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U.S. Department of Health and Human Services

Safety

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Enforcement Report for October 6, 2010

October 6, 2010                                                                                        10-39

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
Raw Shelled Pistachios, 80% whole, in 25 lb. plastic lined cardboard box. Recall # F-2896-2010
CODE
Produced on 04/30/2010, 05/18/2010, 06/04/2010, 06/17/2010, 06/25/2010, and 07/06/2010
RECALLING FIRM/MANUFACTURER
California Delights, Inc., Newman, CA, by telephone on July 26, 2010. Firm initiated recall is ongoing.
REASON
Raw Shelled Pistachios may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
96,000 lbs
DISTRIBUTION
MN, NV, AK, and Canada
___________________________________
PRODUCT
Product’s label states:”Whole Raw Pistachios…Aunt Patty’s…Net Wt 5 lbs. (2.27kg), P/D 07/06/10, Ingredients: Whole Raw Pistachios, UPC 030042700408. Product of USA. Recall # F-2897-2010
CODE
Lot number: MG0017400
RECALLING FIRM/MANUFACTURER
GloryBee Natural Sweeteners, Inc., Eugene, OR, by e-mails on August 18, 2010 and by press release on August 20, 2010. Firm initiated recall is ongoing.
REASON
Pistachios may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
35/5 lb. boxes
DISTRIBUTION
WA, OR
___________________________________
PRODUCT
Haifa Smoked Fish brand Shmaltz Herring, UPC 8 3200 00123 6. The product is individually vacuum-packed in clear plastic pouches of varying weights. According to the lab report, the sampled packaged contained a whole fish measuring approximately 13 inches. Recall # F-2898-2010
CODE
Lot number: 20
RECALLING FIRM/MANUFACTURER
Haifa Smoked Fish, Inc., Jamaica, NY, by press release and letters dated February 3, 2010. New York initiated recall is complete. 
REASON
The product was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Undetermined
DISTRIBUTION
NY
___________________________________
PRODUCT
BIG Original Salted & Roasted Sunflower Seeds Item #55001, 12 CT/5.35 oz, Net Wt: 4 lbs. (Case UPC #10896887002193); Item #55011  72 CT/5.35 OZ, NET WT: 24 LBS 1 0Z,  BIGS Assorted Sunflower Seeds Shipper (Case UPC #00896887002301)  Case (Bag UPC #896887002196); Item #55012  72 CT/5.35 OZ, NET WT: 24 LBS 1 0Z, BIGS Assorted Sunflower Seeds Dump Bin (Case UPC #00896887002318) (Bag UPC #896887002196); Item #55013 36 CT/5.35 OZ, NET  WT: 12 LBS 1 OZ,  BIGS Assorted Sunflower Seeds Power Wing (Case UPC #00896887002325) (Bag UPC #896887002196); Item #55028 12 CT/5.35 OZ, NET WT: 4 LBS,  BIGS Original Salted & Roasted Sunflower Seeds  (Case UPC #50896887002191)  Bag UPC #896887002196).
Recall # F-2908-2010
CODE
Item #55001, Case Code BEST BY 30MAY2011 0890, BEST BY 31MAY2011 0900, Bag Code BEST BY 30MAY2011 0890, BEST BY 31MAY2011 0890; Item #55011, Case Code  BEST BY 15APR2011 0960, BEST BY 17APR2011 0960, BEST BY 18MAY2011 0960, BEST BY 30MAY2011 1050, Bag Code BEST BY 30MAY2011 0890; Item #55012, Case Code  BEST BY 22MAY2011 1040, Bag Code  BEST BY 30MAY2011 0890; Item #55013, Case Code BEST BY 18MAY2011 0960, BEST BY 22MAY2011 1050, BEST BY 30MAY2011 1050, Bag Code BEST BY 30MAY2011 0890; Item #55028, Case code BEST BY 30MAY2011, Bag Code BEST BY 30MAY2011 0890
RECALLING FIRM/MANUFACTURER
Ryt-Way Industries, Inc., Lakeville, MN, by letter dated May 12, 2010. Firm initiated recall is ongoing.
REASON
The recall was initiated after it was discovered that a limited number of sunflower seeds containing dairy were distributed in packaging that did not reveal the presence of dairy.
VOLUME OF PRODUCT IN COMMERCE
12 ct - 3484 cases, 72 ct shipper - 404 cases, 72 ct dump bin - 168, 36 ct - 434 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Candy Blast 10 oz Ice Cream Cups. Recall # F-2909-2010
CODE
NONE
RECALLING FIRM/MANUFACTURER
Wonder Ice Cream Company, Newark, CA, by telephone or in person on February 2, 2009. FDA initiated recall is ongoing.
REASON
The product was manufactured using peanut ingredients recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella
VOLUME OF PRODUCT IN COMMERCE
97,096 cases (1,165,152 cups)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Jaguey Bakery, Frozen Puff Pastries, Keep Frozen. Bulk Meat Flavor Frozen Puff Pastry packed in a cardboard box with a net weight of 8.5 pounds. Recall # F-2916-2010
CODE
NONE
RECALLING FIRM/MANUFACTURER
Jaguey Bakery, Inc, Miami, FL, by mail on February 1, 2010. FDA initiated recall is ongoing.
REASON
This product contains undeclared milk, soy, and wheat.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
FL
___________________________________
PRODUCT
Goya 100% FRUTA Pulp, Mamey Net Wt. 14 oz. Recall #F-2936-2010
CODE
NONE
RECALLING FIRM/MANUFACTURER
Recalling firm: Goya Foods, Inc., Secaucus, NJ, by issued press on August 11, 2010.
Manufacturer: COCO S.A., Colonia La Escuadrilla, Guatemala. FDA initiated recall is ongoing.
REASON
FDA sample of Goya Brand Mamey Pulp tested positive for salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Fruiti Pops brand Mamey Frozen Fruit Bar, Quiescently Frozen Confection, 4 oz.  Recall # F-2937-2010
CODE
NONE
RECALLING FIRM/MANUFACTURER
Fruiti Pops Inc., Santa Fe Springs, CA, by telephone and letter on August 25, 2010. FDA initiated recall is ongoing.
REASON
This recall was initiated after Fruiti Pops, Inc. learned of a recall involving the mamey fruit pulp used in the manufacture of their mamey frozen fruit bars.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
1) Julian Bakery - Spelt Multigrain Bread – UPC 713926001231. Recall # F-2899-2010;
2) Julian Bakery - Bless Your Heart Bread - UPC 813926005673. Recall # F-2900-2010;
3) Julian Bakery - Dinner Bread - UPC 813926004157. Recall # F-2901-2010;
4) Julian Bakery - Pure and Simple Kamut Bread - UPC 813926009107. Recall # F-2902-2010;
5) Julian Bakery - Mama Bear Bread - UPC 81392600101. Recall # F-2903-2010;
6) Julian Bakery - Manna From Heaven Bread - UPC 813926005161. Recall # F-2904-2010;
7) Julian Bakery - Tofu Bread - UPC 813926003457. Recall # F-2905-2010;
8) Julian Bakery - Bible Recipe Bread - UPC 813926001125. Recall # F-2906-2010
CODE
All bread manufactured between 08/01/2010 – 08/14/2010
RECALLING FIRM/MANUFACTURER
Julian Bakery, LLC, La Jolla, CA, via email on August 19, 2010. Firm initiated recall is ongoing.
REASON
This recall was initiated after Julian Bakery became aware that their bread products containing Spelt and Kamut, and marketed as Wheat Free" or "Wheat Alternative," did in fact contain wheat ingredients.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Glory Foods Kale Greens, packaged in 16 oz polyethylene bags. Recall # F-2907-2010
CODE
Code TFM 222 B5, best if used by 08/24/10
RECALLING FIRM/MANUFACTURER
Taylor Farms Maryland, Inc., Annapolis Junction, MD, by telephone and e-mail on August 26, 2010. Connecticut initiated recall is ongoing.
REASON
Bagged kale greens were tested and found positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
665 cases
DISTRIBUTION
MD, PA, VA, OH, NJ, MA, NY
___________________________________
PRODUCT
1) Apple Frozen Puff Pastry with a net weight of 8.5 pounds. Recall # F-2910-2010;
2) Cherry Frozen Puff Pastry with a net weight of 8.5 pounds. Recall # F-2911-2010;
3) Cheese Frozen Puff Pastry with a net weight of 8.5 pounds. Recall # F-2912-2010;
4) Coconut Frozen Puff Pastry with a net weight of 8.5 pounds. Recall # F-2913-2010;
5) Guava Frozen Puff Pastry with a net weight of 8.5 pounds. Recall # F-2914-2010;
6) Guava & Cheese Frozen Puff Pastry with a net weight of 8.5 pounds. Recall # F-2915-2010;
7) Strawberry Frozen Puff Pastry with a net weight of 8.5 pounds. Recall # F-2917-2010
CODE
NONE
RECALLING FIRM/MANUFACTURER
Jaguey Bakery, Inc, Miami, FL, by mail on February 1, 2010. FDA initiated recall is ongoing.
REASON
These products contain undeclared milk, wheat, FD&C Yellow #6 and Red #40.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
FL
___________________________________
PRODUCT
Natalie's Orchid Island Juice Company Orange Juice All Natural Fresh Squeezed, Shake Well, keep Refrigerated. 8 fl. oz. (.5 pt.) 240 mL UPC 7 25341 11115 3. 12 fl. oz. (.75 pt.) 355 mL UPC 7 25341 11120 7. 16 fl. oz. (1 pt.) 473 mL UPC 7 25341 11114 6. 32 fl. oz. (1 Qt.) 946 mL UPC 7 25341 11113 9. 64 fl. oz. (0.5) Gal.) 1.89L UPC 7 25341 11112 2. 128 fl oz. (1 gal.) 3.78L UPC 7 25341 11111 5. Wegman's Fresh Squeezed Orange juice Unpasteurized Shake Well Keep Refrigerated. 16 fl oz (1 pt) 473mL UPC 0 77890 30019 2. 32 fl oz (1 qt) 946 mL UPC 0 77890 90011 6. 64 fl oz (2 qt) 1.89 L UPC 0 77890 90010 9. The Orange Barn Fresh Squeezed Orange Juice No Preservatives Keep Refrigerated Shake Well Before Using Net Wt. 1 Gallon (128 oz.). UPC 3 32195 00002 3. Recall # F-2918-2010
CODE
1/24/10 E8007SDE and 1/24/10 E8007WC
RECALLING FIRM/MANUFACTURER
Orchid Island Juice Co., Fort Pierce, FL, by press release, letters, fax, telephone, e-mail and visits beginning January 10, 2010. Firm initiated recall is complete.
REASON
Product recalled due to irregular quality assurance test results.
VOLUME OF PRODUCT IN COMMERCE
6,902 gal
DISTRIBUTION
NY, FL, GA, SC, NC

