• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for May 11, 2011

 

May 11, 2011                                                                                        11-19
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
White Sub 12" Bleached Wheat Flour, Malted Barley Flour, Potassium Bromate. Enriched Flour (Wheat Flour Malted Barley Flour, Niacin, Reduced Iron Thiamin Mononitrate, Riboflavin, Folic Acid) Datem, Dextrose, Soybean Oil. Contains 2% or less of the following: Asorbic Acid, Enzymes (contains wheat flour) L-Cysteine, Azodicarbonamide. Yeast, contains trace quantities of starch and salt. Yellow Vegetable Margarine, partially hydrogenated soybean oil, Water, Partially hydrogenated cottonseed oil, salt, Mono and Diglycerides. Artificial butter flavor. Colored with annatto. Calcium disodium EDTA Added as a preservative Vitamin A Palmitate Added. Flour, Water, Yeast, Sugar, Salt Net Wt 8oz. Recall # F-1015-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Massimos Dallas, Inc., Dallas, TX, by fax on January 26, 2011. FDA initiated recall is ongoing.
REASON
The label failed to declare eggs as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
1,590 units
DISTRIBUTION
TX
___________________________________
PRODUCT   
1) Louie's Alfalfa Sprout Mix, Net Wt 4 oz, (114g) UPC 11324 04401 and 16 oz bag (food service only), UPC 11324 04401. Keep refrigerated, perishable. Ingredients: Alfalfa & Clover Sprout. Recall # F-1019-2011;
 
2) Louie's Clover Sprouts, Net Wt 4 oz, (114g) and 16 oz bag (food service only). Keep refrigerated, perishable. 4 oz cup and 16 oz bag UPC 11324 04406; UPC code is the same due to small amount of sales for bag. Recall # F-1020-2011;
 
3) Louie's Spicy Sprouts, Net Wt 4 oz, (114g); Keep refrigerated, perishable. Ingredients: Radish, Alfalfa & Clover Sprouts; UPC 11325 04402. Recall # F-1021-2011;
 
4) Louie's Broccoli Keep refrigerated perishable. Ingredients: Radish, Alfalfa & Clover Sprouts. UPC 11325 04407. Recall # F-1022-2011
CODE
All product with a Use By date on or before 4/14/11
RECALLING FIRM/MANUFACTURER
Louie Foods International, Fresno, CA, by telephone on March 29, 2011 and press release on March 30, 2011. Firm initiated recall is ongoing.
REASON
USDA random sample revealed the presence of Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
CA
___________________________________
PRODUCT   
Pierre pbjamwich, peanut butter + strawberry jam, 24 oz. cartons containing 12/2 oz. sandwiches, KEEP FROZEN thaw & serve; UPC 0 75999 21368 7. Recall # F-1023-2011
CODE
Best if purchased by 03-11-2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pierre Foods Inc., Cincinnati, OH, by press release on March 11, 2011 and by letter on March 14, 2011.
Manufacturer: Advance Pierre Foods, Easley, SC. Firm initiated recall is ongoing. 
REASON
Positive result of Listeria Monocytogenese in the product.
VOLUME OF PRODUCT IN COMMERCE
318 cs/12/2 oz sandwiches
DISTRIBUTION
PA
___________________________________
PRODUCT
1) PAN DE NUEZ, UPC 95640 00172, INGREDIENTS: Flour, Water, Eggs, Vegetable Shortening, Raisins, Sugar, Salt, Baking Powder, Mexicantown, PAN NUEZ, MTB050 54 count. Recall # F-1024-2011;
 
2) MAGDELENA, Mexicantown Bakery MAGDELENA, UPC 95640 00019, INGREDIENTS: Flour, Water, Eggs, Vegetable Shortening, Raisins, Sugar, Salt, Baking Powder, Mexicantown, MAGDELENA. Recall #F-1025-2011;
 
3) MEXICANTOWN BAKERY PAN DE MAIZ, UPC 95640 0026, INGREDIENTS: Corn Meal, Flour, Water, Eggs, Vegetable oil, Baking Powder, Sugar, Salt, MEXICANTOWN PAN DE MAIZ, MTB008 75 count. Recall # F-1026-2011;
 
4) Mexicantown Bakery YOYO'S, UPC 95640 00050, INGREDIENTS: Flour, Water, Eggs, Vegetable Shortening, Margarine, Sugar, Salt, Baking Powder, YOYO'S (Mexican Sweet Bread) Imported by Mexico Lindo. Recall # F-1027-2011;
 
5) TACOS QUESO PAN DANES, UPC 9560 00186, INGREDIENTS: Flour, Eggs, Water, Vegetable Shortening, Cheese Filling, Sugar, Yeast, Salt, Cinnamon, MEXICANTOWN TACOS QUESO PAN DANES, MTB056 120 count. Recall # F-1028-2011
CODE
1) All Lots/Dates of Manufacturer; 2) – 5) Manufactured date: 6/27/2010-12/28/2010
RECALLING FIRM/MANUFACTURER
Mexicantown Wholesale, Detroit, MI, by press release, telephone, fax, mail and e-mail on April 8, 2011. Firm initiated recall is ongoing.
REASON
The firm is recalling the products due to undeclared pecans and/or milk, wheat, and FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
18,202 units
DISTRIBUTION
MI, Canada
___________________________________
PRODUCT
Shredded Shrimp (Camaron Molido); packaged under the brand names of La Fiesta and Mi Pueblo. Packed in the following sizes: LaFiesta: - . 1 7/8 oz, 3 oz., 6 oz and 8 oz. MiPueblo: 1 3/4 oz, 2 1/2 oz, 6 1/4 oz and 8 oz. La Fiesta Brand UPC Codes: 32327-00150 - 1 7/8 oz; 32327-00181 - 3 oz. 32337-00259 - 6 oz 32327-00420 - 8 oz Mi Pueblo Brand UPC Codes: 00000-10507 - 1 3/4 oz 00000-10509 - 2 1/2 oz 00000-10705 - 6 1/4 oz 01660-07002 - 8 oz. Recall # F-1029-2011
CODE
None
RECALLING FIRM/MANUFACTURER
Fiesta Food Products, Inc., San Jose, CA, by telephone and visit on April 7, 2011 and by press release on April 8, 2011. FDA initiated recall is ongoing.
REASON
FDA Samples showed sulfites at 651 ppm and 667 ppm, which are not declared on ingredient labeling.
VOLUME OF PRODUCT IN COMMERCE
1,755 doz
DISTRIBUTION
CA
___________________________________
PRODUCT
Organic Coriander, Ground, 40 lb boxes: Product of Egypt; Item # 24CORGND. Recall # F-1030-2011
CODE
Lot number: CORT-5153998A-PW-543N Also put in curry blend lot # 03311-032P
RECALLING FIRM/MANUFACTURER
High Quality Organics, Reno, NV, by e-mail on April 21, 2011. Firm initiated recall is ongoing.
REASON
FDA sample found Salmonella species Poly B in coriander.
VOLUME OF PRODUCT IN COMMERCE
97 lbs
DISTRIBUTION
CA, OR
___________________________________
PRODUCT
Signature Collection, Atlantic Smoked Salmon, The Fresh Market, Net Wt. 4 oz. (113g), SGP32; UPC 737094000370. Recall # F-1031-2011
CODE
Lot number: 1459/2
RECALLING FIRM/MANUFACTURER
Woodsmoke Provisions, LLC, Atlanta, GA, by press release on April 22, 2010. Florida initiated recall is ongoing.
REASON
Product may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
160/4 oz. units
DISTRIBUTION
AR, FL, IL, KY, MD, NC, OH and TN
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
The product is Pina Colada flavor yogurt that was mistakenly packaged in cartons for Plain yogurt. The recalled product is in 6 oz plastic tubs labeled in part: "WESTERN FAMILY 1% MILKFAT Low-Fat Yogurt Plain NET WT. 6 oz”. UPC: 15400 112666. Recall # F-1016-2011
CODE
Production Code: 41-37F-2L "BB: 04-28-11"
RECALLING FIRM/MANUFACTURER
Sunshine Dairy Foods Management, LLC, Portland, OR, by telephone and e-mail on April 14, 2011. Firm initiated recall is ongoing.
REASON
Product is mislabeled; Pina Colada flavored yogurt is packaged in cartons labeled Plain yogurt.
VOLUME OF PRODUCT IN COMMERCE
Approx 140 cases each containing 12 6 oz cups.
DISTRIBUTION
CA, OR, MT, ID, WA
___________________________________
PRODUCT   
Big Train Vivaz Horchata Beverage Mix, Item number 655112 packed in 3.5 lb bags, UPC Code 642628012531. Product labeled as: "BIG TRAIN INC. !VIVAZ! Horchata BEVERAGE MIX NET WT 56 oz (3.5 lb) 1.59 kg***". Recall # F-1017-2011
CODE
Lot numbers: 1741001, 2031001, 2911071, 3171015, and 0331137
RECALLING FIRM/MANUFACTURER
Big Train, Inc., Lake Forest, CA, by letter on March 29, 2011. Firm initiated recall is ongoing.
REASON
Product has undeclared wheat in the list of ingredients. People who have allergies to wheat run the risk of allergic reaction if they consume this product.
VOLUME OF PRODUCT IN COMMERCE
927 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT   
La Carreta Fresh Flour Tortillas one dozen. Net wt. 18 oz. (blue label), 28 oz. (red label), 10" burrito, 12" burrito, and snack size. The product consists of a dozen flour tortillas in a sealed plastic bag. There are two different labels used on the packaging. On one label, the principle display panel consists of a white disc with blue lettering. The label reads in part LA *** Carreta MEXICAN STYLE PRODUCTS Fresh FLOUR *** TORTILLAS ONE DOZEN. There is a picture of a wheel barrel being pulled by 2 animals on the top of the label. The principle display panel of the second label consists of a white disc with red lettering. The information present on the white disc is the same as the first label. The words HECHAS A MANO COMO SI FUERAN are written on top over the white disc and LIKE HOMEMADE is written on the bottom of the package under the white disc. Recall # F-1018-2011
CODE
None
RECALLING FIRM/MANUFACTURER
La Carreta Mexican Foods Co., Colton, CA, by telephone and hand delivered letter on April 4, 2011. Firm initiated recall is ongoing.
REASON
The flour tortillas made with lard lists enriched flour as an ingredient and does not declare wheat. Wheat is an allergen that must be declared on the product label.
VOLUME OF PRODUCT IN COMMERCE
4,044 units
DISTRIBUTION
CA
___________________________________
PRODUCT   
1) Tuna Pita w/Mixed Fruit Net wt. 6.5 oz., Keep Refrigerated, Item 958, packaged in a charcoal colored foam box and wrapped with clear plastic film. UPC 5781500958. Recall # F-1061-2011;
 
