 2618, 2668, 2678, 2708, 2758, 2768, 2778, 2838, 2848, 2878, 2918, 2958, 2988, 3058, 3088, 3108, 3118, 3178, 3198, 3268, 3298, 3318, 3378, 3398, 3408, 3508, 3538, 3548, 3578, 3588, 3668, 0069, 0099, 0129), (all lots 0017 through 3657) and (all lots 0018 through 2258).

3) Sunridge lots (2468, 2708, 2748, 2948, 3098, 3108, 3388, 3398), (all lots 0017 through 3657), (all lots 0018 through 2458);

4) Sell by (3-22-09, 4-3-09, 4-16-09, 4-30-09, 5-15-09, 5-28-09, 6-13-09, 7-11-09, 7-15-09). Any sell by prior to 3-22-09;

5) Marin Brand lots (3188, 3178, 3168, 3038). All lots (0017 through 3657) and all lots (0018 through 2208);

6) Lots (3518, 3038). All lots (0017 through 3657) and all lots (0018 through 2208);

7) Fred Meyer lots (3098, 3368, 2898, and 2958). All lots (0017 through 3657) and all lots (0018 through 1978);

8) Lots (3268, 3238, 3198, 2558, 2488, 2468). All lots (0018 through 2208), and all lots (0017 through 3657);

9) Enjoy by dates 5/7/09 and any prior to 12/20/08;

10) Sell by dates (4/23/09, 2/28/08, 2/21/09, 2/1/09, 1/24/09, 1/10/09, 1/3/09, 12/17/09, 12/12/09), and any prior to 12/17/09;

11) Sell by dates (5/12/09, 4/14/09) and any from 1-1-07 through 12/31/08;

12) Sell by dates (4/12/09, 4/5/09) and any from 1-1-07 through 12-31-08;

13) Sell by dates (5/12/09, 4/7/09) and any from 1-1-07 through 12-31-08;

14) Sell by dates (3/14/09, 3/7/09) and any from 1-1-07 through 11-30-08;

15) Sell by dates (5/12/09, 4/14/09) and any from 1-1-07 through 12/31/08);

16) 16) Lots (0017 through 3657), (0018 through 2248), (2258, 2318, 2358, 2408, 2468, 2498, 2558, 2668, 2838, 2878, 2888, 2908, 2968, 2978, 2988, 3048, 3058, 3088, 3098, 3128, 3268, 3298, 3308, 3378, 3388, 3408, 3438, 3578, 3588, 3658, 0069, 0099);

17) Lots (0017 through 3657), (0018 through 2248), (2258, 2318, 2358, 2408, 2468, 2498, 2558, 2668, 2838, 2878, 2888, 2908, 2968, 2978, 2988, 3048, 3058, 3088, 3098, 3128, 3268, 3298, 3308, 3378, 3388, 3408, 3438, 3578, 3588, 3658, 0069, 0099);

18) Lots (0017 through 3657), (0018 through 2248), (2258, 2318, 2358, 2408, 2468, 2498, 2558, 2668, 2838, 2878, 2888, 2908, 2968, 2978, 2988, 3048, 3058, 3088, 3098, 3128, 3268, 3298, 3308, 3378, 3388, 3408, 3438, 3578, 3588, 3658, 0069, 0099);

19) Lots (2268, 2278, 2288, 2318, 2358, 2388, 2398, 2408, 2468, 2468, 2488, 2498, 2558, 2568, 2618, 2668, 2678, 2708, 2758, 2768, 2778, 2838, 2848, 2878, 2918, 2958, 2988, 3058, 3088, 3108, 3118, 3178, 3198, 3268, 3298, 3318, 3378, 3398, 3408, 3508, 3538, 3548, 3578, 3588, 3668, 0069, 0099, 0129), (all lots 0017 through 3657) and all lots 0018 through 2258;

20) Lots (0017 through 3657), (0018 through 2248), (2258, 2318, 2358, 2408, 2468, 2498, 2558, 2668, 2838, 2878, 2888, 2908, 2968, 2978, 2988, 3048, 3058, 3088, 3098, 3128, 3268, 3298, 3308, 3378, 3388, 3408, 3438, 3578, 3588, 3658, 0069, 0099);

21) Lots (2468, 2708, 2748, 2948, 3098, 3108, 3388, 3398), (all lots 0017 through 3657), (all lots 0018 through 2458);

22) Our Kitchen Enjoy by dates: 5/28/09, 5/14/09, 4/24/09 and any prior to 12/20/08. Whole Foods sell by dates (5/12/09) and any from 11-1-07 through 12-31-08;

23) All lots (0017 through 3657) and all lots (0018 through 1978);

24) Enjoy by dates: 6/19/09 and 5/14/09 and any Enjoy by dates prior to 12/20/08;

25) Lots (3518, 3188, 2918). All lots (0017 through 3657), and all lots (0018 through 2208)
RECALLING FIRM/MANUFACTURER
Marin Food Specialties, Inc., by press release on January 23, 2009 and February 3, 2009 and by telephone and e-mail 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
77,820.3 cases
DISTRIBUTION
CA, CO, HI, MA, TN, TX

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I

___________________________________
PRODUCT 
Stamina Rx, Maximum Sexual Stimulant, Dietary Supplement, 550 mg proprietary blend herbal ingredients, sold in 10, 30 and 40 tablet bottles and in 2 and 6 tablet blister packs. Recall # D-055-2010
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Hi Tech Pharmaceuticals, Norcross, GA, by press release on June 12, 2009 and by letter on/about July 16, 2009. Firm initiated recall is ongoing.
REASON
Unapproved new drug; product contains benzamidenafil.
VOLUME OF PRODUCT IN COMMERCE
18 million tablets
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

Abraxis expanded their recall of Abraxane Injectable that was posted in November 4, 2009 Enforcement Report.  Below are the additional lots that are included in this recall. 

Abraxane recall lot expansion:
PRODUCT 
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), 100 mg Single Use Vial, For IV Use only, Sterile lyophilized Suspension, Rx Only, NDC 68817-134-50 --- Australian label: Abraxane 100 mg Nanoparticle albumin-bound paclitaxel powder for injection (suspension) For Intravenous Use Only, PRESCRIPTION ONLY MEDICINE --- Each vial contains: paclitaxel 100 mg, Human Albumin 900 mg --- Abraxis BioScience LLC Distributed in Australia. Recall # D-028-2010
CODE
Lots 406580 (exp. 6/30/2010), 407545 (exp. 6/30/2010), 406427 (exp 9/30/2010), 406453 (exp. (9/30/2010), 406617 (exp. 10/31/2010), 407150 (exp. 2/28/2011). Product Code 103450 and AU103450 (Australia)
This recall has been expanded to include the following lots, but is NOT a new recall and distribution now also includes the European Union:
Product Code 103450 - lots: 404941(exp. 11/30/2009), 404987 (exp. 11/30/2009), 405138 (exp. 12/31/2009), 405265 (exp. 2/28/2010), 405301 (exp. 1/31/2010), 405307 (exp. 1/31/2010), 405385 (exp. 2/28/2010), 405479 (exp. 3/31/2010), 405512 (exp. 3/31/2010), 405548 (exp. 3/31/2010), 405575(exp. 3/31/2010), 406143 (exp. 7/31/2010), 406177 (exp. 7/31/2010),  406178 (exp. 7/31/2010), 406271 (exp. 8/31/2010), 406315 (exp. 8/31/2010), 406355 (exp. 8/31/2010), 406392 (exp. 8/31/2010);  Product Code E103450*  - lot XL18A1/405693* (exp. 12/31/2009*): Product Code UK103450* - lot 405693A* (exp. 12/31/2009*); Product Code GM103450* - lot 405693B* (exp. 12/31/2009*).  [NOTE: * Lot 405693 was distributed clinically in Germany as Lot XL18A1.  Lot 405693A was distributed commercially in the United Kingdom.  Lot 405693B was distributed commercially in Germany.] 
___________________________________
PRODUCT 
1) Senna-Time Micro-Coated Clear Tablets, Sennosides 8.6mg, NDC 63739-431-10, packed in 100 and 750 tablet blister pack, unit dose containers. Recall # D-048-2010;

2) Senna-Time S Film Coated Orange Tablets, Natural Vegetable Laxative Plus Softener, NDC 63739-432-10, packed in 100 and 750 tablet blister pack, unit dose containers. Recall # D-049-2010
CODE
1) Lot numbers: 57536, 56922, 54816, 51962, 46183, 48214 and 51943;
2) Lot numbers: 46182, 55485, 57950, 54082, 58319, 59996 and 48196
RECALLING FIRM/MANUFACTURER
Recalling Firm: McKesson Packaging Services, Concord, NC, by letter on/about April 20, 2009.
Manufacturer: Time-Cap Laboratories, Inc., Farmingdale, NY. Firm initiated recall is ongoing.
REASON
Product may contain undeclared anhydrous lactose and tartaric acid.
VOLUME OF PRODUCT IN COMMERCE
63,680 boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Motrin IB/Ibuprofen Tablets, 200 mg/650 mg, 8 count Coated Caplets, NDC 50580-110-68. Recall # D-050-2010
CODE
Lot numbers: SHC003, SHC004
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Products, Co., Fort Washington, PA, by visit beginning November 8, 2009.
Manufacturer: McNeil Consumer and Specialty Pharmaceuticals, Las Piedras, PR. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Specifications; 3 month stability test interval.
VOLUME OF PRODUCT IN COMMERCE
88,104 tablets
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Phentermine Hydrochloride, USP, 37.5 mg, 100 count bottle, Rx only, NDC 0603-5192-21. Recall # D-054-2010  
CODE
Lot No. T058E09A, expiration date May 2012
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, by letter on October 1, 2009. Firm initiated recall is ongoing.
REASON
Super Potent Single Ingredient Drug Product: The manufacturer received a product complaint of large tablet thickness for 2 tablets. The manufacturer's investigation determined that tablets contained 136.1% more active ingredient than as specified on product label.
VOLUME OF PRODUCT IN COMMERCE
28,309 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Allopurinol Tablets USP, 300 mg, 1000-count bottle, Rx only, NDC 60505-2517-03. Recall # D-057-2010;  

