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U.S. Department of Health and Human Services

Safety

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Enforcement Report for April 21, 2010

April 21, 2010                                                                                        10-15

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
HAWAIIAN KETTLE STYLE POTATO CHIPS SWEET MAUI ONION labeled TIM"S CASCADE SNACKS Algona, WA in the following sizes: 1 oz. bags, UPC 1159400116; 1.5 oz. bags, UPC 1159402213: 2 oz. bags, UPC 1159420211; 5 oz. bags, UPC 1159400503; 8 oz. bags, UPC 1159410034; 18 oz. bags, UPC 1159402005; 32 oz. bags, UPC 1159403201; 2 oz bags, UPC 1159420211 in 15 pack box UPC 1159499007; 1.5 oz. bags, UPC 1159402213 in Its' Time for Tim's Variety Pack, 36 count, UPC 1159436001, Hawaiian Variety Pack, 30 count tray, UPC 1159430001. Product also labeled for Canadian distribution: HAWAIIAN KETTLE STYLE POTATO CHIPS CROUSTILLES CUITES A LA MARMITE SWEET MAUI ONION OIGNON DOUX DE MAUI TIM'S CASCADE SNACKS Algona, WA. Sizes include: 70 gram bags, UPC 1159400704; 210 gram bags, UPC 1159400754; and 908 gram bags, UPC 1159403201. Recall # F-1740-2010;

2) HAWAIIAN SWEET MAUI ONION RINGS labeled TIM"S CASCADE SNACKS Algona, WA in the following sizes: 0.75 oz. bags, UPC 1159407501; 1.5 oz. bags, UPC 1159402022; and 4 oz. bags, UPC 1159440401. Product also labeled for Canadian distribution HAWAIIAN SWEET MAUI ONION RINGS ANNEAUX A LOIGNON DOUX DE MAUI in 42 gram bags, UPC 1159401501. Recall # F-1741-2010
CODE
1) Date codes MAR 09 10 up to and including JUN 07 10;
2) Date codes MAR 23 10 up to and including JUN 21 10
RECALLING FIRM/MANUFACTURER
Kennedy Endeavors, Inc., Algona, WA, by e-mail and/or telephone on March 1, 2010. Firm initiated recall is complete
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,052,687 bags of potato chips; 1125,334 bags of onion rings
DISTRIBUTION
Nationwide, Canada, Guam, Japan and the Philippines
___________________________________
PRODUCT
1) Elsie Grace's Zippy Bacon Dip, packaged in .12-oz. plastic bags. Recall # F-1742-2010;
2) Elsie Grace's It's Smokin', packaged in .08-oz. plastic bags. Recall # F-1743-2010
CODE
Not coded
RECALLING FIRM/MANUFACTURER
Elsie Grace's Gift Shoppe, Frankfort, KS, by telephone on March 4, 2010 and by fax on March 8, 2010. Firm initiated recall is complete.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
192/.08-oz. plastic bags and 204/.12-oz. plastic bags
DISTRIBUTION
PA, OH, IL
___________________________________
PRODUCT
1. Stop & Shop 24 oz. Party Platter Cookies UPC# 200055639 The product is packaged on a platter in a box and sold through the Stop & Shop In-Store Bakery. 2. Giant Food Party Platter Cookies UPC# 0200148262. The product is packaged on a rectangular platter with a plastic overwrap and sold through Giant's in-store bakery. Recall # F-1744-2010
CODE
All date codes prior to label correction
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Stop & Shop Supermarket Company LLC, Quincy, MA, by email and press release on February 10 2010.
Manufacturer: Golden Glow Cookie, Bronx, NY. Firm initiated recall is complete.
REASON
Label fails to declare almonds and almond paste.
VOLUME OF PRODUCT IN COMMERCE
2698 cases Stop & Shop; 474 cases Giant
DISTRIBUTION
MA, CT, RI, ME, NH, NY, NJ, MD, VA, DE, D.C.
___________________________________
PRODUCT
1) Kitchen Essentials Imitation Bacon Flavored Bits, packaged in 16-oz. film pouches, 10/case.  Recall # F-1760-2010;

2) Ultra-Soy Imitation Bacon Flavored Chiplets, B 100, packaged in 10- and 25-lb plastic-lined boxes. Recall # F-1761-2010;

3) Ultra-Soy Imitation Bacon Flavored Bits, B 109, packaged in 25-lb. plastic-lined boxes. Recall # F-1762-2010;

4) Ultra-Soy Imitation Bacon Flavored Chips, B 117, packaged in 25-lb. plastic-lined boxes. Recall # F-1763-2010;

5) Ultra-Soy Imitation Bacon Flavored Chiplets, B 118, packaged in a) 25-lb. plastic-lined boxes and b) 1,000-lb. cloth totes. Recall # F-1764-2010;

6) Ultra-Soy Imitation Bacon Flavored Chiplets, BEC 100, packaged in 25-lb. plastic lined boxes and 1,000-lb cloth totes. Recall # F-1765-2010;

7) Imagic Imitation Beef Flavored Chunks, BF 101, packaged in 25-lb. plastic-lined boxes. Recall # F-1766-2010;

8) Imagic Imitation Beef Flavored Strips, BF 103, packaged in 25-lb. plastic lined boxes. Recall # F-1767-2010;

9) Ultra-Soy Imitation Beef Flavored Bits, BF 105, packaged in 25-lb. plastic lined boxes. Recall # F-1768-2010;

10) Ultra-Soy Imitation Beef Flavored Bits, BF 108, packaged in 25-lb. plastic-lined boxes. Recall # F-1769-2010;

11) Ultra-Soy Imitation Beef Flavored Bits, BF 110, packaged in 25-lb. plastic-lined boxes. Recall # F-1770-2010;

12) Imagic Imitation Beef Flavored Strips, BF 124, packaged in 25-lb. plastic-lined boxes. Recall # F-1771-2010;

13) Ultra-Soy Imitation Beef Flavored Crumbles, BF 125, packaged in 25-lb. plastic lined boxes. Recall # F-1772-2010;

14) Ultra-Soy Imitation Beef Flavored Bits, BF 140, packaged in a) 25-lb. plastic-lined boxes and b) 4/5-lb. film pouch cases (only the case is labeled). Recall # F-1773-2010;

15) Ultra-Soy Imitation Chicken Flavored Bits, CK 101, packaged in 25-lb. plastic-lined boxes. Recall # F-1774-2010;