2) Low Fat Tuna Salad Sandwich Net wt. 5 oz., Keep Refrigerated, Item 963, packaged in a plastic wedge shaped container with clear plastic top seal. UPC 5781500963. Recall # F-1062-2011;
 
3) Healthy Low Fat Tuna Salad Combo Net wt. 4.25 oz., Keep Refrigerated, Item 428, packaged in a clear plastic tray type container with a side of fresh carrots and celery, UPC 5781500428. Recall # F-1063-2011
CODE
Expiration date from 4/16-4/22/2011
RECALLING FIRM/MANUFACTURER
18th Street Deli, Inc., Hamtramck, MI, by email on April 15, 2011. Firm initiated recall is ongoing.
REASON
The finished product label does not declare yellow # 5 but the product contains relish containing yellow # 5.
VOLUME OF PRODUCT IN COMMERCE
198 sandwiches
DISTRIBUTION
MI
___________________________________
PRODUCT   
Very Berry Mix, in 14 oz. in line container, and 14 oz. deli containers, packaged under the following labels Rocky Peanut Company, Inc., Market Fresh Fine Foods, Zeilers Farm Market, Grand River Grocery, Colasantis Market, Market Square, Heartland Marketplace, Randazzo Fresh Market, Busch's Snacks, VC Value Center Marketplace, Jonna's Market, Kazmaier's Perryburg, VG's Fenton, Sautter's, Hollywood Markets, and 25 lb. brown cardboard box with plastic lining. The 14 oz containers are packed 12 per case. UPC for the 14 oz. containers 4338480410 and 4338481410, UPC for the bulk 25 lb container 43384 20240. Recall # F-1064-2011
CODE
No code, the firm is recalling all products.
RECALLING FIRM/MANUFACTURER
Rocky Peanut Company, Inc., Ferndale, MI, by e-mails beginning on March 28, 2011. FDA initiated recall is ongoing.
REASON
The product contains dried papaya chunks. The papaya has FD & C yellow # 5 and yellow # 6. The finish product label does not declare yellow # 5 and yellow # 6.
VOLUME OF PRODUCT IN COMMERCE
374 pounds
DISTRIBUTION
MI, OH
___________________________________
PRODUCT   
Freses Spices Grajeas (Rainbow Sprinkles). Recall # F-1065-2011
CODE
No code on label
RECALLING FIRM/MANUFACTURER
Freses Spic, Santurce, PR, by visit on April 2, 2011 and April 6, 2011. FDA initiated recall is ongoing.
REASON
FD&C Yellow #5 was not declared on the label or ingredient list, discovered on FDA inspection
VOLUME OF PRODUCT IN COMMERCE
72 bottles of 12 oz.
DISTRIBUTION
PR
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT         
1) Simvastatin Tablets USP, 20 mg, a) 1000-count bottle, NDC 0093-7154-10, b) 30-count bottle, NDC 0093-7154-56, Rx only. Recall # D-459-2011;
 
2) Simvastatin Tablets USP, 80 mg, 1000-count bottle, Rx only; NDC 0093-7156-10. Recall # D-460-2011
CODE
1) Lot number: a) 14S228, Exp 6/2011; and, b) 23S031, Exp 11/2012;
2) Lot number 04S406, expiration 5/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on  
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. FDA initiated recall is ongoing.
REASON
CGMP Deviations. Firm's laboratory investigations were not performed in accordance with strict adherence to the "FDA Guidance for Industry - Investigating Out-of-Specification Test Results for Pharmaceutical Production".
VOLUME OF PRODUCT IN COMMERCE
337 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Bacteriostatic Sodium Chloride Injection, USP, 0.9%, 30 mL, multiple dose vials, Rx only, NDC 0517-0648-25. Recall # D-461-2011
CODE
Lot # 9330, Exp 05/11; 9599, Exp 08/11; 9828, Exp 12/11
RECALLING FIRM/MANUFACTURER
Luitpold Pharmaceuticals, Inc., Shirley, NY, by press release and letters dated March 15, 2011. FDA initiated recall is ongoing.  
REASON
Presence of Particulate Matter: some of the vials of these lots may contain visible particles.
VOLUME OF PRODUCT IN COMMERCE
388,725 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) RectaGel HC, Topical Gel, Lidocaine HCl 2.8%; Hydrocortisone Acetate 0.55% Gel, Net wt 20 g, NDC 66663-357-05. Recall # D-462-2011;
 
2) Breckenridge Pharmaceutical, Inc., Bromphenex DM, 16 fl. oz bottles, Rx only, NDC 51991-147-16. Recall # D-463-2011;
 
3) Breckenridge Pharmaceutical Inc., Coldcough PD Syrup C-V, 4 fl. oz bottle, Rx only, NDC 51991-224-04. Recall # D-464-2011; 
 
4) Breckenridge Pharmaceutical Inc., Coldcough Syrup C-III, 16 fl. oz, Rx, NDC 51991-222-16. Recall #D-465-2011;
 
5) Breckenridge Pharmaceutical Inc., OtiRx Ear Drops, 10 mL, Rx, NDC 51991-671-71.  Recall # D-466-2011;
 
6) Breckenridge Pharmaceutical Inc, Dexphen w/C Liquid C-V, 16 fl oz, OTC, NDC 51991-729-16. Recall # D-467-2011;
 
7) CENTUSS DM LIQUID, 16 oz., Rx only, NDC 23359-020-16. Recall # D-468-2011;
 
8) AIRACOF LIQUID C-V, 16 fl. oz, Rx, NDC 23359-019-16. Recall # D-469-2011;
 
9) BroveX Brompheniramine Tannate/ 12 mg Suspension , 16 fl. oz (473 mL) Rx Only NDC 42919-0272-16. Recall # D-470-2011;
 
10) ED A-HIST Liquid, NDC 0485-0055-16, One Pint and NDC 0485-0055-01, 1 fl. oz, Rx. Recall # D-471-2011;
 
11) ED A-HIST Liquid, 1 pint, OTC, NDC 00485-0155-16. Recall # D-472-2011; 
 
12) ED-A-HIST DM, NDC 0485-0071-16, One Pint Rx, and NDC 0485-0071-30, 1 fl. oz Rx. Recall # D-473-0211;
 
13) MYCI-GC, NDC 0276-4510-08, 8 fl. oz, OTC; and MYCI-GC, NDC 0276-4510-04, 4 fl. oz. OTC. Recall # D-474-2011;
 
14) ED-APAP Children's, 8 fl oz, OTC, NDC 0485-0057-08. Recall # D-475-2011;
 
15) Ed ChlorPed Pediatric Drops, 2 fl oz; Rx, NDC 0485-0094-02. Recall # D-476-2011;
 
16) Ed ChlorPed Pediatric Drops, NDC 0485-0074-02, Rx, 2 fl oz; and NDC 0485-0074-10, Rx, 2 mL. Recall # D-477-2011;
 
17) ENDACOF AC syrup, 4 fl.oz, RX, NDC 68047-138-04. Recall # D-478-2011;
 
18) ENDACOF - C Liquid, 16 fl. oz, RX, NDC 68047-145-16. Recall # D-479-2011;
 
19) ENDACOF - DC Liquid, 16 fl. oz; Rx, NDC 68047-0148-16. Recall # D-480-2011;
 
20) ENDACOF - DH Liquid, 16 fl. oz, Rx, NDC 68047-139-16. Recall # D-481-2011;
 
21) ENDACOF - PD Pediatric Drops, 1 fl oz, Rx, NDC 68047-010-30. Recall # D-482-2011;
 
22) ExeClear-C Syrup, 16 fl oz, Rx, NDC 68047-222-16. Recall # D-483-2011;
 
23) ExeClear-DM Syrup, 16 fl oz, OTC, NDC 68047-120-16. Recall # D-484-2011;
 
24) LoHist D, 16 fl. oz., OTC, NDC 68047-120-16. Recall # D-485-2011;
 
25) LoHist PD Pediatric Drops, 1 fl. oz., Rx, NDC 68047-011-30. Recall # D-486-2011;
 
26) NoHist PDX Drops, 1 fl. oz., RX, NDC 68047-015-30. Recall # D-487-2011;  
 
27) NoHist-PE Syrup, 16 fl. oz., RX, NDC 68047-169-16. Recall # D-488-2011;  
 
28) Z-TUSS DM, 1 Pint, Rx, NDC 58407-810-16. Recall # D-489-2011;
 
29) Z-TUSS AC CV, NDC 58407-0755-16, Rx, 1 Pint; NDC 58407-0920-16, Rx, 1 Pint; and NDC 58407-0755-10, Rx, 10
mL. Recall # D-490-2011;
 
30) Z-Xtra Gel, 4 fl. oz., OTC, NDC 58407-303-04. Recall # D-491-2011;
 
31) Poly Tan DM Suspension, 1/2 fl oz, Rx, NDC 50991-710-15. Recall # D-492-2011;
 
32) Poly Tan D Suspension, 1/2 fl oz, Rx, NDC 50991-817-15. Recall # D-493-2011;
 
33) Brompheniramine, Maleate 1 mg Drops, 1 fl oz., RX, NDC 68032-324-21. Recall # D-494-2011;
 
34) Brompheniramine Maleate 1 mg Pseudoephedrine HCl, 7.5 mg Drops, 1 fl oz., RX, NDC 68032-325-21. Recall # D-495-
2011;
 
35) RE-DRYLEX Syrup, 16 fl. oz; RX, NDC 68032-211-16. Recall # D-496-2011;
 
36) Reme Hist DM, One Pint, RX, NDC 68032-192-16. Recall # D-497-2011;
 