2) Amlodipine Besylate Tablets, 10 mg, 1000-count bottle, Rx only, NDC 60505-0195-03. Recall # D-058-2010;

3) Benazepril Hydrochloride Tablets, 10 mg, 100-count bottle (NDC 60505-0266-01), 500-count bottle (NDC 60505-0266-05), Rx only. Recall # D-059-2010;

4) Benazepril Hydrochloride Tablets, 20 mg, 100-count bottle (NDC 60505-0267-01), 500-count bottle (NDC 60505-0267-05), Rx only. Recall # D-060-2010;

5) Benazepril Hydrochloride Tablets, 40 mg, 100-count bottle (NDC 60505-0268-01), 500-count bottle (NDC 60505-0268-05), Rx only. Recall # D-061-2010;

6) BuPROPion Hydrochloride Tablets USP, 100 mg, 500-count bottle, Rx only, NDC 60505-0157-05. Recall # D-062-2010;

7) BuPROPion Hydrochloride Tablets USP, 75 mg, 90-count bottle (NDC 60505-0158-09), 500-count bottle (NDC 60505-0158-05), Rx only. Recall # D-063-2010;

8) Carvedilol Tablets, 12.5 mg, 100-count bottle (NDC 60505-2608-01), 1000-count bottle (NDC 60505-2608-08), Rx only. Recall # D-064-2010;

9) Carvedilol Tablets, 25 mg, 100-count bottle (NDC 60505-2609-01), 1000-count bottle (NDC 60505-2609-08), Rx only. Recall # D-065-2010;

10) Carvedilol Tablets, 3.125 mg, 100-count bottle (NDC 60505-2606-01), 1000-count bottle (NDC 60505-2606-08), Rx only. Recall # D-066-2010;  

11) Carvedilol Tablets, 6.25 mg, 100-count bottle (NDC 60505-2607-01), 1000-count bottle (NDC 60505-2607-08), Rx only. Recall # D-067-2010;

12) Cefprozil Tablets USP, 250 mg, 100-count bottle, Rx only, NDC 60505-2532-01. Recall # D-068-2010;

13) Cefprozil Tablets USP, 500 mg, 50-count (NDC 60505-2533-05), 100-count (NDC 60505-2533-01), Rx only. Recall # D-069-2010;

14) Cimetidine Tablets USP, 200 mg, 2 kg bottle, OTC, THIS CONTAINER IS FOR REPACKAGE ONLY, NDC 60505-0149-00. Recall # D-070-2010;

15) Cimetidine Tablets USP, 400 mg, 500-count bottle, Rx only, NDC 60505-0020-08. Recall # D-071-2010;

16) Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, NDC 60505-1309-01.
Recall # D-072-2010;

17) Citalopram HBr Tablets, 40 mg, 100-count bottle, Rx only, NDC 60505-2520-01.
Recall # D-073-2010;

18) Clonazepam Tablets USP, 0.5 mg, 100-count (NDC 60505-0066-01), 500-count bottle (NDC 60505-0066-03), Rx only. Recall # D-074-2010;

19) Clonazepam Tablets USP, 1 mg, 100-count bottle (NDC 60505-0067-01), 500-count (NDC 60505-0067-03), Rx only. Recall # D-075-2010;

20) Clonazepam Tablets USP, 2 mg, 100-count bottles (NDC 60505-0068-01), 500-count bottles (NDC 60505-0068-03), Rx only.  Recall # D-076-2010;

21) CycloSPORINE Capsules USP, 100 mg, 30-count bottle, Rx only, NDC 60505-0134-00. Recall # D-077-2010;

22) CycloSPORINE Capsules USP, 25 mg, 30-count bottles, Rx only, NDC 60505-0133-00. Recall # D-078-2010;

23) Diclofenac Potassium Tablets, 50 mg, 100-count bottle, Rx only, NDC 60505-0135-00. Recall # D-079-2010;

24) DILT-CD (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 120 mg, 90-count bottle (NDC 60505-0007-04), 500-count bottle (NDC 60505-0007-08), Rx only. Recall # D-080-2010;

25) DILT-CD (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 180 mg, 90-count bottle (NDC 60505-0008-04), 500-count bottle (NDC 60505-0008-08), Rx only. Recall # D-081-2010;

26) DILT-CD (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 240 mg, 90-count bottle (NDC 60505-0009-04), 500-count bottle (NDC 60505-0009-08), Rx only. Recall # D-082-2010;

27) DILT-CD (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 300 mg, 90-count bottle (NDC 60505-0010-04), 500-count (NDC 60505-0010-08), Rx only. Recall # D-083-2010;

28) DILTZAC (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 120 mg, 30-count bottle (NDC 60505-0210-03), 90-count bottle (NDC 60505-0210-09), Rx only, Recall # D-084-2010;

29) DILTZAC (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 180 mg, 30-count bottle (NDC 60505-0211-03), 90-count bottle (NDC 60505-0211-09), Rx only, Recall # D-085-2010;

30) DILTZAC (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 240 mg, 90-count bottle, Rx only, NDC 60505-0212-09. Recall # D-086-2010;

31) DILTZAC (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 300 mg, 30-count bottles (NDC 60505-0213-03), 90-count bottles (NDC 60505-0213-09), Rx only. Recall # D-087-2010;

32) DILTZAC (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 360 mg, 30-count bottle (NDC 60505-0214-03), 90-count bottle (NDC 60505-0214-09), Rx only. Recall # D-088-2010;

33) Divalproex Sodium Delayed-Release Tablets USP, 500 mg, 100-count bottle (NDC 60505-3067-01), 500-count bottle (NDC 60505-3067-05), Rx only. Recall # D-089-2010;

34) Eplerenone Tablets, 25 mg, 30-count bottle (NDC 60505-2651-03), 90-count bottle (NDC 60505-2651-09), Rx only. Recall # D-090-2010;

35) Eplerenone Tablets, 50 mg, 30-count bottle (NDC 60505-2652-03), 90-count bottle (NDC 60505-2652-09), Rx only. Recall # D-091-2010;

36) Etodolac Tablets USP, 500 mg, 100-count bottle, Rx only, NDC 60505-0102-01. Recall # D-092-2010;

37) Fosinopril Na Tablets, 20 mg, 90-count bottle (NDC 60505-2511-02), 1000-count bottle (NDC 60505-2511-04), Rx only. Recall # D-093-2010;

38) Fosinopril Na Tablets, 40 mg, 1000-count bottle, Rx only, NDC 60505-2512-08. Recall # D-094-2010;

39) Gabapentin Capsules, 300 mg, 3500-count bottle, Rx only, NDC 60505-0113-07. Recall # D-095-2010;

40) Gabapentin Tablets, 600 mg, 500-count bottle, Rx only, NDC 60505-2551-05. Recall # D-096-2010;

41) Gabapentin Tablets, 800 mg, 500-count bottle, Rx only, NDC 60505-2552-05. Recall # D-097-2010;

42) Gemfibrozil Tablets USP, 600 mg, 60-count bottle (NDC 60505-0034-04), 100-count bottle (60505-0034-01), 100-count box (10 x 10 Unit dose) (NDC 60505-0034-00), 180-count bottle (GSMS, Inc.) (NDC 60429-0081-18), 2500-count bottle (NDC 60505-0034-06), 500-count bottle (60505-0034-08), Rx only.  Recall # D-098-2010;

43) Lithium Carbonate Capsules USP, 300 mg, 100-count bottle (NDC 60505-2504-01), 100-count box (10 x 10 Unit dose) (NDC 60505-2504-03), 1000-count bottle (NDC 60505-2504-02), Rx only. Recall # D-099-2010;

44) Meloxicam Tablets, 7.5 mg, 100-count bottle, Rx only, NDC 60505-2553-01. Recall # D-100-2010;

45) Metformin Hydrochloride Tablets, 1000 mg, 100-count bottle (NDC 60505-0192-00), 500-count bottle (NDC 60505-0192-01), 1000-count bottle (NDC 60505-0192-08), 2000-count bottle (NDC 60505-0192-04), Rx only. Recall # D-101-2010;

46) Metformin Hydrochloride Tablets, 500 mg, 100-count bottle (NDC 60505-0190-00), 100-count bottle (BRITESTOCK) (NDC 7713-1316-963), 500-count bottle (NDC 60505-0190-01), 1000-count bottle (NDC 60505-0190-08), 4500-count bottle (NDC 60505-0190-04), Rx only. Recall # D-102-2010;

47) Metformin Hydrochloride Tablets, 850 mg, 100-count bottle (NDC 60505-0191-00), 500-count bottle (NDC 60505-0191-01), 2500-count bottle (NDC 60505-0191-04), Rx only. Recall # D-103-2010;

48) Metformin Hydrochloride Extended-Release Tablets, 500 mg, 100-tablet bottle (NDC 60505-0260-01), 500-count bottle (NDC 60505-0260-02), 2500-count bottle (NDC 60505-0260-07), Rx only. Recall # D-104-2010;

49) Omeprazole Delayed-Release Capsules USP, 20 mg, 30-count bottle (NDC 60505-0065-00), 100-count box (10 x 10 unit dose) (NDC 60505-0065-07), 1000-count bottle (NDC 60505-0065-01), 5000-count bottle (NDC 60505-0065-08), Rx only. Recall # D-105-2010;

50) Omeprazole Delayed-Release Capsules USP, 40 mg, 30-count bottle, Rx only, NDC 60505-0146-00. Recall # D-106-2010;

51) Oxaprozin Tablets USP, 600 mg, 500-count bottle, Rx only, NDC 60505-0176-01. Recall # D-107-2010;