16) Ultra-Soy Imitation Chicken Flavored Chunks, CK 102, packaged in 25-lb. plastic-lined boxes. Recall # F-1775-2010;

17) Imagic Imitation Chicken Flavored Strips, CK 105, packaged in 25-lb. plastic-lined boxes. Recall # F-1776-2010;

18) Imagic Bakon Crumbles, IB 103, packaged in a) 10- and b) 20-lb. plastic-lined boxes. Recall # F-1777-2010;

19) Imagic Bakon Crumbles, IB 104, packaged in 25-lb. plastic-lined boxes. Recall # F-1778-2010;

20) Imagic Bakon Crumbles, IB 105, packaged in 25-lb. plastic-lined boxes. Recall # F-1779-2010;

21) Imagic Bakon Crumbles, IB 112, packaged in 25-lb. plastic-lined boxes. Recall # F-1780-2010;

22) Imagic Imitation Sausage Flavored Crumbles, IS 101, packaged in 25-lb. plastic-lined boxes. Recall # F-1781-2010;

23) Imagic Imitation Sausage Flavored Crumbles, IS 103, packaged in 25-lb. plastic-lined boxes. Recall # F-1782-2010;

24) Imagic Imitation Sausage Flavored Crumbles, IS 105, packaged in 25-lb. plastic-lined boxes. Recall # F-1783-2010;

25) Imagic Imitation Sausage Flavored Crumbles, IS 107, packaged in 25-lb. plastic-lined boxes. Recall # F-1784-2010
CODE:
1) Lot # 09356;
2) 10- and 25-lbs – Lot # 09355; 25-lb. only – Lot # 10025;
3) Lot # 10032;
4) Lot #s 10025 and 10032;
5) a) Lot #s 10025; b) Lot # 10032;
6) 25- and 1,000-lb. – Lot # 10011; 1,000-lb. only – Lot # 10039;
7) Lot # 10020;
8) Lot #s 09351 and 10027;
9) Lot #s 09337, 09357, 10008, and 10018;
10) Lot # 10027;
11) Lots 10019 and 10049;
12) Lot #s 09342, 10004, and 10019;
13) Lots 09342 and 10008;
14) a) Lot # 09363; b) Lot #s 09363 and 10027;
15) Lot # 10046;
16) Lot # 10045;
17) Lot 10028;
18) a) Lot #s 09351 and 10013; b) Lot # 10013;
19) Lot # 10013;
20) Lot #s 09348 and 09364;
21) Lot #s 09342 and 10013;
22) Lot 10012
23) Lot # 10005;
24) Lot # 10005;
25) Lot # 10012
RECALLING FIRM, MANUFACTURER
Recalling Firm: CHS Inc., Hutchinson, KS, by letters dated March 1, 2010 via fax and/or e-mail.
Manufacturer: CHS INC, Hutchinson, KS. Firm initiated recall is ongoing.
REASON:
Products were manufactured using recalled HVP from Basic Food Flavors.
QUANTITY
508/10/1-lb. pouch cases; 170/4/5-lb. pouch cases; 763/10-lb. boxes; 60/20-lb. boxes; 6,040/25-lb. boxes; and 16/1,000-lb. totes
DISTRIBUTION: 
Nationwide

___________________________________
PRODUCT
1) Cream Soup Base (Seasoning), Product code 18874A2, bulk packed in 25 lb. poly lined cartons. Recall # F-1785-2010; 

2) Chicken Flavored Base (Seasoning), Product Code #12063A1, bulk packed in 50 lb. poly lined cartons. Recall # F-1786-2010;

3) Roasted Garlic and Onion Seasoning, Product code 15079B9, bulk packed in 50 lb. poly lined cartons. Recall # F-1787-2010;

4) Sweet Maui Onion Seasoning, Product Code #15896D2, bulk packed in 50 lb. poly lined cartons. Recall # F-1788-2010;

5) Vegetable Base (Seasoning), Product Code #29295A2, bulk packed in 50 lb. poly lined cartons. Recall # F-1789-2010;

6) Chicken Soup Flavoring (Seasoning), Product Code #25188B1, bulk packed in 50 lb. poly lined cartons. Recall # F-1790-2010;

7) Chicken Seasoning, Product Code #26087A2, bulk packed in 50 lb. poly lined cartons. Recall # F-1791-2010;

8) BBQ Seasoning, Product Code #26579A2, bulk packed in 20 lb. poly lined cartons. Recall # F-1792-2010;

9) Beef Base (Seasoning), Product Code #28868A1, bulk packed in 50 lb. poly lined cartons. Recall # F-1793-2010;

10) Garlic Rice, Product Code #26689A2, packed in 2. 5 lb units, 10 units per case. Recall # F-1794-2010;

11) Soup Base, Product Code 26694A2, packed in 1.5 lb units, 25 units per case. Recall # F-1795-2010;

12) Chicken Flavor, Product Code #15365B2, bulk packed in 50 lb. poly lined cartons. Recall # F-1796-2010;

13) Arroz Con Pollo, Product Code #25811B2, bulk packed in 50 lb. poly lined cartons. Recall # F-1797-2010;

14) Shredded Beef Taquito Seasoning, Product Code #11055A9, bulk packed in 50 lb. poly lined cartons. Recall # F-1798-2010;

15) Ground Beef Enchilada Seasoning, Product Code #11057A9, bulk packed in 50 lb. poly lined cartons. Recall # F-1799-2010;

16) Hot Beef Burrito Seasoning, Product Code #28395A9, bulk packed in 50 lb. poly lined cartons. Recall # F-1800-2010;

17) Brown Gravy, Product Code #17171B2, bulk packed in bags.
Recall # F-1801-2010
CODE
1) Lot #: 1-175222;

2) Lot #: 1-170903;

3) Lot #: 1-170412;

4) Lot #s: 2-49701 2-49700 2-49516 2-49515 2-49368 2-49367 2-48574 2-48572 2-48785 2-48784;

5) Lot #: 1-173355;

6) Lot #: 1-171514;

7) Lot #s: 1-170394 1-170623 1-171839;

8) Lot #: 1-169886;

9) Lot #: 2-49191;

10) Lot #s: 2-48280 2-48501 2-48810;

11) Lot #s: 2-48500 2-49030 2-48867 2-49031 2-49215 2-49265 2-49152;

12) Lot #: 1-174897;

13) Lot #: 1-174898;

14) Lot #s: 2-49727 2-49618 2-48821 2-49462 2-49325 2-49076 2-48952;

15) Lot #: 2-48952;

16) Lot #s: 2-49944 2-49833 2-49628;