___________________________________
PRODUCT
1) Donald Duck 100 % Orange Juice from Concentrate with Pulp, Country Style, Unsweetened, Chilled, Orange Juice, 64 fl oz (2 qt) 1.89 L. Recall # F-2919-2010;

2) Suntipt, Concentrate Orange Juice with Preservatives, Shelve Stable, 100% Fruit Juice, 4+ 1, 3/ 3.5 L, Plastic Jug, 3.5 L (118.4 fl. oz.). Recall #F-2920-2010;

3) Donald Duck, Original, 100 % Orange Juice from Concentrate, No Pulp, Unsweetened, Chilled, 64 fl oz (2 qt) 1.89 L. Recall #F-2921-2010;

4) Donald Duck 100% Pure Orange Juice from Concentrate, Plus Calcium, 64 fl oz (2 qt) 1.89 L. Recall #F-2922-2010;

5) Growers Pride, Original, 100 % Pure Orange Juice from Concentrate, Pride Blend, Florida Natural, Growers Pride, 64 fl. oz (2 qt) 1.89. Recall #F-2923-2010;

6) Growers Pride, Country Style, 100 % Pure Orange Juice from Concentrate, Florida Natural, Growers Pride, 64 fl. oz (2 qt) 1.89. Recall #F-2924-2010;