52) Oxcarbazepine Tablets, 150 mg, 100-count bottle (NDC 60505-2534-01), 100-count box (10 x 10 unit dose) (NDC 60505-2534-00), 500-count bottle (NDC 60505-2534-05). Recall # D-108-2010;

53) Paroxetine Tablets USP, 10 mg, 30-count bottle (NDC 60505-0097-01), 100-count bottle (NDC 60505-0097-02), 1000-count bottle (NDC 60505-0097-04), Rx only. Recall # D-109-2010;

54) Paroxetine Tablets USP, 20 mg, 30-count bottle, Rx only, NDC 60505-0083-01. Recall # D-110-2010;

55) Paroxetine Tablets USP, 30 mg, 30-count bottle, Rx only, NDC 60505-0084-01. Recall # D-111-2010;

56) Paroxetine Tablets USP, 40 mg, 30-count bottle (NDC 60505-0101-01), 100-count bottle (NDC 60505-0101-02), 1000-count bottle (NDC 60505-0101-04), Rx only. Recall # D-112-2010;

57) Quinapril Tablets USP, 10 mg, 90-count bottle (NDC 60505-0173-00), 1000-count bottle (NDC 60505-0173-01), Rx only. Recall # D-113-2010;

58) Quinapril Tablets USP, 20 mg, 90-count bottle (NDC 60505-0174-00), 1000-count bottle (NDC 60505-0174-01), Rx only. Recall # D-114-2010;

59) Quinapril Tablets USP, 40 mg, 90-count bottle (NDC 60505-0175-00), 1000-count bottle (NDC 60505-0175-01), Rx only. Recall # D-115-2010;

60) Quinapril Tablets USP, 5 mg, 90-count bottle, Rx only, NDC 60505-0172-00. Recall # D-116-2010;

61) Ranitidine Tablets USP, 150 mg, 60-count bottle (NDC 60505-0025-04), 60-count bottle (GSMS, Inc.) (NDC 60429-0704-60), 100-count bottle (NDC 60505-0025-06), 180-count bottle (GSMS Inc.) (NDC 60429-0704-18), 500-count bottle (GSMS Inc.) (NDC 60429-0704-05), 500-count bottle (NDC 60505-0025-08), 10000-count bottle (GSMS Inc.) (NDC 60429-0704-00). Recall # D-117-2010;

62) Ranitidine Tablets USP, 300 mg, 30-count bottle (GSMS, Inc.) (NDC 60429-0705-30), 100-count bottle (NDC 60505-0026-03), 250-count bottle (GSMS, Inc.) (NDC 60429-0705-25), 250-count bottle (NDC 60505-0026-07). Recall # D-118-2010;

63) Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, 473 mL bottle, Rx only, NDC 60505-0351-01. Recall # D-119-2010;

64) Terbinafine Hydrochloride Tablets, 250 mg, 30-count bottle (NDC 60505-2572-03), 100-count bottle (NDC 60505-2572-01), Rx only. Recall # D-120-2010;

65) Topiramate Tablets, 200 mg, 60-count bottle, Rx only, NDC 60505-2763-06. Recall # D-121-2010;

66) Torsemide Tablets, 20 mg, 100-count bottle, Rx only, NDC 60505-0234-01. Recall # D-122-2010;

67) Tramadol Hydrochloride Tablets, 50 mg, 100-count bottle (NDC 60505-0171-01), 500-count bottle (NDC 60505-0171-02), 1000-count bottle (NDC 60505-0171-08), Rx only. Recall # D-123-2010;

68) Zolpidem Tartrate Tablets, 10 mg, 100-count bottle (NDC 60505-2605-01), 100-count box (10 x 10 Unit dose) (NDC 60505-2605-00), 1000-count bottle (NDC 60505-2605-08), Rx only. Recall # D-124-2010;

69) Zolpidem Tartrate Tablets, 5 mg, 100-count bottle (NDC 60505-2604-01), 1000-count bottle (NDC 60505-2604-08), Rx only. Recall # D-125-2010;

70) Etodolac Tablets USP, 400 mg, 100-count bottle, Rx only, NDC 60505-0041-01. Recall # D-126-2010;  

71) Oxcarbazepine Tablets, 600 mg, 100-count bottle (NDC 60505-2536-01), 100-count box (10 x 10 Unit dose) (NDC 60505-2536-00), 500-count bottle (NDC 60505-2536-05), Rx only. Recall # D-127-2010;

72) Cimetidine Tablets, 800 mg, 100-count bottle (NDC 60505-0021-03), 250-count bottle (NDC 60505-0020-07), Rx only. Recall # D-128-2010;

73) Cetirizine Hydrochloride Tablets, 10 mg, 100-count bottle, OTC, NDC 60505-2633-01. Recall # D-129-2010
CODE
1) Lot HR0069, Exp 01/10;

2) Lot HR2621, HP3312, Exp 11/09; Lot HV1015, Exp 03/10;

3) Lot JA5526, Lot JA5527, Exp 11/10;

4) Lot JA5536, JA5537, Exp 11/10; Lot JD1817, JD1819, Exp 01/11;

5) Lot JA5540, JA5542, JA5541, Exp 11/10; Lot JC2294, Exp 12/10;

6) Lot JA0966, Exp 05/10;

7) Lot JA0974, JA0968, Exp 05/10; Lot JC1965, Exp 06/10; Lot JC7388, Exp 07/10; Lot JD9958, Exp 10/10;

8) Lot HP0611, HP0612, Exp 11/09;

9) Lot HP0628, HP0630, HN1410, HP0631, HN1408, HN1406, Exp 10/09; Lot HP0629, Exp 11/09;

10) Lot HN1349, HN1351, Exp 10/09; Lot HT7439, Exp 02/10;

11) Lot HR0254, HP0602, HP0603, HP7608, Exp 11/09;

12) Lot HV0658, Exp 04/10; Lot HX4076, HX8122, Exp 07/10;

13) Lot HV0661, HV0663, HV0664, Exp 04/10;

14) Lot JA5149, JA5147, Exp 11/09;

15) Lot HT8899, Exp 03/10;

16) Lot HP9566, Exp 2/10; Lot HW5875, Exp 6/10; Lot HZ0890, HZ0896, HZ8033, JA0335, JA0336, JA0337, JA0338, JA0339, JA0341, JA0342, JA0347, JA0348, JA5588, JA5593, Exp 11/10; Lot HZ0889, JA0334, JA0344, JE3863, Exp 12/10;

17) Lot HW3043, Exp 05/10;

18) Lot HX5589, HX5587, Exp 06/10;

19) Lot HY6843, HW7772, HY6850, Exp 06/10; Lot JE7265, JE7287, Exp 04/11;

20) Lot HW7709, HX8337, HW7713, HX8338, Exp 06/10;

21) Lot HP9575, Exp 09/09; Lot JE8041, Exp 05/11;

22) Lot JE8043, Exp 05/11;

23) Lot HV3437, Exp 04/10; Lot HX3580, Exp 07/10;

24) Lot JA8607, Lot JA8603, Exp 09/10; Lot JD8735, JE0412, JD8734, JE0413, Exp 11/10;

25) Lot JA8598, JA8593, Exp 09/10;

26) Lot JA8586, Exp 09/10; Lot JD1487, Exp 10/10; Lot JC4543, Exp 11/10;

27) Lot JA8580, JA8577, Exp 10/10; Lot JD5693, Exp 12/10;

28) Lot JA8395, JA9103, JA9104, Exp 11/10;

29) Lot JC2074, JC2037, JC6029, Exp 11/10;

30) Lot JC7236, JC7237, Exp 11/10;

31) Lot JA8449, JC2092, JD2272, Exp 11/10;

32) Lot JC2085, JD1957, Exp 11/10; Lot JF3739, Exp 05/11;

33) Lot HN9548, HW7202, HW7203, HW7204, Exp 11/09; Lot HN9541, HN9549, Exp 12/09; Lot HN5227, HN9486, HN9495, HN9531, HN9536, HT6602, HT6605, Exp 01/10; Lot HV9738, HV9739, HZ0354, Exp 05/10; Lot HV9716, HV9718, HV9719, HV9721, HV9722, HV9723, HV9724, HV9731, HV9733, HV9734, HV9735, HV9736, HV9737, HV9720, HV9726, HV9727, HV9728, HV9729, HV9730, HV9740, HV9741, HV9742, HV9743, HV9744, HV9745, HV9746, HW7158, HW7163, HW7166, HW7168, HW7195, HW7197, Exp 06/10; Lot HZ4548, HZ4552, HT6604, HZ4549, JC2664, JC2665, Exp 10/10; Lot HZ4550, HZ4551, JD0026, JD0027, JD0028, JD0029, JD0030, JD0031, JD0032, JD0033, JD0034, JD0035, JD0036, JD0012, Exp 02/11; Lot JD6735, JD6736, JD6739, Exp 03/11; Lot JD6752, JD6753, JD6756, JD6757, JD6758, JD6759, JD6760, JE2006, JE2007, JE2008, JE2012, JE2013, JE2014, JD6737, JD6740, JE2015, JE2016, JE2017, JE2018, JE9815, JE9816, Exp 04/11;

34) Lot HT7013, HT7014, Exp 02/10; Lot JA1090, JA1091, Exp 11/10;

35) Lot HW0739, JA1741, JA1743, HW0738, JA1740, Exp 11/10;

36) Lot HN6979, Exp 12/09; Lot HW0830, Exp 04/10; Lot JA2056, Exp 11/10;

37) Lot HX7063, HX7062, Exp 07/10;

38)  Lot HX7104, Exp 07/10;

39) Lot HP3261, Exp 11/09; Lot JD5212, Exp 02/11;

40) Lot JE5764, Exp 09/10;

41) Lot JE7410, Exp 10/10;