17) Lot #s: 2-49023 2-49022 2-49021 2-49020 2-49019 2-49018 2-49013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elite Spice Inc., Jessup, MD, by telephone, fax, e-mail and letter on February 26, 2010 and March 4, 2010.
Manufacturers: Elite Spice Inc., Jessup, MD; Elite Spice Inc., Sparks, NV. Firm initiated recall is complete.
REASON
The products were manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
154,963 pounds
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
___________________________________
PRODUCT
1) MASS TABS capsules, Proprietary Mass Tabs Blend (Kudzo Extract 40%, Trifolium Pratense Extract 8%, Fenugreek Seed Powder, Tibulus Terrestris Extract 40%, MethylSten (17-beta-hydroxy-2-alpha, 17-dimethyl-5-alpha-androstan-3-one azine), Avena Sativa Extract 10:1, Pygeum africanum Bark Extract 4:1, Milk Thistle, Maca Powder Extract .6%, Epidmedium Leaf, Bacopa Monniera Extract 4:1, Rhodiola Rosea 3%, Nettle Leaf Powder) 87,000 mcg, 30-count bottles and 60-count bottles; UPC 6 75941 00149 4. Recall # D-481-2010;

2) RIPPED TABS TR tablets, Anabolic Amplifier Proprietary Blend (Hoenelen, Buplurium, Bergamottin) 300 mg, Energy XT Proprietary Blend (Green Tea, Caffeine USP, Mateine) 425 mg, Anabolic Cutter Blend (1,3,7-trimethyl-1H-purine-2,6(3H,7H) dione, 19 Norandrosta 4, 9 diene 3, 17 dione, Juniper Berry, Cornsilk Stylus, Bulgarian Tribulus Terrestris (Standardized at a 25% saponin content), Fenugreek seed, Theine, Acetyl-L Carnatine, Zinc (as zinc aspartate), Stinging nettle leaf, Maca Root, Eurycoma Longifolia, Couchgrass Rhizome) 234 mg, 60-count Foil Packed Tablets in a box, UPC 6 75941 00162 3. Recall # D-482-2010; 

3) DUAL ACTION GROW TABS capsules, Proprietary Testopen Blend (Kudzu root, Green Tea, zinc aspartate, Pygeum africanum extract, Stinging nettle leaf extract, 17 alpha methyl 17 beta hydroxyl 5 alpha androst 2 ene, 4 Androstene 4 chloro 17 alpha methyl 3 beta 17 beta diol, Urtica Dioca, Tongkat Ali (Malaysian Eurycoma Longifolia Jack), Dodder Seed) 250 mg, Bergamottin 50 mg, Bupleurum 50 mg, Hoelen 50 mg, 60-count foil packed 582 mg capsules in a box, UPC 6 75941 00252 1. D-483-2010; 

4) BROMODROL tablets, Bromodrol Growth Complex [Green Tea (Polyphenols), Hoelene, Bergamottin, Bupleurum, 6 Bromo 3, 17 dioxoetioallochalane, Nettle Root, Chrysin, Saw Palmetto, Schizandra Berry, Wild Yam, Safed Musli] 531 mg, 60-count foil packed in a box, UPC 6 75941 00250 7. Recall # D-484-2010;

5) RIPPED TABS TR capsules, Anabolic Amplifier Proprietary Blend (Hoenelen, Buplurium, Bergamottin) 300 mg, Energy XT Proprietary Blend (Green Tea, Caffeine USP, Mateine) 500 mg, anabolic Cutter Blend (1,3,7-trimethyl-1H-purine-2,6(3H,7H) dione, 19 Norandrosta 4, 9 diene 3, 17 dione, Juniper Berry, Cornsilk Stylus, Bulgarian Tribulus Terrestria (Standardized at a 25% saponin content), Fenugreek seed, Theine, Acetyl-L Carnitine, Zinc (as zinc aspartate), Stinging nettle leaf, Maca Root, Eurycoma Longifolia, Couchgrass Rhizome) 257 mg, 60-count bottle, UPC 675941001623. Recall # D-485-2010
CODE
1) All lots purchased during or after 4/09, Lot # 1022, 0205, and 81509;
2) All lots purchased during or after 12/08, Lot #: CW-20, CY-64;
3) All Lots, CW-68, DA-90;
4) All lots, CU32;
5) All lots, Lot 6597010 
RECALLING FIRM/MANUFACTURER
Recalling Firm: IDS Sports, Oviedo, FL, by press release on November 12, 2009 and by letter on  November 23, 2009. 
Manufacturer: Innovative Health Products, Inc, Div. Dynamic Health Prod., Largo, FL; Redefine Nutrition, Suwanee, GA. Firm initiated recall is ongoing.
REASON
Marketed Without An NDA/ANDA: product contains undeclared steroids or steroid-like substances, making them unapproved new drugs.
VOLUME OF PRODUCT IN COMMERCE
32,340 boxes and bottles
DISTRIBUTION
Nationwide, Brazil, Denmark, India, Lebanon, UAE, and United Kingdom
___________________________________
PRODUCT
1) PAI YOU GUO Slim Capsule, 30-count box, Produce: A Medicine Industry Group Company. Recall # D-491-2010; 

2) PAI YOU GUO, 10 g tea packs individually packaged in a pouch, 18-count pouches per box, Produce: A Medicine Industry Group Company. Recall # D-492-2010 
CODE
1) and 2)  All product shipped between 04/01/2009-09/30/2009;
RECALLING FIRM/MANUFACTURER
Recalling Firm: GMP Herbal Products, Inc., Westminster, CA, by press release and by letter beginning on November 12, 2009.
Manufacturer: Zhejiang Camel Transworld, Hangzhou, China. Firm initiated recall is ongoing.
REASON
Marketed Without An Approved NDA/ANDA: The recall was initiated because PAI YOU GUO, a weight loss dietary supplement, sold and marketed by the firm was found to contains undeclared drug ingredients.
VOLUME OF PRODUCT IN COMMERCE
Approximately 100 boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ROCK HARD WEEKEND capsules, 1 capsule per blister card (UPC 0 94922 14725 7), 3-count bottle (UPC 0 94922 20870 5), and 8-count bottle (UPC 0 94922 14724 0), Made in the USA. Recall # D-493-2010
CODE
Blister Pack Lot T12 705 08 (Exp: 10/11); Lot T12 705 09 (Exp: 03/12, 08/12); 3-ct Bottle (UPC 0 94922 20870 5): R417 0509 (Exp: 09/12); 8-ct Bottle (UPC 0 94922 14724 0): T237 0509 (Exp: 06/12)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rock Hard Laboratories, Roswell, GA, by press release, telephone and email beginning on November 17, 2009.  
Manufacturer: Atlas Operations, Inc., Pompano Beach, FL. Firm initiated recall is ongoing.
REASON
Marketed Without an Approved NDA/ANDA: The product is an unapproved new drug because the product contains sulfoaildenfil.
VOLUME OF PRODUCT IN COMMERCE
250,000 capsules (blisters and bottles)
DISTRIBUTION
Nationwide, Albania, Aruba, Australia, Brazil, Canada, Denmark, Finland, Greece, Ireland, Netherlands, Peru, Portugal, South Africa, Spain and the UK