7) Donald Duck 100% Pure Orange Pineapple Juice from Concentrate, 64 fl oz (2 qt) 1.89 L. Recall #F-2925-2010
CODE
1)Lot Number: 102608BL10R, Expiration Code: Oct 26 10 hh:mm 11 8; 2.) Manufacturer Date: 08/17/2010, Lot Number: 102608BO10R, Expiration Code: Oct 26 10 hh:mm 16 8; 3.) Manufacturer Date: 08/18/2010, Lot Number: 102708BL10R, Expiration Code: Oct 27 10 hh:mm 11 8; 4.) Manufacturer Date: 08/18/2010, Lot Number: 102708BO10R, Expiration Code: Oct 27 10 hh:mm 16 8; 5.) Manufacturer Date: 08/20/2010, Lot Number: 102908DS10R, Expiration Code: Oct 29 10 hh:mm 17 8; 6.) Manufacturer Date: 08/21/2010, Lot Number: 103008DS10R, Expiration Code: Oct 30 10 hh:mm 17 8;

2) Lot Number: EOCTRE8DB10F, Expiration Code: DEC 215 10 hh:mm 07 8;

3) Lot Number: 102808BL10R, Expiration Code: Oct 28 10 hh:mm 11 8; 2.) Manufacturer Date: 08/19/2010, Lot Number: 102808BO10R, Expiration Code: Oct 28 10 hh:mm 16 8; 3.) Manufacturer Date: 08/24/2010, Lot Number 110208BK10R, Expiration Code: Nov 2 10 hh:mm 09 8;

4) Lot Number: 102708BN10R, Expiration Code: Oct 27 10 hh:mm 15 8; 2.) Manufacturer Date: 08/19/2010, Lot Number: 102808BN10R, Expiration Code: Oct 28 10 hh:mm 15 8; 3.) Manufacturer Date: 08/21/2010, Lot Number: 103008DS10R, Expiration Code: Oct 30 10 hh:mm 17 8;

5) Lot Number: 102608BL10R, Expiration Code: Oct 26 10 hh:mm 11 8; 2.) Manufacturer Date: 08/17/2010, Lot Number: 102608BO10R, Expiration Code: Oct 26 10 hh:mm 16 8; 3.) Manufacturer Date: 08/19/2010, Lot Number: 102808BL10R, Expiration Code: Oct 28 10 hh:mm 11 8; 4.) Manufacturer Date: 08/19/2010, Lot Number: 102808BO10R, Expiration Code: Oct 28 10 hh:mm 16 8;

6) Lot Number: 102608BL10R, Expiration Code: Oct 26 10 hh:mm 11 8; 2.) Manufacturer Date: 08/17/2010, Lot Number: 102608BO10R, Expiration Code: Oct 26 10 hh:mm 16 8;

7) Lot Number: 102908BK10R, Expiration Date: Oct 29 10 hh:mm 09 8
RECALLING FIRM/MANUFACTURER
Citrus World, Inc., Lake Wales, FL, by letter on August 26, 2010. Firm initiated recall is ongoing.
REASON
100% Orange Juice from Concentrate and Concentrated Orange Juice was found to contain small, varying amounts of Grapefruit Juice.
VOLUME OF PRODUCT IN COMMERCE
25,783 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Theo brand Organic chocolate covered caramel, 6 pieces packaged in one box. Recall # F-2926-2010
CODE
NONE
RECALLING FIRM/MANUFACTURER
Theo Chocolate Co., Seattle, WA, by letter on December 15, 2008. Firm initiated recall is completed.
REASON
Misbranded - product label states butter and cream, however, fails to list milk.
VOLUME OF PRODUCT IN COMMERCE
5321 packages
DISTRIBUTION
WA
___________________________________
PRODUCT
Super Mom's Select Roast Beef Au Jus, Net Wt 6.25 oz (177g). Recall # F-2927-2010
CODE
Enjoy through 8/8/2010, 8/11/2010, 8/13/2010
RECALLING FIRM/MANUFACTURER
Super Mom's Recipe LLC, St Paul Park, MN, by visits on August 11, 2010. Firm initiated recall is ongoing.
REASON
Monosodium Glutamate was not declared on the ingredient listing of the Super Mom's Roast Beef Au Jus (sandwich).
VOLUME OF PRODUCT IN COMMERCE
513
DISTRIBUTION
MN, WI

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT
1) Minute Maid Lemonade, 12 fl oz/12 pack cans. Recall # F-2928-2010;
2) Minute Maid Lemonade Light, 12 fl oz single cans in vending machines. Recall # F-2929-2010
CODE
Optimum Taste Codes: FEB2811SLB 13:30-13:59
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coca Cola, Atlanta, GA, by telephone and e-mail, visits and hand delivered letters on/about September 15, 2010.
Manufacturer: Central States Coca Cola Bottling Co., Maryland Heights, MO. Firm initiated recall is ongoing.
REASON
Packs may contain mislabeled cans. Cans labeled as Minute Maid Lemonade Light may actually contain a different product, Minute Maid Lemonade sweetened with High Fructose Corn Syrup.
VOLUME OF PRODUCT IN COMMERCE
521 cases (24/12 oz cans per case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Viactiv Calcium Chews, Caramel, 150 soft chews. Recall # F-2938-2010
CODE
Lot code 0143AG1, best by 11/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mcneil Nutritionals Division, Washington, PA, by telephone followed by hardcopy letter on August 25, 2010
Manufacturer: Bestsweet Inc, Mooresville, NC. Firm initiated recall is ongoing.
REASON
Mislabeling issue; Milk Chocolate flavored chews were packaged into pouches containing Caramel labeling. Undeclared cocoa.
VOLUME OF PRODUCT IN COMMERCE
17,457 pouches
DISTRIBUTION
AR, MA

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
___________________________________
PRODUCT
1) Slim-30(TM) Natural Herb for Weight Loss, Herb Supplement, 30 Capsules bottles, UPC 8 31457 005009 2. Recall # D-914-2010;