42) Lot HM5301, HM5324, HM5329, HH7198, HH7199, HH7201, HH7202, HH7203, HJ1838, HJ1839, HK4525, HK4526, HK9383, HK9386, HK9387, HK9388, HM5280, HM5285, HM5295, Exp 09/09; Lot HJ1844, Exp 10/09; Lot HJ1843, HJ8194, HJ8195, HJ8196, HJ8197, HG5059, HG5060, Exp 11/09; Lot HT0980, HT1682, Exp 03/10; Lot JA2344, Exp 07/10; Lot JD4454, JC8491, JC8492, JC8493, JC8494, JD4436, JD4437, JD4438, JC8520, JC8521, JC8523, JC8524, JC8526, JC8527, JC8528, JC8532, Exp 02/11; Lot JD4439, Exp 03/11; Lot JF5346, Exp 05/11;

43) Lot HP8840, HP8834, HP8789, Exp 12/09; Lot HT3527, HT3533, HT3542, Exp 02/10; Lot HT3529, Exp 03/10;

44) Lot JD9477, JE2146, Exp 03/11;

45) Lot HM1984, HM1986, HM1990, HM1992, HM1994, HM1996, HM1999, HM2004, HM2006, HM2007, HM2009, HM2010, HM2011, HM2012, HM7290, HN2781, HN6305, HN6309, HP2811, HM1985, HM1987, HM1989, HM1991, HN2881, HM7301, HM7303, HM7304, HN2860, HN2868, Exp 09/09; Lot HM2018, HM2020, HN2889, HN2886, HN2862, HN2871, HN2872, HN2873, Exp 10/09; Lot HN2897, HP7399, HN7247, Exp 11/09; Lot HT2569, HT2571, HT2574, HT2576, HT2579, HT2582, HT2585, HT2588, HT2592, HT2601, HT9130, HT2508, HT2509, HT2510, HT2511, JC2151, HR7650, HT2498, HT2499, HT2500, HT2501, HT2503, Exp 03/10; Lot HT2597, HT9097, HT9098, HR0165, HT2495, HT2496, HT9075, HT2502, HT2504, HT2505, HT2507, HT9088, HT9091, Exp 04/10; Lot HX3277, HX3279, Exp 07/10; Lot HZ1372, HZ1373, Exp 09/10; Lot JC1147, Exp 11/10;

46) Lot HM2678, HM2679, HM2738, HM2739, HM2740, HM2744, HM8935, HL1700, HL6593, HM2596, HM2603, HM8908, HM2648, HM2661, HM8923, HL1685, HL6611, HL6612, HL6613, HL6614, HL6615, HM2600, HM2606, HM9135, Exp 09/09; Lot HN4931, HN4932, HN4933, HN8236, HN8241, HP4303, HM8911, HM8912, HM8914, HM8915, HM8916, HM8917, HN4906, HN4909, HM8925, HM8926, HM8927, HN4900, HN4902, HN4908, HN4913, HN8227, HN8229, HM9133, HM9136, HM9137, HM9140, HM9143, HM9146, HN4901, HN4903, HN4904, HN4905, HN4907, HN4911, HN4914, HT0236, Exp 10/09; Lot HN8242, HN8244, HP4272, HN4912, HN8200, HN8201, HN8202, HP4230, HP4231, HN8231, Exp 11/09; Lot HN8225, Exp 01/10; Lot HV1283, HV6382, HV1518, HV1519, Exp 04/10; Lot HX3200, Exp 06/10; Lot HZ8957, HZ8844, Exp 10/10, Lot JA3872, JA3873, JA3875, JA3877, Exp 11/10.

47) Lot HN2920, HN2921, HN2923, HM7299, Exp 09/09; Lot HN2922, HN2884, HN2885, HN2896, Exp 10/09;

48)  Lot HM9055, HM9089, HM9091, HM9094, HM9098, HM9101, HM9103, HM9104, HM9106, HM9109, HM9111, HL0403, HN0209, HN1729, HN1730, HN4834, HN4835, HN4836, HN4837, HN4838, Exp 09/09; Lot HM2310, HM2312, HN2714, HN2716, HN2719, HN5744, HN2738, HN2740, HN2742, HN2745, HN2764, HN2765, HN2768, HN2769, Exp 10/09; Lot HY0224, Exp 07/10; Lot HY8533, Exp 08/10; Lot JA7704, JC3169, JC3170, JC3171, JC3172, JC3173, JC3179, Exp 12/10; Lot JC9009, Exp 01/11;

49) Lot HZ8679, Exp 04/10; Lot HM9682, Exp 07/10; Lot HZ8683, HZ2532, HZ2537, HN4407, JF2233, Exp 08/10; Lot JE8761, Exp 12/10; Lot JE0778, Exp 02/11;

50) Lot JE1347, Exp 02/11;

51) Lot HZ9836, HZ9837, Exp 11/10;

52) Lot HP0785, HP0787, HP0788, Exp 10/09; Lot JD0237, JD0240, HD0242, Exp 02/11;

53) Lot HY6616, HY6617, HY6618, Exp 03/10;

54) Lot JE7419, 05/11;

55)  Lot JG0671, Exp 07/11;

56) Lot HY6631, Exp 09/10; Lot JE1950, JE5040, JE5041, JE5042, JE1712, Exp 04/11;

57) Lot HL2342, HV2631, Exp 09/09; Lot HX6621, Exp 01/10; Lot HY4713, Exp 02/10; Lot HX6623, Exp 07/10; Lot HY4714, Exp 08/10; Lot JD7363, Exp 09/10; Lot JD7362, Exp 03/11; 

58) Lot HN1767, Exp 09/09; Lot HR1725, HR1737, Exp 01/10; Lot HR5819, Exp 02/10; Lot HV2607, Exp 03/10; Lot HY4721, HY4722, Exp 08/10; Lot HZ9653, Exp 11/10; Lot JD7365, JE3899, Exp 03/11;

59) Lot HR1756, HR1758, Exp 01/10; Lot HR5838, Exp 02/10; Lot HV2570, Exp 03/10; Lot HX6618, HX6614, Exp 07/10; Lot HY4738, Exp 08/10; Lot HY4735, HY4743, Exp 09/10; Lot HZ9652, Exp 11/10; Lot JD7367, Exp 03/11;

60) Lot JA7369, Exp 11/09; Lot JD7357, Exp 03/10;

61) Lot HN1454, HN1457, Exp 11/09; Lot HN8607, HN8609, HP3260, HP8075, HP8076, HP8077, HP8078, HP8121, HP8122, HP8129, Exp 12/09; Lot HT1187, HT1188, HT1189, HT1190, HT1191, HT1192, Lot HT1196, HT1193, HT1194, HT1197, HT1198, HX5447, HT1199, Exp 02/10; Lot HW9319, Exp 04/10; Lot JC2357, JC2342, Exp 12/10;

62) Lot HM5292, Exp 10/09; Lot HP8185, HR7929, HP8182, HP8186, HP8187, HP8184, Exp 12/09; Lot HV3655, Exp 04/10; Lot HY9984, HY6727, HY9915, Exp 08/10;

63) Lot HT1457, Exp 09/09; Lot HV7807, Exp 11/09; Lot HW5805, HX0575, Exp 12/09; Lot HX7978, Exp 01/10; Lot HX7973, Exp 02/10; Lot HY7604, HY7606, HY7607, Exp 03/10; Lot HZ2508, HZ2510, Exp 04/10; Lot JA0934, JA0936, JA0938, Exp 05/10; Lot JC1560, JC1561, JC1562, JG1019, Exp 07/10; Lot JC7120, JC7121, JC7122, JD3690, Exp 08/10; Lot JD3692, JD9640, Exp 09/10; JD9641, JE6128, Exp 10/10; Lot JE6129, Exp 11/10;

64) Lot JA6687, Exp12/10; Lot JC8845, Exp 02/11;

65) Lot JE4290, Exp 04/11;

66) Lot HT4487, Exp 03/10;

67) Lot JA6764, HZ9217, HZ9219, JA6770, Exp 11/10; Lot JA6772, JC5493, Exp 12/10;

68) Lot HZ9127, Exp 10/10; Lot HZ9124, JA7690, JA7701, JA7746, Exp 11/10; Lot JD8931, JD8918, JD8922, JD8925, Exp 03/11;

69) Lot HZ9119, HZ9121, Exp 10/10;

70) Lot HM5165, HN7005, Exp 09/09; Lot HM0459, Exp 11/09; Lot HT4880, Exp 04/10;

71) Lot HP0802, Exp 09/09; Lot HT7555, HW3500, HW5764, HT7557, Exp 03/10; Lot JD0244, Exp 02/11;

72) Lot HX3598, HT8883, Exp 03/10;

73) Lot HY2910, HY2912, Exp 08/10; Lot JC7926, JD7894, Exp 02/11; Lot JE0940, JE6056, Exp 04/11
RECALLING FIRM/MANUFACTURER
Apotex Inc., Ontario, Canada, by letter on August 28, 2009. Firm initiated recall is ongoing.
REASON
CGMP Deviations: products manufactured in a facility with significant cGMP deficiencies.
VOLUME OF PRODUCT IN COMMERCE
4,578,203 bottles and boxes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
PREMPRO"(conjugated estrogens/medroxyprogesterone acetate tablets) 0.3 mg/1.5 mg, Rx only. One carton contains 3 EZ-DIAL Dispensers of 28 tablets each. NDC 0046-0938-09, One EZ-DIAL Dispenser contains 28 cream PREMPRO Tablets containing 0.3 mg of the conjugated estrogens found in PREMARIN & 1.5 mg of medroxyprogesterone acetate. Recall # D-029-2010
CODE
Lot C18404, exp. March 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Inc., Philadelphia, PA, by letters dated October 5, 2009.
Manufacturers: Wyeth Pharmaceuticals, Inc., Rouses Point, NY, and Wyeth Pharmaceuticals, Co., Guayama, PR. Firm initiated recall is ongoing.
REASON
Failed Dissolution Specification; 9-month test interval.
VOLUME OF PRODUCT IN COMMERCE
24,360 cartons of 3 dispensers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) YAZ (Drospirenone & Ethinyl Estradiol); Rx only; 3.0 mg drospirenone &0.02 mg ethinyl estradiol; 3 x 28 tablets- blister packages 24 active and 4 placebo, NDC 50419-405-03. Recall # D-046-2010;