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 count bottles, Rx only. NDC 63304-580-10. Recall # D-487-2010. 
CODE
Lot #: CGR9009AC, exp 05/11
RECALLING FIRM/MANUFACTURER
Ipca Laboratories Limited, Silvasa (D and NH), India, by telephone, e-mail and letter on February 09, 2010 and by letter February 17, 2010. Firm initiated recall is ongoing.
REASON
Tablet thickness: Metoprolol tablets may be out of specification for tablet thickness.
VOLUME OF PRODUCT IN COMMERCE
1,941 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ST. JOSEPH SAFETY COATED ASPIRIN (aspirin) enteric coated tablet, 81 mg, a) 36-count bottle, NDC 50580-126-36, UPC 3 0045012636 8; b) 100-count bottle, NDC 50580-126-10, UPC 3 0045012610 8; c) 180-count bottle, NDC 50580-126-18, UPC 300450126184 d) 300- count bottle, NDC 50580-126-03, UPC 30045012630; OTC. Recall # D-488-2010;

2) ST. JOSEPH CHEWABLE ASPRIN (aspirin) orange flavored chewable tablet, 81 mg, a) 36-count bottle, NDC 50580-173-36, UPC 300450173362 b) 3x36- count bottle, NDA 50580-173-08, UPC 300450173089; OTC. Recall # D-489-2010
CODE
1) a) Lot # AFM026, AHM327, Exp 04/30/2011; AHM432, Exp 06/30/2011; AJM321, ALM327, Exp 07/31/2011; AMM324, Exp 08/31/2011; APM349, and APM420 Exp 10/31/2011; b) Lot #.AEM050, Exp 03/31/2011; AHM374, Exp 06/30/2011; AJM320, AJM402, Exp 07/31/2011; ALM341, AMM365, Exp 08/31/2011; AMM366, AMM367, Exp 09/30/2011; APM350, and APM351, Exp 10/31/2011; c) Lot #..AMM323, AMM433, Exp 08/31/2011; and APM304, Exp 09/30/2011; d) Lots #: AHM368, ALM377, Exp 06/30/2011; ALM378, AMM354, Exp 08/31/2011; and APM427, Exp 09/30/2011;

2) a) Lot # APM440, Exp 06/30/2011; AMM325, Exp 09/30/2011; and APM430, Exp 10/31/2011; b) AFM360, AHM423, Exp 06/30/2011; ALM346, Exp 08/31/2011; and AMM434, Exp 09/30/2011
RECALLING FIRM/MANUFACTURER
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, on website on November 6, 2009, by letters on November 9, 2009, press release on December 18, 2009, and by letters on December 18, 2009 & January 15, 2010. Firm initiated recall is ongoing.
REASON
Chemical Contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2,4,6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
VOLUME OF PRODUCT IN COMMERCE
4,032,160 Bottles
DISTRIBUTION
Nationwide, Puerto Rico, Canada, Uruguay, Fiji, Dominican Republic, Trinidad, Guatemala, Jamaica, Guam, and UAE
___________________________________
PRODUCT
Digoxin Tablets, USP, 125 mcg (0.125 mg), 1000 count bottle Rx only; NDC 0143-1240-10. Recall # D-494-2010 
CODE
Lot # 66873A, Exp 5/2011
RECALLING FIRM/MANUFACTURER
West-ward Pharmaceutical Corp., Eatontown, NJ, by letters on March 9, 2009. Firm initiated recall is ongoing.
REASON
Superpotent (Single Ingredient Drug): West-Ward received a complaint from a pharmacist stating that some tablets of Digoxin in a bottle of 1000 tablets were thicker than others.
VOLUME OF PRODUCT IN COMMERCE
3,894 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0934-10
CODE
Units: 004FQ10855P1; 004FQ10855P2; 004FQ10856P1; 004FQ10856P2; 004FQ10857P1; 004FQ10858P1; 004FQ10858P2; 004FQ10859P1; 004FQ10859P2; 004FQ10881P1; 004FQ10881P2; 004FQ10884P1; 004FQ10884P2; 004KG39729P1; 004KG39730P1; 004KG39730P2; 004KG39731P1; and 004KG39731P2
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA, by facsimile and telephone on November 03, 2009 and by facsimile on November 13, 2009.
Manufacturer: ARC/Manchester, NH, Manchester, NH. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may compromise the sterility of the product, were distributed
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
ME, NY, MA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1040-10;
2) Fresh Frozen Plasma. Recall # B-1041-10;
3) Recovered Plasma. Recall # B-1042-10
CODE
1) Units: 2874420, 1645967;
2) Unit: 1645967;
3) Unit: 2874420
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati UC Medical Center, Cincinnati, OH, by letter dated September 28, 2007.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OH, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1057-10
CODE
Unit: 041LV44023
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone on May 8, 2009 and facsimile May 12, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who resided in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1066-10
CODE
Unit: 2883560
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter on August 13, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked regarding travel to area with malarial risk, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1085-10
CODE
Unit: W070508318124
RECALLING FIRM/MANUFACTURER
Stanford Medical School Blood Center, Palo Alto, CA, by letter dated October 27, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who emigrated from a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1086-10
CODE
Unit: 72M498877
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on November 30, 2009. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-1087-10
CODE
Unit: 54KP35450
RECALLING FIRM/MANUFACTURER
American National Red Cross, Rio Piedras, PR, by telephone on October 16, 2009 and follow up letters on October 21, 2009 and November 23, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had taken aspirin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PR
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-1088-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1090-10
CODE
1) Unit: 2595901;
2) Units: 2595901; 9189067
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter dated October 20, 2009.
REASON
Blood products, collected from a donor taking the drug Finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
KY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1091-10
CODE
Units: 5030666; 5031177; 5032980; 5033699
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by letter dated September 21, 2009. 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
AK
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1092-10
CODE
Units: W036309506746T; W036309535586N
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on November 13, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1093-10
CODE
Units: 2515317A; 2515317B
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter dated December 16, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1094-10
CODE
Unit: 2508279
RECALLING FIRM/MANUFACTURER
Upstate New York Transplant Services, Inc., Buffalo, NY, by telephone and fax on November 23, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1095-10
CODE
Units: W087909900922; W087909901911
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Blood Bank of Lancaster County Medical Society, Lincoln, NB, by fax on November 16, 2009.
Manufacturer: Nebraska Community Blood Bank, Lincoln, NB. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NB, KY
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1096-10
CODE
Unit: W070509321267
RECALLING FIRM/MANUFACTURER
Stanford Medical School Blood Center, Palo Alto, CA, by electronic delivery note on October 29, 2009. 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
RI
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1097-10;
2) Fresh Frozen Plasma. Recall # B-1098-10
CODE
1) and 2) W010009006247
RECALLING FIRM/MANUFACTURER
Department Of The Army, Armed Services Blood Bank Center, Tacoma, WA, by fax on November 6, 2009.  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
2 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Source Plasma. Recall # B-1108-10
CODE
Unit: 366116208
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Colorado Springs, CO, by Special Investigation Protocol- Final Report, dated August 15, 2008. 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
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1110-10
CODE
Units: 366094571, 366094034, 366089860, 366089643
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Colorado Springs, CO, by fax on November 21, 2008 and December 02, 2008. 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
4 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1111-10
CODE
Units: 366066491, 366066145, 366065515, 366064645, 366060878, 366060809
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Colorado Springs, CO, by fax on November 13, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was deferred for receiving a body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1112-10
CODE
Units: 366067465, 366067802, 366074338, 366085426
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Colorado Springs, CO, by fax on January 15, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1113-10
CODE
Units: 366099505, 366100663, 366102951, 366105576, 366105942, 366107799, 366108642, 366109539, 366110037, 366113839, 366115038, 366117055, 366114691, 366117463
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Colorado Springs, CO, by fax on January 29, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
NC