37) Reme Hist DM Cough Syrup, One Pint, RX, NDC 68032-191-16. Recall # D-498-2011
CODE
1) Lot numbers: 08123, 08124, 09003, 08124, 09003;
2) Lot numbers: 08108, 09020, 09042, 09084, 10029;
3) Lot numbers: 08111UL, 08122UL, 08127UL, 09028UL, 09030UL, 09038UL, 09044UL, 09049UL, 09063UL, 09078UL, 09079UL, 09088UL, 09105UL, 09106UL, 10003UL, 10004UL;
4) Lot numbers: 08115, 08125, 09013, 09019, 09027, 09029, 09040, 09076;
5) Lot numbers: 09017, 09026, 09032, 09045, 09051, 09054, 09061, 09062, 09071, 10005, 10006, 10012;
6) Lot numbers: 10016, 10017, 10018;
7) Lot numbers: 09091, 09092, 09093;
8) Lot numbers: 09100, 09101, 09102;
9) Lot number: 08085;  
10) Lot numbers: 08102, 08106, 08120, 09018, 09031, 09037, 09041, 09052, 09053, 09074, 09075, 09077, 09083, 09096;
11) Lot numbers: 10019, 10027, 10028;  
12) Lot numbers: 08101, 08110, 08113, 08114;
13) Lot number: 08112;
14) Lot numbers: 09004, 09066, 09067, 10002;
15) Lot numbers: 10024 and 10031;
16) Lot number: 08081;
17) Lot number: 09001;
18) Lot numbers: 09046, 09047, 09048, 10007, 10008, 10009;
19) Lot numbers: 09057, 09058, 09059, 09094, 09095, 10025, 10026;
20) Lot numbers 09068, 09069, 09070, 09104;
21) Lot numbers: 08109, 08117, 08119, 09050, 09056, 09090, 09103;
22) Lot numbers: 08103, 10010;
23) Lot numbers: 08105, 09015, 09081, 09086, 09098;
24) Lot numbers: 08126, 09014, 09055, 09082, 09087, 10011, 10013;
25) Lot numbers: 09007, 09008, 09010, 09085, 09099;
26) Lot numbers: 09034, 09035, 09036;
27) Lot numbers: 09022, 09023;
28) Lot numbers: 09002, 09065, 09089, 09097, 10001;
29) Lot numbers: 09006, 09025, 10032;
30) Lot numbers: 09039, 09080;
31) Lot number: 08078;
32) Lot number: 08079;
33) Lot number: 08074;
34) Lot number: 08075;
35) Lot numbers: 09009, 09011, 09012;
36) Lot numbers: 08128, 09016, and 09043;
37) Lot numbers: 08107, 08116, 08118, 08121, 09005, 09021, and 09033
RECALLING FIRM/MANUFACTURER
Deltex Pharmaceuticals, Inc., Rosenberg, TX, by letter on February 12, 2011. FDA initiated recall is ongoing.  
REASON
CGMP Deviations: Firm failed to comply with current good manufacturing practice requirements.
VOLUME OF PRODUCT IN COMMERCE
794,021 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT         
Metformin Hydrochloride Tablets, USP 500 mg, 1000-count bottle, Rx only, NDC 0093-1048-10. Recall # D-501-2011
CODE
Lot # 35201115A, Exp 10/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on March 23, 2011.
Manufacturer: Novopharm Ltd., Scarborough Ontario, Canada. Firm initiated recall is ongoing.
REASON
Failed Tablet Hardness: Some tablets may not meet friability specification.
VOLUME OF PRODUCT IN COMMERCE
6,494 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
CYTARABINE Injection, 2 g/20 mL (100 mg/mL), 20 mL single dose vial, Rx only; Product 102020, NDC 63323-120-20, UPC 3 63323-120-20 7. Recall # D-508-2011
CODE
Lot # 6101204, Exp 03/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: App Pharmaceuticals, LLC, Schaumburg, IL, by letters dated February 11, 2011.
Manufacturer: App Pharmaceuticals, LLC, Melrose Park, IL. Firm initiated recall is ongoing.
REASON
Crystallization: APP has received customer complaints of the presence of particulate matter described as precipitation/crystallization in the vials of Cytarabine Injection.
VOLUME OF PRODUCT IN COMMERCE
7,629 vials
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Valturna (aliskiren and valsartan) Tablets 300 mg/320 mg -- 300 mg aliskiren and 320 mg valsartan per tablet -- 7 Tablets -- Physician Sample - Not For Sale -- NDC 0078-9574-89 -- Rx only. Recall # D-499-2011
CODE
Lot F0003 (JUN 2011)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Pharmaceuticals Corp., Suffern, NY, by letter dated March 24, 2011. 
Manufacturers: Novartis Pharma Stein AG, Stein, Switzerland;
Novartis Pharmaceuticals Corp., Suffern, NY.
Firm initiated recall is ongoing.
REASON
Failed USP dissolution test requirements.
VOLUME OF PRODUCT IN COMMERCE
43,360 shellpacs (7 tablets per shellpacs)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT         
HICON(tm), Sodium Iodide I-131 solution USP, 1000 mCi fill size, Product #502880, NDC number 65174-880-00. Recall # D-500-2011
CODE
Lot number 70663; expiration date 3/1/11
RECALLING FIRM/MANUFACTURER
Draxis Specialty Pharmaceutical Inc., Kirkland Quebec, Canada, by telephone on February 6, 2011, and by letters on February 10, 2011 and February 11, 2011. Firm initiated recall is complete.
REASON
Incorrect expiration date.
VOLUME OF PRODUCT IN COMMERCE
20 vials of 1000 mCi
DISTRIBUTION
Nationwide
___________________________________
PRODUCT         
1) EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, 20 mg/0.8 mg, 100 count bottle, Rx only; NDC 60793-430-01. Recall # D-502-2011;
 
2) EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, 30 mg/1.2 mg, 100 count bottle, Rx only; NDC 60793-431-01. Recall # D-503-2011;
 
3) EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, 50 mg/2 mg, 100 count bottle, Rx only; NDC 60793-433-01. Recall # D-504-2011;
 
4) EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, 60 mg/2.4 mg, 100 count bottle, Rx only; NDC 60793-434-01. Recall # D-505-2011;
 
5) EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, 80 mg/3.2 mg, 100 count bottle, Rx only; NDC 60793-435-01. Recall # D-506-2011
 
6) EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, 100 mg/4 mg, 100 count bottle, Rx only; NDC 60793-437-01. Recall # D-507-2011
CODE
1) Lot number: 422K91, Exp. 07/11; Lot number: 423K91; Exp. 07/11; Lot number: 424K91, Exp. 07/11; Lot number: 425K91, Exp. 9/11; Lot number: 427K91, Exp. 9/11; Lot number: 788E01, Exp. 12/11;
 
2) Lot number: 461K91, Exp. 07/11; Lot number: 462K91, Exp. 09/11; Lot number: 463K91, Exp. 09/11; Lot number: 215C01, Exp. 12/11; Lot number: 787E01, Exp. 12/11;
 
3) Lot number: 453K91, Exp. 07/11; Lot number: 454K91, Exp. 07/11; Lot number: 456K91, Exp. 09/11; Lot number: 222C01, Exp. 12/11; Lot number: 223C01, Exp. 12/11;
 
4) Lot number: 428K91, Exp. 07/11; Lot number: 429K91, Exp. 07/11; Lot number: 431K91, Exp. 09/11; Lot number: 216C01, Exp. 12/11; Lot number: 217C01, Exp. 12/11;
 
5) Lot number: 224C01, Exp: 12/11; Lot number: 225C01, Exp: 12/11;
 