2) Ocella (drospirenone and ethinyl estradiol tablets) 3 mg/0.3 mg, Rx only;This package contains one blister of 28 tablets: 21 yellow tablets, containing 3 mg of drospirenone and 0.3 mg of ethinyl estradiol; and seven white inert tablets', NDC 0555-9131-767. Recall # D-047-2010
CODE
1) Lot 91605A, Exp 12/2013;
2) Lot number 84080A, Exp 12/2011; lot number 84081A, Exp. 12.2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer HealthCare Pharmaceuticals, Inc., Wayne, NJ, by letters on November 6, 2009.
Manufacturer: Schering Gmbh Und Co. Produktio, Weimar, Germany. Firm initiated recall is ongoing.
REASON
CGMP Deviations:Out of Specification analytical value for chemical assays of drospirenone and ethinyl estradiol was averaged with another analytical value to provide a reported result that was within specification.
VOLUME OF PRODUCT IN COMMERCE
1) 32,856 boxes (3 blister packages/box);
2) 122,208 boxes (3 blister packages/box)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Loratadine Oral Solution, 5 mg per 5 mL, Fruit Flavored Syrup, 120 mL bottle (4 fl oz), OTC, NDC 54838-538-40 (SILARX label); and Clear-Atadine (loratadine) Oral Solution, 5 mg per 5 mL, Fruit Flavored Syrup, 120 mL bottle (4 fl oz), OTC, NDC 0904-5727-20 (MAJOR label). Recall # D-053-2010
CODE
(Silarx label): Control #s 5557A (Exp 3/11); 5573A, 5574A, 5576A, 5578A (Exp 4/11); (Major label): Control # 5579A (Exp 4/11) ; RECALL EXPANSION: NDC 54838-538-40 (Silarx label): Control #s 5537A , 5538A , 5539A , 5540A, 5541A, 5554A, 5555A, 5556A (Exp 3/11); 5570A, 5571A, 5572A, 5575A, 5577A (Exp 4/11); 5593A, 5594A, 5595A, 5596A, 5597A (Exp 5/11); 5626A, 5627A, 5628A, 5629A, 5630A, 5631A (Exp 6/11); (Major label): Control #s 5553A (Exp 3/11); 5598A (Exp 5/11); 5632A, 5633A (Exp 6/11)
RECALLING FIRM/MANUFACTURER
Silarx Pharmaceuticals, Inc., Spring Valley, NY, by letters dated October 15, 2009 and November 4, 2009. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter: The manufacturer received several complaints of cloudiness (particulates) in Loratadine Oral Solution. The firm's investigation concluded that the cloudiness was due to EDTA, an inactive ingredient in the OTC drug product.
VOLUME OF PRODUCT IN COMMERCE
280,357 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
1) Platelets. Recall # B-0128-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0129-10
CODE
1) Unit: 2468712;
2) Units: 2364633, 2393074, 2468712
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington KY, by letter dated June 5, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0130-10
CODE
Units: 2495225, 2435237, 2470727
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington KY, by letter dated June 3, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
1) Platelets. Recall # B-0131-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0132-10
CODE
1) Unit: 2468735;
2) Units: 2338740, 2364648, 2435230, 2468735
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington KY, by letter dated June 5, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
1) Platelets. Recall # B-0133-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0134-10
CODE
1) Unit: 2469548;
2) Units: 2310763, 2342988, 2369392, 2379711, 2469548
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington KY, by letter dated June 9, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
1) Platelets. Recall # B-0135-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0136-10
CODE
1) and 2) Unit: 2377974
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington KY, by letter dated June 9, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
1) Platelets. Recall # B-0137-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0138-10
CODE
1) Unit: 2468711;
2) Units: 2435193, 2468711, 2495302
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington KY, by letter dated June 9, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0244-10
CODE
Unit: 72L555227
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on August 26, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0245-10
CODE
Unit: 041FL15772
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone or electronic notification on November 19, 2008 and by letter dated November 21, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0247-10
CODE
Unit: 026GG12489
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by letter and electronic notification on November 27, 2008 and by letter dated November 28, 2008. 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 
1) Plasma Frozen. Recall # B-0249-10;
2) Blood Cells Leukocytes Reduced. Recall # B-0250-10
CODE
1) and 2) Unit: 003LJ47697
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by letter and facsimile on November 14, 2008 and follow-up letter dated December 18, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0251-10
CODE
Unit: 72L143731
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on July 18, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Blood Cells Leukocytes Reduced. Recall # B-0252-10
CODE
Unit: W036509050255
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by letter dated August 27, 2009. 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
LA
___________________________________
PRODUCT 
Source Plasma. Recall # B-0253-10
CODE
Units: 0481216254, 0481214804, 0481208415, 0481207228, 0481203422, 0481201752, 0481200401
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc, Tempe, AZ, by letter dated May 20, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Sweden, Germany, IL
___________________________________
PRODUCT 
1) Platelets Leukocytes Reduced Irradiated. Recall # B-0257-10; 
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0259-10
CODE
1) and 2) Unit: 033FM02595
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by facsimile and electronic notification on December 9, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CT
___________________________________
PRODUCT 
Fresh Frozen Plasma (Apheresis). Recall # B-0262-10
CODE
Units: W036509074034 (2 units)
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter dated August 11, 2009. 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
LA
___________________________________
PRODUCT 
1) Red Blood Cells. Recall # B-0263-10;
2) Fresh Frozen Plasma. Recall # B-0264-10
CODE
1 and 2) Unit: 1663572
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii, by letter dated August 3, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Hawaii
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-265-10
CODE
Unit: W036209438095
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on July 20, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking an antibiotic medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0268-10;  
2) Recovered Plasma. Recall # B-0269-10
CODE
1) and 2) Unit: C350328
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by facsimile and letter dated August 14, 2009. 
Manufacturer: Puget Sound Blood Center and Program, Tukwila, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, WA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0246-10
CODE
Unit: 041FL15772
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone or electronic notification on November 19, 2008 and by letter dated November 21, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0248-10
CODE
Unit: 026GG12489
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by letter and electronic notification on November 27, 2008 and by letter dated November 28, 2008. 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
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0254-10
CODE
Unit: W067309008655
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by telephone on June 10, 2009. Firm initiated recall is complete.
REASON
Blood product, collected using a scale for which the quality control testing was out of range, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0258-10
CODE
Unit: 033FM02595
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by facsimile and electronic notification on December 9, 2008. 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
CT, CA
___________________________________
PRODUCT 
Source Plasma. Recall # B-0261-10
CODE
Units: KZ040238, KP109941, KZ039743, KZ039386, KZ039063, KZ038846, KZ038521, KZ038191, KZ037904, KP109460
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on July 16, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for taking growth hormone, were distributed
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Austria, CA, MO
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0266-10
CODE
Unit: W115909252126
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by-mail on August 14, 2009. 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
Austria

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

___________________________________
PRODUCT 
1) Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # a) 5801,  b) 12-8713, c) 732-E, and d) 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned. Recall # Z-0039-2010;

2) Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: a) 5804; b) 12-8709, c) 727-E; d) 727MM, e) 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recall # Z-0040-2010;

3) Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # a) 5807; b) 12-8703, c) 723-E (Foreign Distribution only), d) 723MM. Packaged under the name of Dynarex and Evergreen. Recall # Z-0041-2010; 

4) Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s a) 5808, b) 12-8704; c) 724-E; d) 724MM, e) 32612. Packaged under the name of Dynarex, Evergreen, Hospitak and Select Medical Products. Recall # Z-0042-2010;

5) Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID #: 12-8702; 778500; 721-E, 778500; 2200; 2201, 86-721E, 40-116722 (foreign distribution only), 721MM. Packaged under the name of Evergreen, Hospitak, Kentron, McKesson and Mada. Recall # Z-0043-2010;

6) Manual Pulmonary Resuscitator, Adult w/ Large Adult Mask & Reservoir Bag. Product # 12-8705. Packaged under the name of Evergreen. Recall # Z-0044-2010;

7) Pediatric Manual Pulmonary Resuscitator w/Luer-lock Sampling Elbow & Reservoir bag (No mask). Product ID# 12-8707. Packaged under the name of Evergreen. Recall # Z-0045-2010;

8) Pediatric Manual Pulmonary Resuscitator. Product ID # 12-8708. Packaged under the name of Evergreen. Recall # Z-0046-2010;

9) Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask & standard elbow. Product ID # 12-8710, 726-E; 86-722E, 726MM. Packaged under the name of Evergreen, Hospitak, and McKesson. Recall # Z-0047-2010;

10) Infant Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas sampling elbow. Product ID # 12-8714; 731-E, 731MM; 86-731E. Packaged under the name of Evergreen, Hospitak and McKesson. Recall # Z-0048-2010;

11) Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & standard elbow. Product ID # 722-E, 86-722-E; 722MM. Packaged under the name of Hospitak and McKesson. Recall # Z-0049-2010;

12) Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas Sampling Elbow. Product ID #: 728-E. Recall # Z-0050-2010;

13) Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 Cm H2O Elbow. Product ID #s: 729-E; 40-116730; Foreign distribution only; 729MM. Recall # Z-0051-2010;

14) Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow. a) Product ID # 730-E; Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 cm H2O Elbow, b) Product ID # 730MM. Recall # Z-0052-2010;

 