___________________________________
PRODUCT
Source Plasma. Recall # B-1114-10
CODE
Unit: 366123326
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Colorado Springs, CO, by Special Investigation Protocol-Final Report dated August 15, 2008. 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
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1115-10
CODE
Unit: 366123181
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Colorado Springs, CO, by Special Investigation Protocol-Final Report dated August 15, 2008. 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
NC
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-1124-10;
2) Fresh Frozen Plasma. Recall # B-1125-10;
3) Red Blood Cells Leukocytes Reduced. Recall # B-1126-10;
4) Recovered Plasma. Recall # B-1127-10
CODE
1) and 4) Unit: KL19746;
2) Unit: KL21504;
3) Units: KL19746 and KL21504;
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on April 11, 2007. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
WI
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-1128-10;
2) Platelets. Recall # B-1129-10
CODE
1) and 2) Unit: 2383219
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter on January 7, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had previously reported travel to a malarial area of Tanzania, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
___________________________________
PRODUCT
Source Plasma. Recall # B-1136-10
CODE
Unit: 370084735
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Salem, OR, by fax on May 16, 2008. Firm initiated recall is complete.
REASON
Blood product, collected using an abbreviated screening process, for which the donor was not eligible, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1137-10
CODE
Unit: 391051788
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., N Las Vegas, NV, by fax on March 06, 2008. Firm initiated recall is complete.
REASON
Blood product, collected using an abbreviated screening process, for which the donor was not eligible, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1138-10
CODE
Units: 382072163, 382072123
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Tuscaloosa, AL, by fax on July 31, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1141-10
CODE
Units: 366121102, 366120336, 366120086, 366122436, 366122238, 366121399
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Colorado Springs, CO, by Special Investigation Protocol - Final Report dated August 15, 2008.  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
6 units
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1148-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1149-10
CODE
1) Unit: 2888893 (split unit);
2) Unit: 2855869
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH, by letter dated August 13, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who gave history information which warranted deferral or follow up and was not deferred or follow up questions were not asked for travel to area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III
____________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0981-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-0982-10;

3) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated. Recall # B-0983-10
CODE
1) Unit: 53E29469;

2) Units: 53FX31502, 53FL58865, 53FP65544, 53V54812, 53T21073, 53FQ15579;

3) Unit: 53FC81282
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on November 3, 2007 and by letter dated November 8, 2007. Firm initiated recall is complete.
REASON
Blood products, tested for red cell antigens using equipment for which the daily quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
MD, VA
___________________________________
PRODUCT
Source Plasma. Recall # B-1018-10
CODE
Unit: 366120335
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Colorado Springs, CO, by fax on November 13, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1063-10
CODE
Unit: W045009067933
RECALLING FIRM/MANUFACTURER
Community Blood Center Of Greater Kansas City, Kansas City, MO, by telephone on August 17, 2009 and by letter on September 8, 2009. Firm initiated recall is complete.
REASON
Blood product, manufactured without the entire quantity of additive solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1089-10
CODE
Unit: 9189067
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter dated October 20, 2009.
REASON
Blood product, collected from a donor taking the drug Finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT
Source Plasma. Recall # B-1107-10
CODE
Unit: 366080976
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Colorado Springs, CO, by fax on November 13, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1109-10
CODE
Units: 366056074, 366056114, 366058931, 366059205, 366060328, 366061299, 366061843, 366062183
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Colorado Springs, CO, by fax on November 10, 2008. 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
8 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-1139-10
CODE
Units: 3740032067, 3740012187, 374127694, 374124471, 374124073, 374123185, 374122799, 374118175, 374117663
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., El Paso, TX, by fax on December 15, 2008. 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
9 units
DISTRIBUTION
NC

___________________________________
PRODUCT
Source Plasma. Recall # B-1140-10
CODE
Units: I52000149, I52003712, I52007856, I52008639, I52010282, I52010375, I52010686, I52010975, I52011113, I52011350
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Colorado Springs, CO, by fax on January 29, 2009. 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
10 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1142-10
CODE
Units: 8996458 (part 1 and 2), 5817416 (part 1 and 2), 5802144 (part 1 and 2), 8995282 (part 1 and 2), 5817826 (part 1 and 2), 1941878 (part 1 and 2), 1943429 (part 1 and 2), 1944787 (part 1 and 2), 8314196 (part 1 and 2), 1947317 (part 1 and 2), 1944450 (part 1 and 2), 1941930 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by letter dated September 06, 2005. Firm initiated recall is complete.
REASON
Blood products, for which the quality control testing for total component hemoglobin was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Source Plasma. Recall # B-1143-10
CODE
Unit: 364071720
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Fort Worth, TX, by fax on February 6, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT
1) Pelton & Crane Dental Chairs, Chairman 5000 with magnetic headrest. Intended for the properly positioning of patients to perform dental procedures. Recall # Z-1179-2010;