6) Lot number: 464K91, Exp: 07/11; Lot number: 465K91, Exp: 07/11; Lot number: 466K91, Exp: 09/11; Lot number: 235C01, Exp: 12/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals Inc., Bristol, TN, by letter beginning on March 10, 2011.
Manufacturer: Actavis Elizabeth LLC, Elizabeth, NJ. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Stability data do not support the acceptance criteria for related compounds through the product's labeled expiry.
VOLUME OF PRODUCT IN COMMERCE
106,113 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT         
Critic-Aid� Skin Paste 2.5 oz/71 g with lot number 2441567, NDC 11701-050-33 and 6 oz/170g with lot number 2461319, NDC, 11701-050-32; Recall # D-509-2011
CODE
Units: 2441567 and 2461319
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coloplast Manufacturing US, LLC, Minneapolis, MN, by telephone and letter on November 24, 2010.
Manufacturer: Coloplast Manufacturing US, LLC, Mankato, MN. Firm initiated recall is ongoing.
REASON
Product lacks stability: Recent observations and stability testing conducted by Coloplast showed a slight separation within the Critic-Aid Skin Paste formulation which may result in varying concentrations of the active ingredient, petrolatum.
VOLUME OF PRODUCT IN COMMERCE
38,004 containers ((3167 cases)
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT         
1) Red Blood Cells. Recall # B-1215-11;
2) Plasma Frozen. Recall # B-1216-11
CODE
1) and 2) Unit: W071910008550
RECALLING FIRM/MANUFACTURER
So Ca Permamente Med Group Blood Donor Center, Los Angeles, CA, by facsimile and letter on February 01, 2011. 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
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1217-11
CODE
Units: 012GK53420; 012GK52735
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by electronic notification and telephone on July 13, 2007. 
Manufacturer: Whole Blood Collections-Fixed Site-Carolinas Region, Johnson City, Johnson City, TN. Firm initiated recall is complete.  
REASON
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, NC
___________________________________
PRODUCT         
1) Platelets Pheresis Leukocytes Reduced. Recall # B-1235-11;
2) Red Blood Cells (Apheresis). Recall # B-1236-11;
3) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1237-11;
4) Fresh Frozen Plasma (Apheresis). Recall # B-1238-11
CODE
1) Units: FM16083, FM16085, FM23853, FM16158, FM16180, FM25344 (part 1), FM25344 (part 2), FM25353, FM16234, FM16235 (part 1), FM16235 (part 2), FM16235 (part 3);
2) Units: FM16085, FM16180;
3) Unit: FM16085;
4) Unit: FM16180
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on August 19, 2004, October 25, 2004 and October 28, 2004. Firm initiated recall is complete. 
REASON
Blood products, collected from unsuitable donors based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
CA, TN, MA, AZ
___________________________________
PRODUCT         
1) Fresh Frozen Plasma. Recall # B-1239-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1240-11;
3) Platelets Leukocytes Reduced. Recall # B-1241-11
CODE
1), 2) and 3) Unit: 032KV53672
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by letter on February 1, 2007. 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
3 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1242-11
CODE
Unit: 17FM13662
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, Saint Paul, MN, by facsimile on November 19, 2007. Firm initiated recall is complete.  
REASON
Blood product, mislabeled as to antigen phenotype, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT         
1) Cryoprecipitated AHF. Recall # B-1243-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1244-11;
3) Platelets. Recall # B-1245-11
CODE
1) Unit: W0352103357069;
2) Units: W0352103357069; W035208244377V;
3) Unit: W035208244377V
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on February 7, 2011, by letter February 25, 2011, and by e-mail on February 28, 2011. 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
4 units
DISTRIBUTION
Austria, TX
___________________________________
PRODUCT         
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1258-11; 
2) Red Blood Cells Leukocytes Reduced. Recall # B-1259-11;
3) Plasma Frozen within 24 hours (FP24). Recall # B-1260-11
CODE
1) Unit: W038110230992;
2) and 3) Unit: W038110180734
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by letter on January 26, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had a history of receiving a tattoo within twelve months of the donations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Leukocytes Reduced. Recall # B-1272-11
CODE
Units: 032KV60392; 032KV60393; 032KV60394; 032KV60396; 032KV60403; 032KV60404; 032KV60407; 032KV60408; 032KV60411; 032KV60416
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by facsimile on May 3, 2007. Firm initiated recall is complete.
REASON
Blood products, with low platelet counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
IL, WI, MN
___________________________________
PRODUCT         
Source Plasma. Recall # B-1275-11
CODE
Units: 07JWIE6717; 07JWIE6226; 07JWIE5416; 07JWIE4636; 07JWIE4074; 07JWIE2386; 07JWIE1783; 07JWID7602; 07JWID7072; 07JWID2830; 07JWID2280; 07JWID1683; 07JWID1149; 07JWID0420; 07JWIC9864; 07JWIC9102; 07JWIC8527; 07JWIC7817 06JWID8466; 06JWID8869; 06JWIE0195; 06JWIE0828 ; 06JWIE1608; 06JWIE1927; 06JWIE2619; 06JWIE2943; 06JWIE3592 ; 06JWIE4190; 06JWIE4779; 06JWIE5392; 06JWIE5762; 06JWIE6218; 06JWIE6577; 07JWIA0385; 07JWIA0858; 06JWIA1602; 07JWIA2048; 07JWIA3215; 07JWIA3495; 07JWIA4652; 07WIA5096; 07JWIB1404 ; 07JWIB1837; 07JWIB2611; 07JWIB3529; 07JWIB3976; 07JWIC4846; 07JWIC5307; 07JWIC5970; 07JWIC6517; 07JWIC7252; 07JWIB5981; 07JWIB7770 07JWIB8514; 07JWIB9064; 07JWIC0083; 07JWIC0561; 07JWIC1550; 07JWIC2286; 07JWIC2808; 07JWIC3548; 07JWIC4104
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield, IL, by facsimile on December 7, 2007.
Manufacturer: BioLife Plasma Services, L.P., Janesville, WI. 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
62 units
DISTRIBUTION
Austria, CA
___________________________________
PRODUCT         
1) Red Blood Cells Leukocytes Reduced. Recall # B-1276-11;
2) Plasma Frozen within 24 hours (FP24). Recall # B-1277-11
CODE
1) and 2) Unit: 12X45280
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated August 13, 2009. 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-1279-11
CODE
Unit: 032GM25543
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by facsimile on October 3, 2007. Firm initiated recall is complete.  
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA, CA
___________________________________
PRODUCT         
1) Red Blood Cells Leukocytes Reduced. Recall # B-1282-11;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1283-11
CODE
1) Units: 032LF76057; 032LJ25213;
2) Units: 032LF76057; 032LX79431
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Madison, WI, by fax and electronic notification on August 1, 2007. 
Manufacturer: American Red Cross - Dubuque Facility, Dubuque, IA. 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
4 units
DISTRIBUTION
WI, CA, MI, ME
___________________________________
PRODUCT         
Red Blood Cells Leukocytes Reduced. Recall # B-1285-11
CODE
Units: W115910048804; W115910056611
FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by electronic mail and facsimile on March 29, 2011. Firm initiated recall is complete.
REASON                                                                                                                             
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT         
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1286-11
CODE
Unit: W051510130501
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by letter on January 27, 2011.  
Manufacturer: Memorial Blood Centers, Minneapolis, MN. Firm initiated recall is complete.
REASON
Blood product, did not meet the acceptable product specifications for release, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT         
Red Blood Cells Leukocytes Reduced. Recall # B-1213-11
CODE
Unit: W035211026107O
RECALLING FIRM/MANUFACTURER
Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by telephone on February 7, 2011. Firm initiated recall is complete. 
REASON
Blood product, collected from a donor with an incorrect documented body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1218-11
CODE
Unit: 012GK53420
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, by electronic notification and telephone on July 13, 2007. 
Manufacturer: Whole Blood Collections-Fixed Site-Carolinas Region, Johnson City, Johnson City, TN. Firm initiated recall is complete.  
REASON
Blood product, collected from a donor for which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, NC
___________________________________
PRODUCT         
Recovered Plasma. Recall # B-1246-11 
CODE
Units: W0352103357069; W035208244377V
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on February 7, 2011, by letter February 25, 2011, and by e-mail on February 28, 2011. 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
Austria, TX
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1278-11
CODE
Unit: 032GM25543
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by facsimile on October 3, 2007. Firm initiated recall is complete. 
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA, CA
___________________________________
PRODUCT         
Source Plasma. Recall # B-1280-11
CODE
Units: 3560048567, 3560049517, 3560057110, 3560057709, 3560060858, 3560042587, 3560044361, 3560048246, 3560049171, 3560036229, 3560037060, 3560037881, 3560038743, 3560039516, 3560040474, 3560041293, 3560042291, 3560043241, 3560044184, 3560045441, 3560045959, 3560046987, 3560047835, 3560049408, 3560049904, 3560051291, 3560053582, 3560054489, 3560056920, 3560057237, 3560061016, 3560061957, 3560063241, 3560065291, 3560066106, 3560067446, 3560068475, 3560069330, 3560070512, 3560071422, 3560073224, 3560074282, 3560075311, 3560080096, 3560042753, 3560043642, 3560044407, 3560045392, 3560048033, 3560048719, 3560050535, 3560051228, 3560052413, 3560052975, 3560054216, 3560054956, 3560056152, 3560056868, 3560058106, 3560058755, 3560059950, 3560063967, 3560064676, 3560066032, 3560066883, 3560068031, 3560068682, 3560070088, 3560070692, 3560072062, 3560073012, 3560074104, 3560075258, 3560076385, 3560077961, 3560079650, 3560080647, 3560082414, 3560083005, 3560085442, 3560032245, 3560033046, 3560033990, 3560034929, 3560035754, 3560075476, 3560076236, 3560081636, 3560082640, 3560083577, 3560049910, 3560050796, 3560044440, 3560044983, 3560046164, 3560046857, 3560048420, 3560048839, 3560051374, 3560052329, 3560053393, 3560054121, 3560055578, 3560056482, 3560057390, 3560058417, 3560059936, 3560060705, 3560062003, 3560062555, 3560042711, 3560064834, 3560067056, 3560077882, 3560081520, 3560082589, 3560032601, 3560033091, 3560034798, 3560035409, 3560039135, 3560040400, 3560040876, 3560042430, 3560042996, 3560044031, 3560048696, 3560049645, 3560050495, 3560051909, 3560052840, 3560061847, 3560062631, 3560064180, 3560064931, 3560066439, 3560067859, 3560068645, 3560070029, 3560048039, 3560051828, 3560057043, 3560069189, 3560069953, 3560073912, 3560074661, 3560075928, 3560076789, 3560078836, 3560079297, 3560080671, 3560081651, 3560082720, 3560084551, 3560040556, 3560041217, 3560042424, 3560043007, 3560043991, 3560044516, 3560049040, 3560037757, 3560038317, 3560043307, 3560050968, 3560053521, 3560054670, 3560037601, 3560038213, 3560039396, 3560040253, 3560041042, 3560042194, 3560044972, 3560045632, 3560046675, 3560047423, 3560049837, 3560050483, 3560052447, 3560053054, 3560054284, 3560055049, 3560045601, 3560057386, 3560070268, 3560070996, 3560072355, 3560073056, 3560034051, 3560034747, 3560035650, 3560036297, 3560039953, 3560040481, 3560042303, 3560039319, 3560039920, 3560041116, 3560041753, 3560044618, 3560045307, 3560046404, 3560047143, 3560048312, 3560048987, 3560050248, 3560052325, 3560053018, 3560054169, 3560054833, 3560056465, 3560057673, 3560058355, 3560059462, 3560060144, 3560042754, 3560043234, 3560044300, 3560045120, 3560046136, 3560046826, 3560048307, 3560049023, 3560057116, 3560057744, 3560030714, 3560031509, 3560032250, 3560033048, 3560033929, 3560034749, 3560036260, 3560050119, 3560053808, 3560057913, 3560039110, 3560040108, 3560057227, 3560058922, 3560062970, 3560064372, 3560064972, 3560034181, 3560034607, 3560041191, 3560046861, 3560047369, 3560048561, 3560049466, 3560050468, 3560055250, 3560060690, 3560061777, 3560033205, 3560033591, 3560034632, 3560035228, 3560036152, 3560036804, 3560037809, 3560038484, 3560039730, 3560040247, 3560041489, 3560041996, 3560047985, 3560049216, 3560049916, 3560051099, 