15) Manual Pulmonary Resuscitator with reservoir tube and Peep Valve. Product ID #s 742-E; 86-742E. Packaged under the name of Hospitak, McKesson. Recall # Z-0053-2010;

16) Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 Cm H2O Elbow. a) Product ID # 735-E; Distributed in France only: b) product code: 40-116735. Recall # Z-0054-2010;

17) Hospitak Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel gas sampling elbow. Foreign distribution only. Product code: 725-E. Recall # Z-0055-2010;

18) Drager Medical Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and swivel gas sampling elbow, Peep Valve. Product code: 40-116733, Distribution to France only. Recall # Z-0056-2010;

19) Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas sampling elbow. Foreign Distribution only: Product number 733-E. Recall # Z-0057-2010;

20) Hospitak Infant Manual Pulmonary Resuscitator with reservoir tube, face mask and Pop-Off 40 cm H2O Elbow. Foreign distribution only: Product codes: 734-E, 734MM. Recall # Z-0058-2010;

21) Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag. Product ID # 779725. Recall # Z-0070-2010;

22) Unomedical Pediatric Manual Pulmonary Resuscitator, Child Mask & Reservoir Hose, Product ID # 779728. Recall # Z-0071-2010;

23) Unomedical Infant Manual Pulmonary Resuscitator, Infant Mask & Reservoir Hose. Product ID # 779733. Recall # Z-0072-2010
CODE
1) a) Lot numbers 07-39, 07-49; b) lot numbers: 04-08 04-18 04-28 06-11 06-26 07-07 07-12 07-14; c) lot numbers: 03-11 03-22 03-25 03-29 03-34 03-42 04-05 04-42 05-12 05-32 05-34 05-42 05-43 06-04 06-19 06-30 07-12 07-20 07-25 07-30 07-35 07-38 07-43 07-47; d) lot number: 04-05;

2) a) Lot numbers 07-39, 07-49; b) Lot numbers: 03-46 03-47 04-42 04-43 06-40 06-43 06-46 06-49; c) lot numbers: 03-17 03-19 03-22 03-25 03-28 03-29 03-33 03-34 03-42 03-45 04-05 04-21 04-31 04-33 04-39 04-40 04-41 04-50 04-51 05-17 05-20 05-32 05-34 05-47 06-04 06-13 06-22 06-25 06-30 06-39 06-40 06-47 06-51 07-07 07-08 07-25 07-29 07-34 07-36 07-42 07-44: Denmark: 04-05; Japan: 06-25 06-30; Mexico: 03-02 03-03 03-40 03-42 03-45 04-05 04-19 04-21 04-37 05-32 05-34 05-42 06-04 07-20 07-29 07-34 07-42 07-44 Peru: 02-36; d) Czech Republic lot 07-28; Japan: 07-14 Product ID # 2203; lot numbers: 03-19 03-20 03-31 03-32 03-47 04-13 04-19 04-34 04-45 04-46 05-08 e) lot codes: Poland: 05-07; Italy: 06-38 07-11; Denmark: 06-04 07-28 07-36;

3) a) Lot numbers 07-39, 0749; b) lot numbers: 04-28 05-07 05-20 05-43 07-08: c) (Foreign Distribution only) Greece: 04-09; Japan: 04-22; Peru: 02-36; d) lot code: Vietnam: 03-45 04-06 04-38 05-10 05-11 05-29 05-42 05-49 06-30 06-40 06-41 07-02 07-07 07-09 07-16 07-17 07-38 07-47;

4) a) Lot numbers 07-49, 07-; b) lot numbers: 04-28 04-34 04-45 05-24 05-26 05-32 05-42 05-43 05-48 06-24 06-34 06-43 06-46 06-49 07-03 07-07 07-11 07-20 07-26 07-38 07-48 07-50: c) lot numbers: 03-03 05-42 06-11 06-49 07-37 07-51 03-18 03-31 03-42 03-43 03-45 04-05 04-18 04-25 04-31 04-33 04-37 04-38 05-07 05-20 05-27 05-30 05-38 05-42 05-46 06-04; Paraguay: 02-32 Mexico: 03-02 03-03 03-05 03-45 03-48 03-49 04-18 04-21 04-38 05-07 05-23 05-32 05-38 05-42 06-04 06-19 06-20 06-49 07-22 07-29 07-35 07-38 07-43 Japan: 06-20 Italy: 07-09 Greece: 04-38 Canada: 03-25; d) Finland - lots 04-17 07-14; Italy 07-14: Mexico, lot 04-19 Product ID # 32612; lot numbers: 04-19 04-24 04-45 05-30 05-34 05-39 05-42 06-07 06-10 06-12 06-13 06-20 06-22 06-24 06-26 06-28 06-29 06-30 06-34 06-36 06-37 06-38 06-42 06-47 07-04 07-10 07-19 07-20 07-27 07-38 07-39 07-43 07-46 07-51 08-03 Product ID # 724MM: Denmark: 04-17 04-19 05-07 06-04 07-14 07-33 07-35 07-37;

5) Product ID #: 12-8702; lot numbers: 04-28 04-31 04-34 04-45 04-51 05-07 05-17 05-19 05-22 05-23 05-24 05-26 05-27 05-31 05-42 05-43 05-48 05-52 06-11 06-12 06-22 06-24 06-26 06-34 06-36 06-43 06-46 06-48 06-49 07-04 07-09 07-12 07-20 07-26 07-33 07-37 07-48 07-50; Product ID # 778500; lot codes:04-19 04-20 04-40 05-13 05-14 05-35 Product ID # 721-E: lot numbers: Mexico only: 04-21 04-31 04-38 04-39 04-44 05-07 05-26 05-33 05-43 05-46 05-48 06-11 06-25 06-36 06-43 06-51 07-07 07-12 07-38 07-48 07-51; Russia only: 03-15 Russia and Vietnam, 3-17 US Distribution. 04-21 04-31 04-33 04-39 04-44 04-45 05-07 05-17 05-20 05-31 05-33 05-43 06-11 06-20 06-25 (Japan only) 06-43 06-51 07-07 07-12 07-14 07-33: 03-17 03-21 Product ID # 778500; lot numbers: 06-10 06-24 06-38 07-11 07-26: Product ID # 2200; lot numbers: 04-34 04-35 04-45 05-05 05-06 05-07 05-08: Product ID # 2201, lot numbers: 04-23 04-34 05-05 05-06 05-51; Product ID# 86-721E: lot numbers: 06-11 06-43 06-46 06-49 06-50 07-10 07-12 07-17 07-19 07-20 07-21 07-22 07-25 07-26 07-35 07-37 07-39 07-40 07-43 07-45 07-47 07-48 07-50 08-05; Product Code: 40-116722 (foreign distribution only). lot codes: 04-18 04-20 04-26 04-30 04-31 05-12 05-13 05-16 05-18 05-19 06-48 07-02 07-16 07-17 07-18; Product ID # 721MM, lot codes: India: 04-28; Italy: 07-13; Russia: 03-34 03-36 03-38 04-07 04-09 04-24 04-33 04-34 04-41 04-42 04-43 04-44 05-11 05-12 05-36 05-45 05-46 06-16 06-17 06-37 06-41 06-42 07-03 07-09 07-22 07-34 07-35 08-04;

6) Lot numbers: 04-51;

7) Lot numbers: 04-08 04-28;

8) Lot numbers: 03-46 03-47;

9) Product ID # 12-8710, lot numbers: 03-46 05-20 06-11 06-24 06-33 06-51 07-33: Product ID#: 726-E; lot numbers: 03-22 03-41 03-42 04-06 04-17 04-19 04-22 04-31 04-33 04-41 04-42 04-49 05-07 05-17 05-21 05-30 05-33 05-34 05-46 06-04 06-11 06-24 06-30 06-40 07-07 07-10 07-13 07-16 07-20 07-36; Japan: 04-05 05-42 06-04 06-12 06-24 Mexico: 04-19 04-31 04-38 04-42 04-43 04-49 04-51 05-07 05-26 05-46 05-48 06-12 06-24 06-25 06-26 06-39 07-07 07-10 07-45 08-02 Russia: 03-17 Vietnam: 03-19 03-20 Product ID# 86-722E: lot numbers: 06-18 06-38 06-43 07-02 07-11 07-12 07-16 07-20 07-25 07-34 07-39 07-40 07-43 07-45 08-03 Product ID # 726MM, lot codes: Russia: 03-38 04-07, Vietnam: 03-36 04-25 04-38 05-08 06-12 07-36;

10) Product ID # 12-8714; lot numbers: 04-04 04-10 04-13 04-35 04-42 04-47 04-51 05-07 05-17 05-28 05-32 05-48 07-13 07-17; Product ID# 731-E: lot numbers: 03-24 03-42 03-43 04-06 04-09 04-18 04-31 04-33 04-38 04-39 04-45 04-49 05-08 05-12 05-17 05-21 05-28 05-42 07-14 07-29 07-51: Russia: 03-17 Mexico: 04-06 04-09 04-19 04-31 04-38 04-42 05-05 05-08 05-26 05-28 05-42 05-46 05-48 06-04 06-13 06-26 06-39 07-09 07-51 Japan: 03-20 03-34 04-05 04-06 04-19 04-49 04-50 05-08 06-13 06-26: Product ID # 731MM; Japan, Lot code 07-14; Mexico, lot code: 04-20 Product ID # 86-731E; lot numbers: 06-18 06-39 06-43 07-11 07-17 07-43 07-47 07-51; Product ID # 731MM, lot codes: Russia: 04-07; Vietnam: 04-07;