2) Pelton & Crane Dental Chairs, Spirit 1500 with magnetic headrest. Intended for the properly positioning of patients to perform dental procedures. Recall # Z-1180-2010;

3) Pelton & Crane Dental Chairs, Spirit 1800 with magnetic headrest. Intended for the properly positioning of patients to perform dental procedures. Recall # Z-1324-2010;

4) Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest. Intended for the properly positioning of patients to perform dental procedures. Recall # Z-1325-2010;

5) Pelton & Crane Dental Chairs, Spirit 3000 with magnetic headrest. Intended for the properly positioning of patients to perform dental procedures. Recall # Z-1326-2010
CODE
1) All Devices with Model Number L5;
2) All Devices with Model Number SP15;
3) All Devices with Model Number SP18;
4) All Devices with Model Number SP20;
5) All Devices with Model Number SP30
RECALLING FIRM/MANUFACTURER
Pelton & Crane Company, Charlotte, NC, by letter dated February 24, 2010. Firm initiated recall is ongoing.
REASON
Magnetic headrests may affect patients with implantable pacemakers and defibrillators.
VOLUME OF PRODUCT IN COMMERCE
498 chairs and 619 replacement upholstery parts
DISTRIBUTION
Nationwide, Australia, the Netherlands, Canada and Germany
___________________________________
PRODUCT
Howmedica Restoration ADM Trial Cup Holder; Non Sterile; The intended use: The Restoration ADM Window Trial is locked onto the Restoration ADM Trial Cup Holder and placed into the acetabulum to evaluate the size and congruity of the preparation for visualization and assessment of fit, contact and congruency of the trial within the acetabulum. Catalog number: 1235-0-000. Recall # Z-1201-2010
CODE
Lot number: G2012869
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated January 21, 2010.
Manufacturer: Stryker, Saint Clair, Cedex, France. Firm initiated recall is ongoing.
REASON
The Restoration ADM Trial Cup Holder may not have been assembled correctly.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Leksell Gamma Knife Perfexion, Product Number: 715000. Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters. Recall # Z-1232-2010
CODE
Serial Numbers: 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, 6030, 6032, 6034, 6035, 6036, 6037, 6045, 6047, 6048, 6049, 6053, 6054, 6056, 6057, 6059 and 6061
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross , GA, by letter dated November 6, 2009. 
Manufacturer: Elekta Instrument AB, Stockholm, Sweden. Firm initiated recall is ongoing.
REASON
There may be a situation where the Frame Adapter might lock the stereotactic Frame in the wrong position.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Leksell Gamma Knife. Leksell Gamma Knife is a teletherapy device indicated for use in the stereotactic irradiation of intracranial structures. Recall # Z-1236-2010
CODE
LGK 4203, LGK 4309, LGK 4333, LGK 4343 and LGK 4354
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by Field Change Order, October 1, 2007.
Manufacturer: Elekta Instrument AB, Stockholm, Sweden. Firm initiated recall is ongoing.
REASON
After updating the LGK actuator in spare part 810361, the old sleigh became obsolete due to causing insufficient locking of the helmet in combination with the new actuator.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA, TN, TX, WA and Taiwan
___________________________________
PRODUCT
Agendia MammaPrint, Catalog Numbers MP01, MP US version 03. Recall # Z-1321-2010
CODE
MP US version 03
RECALLING FIRM/MANUFACTURER
Agendia Inc., Huntington Beach, CA, by visit on March 3, 2010. Firm initiated recall is ongoing.
REASON
Over a period of about 6 months in about 15% of results provided Agendia has been "over reporting" the chance of metastasis risk being 29% risk of recurrence instead of 10% risk. This over reporting of risk did not cause direct injury to patients. However, if used by physicians as the sole basis for decision-making, affected patients may have received unnecessary therapy.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Baxter 1550 Single Patient System Hemodialysis Machines; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R. Recall # Z-1322-2010
CODE
All Baxter 1550 instruments and/or spare circuit boards that do not have software versions 3.0A or 4.1B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letter dated January 29, 2010. 
Manufacturer: Baxter Healthcare Corp., Largo, FL. Firm initiated recall is ongoing.
REASON
Some of the 1550 Hemodialysis Instruments may have replacement circuit boards with incorrect versions of software.
VOLUME OF PRODUCT IN COMMERCE
443 boards
DISTRIBUTION
Nationwide, Argentina, Brazil, Canada, Chile, China, Colombia, Ecuador, Guatemala, Honduras, Mexico, Panama, Philippines, Romania, Turkey and Venezuela
___________________________________
PRODUCT
The Bigger Better-Bladder, Catalog Number BBB38 (with 3/8 inch ID tubing), Sterile, Single use only --- 510 (k) 981284 The intended use: Bigger Better-Bladder serves as an inline reservoir providing compliance and allowing noninvasive pressure measurements. It is a length of standard perfusion tubing with a thin walled, elongated balloon sealed with a rigid housing. Recall # Z-1323-2010
CODE
Lot Number 9910-18907, Exp. 10/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Circulatory Technology Inc., Oyster Bay, NY, by emails and telephone on June 3, 2009 and on June 13, 2009. 
Manufacturer: Metrix Co, Dubuque,IA. Firm initiated recall is complete.
REASON
During an FDA inspection, it was discovered that the firm had conducted a silent recall of its Bigger Better Bladder device after receiving a complaint from a hospital that the device collapsed during a procedure thereby obstructing flow.
VOLUME OF PRODUCT IN COMMERCE
144 units
DISTRIBUTION
Nationwide and Germany
___________________________________
PRODUCT
1) GE Centricity PACS-IW software; The intended use: The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Recall # Z-1394-2010;