2) Joyful Slim(TM) Natural Herb for Weight Loss, Herb Supplement, 30 Capsules bottles, UPC 8 97966 00200 7. Recall # D-915-2010
CODE
1) Code: 032009, 6032101;
2) Code: 101408
RECALLING FIRM/MANUFACTURER
J & H Besta Corp., Hicksville, NY, by press release on July 16, 2010, July 22, 2010 and August 18, 2010. Firm initiated recall is ongoing.
REASON
Marketed without an Approved NDA/ANDA; found to contain undeclared N-desmethy lsibutramine and traces of sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss.
VOLUME OF PRODUCT IN COMMERCE
1) 10,011 bottles; 2) approximately 15,000 bottles
DISTRIBUTION
Nationwide and China
___________________________________
PRODUCT
1) Diene Drone capsules, (Estra-4, 9-diene-3, 17-dione) 50 mg, Enhancement Complex: Milk Thistle 100 mg, Piperine 5 mg, Luteolin 4 mg, 60-count bottle, UPC 893461001194, Product Code: AMS010. Recall # D-920-2010;

2) Liquid Drone UTT anabolic suspension, (Estra-4, 9-diene-3, 17-dione) 12.5 mg, 60 mL bottle, UPC 893461001279, Product Code: AMS014. Recall # D-921-2010;

3) M1, 4AD; Methyl-1,4AD 30mg; (17a-methyl-1, 4-Androstadiene-3,17diol) capsules, 60-count bottle, Product Code: ANF005. Recall # D-922-2010;

4) 1, 4 AD (1, 4 Androstadiene-3, 17-Dione) capsules, 200 mg, 60-count bottle, Product Code: ANF008. Recall # D-923-2010;

5) HyperDROL X2 capsules, (6-BROMODIONE) 50 mg, X2 Support Matrix 260 mg, 120-count bottle, UPC 791851111266, Product Code: ANX001. Recall # D-924-2010;

6) Anabolic Xtreme 3-AD [3-AD Alpha-Trophic Complex; 2-Androstenol Acetate Ester, Androsterone [3a-Hydroxy-5a-Androstan-17-One]; anabolic Xtreme 3-AD Performance Optimization Tri-Matrix; Picamilon, Propionyl L-Carnitine, 11-Alpha[11alpha,20R-dihydroxyecdysone(20%)]; gelatin (capsule); rice filler; flaxseed] capsules, 90-count bottles, Product Code: ANX010. Recall # D-925-2010;

7) Testra Flex capsules, (Estra 4, 9-diene-3, 17-dione) 25 mg, 90-count metal cans, BCS Labs PC 689076771733, Product Code: BCS006. Recall # D-926-2010;

8) M-DROL capsules, (2a 17a di methyl etiocholan 3-one. 17b-ol) 10 mg, 90-count bottles, UPC 891192002015, Product Code: CEL003. Recall # D-927-2010;

9) P-PLEX capsules, (17a-Methyl-etioallocholan-2-ene-17b-ol) 10 mg, 90-count bottles, UPC 891192002046, Product Code: CEL004. Recall # D-928-2010;

10) X-TREN capsules, (19-Noradrosta-4,9 diene-3,17 dione) 30 mg, 90-count bottles, UPC 891192002091, Product Code: CEL010. Recall # D-929-2010;

11) D-DROL capsules, D-Drol Complex 52.5 mg, (2a,17a-dimethyl-5a-androstane-3-one-17b-ol, Estra-4,9-diene-3,17-dione,17a-Methyl-etioallocholan-2-ene-17b-ol), Bergamottin (DHB) 25 mg, Liver Support Complex 300 mg, 60-count bottles, UPC 871938009560, Product Code: FF-022. Recall # D-930-2010;

12) Novedex XT capsules, Proprietary Blend (6, 17-keto-etiocholeve-3-ol tetrahydropyranol), (3,17-keto-etiochol-triene), (3,5,7-trihydroxy-4-methoxyflavone) 60 mg, 60-count bottle, Product Code: GA-001. Recall # D-931-2010;

13) Halodrol Liquigels, (Proprietary Blend of Arachadonic Acid (40% in a proprietary fatty acid/oil blend), 5-ALPHA (5a-etioallocholan-3, 6, 17-trione), DHEA, 20-hydroxy-ecdysterone,-(-)3,4-divanillytetrahydrofuran) 480 mg, 60-count gels per box, Product Code: GA-013. Recall # D-932-2010;

14) 1, 4 AD BOLD 200 capsules, (1,4 Androstadiene-3, 17-dione) 200 mg, 60-count bottles, iFORCE NUTRITION, UPC 854503001145, Product Code: IF0015. Recall # D-933-2010;

15) 2a, 17a Methadrol capsules, (2a 17a di methyl etiocholan 3-one, 17b-ol) 10 mg, 90-count bottles, iFORCE NUTRITION, UPC 854503001152, Product Code: IF0016. Recall # D-934-2010;

16) DYMETHAZINE capsules, 15 mg, 60-count box, iFORCE NUTRITION, UPC 854503001206, Product Code: IF0021. Recall # D-935-2010;

17) MONSTER CAPS capsules, Milk Thistle 150 mg, Proprietary Blend (4-chloro-17a-methyl-etioallocholan-1, 4-diene-3, 17-diol 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one 2a,17a di-methyl etiocholan 3-one, 17b-ol 6,7 Dihydroxybergamottin) 60 mg, 60-count bottles, UPC 689076956505, Product Code: MCP001. Recall # D-936-2010
CODE
All lots and codes
RECALLING FIRM/MANUFACTURER
Musclemaster.com, Inc., Northborough, MA, by press release on January 15, 2010 and by letter on January 19, 2010. Firm initiated recall is ongoing.
REASON
Marketed Without An Approved NDA/ANDA: These products are being recalled because they are marketed as dietary supplements, but have been found to contain steroids or steroid-like substances, making them unapproved new drugs.
VOLUME OF PRODUCT IN COMMERCE
10,230 bottles, boxes and cans
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Vialipro Capsules (Prostancus HCI), Dietary Supplement, 375 mg, 10 count blister packs. Recall # D-937-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Desert Rose Manufacturing Inc., Anthony, NM, by e-mail on July 16, 2010 and by press release on July 19, 2010. Firm initiated recall is ongoing.
REASON
Marketed without an Approved NDA/ANDA: product contains sulfoaildenafil, an analogue of Sildenafil, an active ingredient used in the treatment of erectile dysfunction.
VOLUME OF PRODUCT IN COMMERCE
370,000 capsules
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
Midazolam Injection, USP, 2 mg/2 mL (1 mg/mL), 10 x 2 mL Single-dose Sterile Cartridge Unit with Luer Lock per carton, Rx only, USA, NDC 0409-2306-22. UPC (01) 1 030409 230622 2. Recall # D-916-2010
CODE
Lot 82845LL, Exp 10/01/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc., Lake Forest, IL, by letter dated June 29, 2010.
Manufacturer: Hospira, Inc., McPherson, KS. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: Quality procedures were incomplete prior to the release of the product which could result in cracked vials which could compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
840 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Aloecaine Clear (aka Aloecaine) 4% Lidocaine gel, 1-oz and 8-oz bottles. Recall # D-917-2010;