11) Product ID # 722-E; lot numbers: 04-28 04-30 04-31 04-33 04-35 04-37 04-38 04-41 04-43 04-44 04-45 04-48 04-51 05-08 05-17 05-23 05-26 05-31 05-34 05-39 05-43 05-47 06-09 06-12 06-20 06-24 06-25 06-36 06-49 07-07 07-11 07-12 07-17 07-20 07-23 07-25 07-37 07-48: 722-E foreign distribution: Argentina: 03-17; France: 04-17; Greece: 04-09, 05-05; India: 04-38 04-41 04-45 Japan: 06-24 Mexico: 07-37 Product ID# 86-722-E; lot numbers: 06-18 06-36 06-38 06-43 06-46 06-49 06-51 07-10 07-14 07-16 07-20 07-22 07-26 07-35 07-39 07-40 07-45 07-48 Product ID # 722MM, lot codes: Poland: 05-07 05-50 Mexico: 05-23 05-32 06-36 India: 04-28;

12) Product ID #: 728-E; lot number: 06-40. Argentina: 04-50 Japan: 06-30 Mexico: 02-29 02-43 03-02 03-10 03-15 04-05 04-06 06-19 06-30 06-37 06-40;

13) Product ID # 729-E; lot number: 04-25, 03-05 03-15 03-31 04-08 04-09 04-18 04-25 04-31 04-33 04-37 04-38 05-28 05-29 05-39 05-43: Japan: 06-30 Argentinia: 03-44 04-20 04-37 05-08 05-39 06-11 07-03 07-37 07-38. Product number: 40-116730; Foreign distribution only - France Lot codes: 04-18 04-20 04-26 04-30 04-31 06-26 06-38 06-39 06-49; Product ID# 729MM: Russia: 04-25 04-41 05-36 05-38 05-46 06-16 06-17 06-39 07-11 07-16 07-17;

14) a) Lot numbers: 02-29 02-35 03-14 Argentina: 04-07 04-17 04-18 04-19 04-37 05-07 05-19 06-11 06-20 06-34 07-03 07-34 07-35 07-50 France: 04-07 04-17 Japan: 06-30 Mexico: 02-43 03-39; Product ID # 730MM, b) lot codes: Denmark: 04-24 06-26 07-17 Italy: 07-17;

15) a) Lot number: 04-31; b) Lot numbers: 06-22 06-26 06-43 06-49 07-34 07-37;

16) a) Lot codes: 03-05 03-15 03-28 04-06 04-26 04-33 05-43 05-44 05-47 07-34; 04-19 04-37 05-07 05-09 05-19 06-09 06-20 06-34 07-04 07-34 Argentina: 03-14; Japan: 06-29; Mexico: 02-29 02-42 03-15 03-17b) lot codes: 04-34 04-38 04-45 04-50 06-43;

17) Lot codes: Greece: 03-17; Italy: 07-09 07-29; Japan: 06-30; Mexico: 02-29 03-02 03-15 03-17;

18) Lot codes: 04-38;

19) Foreign Distribution only: Lot codes: Argentina: 04-41 India: 04-06 04-41 Japan: 06-29 Mexico: 02-29 02-42 03-02 03-10 03-15 03-22 04-05 04-06 05-38 06-36;

20) Foreign Distribution only: Lot codes: Argentina: 04-41 India: 04-06 04-41 Japan: 06-29 Mexico: 02-29 02-42 03-02 03-10 03-15 03-22 04-05 04-06 05-38 06-36;

21) Lot code: 04-35;

22) Lot code: 04-34;

23) Lot code: 04-39
RECALLING FIRM/MANUFACTURER
Recalling Firm: Unomedical, McAllen, TX, by press release on October 6, 2009 and by letters on October 7, 2009. 
Manufacturer: Unomedical S.A. de C.V., Reynosa, Mexico. Firm initiated recall is ongoing.
REASON
In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pressure necessary to ventilate the patient.
VOLUME OF PRODUCT IN COMMERCE
60,258 units
DISTRIBUTION
Nationwide, Argentina, Canada, Denmark, France, Greece, India, Italy, Japan, Mexico, Paraguay, Peru, Poland, Russia and Vietnam
___________________________________
PRODUCT 
Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. The Cordis CROSSOVER Sheath Introducer is intended for use in arterial and venous procedures requiring percutaneous introduction of therapeutic or diagnostic intravascular devices or fluids. a) Catalog Number: 403545S; Catalog Number: 403585S; Catalog Number: 403645S; d) Catalog Number: 403685S; e) Catalog Number: 403745S; f) Catalog Number: 403785S, Recall # Z-0087-2010
CODE
a) Lot Numbers: U0000027, U0000041 and U0000047; b) Lot Number U0000025; c) Lot Numbers U0000026, U0000030, U0000031, U0000038 and U0000052; d) Lot Numbers U0000033, U0000042 and U0000050; e) Lot Numbers U0000034, U0000035, U0000040, U0000043 and U0000055; and f) Lot Numbers U0000037 and U0000046
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cordis Corp., Miami Lakes, FL, by letter dated October 19, 2009.
Manufacturer: Thomas Medical Products, Inc., Malvern, PA. Firm initiated recall is ongoing.
REASON
Complaints of stretching or fracture of the sheath shaft during use.
VOLUME OF PRODUCT IN COMMERCE
2,362 units
DISTRIBUTION
Nationwide, Belgium, Switzerland, Germany, Finland, France, Italy, Netherlands, Sweden and United Kingdom

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.
a) Part 133-2846, b) Part 133-2847; c) Part 133-2848; d) Part 133-2851; e) Part 133-2852. Recall # Z-0086-2010
CODE
a) Lots 3370, 3534, 3620, 3731; b) Lots 3492, 3535, c) Lot 3509 d), Lot 3433, e) Lot 3661
RECALLING FIRM/MANUFACTURER
Ortho Development Corp., Draper, UT, by Memo dated April 2, 2009 and by telephone on April 29, 2009. Firm initiated recall is ongoing.
REASON
A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited. Recall # Z-0119-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Cochlear Americas, Inc, Englewood, CO., by letter on September 28, 2009. Firm initiated recall is ongoing.
REASON
Cochlear implant device component was mislabeled.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide, Brazil, Argentina
___________________________________
PRODUCT 
VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Recall # Z-0133-2010
CODE
Codes: H850008, H850904, H851353, H851333, H880033, H850907, H851388, H881354, H850078, H850912, H851674, H881389, H850110, H850920, H851838, H881392, H850129, H850930, H851992, H881393, H850130, H850962, H852053, H881410, H850211, H850963, H852544, H881482, H850217, H850964, H852546, H881483, H850258, H850965, H880004, H881484, H850322, H850967, H880012, H881515, H850345, H850968, H880098, H881524, H850350, H850969, H880221, H881557, H850451, H851020, H880449, H881576, H850474, H851025, H880699, H881586, H850555, H851032, H880720, H881641, H850616, H851059, H880734, H881642, H850686, H851080, H880809, H881658, H850696, H851087, H880862, H881671, H850739, H851091, H881033, H881839, H850759, H851132, H881037, H881865, H850788, H851138, H881060, H881895, H850830, H851145, H881102, H881951, H850831, H851252, H881205, H881993, H850861, H851290, H881207, H882003, H850877, H851327, H881220, H882049, H882623, H885074
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on September 15, 2009. Firm initiated recall is ongoing.
REASON
Software issue: Under certain circumstances, when a therapy treatment field is transferred to VARiS Vision 6.2, 6.1 and 6.0 via LINK procedures, the rotation direction will be reversed.
VOLUME OF PRODUCT IN COMMERCE
100 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
1) GE Healthcare, GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector), Recall # Z-0135-2010;

2) GE Healthcare, GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Recall # Z-0136-2010;

3) GE Healthcare, GE Innova 4100 / 4100 IQ. , (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Recall # Z-0137-2010;

4) Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System. Recall # Z-0138-2010  
CODE
1) SYSTEM ID: 65049331 850060732 2538483100 4082593100 7133933100 9284533100 82416060004 0002728403 01224VAS04 082416040025 082416100008 082416120017 082416230005 202782LABB 214324INNOVA2 27305ANGI1 303629CL4 303788CL2 318254CL 325428CATH1 361857CATH1 361980INNOVA2 478274CTH1 479441CV1 4959INV31 503561CL3 512901NI3100 563421CATHLAB8 573AMC3100 600123VA02 619482INNOVA1 650369SV3 704355RM2 706774HT8 717270INNOVA31 727942CATH 732776CATH6 770HMCCL2 787844INNOVACL 803256LAB2 808485INNOVA 814231C1 815226INN2 864512CL1 864512CL2 865481CCL2 951788INNOVA2 A51273120 BPINNOVA4 BPINNOVA5 BY4067VA02 BY4069VA01 FPG30528 HU1042VA01 IL1098VA01 NPV15952 PL1008VA02 RU1295VA03 RU1295VA04 RU1453VA01 RU1618VA01 RU1999VA01 RU2076VA02 RU2741VA03 RU2747VA01 RU3260VA01 RU3290VA01 RU3304VA01 RU3317VA01 RU3328VA01 UA4230VA01 XF0158 YV0044 YV0171 YV0175 YV0180 YV0700 Z001RX07;

2) SYSTEM ID: 850060731 853060205 82416020006 82416090003 82416120015 82416120016 82416210014 83016022101218 83016842101519 0002780363 00052VAS04 00052VAS05 00060VAS03 010120RX44 082416030012 082416130029 083016002001498 083016802101749 083016822101709 083016862101268 0910064010 110019RX13 1299563 17005VAS01 304526INNOVA 318449INNOVA3 407321INCL2 410368INNOVA1 503561CL1 503561CL4 526354XR13 573815BCR3 603882CATH1 609757IN2100 706774HT4 717217INN21 717544GECATH2 732776CATH4 732923INN 816347SLE2100 816861KCVAI2 818INNOVAHMS1 828315FEP 910343NHIN3 A5152993 A5330714 B5483438 BG4033VA01 C5123626 GOLD010016 HR4106VA01 HR4107VA01 HU1173VA03 LV4000VA04 M4183841 M4484974 RO1180VA01 RU3301VA01 YV0562;