3560052932, 3560057880, 3560058713, 3560064993, 3560065723, 3560043224, 3560044218, 3560044815, 3560046260, 3560047279, 3560045647, 3560046333, 3560057071, 3560061815, 3560063781, 3560068338, 3560077583, 3560079545, 3560080229, 3560081550, 3560082209, 3560030512, 3560031257, 3560033459, 3560045372, 3560046357, 3560047585, 3560060619, 3560069227, 3560069937, 3560073322, 3560032743, 3560033310, 3560034273, 3560034910, 3560036320, 3560037536, 3560038188, 3560039341, 3560040032, 3560060903, 3560062202, 3560066218, 3560067304, 3560072559, 3560073158, 3560074554, 3560046725, 3560048761, 3560051833, 3560066047, 3560047644, 3560049181, 3560045631, 3560045812, 3560047734, 3560048814, 3560049615, 3560050728, 3560051320, 3560052597, 3560053213, 3560054473, 3560055166, 3560056508, 3560057156, 3560058268, 3560058940, 3560060117, 3560060862, 3560062067, 3560062839, 3560064212, 3560064880, 3560066172, 3560067090, 3560068198, 3560069591, 3560071722, 3560082055, 3560082522, 3560084583, 3560043275, 3560049882, 3560050966, 3560053519, 3560054669, 3560060664, 3560046820, 3560084423, 3560032525, 3560033072, 3560034174, 3560035785, 3560036329, 3560040616, 3560045602, 3560046063, 3560051989, 3560053027, 3560056745, 3560059099, 3560060280, 3560061486, 3560062260, 3560064901, 3560065403, 3560040516, 3560040978, 3560046364, 3560047071, 3560048301, 3560048873, 3560050210, 3560050834, 3560052523, 3560052923, 3560048196, 3560048790, 3560050020, 3560050732, 3560051859, 3560052938, 3560054063, 3560054748, 3560055953, 3560056657, 3560057903, 3560058587, 3560059747, 3560060460, 3560061697, 3560062407, 3560065341, 3560066165, 3560067484, 3560068187, 3560071876, 3560072644, 3560073964, 3560074756, 3560076154, 3560076972, 3560078156, 3560078875, 3560080146, 3560080871, 3560082120, 3560040798, 3560041306, 3560042783, 3560043460, 3560045744, 3560046996, 3560049445, 3560050383, 3560051332, 3560052227, 3560062807, 3560063700, 3560065230, 3560066472, 3560067374, 3560068450, 3560069321, 3560070488, 3560071380, 3560072552, 3560073490, 3560074679, 3560075644, 3560077037, 3560077702, 3560079014, 3560079668, 3560081185, 3560033088, 3560036543, 3560032269, 3560039095, 3560039567, 3560043129, 3560044391, 3560045105, 3560046852, 3560052702, 3560053345, 3560054563, 3560055128, 3560030254, 3560030688, 3560031721, 3560032201, 3560033344, 3560033821, 3560036538, 3560037037, 3560039172, 3560039649, 3560040913, 3560041997, 3560043450, 3560047731, 3560049725, 3560050971, 3560051934, 3560054692, 3560055247, 3560056359, 3560057012, 3560058295, 3560058902, 3560044939, 3560047931, 3560048437, 3560050501, 3560051712, 3560052327, 3560053504, 3560057378, 3560058020, 3560061819, 3560065500, 3560066333, 3560071660, 3560032486, 3560033256, 3560034084, 3560036084, 3560041087, 3560041696, 3560042834, 3560043487, 3560044538, 3560045186, 3560047073, 3560048352, 3560049067, 3560072443, 3560073704, 3560078767, 3560040985, 3560041986, 3560045094, 3560045613, 3560031318, 3560031733, 3560037303, 3560038198, 3560044284, 3560049800, 3560050500, 3560051683, 3560052343, 3560053629, 3560054622, 3560030055, 3560030457, 3560033255, 3560033632, 3560039601, 3560040331, 3560030999, 3560031535, 3560032702, 3560033338, 3560047376, 3560047792, 3560051634, 3560052479, 3560053992, 3560054917, 3560055875, 3560056838, 3560059763, 3560060613, 3560062593, 3560035999, 3560036541, 3560037893, 3560038521, 3560039597, 3560040212, 3560043694, 3560045009, 3560045496, 3560047318, 3560048161, 3560050094, 3560050814, 3560051960, 3560052634, 3560054160, 3560054858, 3560056061, 3560056740, 3560059817, 3560030550, 3560030771, 3560048252, 3560049013, 3560051264, 3560051496, 3560053099, 3560053696, 3560055009, 3560044552, 3560051343, 3560066021, 3560066687, 3560068397, 3560084569, 3560036073, 3560036670, 3560037617, 3560038346, 3560039394, 3560040153, 3560042866, 3560045040, 3560046735, 3560047474, 3560048689, 3560041048, 3560062841, 3560063750, 3560065838, 3560067609, 3560068235, 3560039136, 3560040061, 3560044105, 3560044938, 3560046435, 3560043355, 3560043942, 3560049924, 3560050768, 3560029940, 3560030834, 3560041235, 3560041736, 3560048592, 3560049523, 3560051556, 3560052079, 3560053978, 3560048213, 3560049017, 3560051442, 3560052041, 3560053327, 3560054610, 3560055721, 3560056463, 3560057723, 3560058451, 3560059527, 3560060274, 3560061469, 3560062209, 3560064528, 3560065547, 3560066818, 3560069653, 3560070467, 3560071696, 3560072527, 3560073773, 3560074579, 3560077435, 3560078359, 3560079631, 3560080417, 3560032887, 3560033426, 3560034349, 3560035056, 3560036008, 3560036652, 3560037641, 3560038401, 3560039347, 3560040069, 3560041176, 3560041830, 3560042963, 3560043644, 3560044646, 3560045386, 3560046455, 3560047221, 3560048276, 3560049025, 3560050181, 3560050915, 3560052408, 3560052976, 3560054265, 3560054955, 3560056147, 3560056823, 3560058145, 3560058767, 3560059929, 3560060711, 3560061921, 3560062708, 3560063909, 3560064619, 3560066031, 3560066908, 3560068061, 3560068738, 3560070776, 3560072093, 3560072778, 3560074201, 3560074939, 3560076449, 3560077113, 3560081023, 3560082330, 3560083056, 3560040530, 3560044231, 3560053540, 3560054138, 3560057268, 3560057941, 3560059104, 3560060158, 3560061358, 3560062080, 3560063347, 3560064089, 3560065792, 3560066640, 3560068826, 3560069404, 3560072340, 3560072988, 3560038077, 3560039065, 3560039656, 3560044304, 3560045010, 3560046100, 3560046727, 3560036569, 3560037035, 3560046681, 3560047945, 3560049019, 3560030975, 3560032403, 3560057192, 3560060825, 3560030762, 3560031138, 3560032297, 3560032785, 3560034373, 3560049931, 3560050594, 3560051639, 3560047088, 3560048574, 3560034734, 3560035305, 3560036254, 3560037876, 3560038641, 3560039609, 3560040347, 3560042103, 3560043154, 3560043842, 3560044892, 3560045611, 3560046686, 3560047382, 3560048527, 3560049311, 3560050411, 3560051175, 3560052242, 3560052962, 3560054206, 3560055162, 3560056057, 3560057105, 3560057994, 3560058965, 3560059819, 3560060854, 3560061797, 3560062805, 3560063736, 3560064840, 3560065855, 3560036019, 3560036544, 3560037658, 3560038295, 3560039312, 3560039954, 3560041391, 3560042131, 3560043202, 3560043829, 3560046393, 3560047035, 3560048183, 3560048853, 3560050215, 3560051169, 3560052006, 3560053050, 3560053888, 3560054795, 3560056020, 3560056782, 3560057985, 3560058704, 3560059842, 3560060647, 3560061747, 3560063807, 3560065883, 3560066781, 3560067984, 3560068728, 3560069803, 3560070624, 3560034497, 3560035030, 3560035983, 3560037389, 3560038003, 3560039098, 3560039596, 3560043027, 3560044546, 3560045308, 3560046645, 3560047447, 3560044424, 3560045143, 3560046257, 3560046926, 3560049819, 3560050593, 3560051761, 3560052436, 3560077657, 3560078310, 3560079644, 3560080282, 3560040458, 3560041097, 3560042903, 3560044276, 3560044918, 3560040768, 3560029919, 3560030525, 3560031425, 3560031950, 3560033145, 3560033619, 3560034698, 3560035215, 3560036549, 3560037603, 3560038255, 3560047153, 3560047608, 3560048876, 3560049487, 3560050807, 3560051415, 3560052773, 3560053240, 3560054663, 3560032797, 3560033323, 3560034292, 3560034926, 3560035887, 3560036494, 3560037515, 3560039216, 3560034824, 3560036001, 3560049808, 3560050772, 3560048283, 3560048983, 3560046746, 3560047395, 3560049682, 3560030616, 3560030904, 3560032120, 3560032557, 3560033705, 3560034185, 3560042376, 3560044081, 3560045664, 3560046076, 3560047441, 3560048260, 3560049334, 3560051509, 3560052155, 3560047738, 3560048102, 3560029959, 3560030562, 3560034066, 3560034650, 3560037375, 3560038004, 3560041171, 3560041939, 3560043031, 3560044756, 3560045258, 3560047262, 3560048370, 3560049039, 3560050299, 3560050994, 3560052157, 3560055536, 3560056129, 3560063166, 3560064365, 3560079561, 3560044592, 3560047131, 3560050925, 3560051512, 3560039390, 3560043284, 3560048514, 3560049680, 3560049960, 3560051778, 3560052375, 3560053690, 3560054381, 3560055530, 3560061869, 3560062648, 3560045663, 3560045877, 3560049617, 3560050235, 3560053959, 3560054657, 3560050168, 3560050757, 3560068130, 3560069723, 3560071107, 3560071566, 3560073473, 3560074638, 3560075646, 3560046711, 3560050692, 3560047867, 3560049443, 3560037628, 3560038199, 3560049900, 3560051633, 3560038319, 3560038834, 3560034748, 3560035524, 3560037131, 3560037696, 3560038197, 3560039308, 3560040004, 3560033104, 3560034105, 3560030743, 3560031759, 3560034133, 3560037136, 3560038915, 3560045942, 3560032868, 3560033699, 3560034457, 3560035323, 3560040858, 3560041305, 3560043123, 3560085231, 3560085725, 3560086749, 3560087704, 3560039099, 3560040494, 3560041366, 3560063155, 3560064087, 3560038193, 3560038822, 3560054468, 3560058304, 3560060824, 3560063013, 3560066276, 3560069842, 3560071209, 3560078877, 3560079807, 3560080914, 3560039054, 3560040110, 3560056232, 3560056845, 3560057976, 3560058838, 3560060001, 3560065202, 3560066017, 3560067557, 3560068656, 3560034035, 3560040979, 3560053460, 3560054456, 3560055636, 3560056353, 3560057551, 3560058285, 3560059397, 3560060122, 3560041253, 3560041724, 3560047938, 3560049844, 3560057445, 3560058473, 3560065538, 3560078110, 3560033154, 3560033894, 3560034930, 3560035899, 3560036608, 3560037932, 3560048867, 3560049508, 3560051120, 3560052297, 3560053040, 3560054294, 3560054813, 3560056160, 3560056974, 3560047113, 3560048623, 3560049567, 3560050531, 3560051695, 3560053481, 3560054477, 3560055712, 3560056402, 3560058201, 3560058785, 3560059975, 3560060646, 3560061928, 3560062613, 3560063961, 3560064634, 3560065908, 3560066730, 3560067914, 3560068764, 3560070593, 3560032221, 3560032674, 3560033968, 3560034542, 3560035640, 3560036233, 3560037258, 3560037800, 3560039199, 3560039850, 3560041092, 3560041627, 3560049823, 3560050874, 3560051706, 3560057931, 3560058660, 3560059851, 3560060622, 3560061796, 3560062570, 3560063794, 3560064694, 3560065868, 3560066842, 3560068043, 3560039918, 3560040786, 3560042331, 3560043253, 3560044556, 3560045303, 3560046448, 3560047130, 3560048251, 3560048922, 3560050167, 3560051016, 3560052124, 3560052819, 3560054570, 3560055508, 3560056531, 3560057736, 3560058454, 3560059467, 3560060207, 3560061484, 3560062169, 3560065087, 3560065864, 3560068036, 3560068663, 3560070452, 3560039618, 3560040638, 3560041911, 3560042508, 3560044189, 3560046185, 3560047229, 3560048020, 3560049146, 3560049718, 3560051285, 3560053689, 3560055579, 3560056645, 3560015136, 3560015474, 3560016354, 3560016749, 3560041035, 3560041634, 3560042803, 3560043445, 3560044526, 3560045212, 3560046321, 3560047004, 3560060851, 3560061347, 3560062778, 3560063335, 3560064761, 3560065364, 3560067492, 3560068190, 3560069405, 3560070194, 3560071492, 3560072300, 3560047599, 3560048185, 3560051162, 3560051417, 3560053269, 3560053827, 3560055882, 3560058987, 3560060018, 3560060887, 3560061961, 3560062925, 3560063921, 3560064817, 3560071230, 3560072014, 3560073289, 3560074218, 3560075435, 3560076439, 3560077637, 3560078400, 3560079540, 3560080362, 3560047905, 3560048656, 3560051538, 3560052123, 3560053348, 3560053998, 3560057114, 3560057848, 3560059055, 3560060336, 3560061994, 3560062501, 3560074797, 3560075599, 3560077255, 3560078715, 3560079567, 3560081450, 3560083126, 3560084749, 3560046766, 3560047407, 3560049733, 3560050455, 3560052001, 3560052733, 3560053755, 3560054591, 3560055752, 3560056360, 3560059762, 3560060655, 3560063920, 3560051767, 3560052493, 3560055573, 3560056378, 3560057666, 3560058639, 3560102791, 3560041458, 3560032274, 3560033391, 3560034153, 3560034947, 3560035738, 3560036552, 3560037347, 3560038209, 3560039028, 3560039957, 3560041121, 3560041905, 3560042924, 3560043527, 3560044585, 3560045267, 3560046413, 3560047189, 3560048334, 3560049036, 3560050115, 3560050827, 3560051908, 3560052716, 3560053880, 3560054629, 3560055862, 3560056524, 3560057735, 3560058372, 3560059491, 3560060288, 3560061432, 3560062226, 3560063417, 3560064174, 3560048053, 3560048476, 3560049743, 3560050412, 3560051611, 3560052340, 3560055387, 3560056063, 3560060996, 3560061661, 3560063253, 3560063998, 3560065294, 3560066132, 3560067435, 3560068596, 3560069373, 3560070870, 3560071466, 3560072874, 3560080468, 3560081065, 3560082431, 3560036053, 3560040751, 3560041823, 3560042543, 3560043508, 3560044315, 3560045192, 3560046050, 3560047065, 3560047844, 3560049047, 3560049751, 3560050805, 3560052596, 3560053484, 3560054504, 3560055337, 3560056411, 3560057298, 3560058688, 3560059438, 3560061047, 3560062092, 3560063009, 3560064070, 3560065072, 3560066329, 3560067284, 3560068365, 3560069186, 3560070279, 3560071236, 3560072403, 3560073295, 3560074438, 3560075390, 3560076620, 3560077568, 3560078663, 3560079515, 3560080999, 3560081843, 3560083301, 3560083783, 3560034461, 3560035492, 3560035917, 3560037287, 3560037901, 3560040378, 3560040599, 3560042276, 3560042689, 3560048732, 3560049287, 3560051273, 3560051421, 