2) Aloecaine (aka Aloecaine Quick) 4% Lidocaine 20% Benzocaine gel, 1-oz and 8-oz bottles, SkinTherapeutic is a registered trademark of Bionet, Inc. Recall # D-918-2010;

3) Laser Soothe Gel 2% Lidocaine (Pure Aloe Vera, 2% Lidocaine, (Aloe Vera Barbadensis), 1% Carbomer 940, Triethanolamine, Germall II, disodium EDTA, Glydant), 8 oz bottle. Recall # D-919-2010
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Bionet Esthetics, Inc., Little Rock, AR, by telephone, and letter on July 2, 2010. Firm initiated recall is ongoing.
REASON
Marketed Without An Approved NDA/ANDA: Firm was distributing Lidocaine based products as cosmetics.
VOLUME OF PRODUCT IN COMMERCE
1,075 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Lipitor (atorvastatin calcium), tablets, 40 mg, 90 count bottle, Rx Only, NDC 0071-0157-23. Recall # D-939-2010
CODE
Lots 0855020, 0819020, 0842020, 0843020, 0854020; All Exp 01/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY, by letters on August 18, 2010. 
Manufacturers: Pfizer Ireland Pharmaceuticals, Ringaskiddy, Co. Cork, Ireland;
Pfizer Manufacturing Deutschland Gmbh, Freiburg, Germany; Rexam, Las Piedras Puerto Rico. Firm initiated recall is ongoing.
REASON
Chemical Contamination: complaints of an uncharacteristic odor identified as 2, 4, 6 tribromoanisole.
VOLUME OF PRODUCT IN COMMERCE
4,607,808 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Cryoprecipitated AHF, Pooled. Recall # B-2152-10
CODE
Units: 003FG76865; 003FQ84075; 003FQ84081; 003FQ84099; 003FQ84125; 003FQ84149; 003FQ84184; 003FQ84203; 003FQ84298; 003GP07857; 003GP07870; 003GP07872; 003GP08052; 003GP08119; 003GP08184; 003GP08228; 003GZ08064; 003LM38379
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by telephone on May 23, 2009 and by letter on June 3, 2009. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
PA
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-2187-10;
2) Recovered Plasma. Recall # B-2188-10
3) Red Blood Cells Leukocytes Reduced. Recall # B-2189-10
CODE
1), 2), 3) Unit: W044609297561
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on May 12, 2010, May 18, 2010 and June 18, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 Units
DISTRIBUTION
WI, TX, NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2198-10
CODE
Unit: 024KJ10982
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, River Valley Region, Louisville, KY, by facsimile and electronic notification on March 27, 2010 and by letter dated June 8, 2010. 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
KY, CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2224-10;
2) Fresh Frozen Plasma.  Recall # B-2225-10
CODE
1) Units: 72L421772, 72L687445;
2) Units: 72L421772, 72L687445, 72N064249
RECALLING FIRM/MANUFACTURER
Lifesouth Community Blood Centers Inc - Birmingham Region, Birmingham, AL, by fax on February 19, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously indefinitely deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
GA, AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2285-10
CODE
Unit: 53FN52316
RECALLING FIRM/MANUFACTURER
American National Red Cross – Greater Chesapeake & Potomac Region, Baltimore, MD, by facsimile on May 21, 2010, by e-mail on June 15, 2010, and by letter dated June 15, 2010. 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, MD
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-2286-10;
2) Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-2287-10;
3) Red Blood Cells Leukocytes Reduced. Recall # B-2288-10;
4) Platelets Pooled Leukocytes Reduced. Recall # B-2289-10
CODE
1) Units: W120610281619, W120609275022;
2) Unit: W120609384218;
3) Unit: W120609292787;
4) Units: W120610380829, W120609383276
RECALLING FIRM/MANUFACTURER
Michigan Blood, Saginaw, MI, by facsimile on June 21, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received the rabies vaccine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
MI
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2290-10;
2) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2291-10
CODE
1) Unit: W071210006376;
2) Unit: W071209034835 (2 units)
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated June 1, 2010. 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
TN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2292-10
CODE
Unit: 72P032765
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile on July 2, 2010. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2293-10
CODE
Unit: 026FY49391
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by facsimile and electronic notification on June 2, 2010.
Manufacturer: American Red Cross Blood Services, Montgomery, AL. 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, AL
___________________________________
PRODUCT
Source Plasma. Recall # B-2295-10
CODE
Units: 3440023714, 3440023841
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Dayton, OH, by facsimile on July 12, 2010. 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
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2296-10
CODE
Unit: 18FG37422
RECALLING FIRM/MANUFACTURER
American National Red Cross – Great Lakes Region, Lansing, MI, by facsimile and electronic notification on April 7, 2010 and by letter dated April 7, 2010. 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, MI
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2298-10
CODE
Unit: W042209006049* (2 units)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by letter dated July 7, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NV
___________________________________
PRODUCT
Platelets. Recall # B-2299-10
CODE
Unit: W035210148803I
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated July 1, 2010. 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
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2303-10
CODE
Unit: 49LG98700
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW Region – HT, Tulsa, OK, by fax and e-mail on May 19, 2010.
Manufacturer: American National Red Cross Blood Services – SW Region, Waco, TX. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2306-10
CODE
Unit: W137508110097
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by fax on June 10, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-2307-10;
2) Fresh Frozen Plasma. Recall # B-2308-10
CODE
1) and 2) Unit: 4037288
RECALLING FIRM/MANUFACTURER
Hemacare Corp., Van Nuys, CA, by letter dated May 25, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously permanently deferred for unsuitable test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2348-10
CODE
Units: W041609075327D (part a and b), 3922801 (part a and b)
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone and fax on May 26, 2010 and May 28, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MS
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2349-10;
2) Platelets Pooled Leukocytes Reduced. Recall # B-2350-10
CODE
1) Unit: W051710615329; 
2) Unit: W51710802932
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by letter on June 11, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
RI, CT
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2351-10
CODE
Unit: 012FT82432
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by fax and letter on May 12, 2010 and by follow-up letters on May 25, 2010 and June 13, 2010.
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, NC
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-2353-10;
2) Plasma Frozen. Recall # B-2354-10
CODE
1) and 2) Unit: 19LV63595
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services – Tennessee Valley Region, Nashville, TN, by fax and telephone on April 30, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN, OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2358-10
CODE
Unit: W0352101394619
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by telephone and fax on May 14, 2010. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving post donation information concerning drug use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2360-10
CODE
Unit: 72N774099
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on June 15, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Source Plasma. Recall # B-2361-10
CODE
Unit: 0481342966
RECALLING FIRM/MANUFACTURER
CSL Plasma Inc., Tempe, AZ, by e-mail on April 23, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose scheduled physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Germany
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-2363-10;
2) Cryoprecipitated AHF, Pooled. Recall # B-2364-10;
3) Red Blood Cells Leukocytes Reduced. Recall # B-2365-10
CODE
1) and 3) Units: 2613522, 2578779;
2) Unit: 2578779
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax and e-mail on May 5, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2424-10
CODE
Unit: W141610082545
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by letter on June 22, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2426-10
CODE
Unit: W067309026828
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter on June 7, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Cryoprecipitated AHF, Pooled. Recall # B-2427-10
CODE
Unit: W067310500040
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by telephone on May 27, 2010. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2428-10
CODE
Unit: 72P241968
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by fax on July 7, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2429-10
CODE
Unit: 72P341052
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on July 20, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2430-10
CODE
Unit: 72P340541
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on July 20, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2431-10
CODE
Unit: 72N748659
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on July 20, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-2432-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-2433-10
CODE
1) and 2) Unit: 27C06270
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA, by telephone, fax and letter on June 8, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH, WV
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-2440-10
CODE
Unit: 72P325734
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers – Montgomery Region, Montgomery, AL, by fax on July 7, 2010. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2441-10
CODE
Unit: 21FV13508
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by fax on June 19, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-2443-10;
2) Red Blood Cells. Recall # B-2444-10;
3) Platelets. Recall # B-2445-10
CODE
1), 2) and 3) Unit: KC38416
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by fax on June 1, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-2446-10
CODE
Unit: W227710020341
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by telephone on May 28, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Cryoprecipitated AHF, Pooled. Recall # B-2447-10
CODE
Unit: 72Z641145
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by fax on June 21, 2010. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-2448-10;
2) Red Blood Cells. Recall # B-2449-10;
3) Cryoprecipitated AHF. Recall # B-2450-10;
4) Plasma. Recall # B-2451-10
CODE
1) Units: W038509802210, W038509800965;
2) Units: W038509802210, W038509800965, W038508801111, W038508330725;
3) Unit: W03850830725;
4) Units: W038509801111, W038508330725
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on July 9 and 21, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Korea, SC, GA
___________________________________
PRODUCT
Source Plasma. Recall # B-2452-10
CODE
Units: JB0237660, JB0237886, JB0238492, JB0238709, JB0239524, JB0239832, JB0240415, JB0240783
RECALLING FIRM/MANUFACTURER
DCI Biologicals Jonesboro, LLC, Jonesboro, AR, by fax on July 3, 2010 and by e-mail on July 28, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
UK