2) GE Centricity Web Diagnostic 1.0 (WebDX) software; The Intended use: The Centricity PACS-IW is used to receive medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Recall # Z-1395-2010
CODE
1) Software version 3.x;
2) Software version 3.7.7.x
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ge Healthcare It, Barrington, IL, by letters dated February 18, 2010.  
Manufacturer: Dynamic Imaging, LLC, Allendale, NJ. Firm initiated recall is ongoing.
REASON
There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software related to use of built-in reconstruction functions which may result in incorrect anatomic orientation markers.
VOLUME OF PRODUCT IN COMMERCE
670 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Canada, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korean, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysia, Netherlands, Philippines, Poland, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates and United Kingdom
___________________________________
PRODUCT
SmarTemp Probe Covers with the Accutorr V Monitor; Rx only. Packaged in boxes of 20, Model ST010, also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains one box of 20 probes). Probe Cover for use with the SmarTemp Reusable Temperature Probe. The following product numbers: 1) M09A-20-62124 Covers, Temp Probe- box of 20 probes and M09A-30-62128 Covers, Temp Probe - box of 2000 (10 boxes of 200); 2).A box of 20 Disposable Probe Covers (part number M09A-20-62124) are also included in the following kits: 0020-00-0192 - SmarTemp Module Kit and 6006-30-39590 - SmarTemp Temperature Probe Kit. Recall # Z-1396-2010;

2) SmarTemp Probe Covers for use with the DPM3 Monitor; Rx only, Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010 also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains one box of 20 probes). Probe Cover for use with the SmarTemp Reusable Temperature Probe. 1) M09A-20-62124 Covers, Temp Probe- box of 20 probes and M09A-30-62128 Covers, Temp Probe - box of 2000 (10 boxes of 200); 2) A box of 20 Disposable Probe Covers (part number M09A-20-62124) are also included in the following kits: 0020-00-0192 - SmarTemp Module Kit and 6006-30-39590 - SmarTemp Temperature Probe Kit. Recall # Z-1397-2010;

3) SmarTemp Probe Covers for use with the VS-800 Monitor; Rx only, Mindray DS USA, Inc. Mahway, NJ 07430. Packaged in boxes of 20, Model ST010, also distributed in boxes of 2000 (10 individual boxes of 200); SmarTemp Module Kit (contains one box of 20 probes) and SmarTemp Temperature Probe Kits (contains one box of 20 probes). Probe Cover for use with the SmarTemp Reusable Temperature Probe. 1) M09A-20-62124 Covers, Temp Probe- box of 20 probes and M09A-30-62128 Covers, Temp Probe - box of 2000 (10 boxes of 200); 2) A box of 20 Disposable Probe Covers (part number M09A-20-62124) are also included in the following kits: 0020-00-0192 - SmarTemp Module Kit and 6006-30-39590 - SmarTemp Temperature Probe Kit. Recall # Z-1398-2010
CODE
All lots of the listed product numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mindray DS USA, Inc., dba Datascope Patient Monitoring, Mahwah, NJ, by letter dated December 31, 2009.
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Nanshan, Shenzhen, China. Firm initiated recall is ongoing.
REASON
SmarTemp Disposable Probe covers may contain microscopic holes in the molded seam that would allow liquids or body fluids inside the cover and potentially contaminate the temperature probe.
VOLUME OF PRODUCT IN COMMERCE
33,976 boxes of 20 probe covers Nationwide; 801 boxes of 20 probe covers Internationally
DISTRIBUTION
Nationwide, Canada, Australia

___________________________________
PRODUCT
Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick, Qty 1 Non Sterile Mat: 17-4PH. The intended use: Used to stabilize and aid in the fixation of fractures, fusions, and osteotomies. Recall # Z-1399-2010
CODE
Lot #’s: GB759, GB-924, 1014001 & 1101011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Orthohelix Surgical Designs Inc, Medina, OH, by letters, dated October 16, 2009, and November 19, 2009.
Manufacturer: Gauthier Biomedical Inc., Grafton, WI. Firm initiated recall is ongoing.
REASON
The adapters are able to come apart when a retaining ring in the proximal end of the adapter can dislodge from the retaining ring groove and the two ends of the adapter fall apart and are unable to be reassembled without special tools and knowledge of the instrument. Also the adapters have a wobble between the two ends. This is caused when the distal and proximal ends of the adapter assembly were welded non-concentric to one another.
VOLUME OF PRODUCT IN COMMERCE
127 pieces
DISTRIBUTION
Nationwide

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PRODUCT
Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4. Recall # Z-1409-2010
CODE
SERIAL #'s: 27059297H, 46080743H, 46080918H, 56066331H, 56069528H, 56069671H, 56069673H, 56069686H, 56072440H, 56072655H, 56072666H, 56072674H, 57014750H, 57014755H, 57014757H, 66084643H, 77048447H, 87040459H, 87040630H, 87040942H, 87040947H, 87040951H, 87040957H, 87042729H, 87042732H, 87043106H, 87043119H, 87058615H 87058616H, 87058618H, 87058849H, 87059667H, 87082650H, 87082900H, 87086049H, 87094579H, 87094580H, 87094590H, 87094593H, 87094596H, 87094597H, 87094738H, 96026241Hu, 96026251Hu, 97045074H, 97047825H, 97072474H, 97076337H, 97076339H, 97076666H, 97076671H, 97076770H, 97079617H, 97081025H, 97081842H, X6090220H, X6098238H, X6099082H, X7021190H, X7087236H, Z7014824H, Z7060102H
RECALLING FIRM/MANUFACTURER
Boston Scientific Neuromodulation Corp., Valencia, CA, by letter dated March 19, 2010. Firm initiated recall is ongoing.
REASON
Toshiba has determined that certain Sony battery packs installed in Toshiba portable computers can overheat, posing fire hazard to customers. Based on Toshiba's investigation with Sony Corporation, they concluded that the battery cells in specific manufacturing lots could be affected.
VOLUME OF PRODUCT IN COMMERCE
62 units
DISTRIBUTION
Nationwide and Italy

___________________________________
PRODUCT
Syngo Imaging XS model number 10496279. The intended use: image processing radiological. Recall # Z-1423-2010
CODE
Serial numbers: 1165, 1213, 1361, 1373, 1395, and 1424
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated February 16, 2010.
Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Images can be overwritten.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  VETERINARY - CLASS II
___________________________________
PRODUCT
1) Electrolytes/Dextrose/Amino Acid oral solution, each 1,000 ml of aqueous solution contains 275.0 g dextrose hydrate, 36.5 g calcium hypophosphite, 15.0 g potassium chloride, 2.0 g sodium chloride, 0.5 g potassium phosphate monobasic, and amino acids, packaged in 1,000-ml. bottles, OTC, under the following product names and labels: (1) Butler Aminocal Plus Oral Solution; (2) AmTech Group, Inc. Amcal High Potency Oral Solution; and (3) VEDCO Amcalcilyte Forte. Recall # V-077-2010;