3560053149, 3560053250, 3560055038, 3560055289, 3560056744, 3560057174, 3560047623, 3560048126, 3560051372, 3560052245, 3560054180, 3560055183, 3560057468, 3560057966, 3560059500, 3560061550, 3560063137, 3560064276, 3560074200, 3560074887, 3560076392, 3560077133, 3560081236, 3560082719, 3560083261, 3560040371, 3560040926, 3560042011, 3560042627, 3560043702, 3560044364, 3560045609, 3560046154, 3560047288, 3560047969, 3560049221, 3560049831, 3560051184, 3560051679, 3560052969, 3560053640, 3560054779, 3560055335, 3560056709, 3560038247, 3560039355, 3560040046, 3560041163, 3560041858, 3560042888, 3560043510, 3560044481, 3560045229, 3560049887, 3560051195, 3560051741, 3560053049, 3560054403, 3560054913, 3560056298, 3560057433, 3560058794, 3560059205, 3560060637, 3560073918, 3560074850, 3560077178, 3560078119, 3560078990, 3560079946, 3560081045, 3560082076, 3560083066, 3560047987, 3560048915, 3560051791, 3560052761, 3560054246, 3560055711, 3560057693, 3560058505, 3560061554, 3560062298, 3560063604, 3560064335, 3560066285, 3560067352, 3560069522, 3560071284, 3560072609, 3560073833, 3560074459, 3560076022, 3560076906, 3560080087, 3560080739, 3560081965, 3560038221, 3560039356, 3560040041, 3560041158, 3560041856, 3560042876, 3560043509, 3560044643, 3560045350, 3560046475, 3560037732, 3560039452, 3560040202, 3560041203, 3560042179, 3560044740, 3560045692, 3560047749, 3560048342, 3560050280, 3560053536, 3560054322, 3560055531, 3560056237, 3560057456, 3560058501, 3560059676, 3560060411, 3560061629, 3560062396, 3560065728, 3560066506, 3560039304, 3560039917, 3560041119, 3560041754, 3560044620, 3560045309, 3560046405, 3560047158, 3560048317, 3560048988, 3560050553, 3560051202, 3560052347, 3560053021, 3560054172, 3560054838, 3560056467, 3560057676, 3560058357, 3560059466, 3560060145, 3560066343, 3560067250, 3560068391, 3560069719, 3560070442, 3560071525, 3560072902, 3560074905, 3560077173, 3560079532, 3560081654, 3560082725, 3560083573, 3560034393, 3560037228, 3560037711, 3560039481, 3560040116, 3560041245, 3560042497, 3560043902, 3560045431, 3560046905, 3560047801, 3560049099, 3560049679, 3560050997, 3560053403, 3560054961, 3560055263, 3560057856, 3560060058, 3560061745, 3560062713, 3560039291, 3560039878, 3560040987, 3560041678, 3560043118, 3560043727, 3560045203, 3560045925, 3560047014, 3560047589, 3560049200, 3560049470, 3560051152, 3560051350, 3560053125, 3560054584, 3560055690, 3560056388, 3560058365, 3560059601, 3560060156, 3560061503, 3560062166, 3560063824, 3560064545, 3560066102, 3560066705, 3560068281, 3560068941, 3560070236, 3560070919, 3560072393, 3560074029, 3560075857, 3560076730, 3560081948, 3560082652, 3560038337, 3560048204, 3560048882, 3560050681, 3560051514, 3560052376, 3560053262, 3560054231, 3560055482, 3560056540, 3560057786, 3560060074, 3560060917, 3560061918, 3560063161, 3560064213, 3560065135, 3560066263, 3560067217, 3560068295, 3560069133, 3560070206, 3560071202, 3560072341, 3560073367, 3560074535, 3560075405, 3560076624, 3560079757, 3560080477, 3560042736, 3560043288, 3560045107, 3560045895, 3560046793, 3560047724, 3560048694, 3560050884, 3560051426, 3560052803, 3560053635, 3560054989, 3560055445, 3560057780, 3560058784, 3560060043, 3560060726, 3560062024, 3560062706, 3560063740, 3560064606, 3560066155, 3560066798, 3560068138, 3560068672, 3560073176, 3560076560, 3560044329, 3560045233, 3560046037, 3560047031, 3560047848, 3560048914, 3560049742, 3560050981, 3560051771, 3560052752, 3560053683, 3560054624, 3560055539, 3560056585, 3560057857, 3560058544, 3560059679, 3560060403, 3560061644, 3560062735, 3560063584, 3560064450, 3560065707, 3560083461, 3560032755, 3560033330, 3560035470, 3560036860, 3560038166, 3560040755, 3560041847, 3560042593, 3560043563, 3560044331, 3560045289, 3560046104, 3560046988, 3560048018, 3560049123, 3560064636, 3560064980, 3560069010, 3560070253, 3560071741, 3560072714, 3560074312, 3560074896, 3560076487, 3560077126, 3560078518, 3560078904, 3560080181, 3560080968, 3560082189, 3560082888, 3560084109, 3560045073, 3560045780, 3560046663, 3560048270, 3560055840, 3560056566, 3560063471, 3560065444, 3560067656, 3560071412, 3560072555, 3560075905, 3560076792, 3560038038, 3560038675, 3560039698, 3560040563, 3560041402, 3560042335, 3560043201, 3560044067, 3560044886, 3560045798, 3560046684, 3560047670, 3560048523, 3560049565, 3560050651, 3560051427, 3560052286, 3560053203, 3560054176, 3560055121, 3560056042, 3560057016, 3560057972, 3560058976, 3560059941, 3560060835, 3560061761, 3560062801, 3560063732, 3560064809, 3560065836, 3560066955, 3560067882, 3560068872, 3560070086, 3560073003, 3560074051, 3560075125, 3560042643, 3560043254, 3560044232, 3560044850, 3560046015, 3560046625, 3560048012, 3560048703, 3560049840, 3560050578, 3560051796, 3560052494, 3560053660, 3560054342, 3560055564, 3560056268, 3560058931, 3560059561, 3560061199, 3560061917, 3560063044, 3560063978, 3560065257, 3560066085, 3560067255, 3560067904, 3560069600, 3560070342, 3560072992, 3560074623, 3560076457, 3560078393, 3560040210, 3560040950, 3560041964, 3560042757, 3560043968, 3560044713, 3560045777, 3560046597, 3560047548, 3560048431, 3560049607, 3560050349, 3560051789, 3560052191, 3560054400, 3560055048, 3560056303, 3560056947, 3560058893, 3560059735, 3560061009, 3560061681, 3560062931, 3560063640, 3560065720, 3560066519, 3560067818, 3560068514, 3560069786, 3560070566, 3560071858, 3560073229, 3560073939, 3560076072, 3560076991, 3560078147, 3560038116, 3560039776, 3560041528, 3560042645, 3560054259, 3560055022, 3560056284, 3560056925, 3560058075, 3560059624, 3560060793, 3560062321, 3560063854, 3560065293, 3560066873, 3560068018, 3560071146, 3560072605, 3560076089, 3560076941, 3560047080, 3560048187, 3560048869, 3560052643, 3560053239, 3560054493, 3560055130, 3560056401, 3560057290, 3560058305, 3560059089, 3560060165, 3560061086, 3560062087, 3560063010, 3560064095, 3560065038, 3560066221, 3560067203, 3560068244, 3560069169, 3560071210, 3560072359, 3560073274, 3560074411, 3560075425, 3560076696, 3560077595, 3560078587, 3560079509, 3560080563, 3560081497, 3560082908, 3560083476, 3560045046, 3560045840, 3560046779, 3560049522, 3560050451, 3560051358, 3560052265, 3560053315, 3560054506, 3560055346, 3560056368, 3560057279, 3560058307, 3560059161, 3560060114, 3560061024, 3560062104, 3560063094, 3560064179, 3560065106, 3560066224, 3560067201, 3560068269, 3560069138, 3560070269, 3560071265, 3560072419, 3560073290, 3560074442, 3560075880, 3560076669, 3560077859, 3560053927, 3560038018, 3560039366, 3560040865, 3560041507, 3560042688, 3560044147, 3560046165, 3560049060, 3560050261, 3560051411, 3560055846, 3560057464, 3560058123, 3560059637, 3560060384, 3560061977, 3560062703, 3560063721, 3560065560, 3560066464, 3560067764, 3560068366, 3560071125, 3560071697, 3560073733, 3560074699, 3560076107, 3560076742, 3560077965, 3560078640, 3560080098, 3560080836, 3560039584, 3560040189, 3560041287, 3560041968, 3560043092, 3560043664, 3560044809, 3560045466, 3560046596, 3560047278, 3560048429, 3560049141, 3560050348, 3560051054, 3560052871, 3560054060, 3560054749, 3560055948, 3560056659, 3560057896, 3560058576, 3560059744, 3560060456, 3560061695, 3560062409, 3560063662, 3560064476, 3560065748, 3560066547, 3560069124, 3560069899, 3560071182, 3560071871, 3560073261, 3560073962, 3560075397, 3560076150, 3560077558, 3560078157, 3560079500, 3560080147, 3560083684, 3560083909, 3560084686, 3560052188, 3560032494, 3560033269, 3560034228, 3560034886, 3560035848, 3560036452, 3560041608, 3560042510, 3560043385, 3560044201, 3560045973, 3560046913, 3560047803, 3560048758, 3560049685, 3560050695, 3560051416, 3560052507, 3560053263, 3560054394, 3560055292, 3560056300, 3560057220, 3560058537, 3560058961, 3560061002, 3560062389, 3560064985, 3560065715, 3560067158, 3560067804, 3560069092, 3560069777, 3560071162, 3560071821, 3560073227, 3560073935, 3560075337, 3560076065, 3560077492, 3560078106, 3560079418, 3560080081, 3560081378, 3560082061, 3560039541, 3560040745, 3560042281, 3560044310, 3560045221, 3560046005, 3560047007, 3560047838, 3560049064, 3560050186, 3560050788, 3560052259, 3560053181, 3560054821, 3560056082, 3560056683, 3560058033, 3560058598, 3560060103, 3560060610, 3560062046, 3560062571, 3560064034, 3560065001, 3560066537, 3560067186, 3560068579, 3560070620, 3560071895, 3560072659, 3560074007, 3560074759, 3560076193, 3560077021, 3560078163, 3560078881, 3560080153, 3560080867, 3560041303, 3560049622, 3560050040, 3560051321, 3560052091, 3560053173, 3560053977, 3560055063, 3560055632, 3560056980, 3560057553, 3560058901, 3560059412, 3560060808, 3560061318, 3560062758, 3560063295, 3560064893, 3560065351, 3560067099, 3560067485, 3560069129, 3560069799, 3560071190, 3560071878, 3560073253, 3560073973, 3560075625, 3560076182, 3560077718, 3560078725, 3560079719, 3560041317, 3560042279, 3560043098, 3560043970, 3560044821, 3560045734, 3560046609, 3560047552, 3560048660, 3560049430, 3560050360, 3560051322, 3560052686, 3560053209, 3560054515, 3560055191, 3560056349, 3560056978, 3560058275, 3560058892, 3560060127, 3560042632, 3560043493, 3560044669, 3560045366, 3560046319, 3560047195, 3560048305, 3560048825, 3560050052, 3560050749, 3560051879, 3560052576, 3560053983, 3560054442, 3560055627, 3560056343, 3560057614, 3560058274, 3560059574, 3560060131, 3560061353, 3560062111, 3560063298, 3560064046, 3560065387, 3560066214, 3560067529, 3560068272, 3560069457, 3560070190, 3560071509, 3560072329, 3560073585, 3560074393, 3560075777, 3560076646, 3560077869, 3560047637, 3560048569, 3560050601, 3560051529, 3560053950, 3560055821, 3560056588, 3560057806, 3560059179, 3560059901, 3560061080, 3560062093, 3560063114, 3560064314, 3560065175, 3560066331, 3560067392, 3560069315, 3560070017, 3560071370, 3560072086, 3560075612, 3560076383, 3560079690, 3560081632, 3560082322, 3560042943, 3560043560, 3560044801, 3560045454, 3560046943, 3560047812, 3560048776, 3560049782, 3560050720, 3560051847, 3560052528, 3560053712, 3560054408, 3560057246, 3560057893, 3560059385, 3560060449, 3560061686, 3560062399, 3560063652, 3560064378, 3560065742, 3560066531, 3560067809, 3560068525, 3560069781, 3560070550, 3560073563, 3560074335, 3560075738, 3560076590, 3560082108, 3560082825, 3560047405, 3560047872, 3560049193, 3560049783, 3560051182, 3560053056, 3560068752, 3560069206, 3560050131, 3560051780, 3560057355, 3560058406, 3560063518, 3560064348, 3560065692, 3560066473, 3560071109, 3560071837, 3560073220, 3560049834, 3560050512, 3560051796, 3650053691, 3560054204, 3560056246, 3560063370, 3560064188, 3560079865, 3560042606, 3560043104, 3560044406, 3560044950, 3560046214, 3560047260, 3560048027, 3560049296, 3560050654, 3560051165, 3560052543, 3560053116, 3560054241, 3560070912, 3560072187, 3560052551, and 3560053223
RECALLING FIRM/MANUFACTURER
Recalling Firm: Talecris Plasma Resources, Inc., Research Triangle Park, NC, by fax between February 25, 2009 and August 28, 2010.
Manufacturer: Talecris Plasma Resources, Inc., San Antonio, TX. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2,228 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1281-11
CODE
Unit: 032KP65882
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by facsimile on May 30, 2007. Firm initiated recall is complete.
REASON
Blood product, for which the quality control testing was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT         
Recovered Plasma. Recall # B-1284-11
CODE
Units: 032LF76057; 032LJ25213; 032LX79431; 032LX79431
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Madison, WI, by fax and electronic notification on August 1, 2007. 
Manufacturer: American Red Cross - Dubuque Facility, Dubuque, IA. 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
4 units
DISTRIBUTION
WI, CA, MI, ME
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT         
LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Electronic patient records management system.  Model Product Number LANTIS COMMANDER 4503178 LANTIS System 5835991 LANTIS Commander 6.1 5493072 LANTIS 6.1 Complete 8147527 LANTIS 6.1 Essential 8147535 LANTIS 8.3 Complete 8147543 LANTIS 8.3 Essential 8147550 LANTIS 8.3 Commander 8148178. Recall # Z-2151-2011
CODE
Model number only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letter on March 23, 2011.
Manufacturer: Impac Medical Systems Inc., Sunnyvale, CA. Firm initiated recall is ongoing.
REASON
There is a potential safety issue in regard to data transfer between LANTIS OIS system and the hospital Information System (HIS) when the HL7 (ADT) interfact is used.
VOLUME OF PRODUCT IN COMMERCE
47
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) Argon Medical Devices Catheter Introducer Kit, PCI 5 Kit 7F, Part Number 496183, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters. Recall # Z-2083-2011;
 