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2199-10
CODE
Unit: 024KJ10982
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, River Valley Region, Louisville, KY, by facsimile and electronic notification on March 27, 2010 and by letter dated June 8, 2010. 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
KY, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2284-10
CODE
Unit: 53FN52316
RECALLING FIRM/MANUFACTURER
American National Red Cross – Greater Chesapeake & Potomac Region, Baltimore, MD, by facsimile on May 21, 2010, by e-mail on June 15, 2010, and by letter dated June 15, 2010. 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, MD
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2294-10
CODE
Unit: 026FY49391
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by facsimile and electronic notification on June 2, 2010.
Manufacturer: American Red Cross Blood Services, Montgomery, AL. 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, AL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2297-10
CODE
Unit: 18FG37422
RECALLING FIRM/MANUFACTURER
American National Red Cross – Great Lakes Region, Lansing, MI, by facsimile and electronic notification on April 7, 2010 and by letter dated April 7, 2010. 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, MI
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2304-10
CODE
Unit: 49LG98700
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross SW Region – HT, Tulsa, OK, by fax and e-mail on May 19, 2010.
Manufacturer: American National Red Cross Blood Services – SW Region, Waco, TX. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced.  Recall # B-2305-10
CODE
Unit: W036210815475
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on April 20, 2010. Firm initiated recall is complete.
REASON
Blood product, with insufficient red cell preservative solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2352-10
CODE
Unit: 012FT82432
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by fax and letter on May 12, 2010 and by follow-up letters on May 25, 2010 and June 13, 2010.
Manufacturer: American Red Cross Blood Services, Durham, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2355-10
CODE
Unit: W035810305873
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA, by telephone on April 29, 2010. Firm initiated recall is complete.
REASON
Blood product, documented as being out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Platelets Leukocytes Reduced. Recall # B-2356-10
2) Platelets Pooled Leukocytes Reduced. Recall # B-2357-10
CODE
1) Unit: 13GZ89769;
2) Units: 13N32838, 13N32840, 13N32846
RECALLING FIRM/MANUFACTURER
American Red Cross – Southeastern Michigan Region, Detroit, MI, by telephone on April 29, 2010 and fax on April 30, 2010. Firm initiated recall is complete.
REASON
Blood products, possible exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Source Plasma. Recall # B-2362-10
CODE
Unit: 5080053640
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Norfolk, VA, by form on February 2, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-2425-10
CODE
Unit: W0411100809866
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., dba United Blood Services, El Paso, TX, by telephone and fax on June 17, 2010.
Manufacturer: Blood Systems, Inc., McAllen, TX. Firm initiated recall is complete.
REASON
Blood product, which reached an unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-2434-10
CODE
Unit: W037910106376 (part a and b)
RECALLING FIRM/MANUFACTURER
Blood Center of Iowa, Des Moines, IA, by letter on April 30, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a leishmania endemic risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2436-10
CODE
Unit: 06LM72339 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by Logic Report on May 1, 2010 and by fax on May 3, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-2442-10
CODE
Unit: 21FV13508
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by fax on June 19, 2010. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I
___________________________________
PRODUCT
Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog number: 7CBD10. Recall # Z-2425-2010
CODE
Lot numbers: 1057983, 0158170, 0158391, 0158587, 0158739, 0159085, 0159411, 0159499, 0159938, 0161630, and 0161857
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra LifeSciences Corp., Plainsboro, NJ, by fax, e-mail and letter on July 2, 2010.
Manufacturer: Integra Neurosciences Implants S.A., Sophia Antipolis, France. Firm initiated recall is ongoing.
REASON
Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions.
VOLUME OF PRODUCT IN COMMERCE
338 units
DISTRIBUTION
Nationwide, Canada, Taiwan and to Integra, Australia