3) SYSTEM ID: 80158241 06014VAS01 06063VAS01 082406100018 0828160011 205759CL2 207662OR4100 215662INNOVA1 216844INNOVA 228809VASC 22925941V2 309672M4100 414649DVI 508383IN4100 509575YM4100 6012884100SUR 715369INN4100 718518CVL1 801268INNOVA 812825INNOVA1 843789SP1 865373SP 865541CCL5 904BSSP 910907WAVAS1 9408984100 A56364110 BG4037XR01 HC1819XR09 HC2001XR02 M2030711 NO1017VA03 NO1064VA04 RU2526VA01 XF0160;

4) SYSTEM ID: 0847160005 542120XR02 561548BIP 561881BP1 630856H3131 817465AR3131 985867INNOVA31 COR373301 EG1000VA01 LY1086VA01 M4166990 05448VAS01 VAD2121 YE1002VA01 YV0365 NOT LOCOLIZED S/N CHILLER 798080-21 796259-09 794637-08 795371-01 796133-12 796259-05 796464-08 796464-13 796464-15 796767-05 796941-03 796941-04 796941-07 796941-09 797178-05 797179-03 797179-08 797179-12 797449-03 797449-06 797632-02 797812-04 797812-09 797812-10 797812-12 767326-03 770355-02 772153-13 767746-05 785678-16 794637-11 799172-07 799347-03 799347-05 796260-01 783679-01 797178-03 797179-07 797179-09 797179-11 797812-14 797812-16 799347-02 798449-01 798449-02 798449-03
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated April 16, 2009.
Manufacturer: GE Medical Systems, SCS, Bue Cedex, France. Firm initiated recall is ongoing.
REASON
Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the X-ray is inhibited. This could lead to a delay in treatment and possible additional X-ray exposure and contrast media when examination is resumed on other equipment.
VOLUME OF PRODUCT IN COMMERCE
235 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube. Recall # Z-0139-2009
CODE
Codes: Stock Code: 1#4, 3x 8mm, PO Number: 010707, 011512, 017479, 025991, 027823, 028364 and 029447; Stock Code: 1#5, 3 3/8 x 9mm, PO Number: 010707, 011512, 024048, 025151, 028364, 029447, 031261 and 034276; Stock Code: 1#7, 4 x 11 mm, PO Number: 011512, 020608, 023244, 031261, 033471 and 034276; Stock Code: 1#8, 4 x 12 mm, PO Number: 011512, 017756, 023244, 027339 and 033252; Stock Code: 1#9, 4 3/8 x 13 mm, PO Number: 011512 and 012479 and Stock Code: 1#10, PO Number: 010707 and 011512
RECALLING FIRM/MANUFACTURER
Recalling Firm: GF Health Products, Inc., Atlanta, GA, by letter on/about September 14, 2009.
Manufacturer:  Fine Surgical Corp., Hempstead, NY. Firm initiated recall is ongoing.
REASON
Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications.
VOLUME OF PRODUCT IN COMMERCE
396 units
DISTRIBUTION


Nationwide

___________________________________
PRODUCT 
Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog # OS5000-005, sold separately, or as a component of the Craig Vertebral Biopsy Set, catalog # OS5000. Recall # Z-0141-2010
CODE
Lot number K08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Mc Gaw Park, IL, by letters dated August 28, 2009. 
Manufacturer: Cardinal Health, Medical Products & Services Div., Maplewood, MO. Firm initiated recall is ongoing.
REASON
he Craig Calibrated Cannula does not interface with the toothed cutter properly, which may prevent the toothed cutter from properly advancing through the cannula to the biopsy site.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
Nationwide
________________________________
PRODUCT 
1) Power cord for Model 3300 Cardiac Output Computer, List # 41245-04-03. AC power cords, all units of Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, 826-96057-003. Recall # Z-0142-2010;

2) Power cord for Optional Thermal Printer (For use with Model 3300 COC), Oximetrix 3 SO2/CO Computer, Q-Vue CCO Computer and Q2 CCO/SO2 Computer, List Number 50132-04-05, AC power cords, all units of Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, 826-96057-003. Recall # Z-0143-2010;

3) Power cord for Oximetrix 3 SO2/CO Cardiac Output Computer, list # 50130-04-07, AC power cords, all units of Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, 826-96057-003. Recall # Z-0144-2010;

4) Power cord for Q2 Continuous Cardiac Output (CCO)/SO2 Computer, list #s 52235-04-01, 52235-04-03, 52236-04-05, 52235-04-07, 52235-04-11, AC power cords, all units of Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, 826-96057-003. Recall # Z-0145-2010;

5) Power cord for Q2Plus/Continuous Cardiac Output (CCO)/SO2 Computer, list #s 56711-04-01, 56711-04-03, 5671-04-05, 56711-04-51. AC power cords, all units of Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, 826-96057-003. Recall # Z-0146-2010;

6) Power cord for QVue Continuous Cardiac Output (CCO)/SO2 computer, list #s 52230-04-03, 52230-04-05, 52230-04-07, 52230-04-09, 52230-04-11, 52230-04-13, 52230-04-15, 52230-04-17, 52230-04-25, 52230-04-31, 52230-04-33. AC power cords, all units of Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, 826-96057-003. Recall # Z-0147-2010
CODE
All units of listed part numbers
RECALLING FIRM/MANUFACTURER
Hospira, Inc., Morgan Hill, CA, by press release and letter on August 14, 2009. Firm initiated recall is ongoing.
REASON
Fire/Shock hazard-- The power cord used in the device may cause sparks/flashes and poses a fire and shock hazard.
VOLUME OF PRODUCT IN COMMERCE
204,999 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
1) Stryker Medical Stair-PRO Stair Chair with wheels, patient transport device, Model 6251. Recall # Z-0148-2010;

2) Stryker Medical Stair-PRO Stair Chair with wheels and a track system, patient transport device, Model 6252. Recall # Z-0149-2010
CODE
1) Serial numbers 080639995, 080640003, 081039395, 080639996, 080640004, 081039396, 080639997, 080739856, 081039397, 080639998, 080739857, 081039398, 080639999, 080739858, 081039399, 080640000, 080739859, 081039400, 080640001, 080739860, 081039401, 080640002, 080740001, 081039402, 080439860, 080439861, 080439862, 080439863, 080439864, 080439865, 080439866, 080439867, 080441124, 080439868, 080541216, 080541293, 080541294, 080541295, 080541296, 080541297, 080541298, 081039403, 081039404, 081040900, 081040901, 081040902, 090139365, 090139366, 090139367, 090139368, 090139369, 090139373, 090140687, 090140691, 090140692, 090140693, 090140694, 090140688, 090140695, 090140689, 090140696, 090140690, 090241071, 090241072 and 090241073;

2) Serial numbers 080340370, 080340371, 080340372, 080340373, 080340374, 080340375, 080340376, 080340377, 080340378, 080340379, 080340380, 080340381, 080340382, 080340383, 080340384, 080340385, 080340386, 080340387, 080340388, 080340389, 080439732, 080539750, 080539751, 080539752, 080539755, 080539756, 080539757, 080540101, 080540102, 080540103, 080540104, 080540105, 080540106, 080540107, 080540108, 080540109, 080540110, 080540111, 080540112, 080540113, 080540114, 080540115, 080541118, 080541119, 080541120, 080541121, 080541122, 080541123, 080541124, 080541125, 080541126, 080541127, 080541128, 080541129, 080541130, 080541131, 080541132, 080541163, 080541164, 080541165, 080541166, 080541167, 080541168, 080541169, 080541170, 080541171, 080541172, 080541173, 080541174, 080541175, 080541176, 080541177, 080541188, 080541189, 080541190, 080541223, 080541224, 080541225, 080541226, 080541227, 080541228, 080541229, 080541230, 080541231, 080541232, 080541233, 080541234, 080541235, 080541236, 080541237, 080541238, 080541239, 080740000, 080839665, 080839666, 080839667, 080940219, 080940220, 080940221, 080940598, 080940753, 080940754, 080940755, 080940756, 080940757, 080940758, 080940759, 081040840, 081040841, 081040842, 081040843, 081139364, 081139365, 081139366, 081139367, 081139368, 081139369, 081139370, 081139371, 081139372, 081139373, 081139374, 081139375, 081139376, 081139377, 081139378, 081139664, 081140082, 081140083, 081140084, 081140085, 090140100, 090140101, 090140102, 090140103, 090140104, 090140105, 090239555, 090239587, 090240122, 090240123, 090240124, 090240125, 090240126, 090240127, 090240128, 090240129, 090240130, 090240131, 090240132, 090240133, 090240134, 090240135, 090240136, 090240137, 090240138, 090240139, 090240140, 090240141, 090240488, 090240988, 090240989, 090240990, 090240991 and 090240992
RECALLING FIRM/MANUFACTURER
Stryker Medical Div. of Stryker Corp., Portage, MI, by letter dated September 9, 2009. Firm initiated recall is ongoing.
REASON
The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury.
VOLUME OF PRODUCT IN COMMERCE
230 units
DISTRIBUTION
CO, OH, WI, Germany, Italy, Netherlands, Poland, and Switzerland

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II

___________________________________
PRODUCT 
HOMEGROWN ™ Turkey & Quail starter 30% BMD 200, net wt. 50 lbs., Item number 0015447, 59FC-ARC-G. Recall # V-009-2010
CODE
Lot number: 9AUG20ARC1
RECALLING FIRM/MANUFACTURER
Longview Research Manufacturing, Gray Summit, MO, by telephone, email, fax and press release on October 13, 2009. Firm initiated recall is ongoing.
REASON
Turkey and quail feed was found to contain less than the labeled amount of protein.
VOLUME OF PRODUCT IN COMMERCE
270 bags
DISTRIBUTION
LA, MS, AR, TX

END OF ENFORCEMENT REPORT FOR NOVEMBER 25, 2009

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