2) Argon Medical Devices, Catheter Introducer Kit, Argon PCI Kit with Feather Dilator - Pediatric, 4F, Part Number 496308, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters. Recall # Z-2084-2011;
 
3) Argon Medical Devices Catheter Introducer Kit, PCI Kit with Feather Dilator - Pediatric, 6F, Part Number 496310, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters. Recall # Z-2085-2011;
 
4) Argon Medical Device Catheter Introducer Kit, Argon PCI Kit with Feather Dilator - Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters. Part Number 496311. Recall # Z-2086-2011;
 
5) Argon Medical Devices Catheter Introducer Kit, One-Piece/Tuohy-Borst Catheter Introducer Tray 8F, Part number 497444. Recall # Z-2087-2011;
 
6) Argon Medical Devices Arterial Line Kit/1 20ga x 6", Part Number 498100, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2088-2011;
 
7) Argon Medical Devices, Arterial Line Kit, Arterial Catheter Mini Kit 20gax6in, Part Number 498101, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2089-2011;
 
8) Argon Medical Devices, Arterial Line Kit/1 18ga x 6", Part Number 498104, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2090-2011;
 
9) Argon Medical Devices, Arterial Line Kit/1, 20ga x 3", Part Number 498106, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2091-2011;
 
10) Argon Medical Devices Arterial Line Kit/1, 18ga x 3", Part Number 498110, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2092-2011;
 
11) Argon Medical Devices, Arterial Line Kit, 20ga x 3", Part Number 498411B, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2093-2011;
 
12) Argon Medical Devices Arterial Line Kit, 20ga x 1.75", Part Number 498418, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall #Z-2094-2011;
 
13) Argon Medical Devices, Arterial Line Kit, Arterial Catheter Mini Kit, 20GX3in, Part Number 498435, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2095-2011;
 
14) Argon Medical Devices, Arterial Line Kit, 18ga x 6", Part Number 498443, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2096-2011;
 
15) Argon Medical Devices, Catheter Introducer Kit 5F, Part Number 496190A, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters. Recall # Z-2097-2011;
 
16) Argon Medical Devices, Arterial Line Kit, Part Number 498410B, 20gax6", Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall #Z-2098-2011;
 
17) Argon Medical Devices Arterial Line Kit, 18ga x 6", Part Number 498412B, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2099-2011;
 