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT
Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with Alpha Pinnacle 10kVA UPS External Battery Pack. Part numbers: 070200001, 070200011, 070200021; Dimension Vista 1500 and 3000T instruments within the Product Effect. Recall # Z-2423-2010
CODE
Serial number range of B01060900055 through B01090100414R0, excluding B01081100388R0, B01081100389R0, B01081200396R0, B01081200402R0, B01081200403R0, B01081200404R0, B01081200406R0, B01081200408R0, B01081200410R0, B01081200411R0, B01090100412R0, B01090100413R0
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter in May 2010. Firm initiated recall is ongoing.
REASON
Defective batteries used in the Alpha Pinnacle P10 UPS External Battery Pack may overheat and cause a strong sulfuric odor to be released and a corrosive sulfuric acid solution leak to occur.
VOLUME OF PRODUCT IN COMMERCE
228 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Portugal, Slovenia, Spain, and Switzerland
___________________________________
PRODUCT
NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4), immunochemistry Reagent and Kit, For In Vitro Diagnostic use. Catalog number RM-910. Recall # Z-2424-2010
CODE
Lots 9104S911A through 9104S911E and 9104S1001A, Expiration dates November 2011 and January 2012
RECALLING FIRM/MANUFACTURER
Lab Vision Corp., Fremont, CA, by letter dated March 5, 2010. Firm initiated recall is ongoing.
REASON
Two lots may be contaminated with Ki-67 antibody, which could cause abnormal staining patterns, and produce false positive results.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons, UPC #0-57800-23314-5. Recall # Z-2466-2010
CODE
Lot 09DPC24P
RECALLING FIRM/MANUFACTURER
First Quality Hygienic Inc., Elhattan, PA, via telephone and letter on March 25, 2010. Firm initiated recall is ongoing.
REASON
Life Brand Regular Absorbency 40 Count Unscented Plastic Applicator Tampons package contained Super Plus Unscented Plastic Applicator Tampons.
VOLUME OF PRODUCT IN COMMERCE
195 cases/2,340 cartons
DISTRIBUTION
Canada
___________________________________
PRODUCT
Driver Star #8 Cannulated Dart-Fire (TM), Compression Screw, Size: #8, REF: DSDS-0008, 1 Each, Rx only Non-Sterile, EC REP. Recall # Z-2470-2010
CODE
Lot number 040754491
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wright Medical Technology Inc., Arlington, TN, by letter on August 26, 2010.
Manufacturer: Southeastern Technology Inc., Murfreesboro, TN.  Firm initiated recall is ongoing.
REASON
After autoclaving, the epoxy identifier (colored) band bled and there is concern that it may flake.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
TX, PA, TN, VA, GA, and Spain
___________________________________
PRODUCT
1) 7 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900727, Sterile. Usage: Bone Coring Device used in ACL and PCL procedures. Recall # Z-2597-2010;

2) 8 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900728, Sterile. Usage: Bone Coring Device used in ACL and PCL procedures. Recall # Z-2598-2010;

3) 9 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900729, Sterile. Usage: Bone Coring Device used in ACL and PCL procedures. Recall # Z-2599-2010;

4) 10 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900730, Sterile. Usage: Bone Coring Device used in ACL and PCL procedures. Recall # Z-2600-2010;

5) 7 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737, Sterile. Usage: Bone Coring Device used in ACL and PCL procedures. Recall # Z-2601-2010;

6) 8 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900738, Sterile. Usage: Bone Coring Device used in ACL and PCL procedures. Recall # Z-2602-2010;

7) 9 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900739, Sterile. Usage: Bone Coring Device used in ACL and PCL procedures. Recall # Z-2603-2010;

8) 10 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900740, Sterile. Usage: Bone Coring Device used in ACL and PCL procedures. Recall # Z-2604-2010;