18) Argon Medical Devices, Arterial Line Kit 20ga x 3", Part Number 498421B, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall #Z-2100-2011;
 
19) Argon Medical Devices, Arterial Line Kit/1, 18ga x 6", Part Number 498447, Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Recall # Z-2101-2011
CODE
1) Lot number: 99767488;
2) Lot number: 99767641;
3) Lot number: 99767643;   
4) Lot number: 99768100;
5) Lot number: 99766895;
6) Lots numbers: 99767185, 99767266, and 99768223;
7) Lot number: 99767264;
8) Lot numbers: 99767186 and 99768103;
9) Lot numbers: 99767187 and 99767388;
10) Lot numbers: 99768048 and 99768520;
11) Lot number: 99767966;
12) Lot number: 99738059;
13) Lot number: 99738059;
14) Lot number: 99767778;
15) Lot number: 99766894;
16) Lot number: 99766894;
17) Lot number: 99767958;
18) Lot number: 99766896;
19) Lot number: 99767634
RECALLING FIRM/MANUFACTURER
Argon Medical Devices, Inc., Athens, TX, by letter dated March 14, 2011. Firm initiated recall is ongoing.
REASON
Packaging for sterile tray has the potential to have a hole which could compromise sterility for the products inside.
VOLUME OF PRODUCT IN COMMERCE
5,780 units
DISTRIBUTION
Nationwide, Japan, Australia, Canada, Singapore, and the Netherlands
___________________________________
PRODUCT         
UniCel DxH 800 Coulter Cellular Analysis System Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides: - Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood - Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF). Recall # Z-2128-2011
CODE
All serial numbers, SW version 1.1.3.0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated October 20, 2010. 
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
Body Fluids results may be incorrectly interpreted by the Laboratory Information System (LIS). Body Fluid results ~ 1,000 celis/uL are reported using the US numeric separators to demark thousandths places (comma, ",") and partial units (decimal, "."). An LIS that uses non-US formats could interpret the comma as a partial units separator, which could lead to reporting erroneously low body fluid results. For example, if the LIS format uses commas to denote partial units, the figure transmitted as "1,586" (one thousand five hundred eighty-six) could be interpreted at the LIS as "1,6" (one and six tenths). IMPACT: Specimens with Body Fluid results ~1000 cells/uL could be reported erroneously low in the LIS. The impact of erroneously low results could be most severe in relation to cerebral spinal fluid (CSF) analysis. This could potentially result in a misdiagnosis or a delay in diagnosis that could affect patient management leading to permanent injury. A long-term delay in the diagnosis of an acute event may result in neurological sequelae such as acute meningitis or cerebral hemorrhage.
VOLUME OF PRODUCT IN COMMERCE
422 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Catheter Insertion Kit (containing, Under pad, PVP Pad, BZK Prep Pad, Sterile Lubricating Jelly, Vinyl Gloves and Poly Zipper Bag). Intended usage: Kit components to be used during Intermittent Urinary Catheterizations. Catalog Reference number: 6100A. Recall # Z-2133-2011
CODE
Lot numbers: 8315, 9317, 0317, 9G176, 0C046, 0G226, 0K186, 1A316, 8316, 9318, 0318, 9G206, 0C086, 0G236, 0K196, 1B016, 8317, 9320, 0319, 9G236, 0C096, 0G246, 0K206, 1B026, 8319, 9321, 0320, 9G286, 0C106, 0G296, 0K226, 1B036, 8320, 9324, 0321, 9G296, 0C186, 0G306, 0K236, 1B046, 8321, 9325, 0322, 9H066, 0C196, 0H216, 0K246, 1B056, 8324, 9326, 0323, 9H076, 0C206, 0H226, 0K256, 1B076, 8325, 9327, 0324, 9H086, 0C226, 0H266, 0K286, 1B186, 8326, 9328, 0325, 9H126, 0C236, 0H276, 0K296, 1B196, 8327, 9329, 0326, 9H176, 0C256, 0H286, 0K306, 1B176, 8329, 9340, 0327, 9H236, 0C266, 0I166, 0L036, 1B196, 8340, 0301, 0328, 9H246, 0C276, 0I176, 0L046, 1B216, 8341, 0302, 0329, 9H256, 0D076, 0I186, 0L066, 1B226, 8342, 0303, 0330, 0A186, 0D086, 0I206, 0L076, 1B236, 9301, 0304, 0331, 0A196, 0D096,0I256, 0L086, 1C016, 9302, 0305, 0332, 0A206, 0D106, 0I276, 0L096, 1C026, 9304, 0306, 1302, 0A216, 0D126, 0J236, 0L226, 1C036, 9305, 0307, 1303, 0A226, 0E086, 0J256, A196 and 1C046
RECALLING FIRM/MANUFACTURER
Apogee Medical, Inc., Youngsville, NC, by letter dated March 23, 2011. FDA initiated recall is ongoing.
REASON
Kits contain PVP (Providone Iodine) prep pads that are being recalled by the Triad Group due to possible micro contamination, Elizabethkingia meningoseptica.
VOLUME OF PRODUCT IN COMMERCE
5,503,430 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery system; REF 2C1071KJP The Infusor device is indicated for patients requiring slow, continuous intravenous, intra-arterial, epidural, or subcutaneous administration of medications; a) Product code 2C1071KJP, b) product code 2C1073KJP. Recall # Z-2146-2011
CODE
a) and b) Lot 10H054
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, by letters dated March 15, 2011.
Manufacturer: Baxter Healthcare Corp., Irvine, CA. Firm initiated recall is ongoing.
REASON
Some of the Single Day Infusor System 2 mL/h have a foil over-pouch that was incorrectly labeled as the Half Day Infusor System 5 mL/h, product code 2C1073KJP, lot 10H054.
VOLUME OF PRODUCT IN COMMERCE
3,696 units
DISTRIBUTION
Nationwide, Mexico and Spain
___________________________________
PRODUCT         
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029 The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial). Recall # Z-2148-2011
CODE
All Serial Numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter dated February 11, 2011.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
The recall was initiated because: The DxH 800 may fail to meet the carryover specification for NRBC% when the WBC is greater than 50 X 10 to the 3rd power cells/micro L (50 X 10 to the 9th power cells/L) Beckman Coulter indicated the NRBC% carryover is unlikely to have clinical impact.
VOLUME OF PRODUCT IN COMMERCE
566 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT         
Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected sub-components Numbers: (1) 10434968, Boom Welding; (2) 10434969, Arm Welding; The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging the breast allows volumetric acquisition of the breast image. It provides the operator with the option of using a controlled user independent automated scan motion. The resulting 3D display information enables comprehensive image review by the medical professional. In particular, the coronal plane is scanned, which is not easily accessible with hand-held ultrasound transducers. Recall # Z-2150-2011
CODE
Serial Numbers: 1) 250157, 250162, 250163, 250164, 250166, 250167 and 250169; 2) 250171, 250173, 250177
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by telephone and e-mail on March 28, 2011. Firm initiated recall is complete.
REASON
The weld connecting the ABVS arm to the system base has the potential to fail, causing the arm to fall off of the unit.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide, Portugal, Germany, Russia, Estonia, Brazil, France, and Saudi Arabia
___________________________________
PRODUCT         
Allied Healthcare Products Inc. CarbO2Lime Carbon Dioxide Absorbent Granules for Canister Refill, Non-Hygroscopic Soda Lime USP-NF, Type: High Moisture (12% to 19%), Granule Size: 4 to 10 Mesh (4.8-2.0mm), packaged in 5-gal. pails, #55-01-0003; prepacked canisters (12 canisters/case), #55-01-0005; and replacement bags (12 bags/case), #55-01-0006, RX. The product is a non-hygroscopic soda lime compound that is specially formulated to absorb carbon dioxide from the respiratory gas stream in anesthesia applications. Recall # Z-2152-2011
CODE
Lot numbers C06910, C12410, C13810, C14410, C15510, C16210, C16610, C16810, C17210, C17410, C17610, and C17910
RECALLING FIRM/MANUFACTURER
Recalling Firm: Allied Healthcare Products Inc., Saint Louis, MO, by letters dated August 10, 2010.
Manufacturer: Allied Healthcare Products, Inc., Stuyvesant Falls, NY. Firm initiated recall iscomplete.
REASON
The granules do not absorb as long as expected in the anesthesia machines.
VOLUME OF PRODUCT IN COMMERCE
949 pails, 335/12-canister cases, and 706/12-refill bag cases
DISTRIBUTION
Nationwide, Canada and Grenada
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT         
VARIANT nbs Sickle Program Resin Update CD-ROM; Model Number:250-3020, included in 250-3000; The VARIANT nbs Sickle Cell Program is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography(HPLC). The VARIANT nbs Sickle Cell Program is intended for Professional use only. Recall # Z-1984-2011
CODE
Resin Update CD-ROM, 250-3020 lot # AA 00092 goes with Reorder Pack Lot No. 50392618 Resin Update CD-ROM, 250-3020 lot # BA 00092 goes with Reorder Pack Lot No 50300210. Resin Update CD-ROM, 250-3020 lot # CA 00092 Reorder Pack Lot No 50300645 & 50300650. Expiration date: 05/31/2011, 06/30/2011, 08/31/2011 PIN No. 250-3000
RECALLING FIRM/MANUFACTURER
Bio-Rad, Laboratories Inc., Hercules CA, by letters on April 14, 2011 and update on May 13, 2011. Firm initiated recall is ongoing.
REASON
The affected resin Update CD-ROMs cause all user-defined settings in the Setup/Test/Data Setup sub screen and Set/Test/Pattern Setting sub screen to be overwritten when the Update Kit procedure is performed.
VOLUME OF PRODUCT IN COMMERCE
658 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
SharpointTM 4-0 Black Monofilament Non-Absorbable Nylon 18"/DS24mm Reverse Cutting Edged Needle. Intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, opthalmic, and neurological procedures. Product Code - AC-0584D. Recall # Z-2138-2011
CODE
Lot number M446840
RECALLING FIRM/MANUFACTURER
Surgical Specialties Corp., Reading, PA, by letter on March 30, 2011. Firm initiated recall is ongoing.  
REASON
Mislabeled - a number of units of the product labeled as 4-0 Black Mono Nylon suture product contain a 4-0 Black Braided Silk suture.
VOLUME OF PRODUCT IN COMMERCE
2,628 units
DISTRIBUTION
Nationwide and Australia
 
END OF ENFORCEMENT REPORT FOR MAY 11, 2011
 
#