9) 8 MM DISPOSABLE CORING TREPHINE STAGGERED TEETH WITH PROTECTION SLEEVE, REF 900788, Sterile. Usage: Bone Coring Device used in ACL and PCL procedures. Recall # Z-2605-2010
CODE
1) Lot # 804350, exp. 11/30/2014;
2) Lot # 648180 and 648200;
3) Lot # 821010 and 821020;
4) Lot # 092620;
5) Lot # 705630;
6) Lot # 648210 and 648220:
7) Lot # 705650 and 804380;
8) Lot # 019900, 019950 and 821060;
9) Lot # 780470
RECALLING FIRM/MANUFACTURER
Biomet, Inc. Warsaw, IN, by letters dated July 1, 2010 and July 15, 2010. Firm initiated recall is ongoing.
REASON
The affected instruments are discolored and/or have a sticky residue on the end.
VOLUME OF PRODUCT IN COMMERCE
626 units
DISTRIBUTION
Nationwide, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan
___________________________________
PRODUCT
Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular Procedure Kits, P/N 3ZZ164275X, 3ZZ164275, CEOT028, CEOT032; and as single sterile units with product codes CV-164275, 164275 and 164275X. CV-164275 is an item number for product that is sold to foreign affiliate. Usage: The Sarns Centrifugal Pump (with X-Coating) is indicated as an extracorporeal blood pump for use in cardiopulmonary bypass procedures. Recall # Z-2606-2010
CODE
Lots: MA04 MA11 MA18 MA25 MC01 MC08 MC15 MC22 MD01 LM12 LM19 LN30 LN23 LP21 LM05 MD22 LP14A LP14 LP14AR MA04R LF04A LM26A LN02A MD29 ME05 MA11R MD15 LE13R LF04R LF11R LF18R LM26T LN02T LN09T LN16T LN23T LN30T LP07T LP14T LP21T MA04T MA11T MA11TA MA18A MA18R MA18T MA18TR MA25R MA25T MA25TA MC01T MC08T MC15T MC22T MD08 MD08T MD22T ME12 ME12T ME19 ME19T
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Corp., Elkton, MD, by telephone, fax, email and mail on March 15, 2010  and May 17, 2010. Firm initiated recall is ongoing.
REASON
Medical device component may malfunction and require user intervention during surgical bypass procedures.
VOLUME OF PRODUCT IN COMMERCE
28,257 pumps
DISTRIBUTION
Nationwide and Japan
___________________________________
PRODUCT
IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the quantitative measurement of IGFBP-3 in serum. This assay is intended for in vitro diagnostic use. Recall # Z-2607-2010
CODE
Lot Numbers: 991017, 991225, 991384, 991694, 991938, 992171, 992372, 992703, 100115A, 100205A, 100205B, 100226A, 100319A, 100409A, 100409B, 100430A and 100521A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on August 09, 2010.
Manufacturer: Diagnostic System Laboratories Inc., Webster, TX, Firm initiated recall is ongoing.
REASON
The recall was initiated after Beckman Coulter confirmed customer reports that IGFBP-3 measurements using IGFBP-3 IRMA kit (REF DSL-6600) lots identified above may result in IGFBP-3 levels that are not in agreement with simultaneously measured levels of IGF-1. The investigation confirmed that above mentioned lots of IGFBP-3 kit provide results elevated by 84% on average. Erroneously elevated IGFBP-3 results, when not reviewed in the light of additional tests (e.g., IGF-1) and the patient's clinical status and history, may affect clinical decisions and patient safety, leading to inadequate administration of growth hormone.
VOLUME OF PRODUCT IN COMMERCE
63 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, 110 cm length. Recall # Z-2608-2010
CODE
Lot 548110, 548227, 548364, 548430, 548554, and 548723
RECALLING FIRM/MANUFACTURER
Vascular Solutions, Inc., Maple Grove, MN, letter dated September 1, 2010. Firm initiated recall is ongoing.
REASON
Recently, it was reported that pouches containing Langston Pigtail catheter (Model 5540) were missing a seal, posing a risk of product contamination. It is possible that a compromised sterile barrier could go unnoticed and the contaminated product could be used on a patient. Use of contaminated product could lead to an infection possibly requiring medication, hospitalization and/or medical intervention. Although there have been no reports of adverse patient events related to this problem considering the potential for harm, Vascular Solutions will remove and replace the affected Langston catheters.
VOLUME OF PRODUCT IN COMMERCE
1,128 (5 pack)
DISTRIBUTION
Nationwide, Singapore, Mexico, Canada, Spain, Austria, Germany, Italy, England and Switzerland
___________________________________
PRODUCT
Access Immunoassay Systems Free T4, Part Number: 33880. Recall # Z-2658-2010
CODE
Lot Number 916293
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on March 24, 2010. 
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
The recall was initiated after Beckman Coulter determined that kit boxes for Access Free T4 reagent (REF 33880), lot number 916293 may contain reagent packs labeled as Access Vitamin B12, (REF 33000), lot 916277. Using an Access Vitamin B12 reagent pack, lot 916277, filled with Access Free T4 reagents may generate incorrect patient results.
VOLUME OF PRODUCT IN COMMERCE
10,827 units
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS:  VETERINARY - CLASS I
___________________________________
PRODUCT
1) Premium Edge Finicky Adult Cat, Net Wt. 18 lbs. (8.16kg). Recall # V-010-2010;

2) Premium Edge Adult Cat Hair Ball Control, Net Wt. 18 lbs. (8.16kg). Recall # V-011-2010;

3) Nutra Gold Finicky Adult Cat (international only), Net Wt/Poids Net 3kg (6.6 lbs). Recall # V-012-2010;

4) Nutra Gold Adult Cat Hair Ball Control (international only), Net Wt/Poids Net 3kg (6.6 lbs). Recall # V-013-2010
CODE
1) RAF0501 (with BB28NOV10 and BB29NOV10) and RAF0802 (with BB30FEB11);
2) RAH0501 (with BB28NOV10 or BB29NOV10);
3) RAF0501 (with BB28NOV10 or BB29NOV10);
4) RAH0501 (with BB28NOV2010, BB29NOV10, BB30NOV10 or BB08DEC10)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diamond Pet Foods, Meta, MO, by telephone and email on/about September 23, 2009, by Website posting On October 16th and by e-mail on October 21, 2009.
Manufacturer: Diamond Pet, Gaston, SC. Firm initiated recall is ongoing.
REASON
Products were found to be thiamine deficient.
VOLUME OF PRODUCT IN COMMERCE
6042 units
DISTRIBUTION
MA, NC, NY, PA, VA, Canada, Croatia, Korea, Latvia, Lithuania, Moscow, Malaysia, Poland, Portugal, Russia, Sweden, Taiwan and Thailand

END OF ENFORCEMENT REPORT FOR OCTOBER 6, 2010

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