2) Dextrose/Electrolytes/Amino Acid oral solution, each 1,000 ml of aqueous solution contains 300.0 g dextrose hydrate, 5.4 g sodium chloride, 3.0 g sodium acetate anhydrous, 1.0 g potassium acetate, 330.0 mg calcium chloride dihydrate, 260.0 mg magnesium chloride hexahydrate, total protein 2.3 g, and amino acids, packaged in 1,000-ml. bottles, OTC, under the following product names and labels: (1) AmTech Group, Inc. Amino-Dex-Forte Oral Solution; (2) Butler Keto Amino Forte Oral Solution; (3) VEDCO Glucaminolyte Forte. Recall # V-078-2010;

3) Amino acid oral solution, each 100 ml. of aqueous solution contains 5 g dextrose hydrate, 250 mg sodium acetate trihydrate, 20 mg magnesium sulfate heptahydrate, 20 mg potassium chloride, 15 mg calcium chloride dihydrate, 150 mg niacinamide, 10 mg pyridoxine hydrochloride (B6), 10 mg thiamine hydrochloride (B1), 4 mg riboflavin (B2), 28.5 mg total protein, and amino acids, OTC, packaged in 500-ml. bottles under the following product names and labels: (1) AgriLabs Amino Acid Oral Solution; (2) AmTech Group, Inc. Amino Acid Oral Solution; (3) Butler Aminoplex Oral Solution; and (4) VEDCO Double "A" Solution. Recall # V-079-2010;

4) Amino acid concentrate oral solution, each 100 ml of aqueous solution contains 5 g dextrose hydrate, 250 mg sodium acetate trihydrate, 200 mg magnesium sulfate heptahydrate, 200 mg potassium chloride, 150 mg calcium chloride dihydrate, 150 mg niacinamide, 10 mg pyridoxine hydrochloride (B6), 10 mg thiamine hydrochloride (B1), 4 mg riboflavin (B2), 1,158.7 mg total protein, and amino acids, OTC, packaged in 500-ml. bottles under the following product names and labels: (1) AgriLabs Amino Acid Concentrate Oral Solution; (2) AmTech Group, Inc. Amino Acid Oral Concentrate; (3) Butler Aminoplex Concentrate Oral Solution; (4) Phoenix Pharmaceutical, Inc. Amino Acid Oral Concentrate; and (5) VEDCO Double "A" Concentrate. Recall # V-080-2010;

5) Neomycin oral solution, each ml contains 200 mg neomycin sulfate (equivalent to 140 mg neomycin base), OTC, ANADA 200-118, packaged under the following product names and labels: (1) AgriLabs Neomycin Oral Solution, 1-gal. and 1-pt. bottles; (2) AmTech Group, Inc. Neomycin Oral Solution, 1-gal. and 1-pt. bottles; (3) Aspen Neomycin 200, 1-gal. bottles; (4) Durvet Neomycin Oral Solution, 1-gal. and 1-pt. bottles; (5) IBA Neomycin Oral Solution, 1-pt. bottles; (6) Phoenix Pharmaceutical, Inc. Neomycin Oral Solution, 1-pt. bottles; (7) TEVA Neomycin Oral Solution, 1-pt. bottles; and (8) VEDCO Neoved 200, 1-pt. bottles. Recall # V-081-2010;

6) Pyrantel pamoate equine anthelmintic suspension, each ml contains 50 mg pyrantel base as pyrantel pamoate, administered by means of a stomach tube, dose syringe, or by mixing into the feed, RX, ANADA 200-246, packaged under the following product names and labels: (1) AmTech Group, Inc. Anthelban V, 1-pt. and 1-qt. bottles; (2) Phoenix Pharmaceutical, Inc. Anthelban V, 1-pt. bottles; (3) VEDCO Equi-Phar ProTal, 1-pt. and 1-qt. bottles; and (4) FARNAM Liqui-Care P, 75-, 300-, and 900-ml bottles; Recall # V-082-2010;

7) AmTech Group, Inc. Gentamicin Sulfate Pig Pump Oral Solution, each ml contains gentamicin sulfate equivalent to 5 mg gentamicin, packaged in 118-ml bottles, OTC, ANDA 200-174. Recall # V-083-2010;
 
8) Sulfadimethoxine oral solution, 12.5% Concentrated Solution for Use in Drinking Water, each fl. oz. contains 3.75 g sulfadimethoxine solubilized with sodium hydroxide, OTC, ANADA 200-192, packaged in 1-gal. bottles under the following product names and labels: (1) AGRIpharm Sulfadimethoxine Oral Solution; (2) AmTech Group, Inc. Sulfadimethoxine 12.5% Oral Solution; (3) Aspen Sulfadimethoxine 12.5% Oral Solution; (4) Durvet Sulfadimethoxine Oral Solution; and (5) VEDCO SulfadiVed 12.5% Solution. Recall # V-084-2010;

9) Double Strength D-Worm 120 (pyrantel pamoate) Dog Dewormer, Liquid for Puppies & Dogs, containing 4.54 mg of pyrantel base as pyrantel pamoate per mL, packaged in 60-ml bottles, OTC, ANDA #200-248. Recall # V-085-2010;

10) Clindamycin Hydrochloride Oral Liquid, each ml contains 25 mg clindamycin hydrochloride equivalent to clindamycin and 8.64% ethyl alcohol, packaged in 20-ml bottles, RX, ANDA 200-193, under the following product names and labels: (1) AmTech Group, Inc., Clindamycin Hydrochloride Oral Liquid; (2) Butler ClinDrops; (3) Phoenix Pharmaceutical, Inc. Clindamycin Hydrochloride Drops; and (4) VEDCO ClindaCure. Recall # V-086-2010;

11) Ivermectin Pour-On for Cattle, 5 mg. Ivermectin per ml, OTC, ANADA 200-219, packaged under the following product names and labels: (1) AmTech Group, Inc. Phoenectin, 250-ml, 1-, 2.5-, 5-, and 25-liter, and 1-gal bottles; (2) Aspen Ivermectin, 250-ml, 1-, 2.5-, 5-, and 25-liter, and 1-gal bottles; (3) Durvet Ivermectin, 250- and 500-ml, 1-, 2.5-, 5-, and 25-liter, and 1-gal bottles; (4) RXV Ivermax, 250-ml and 1-liter bottles; (5) VEDCO ProMectin B, 250- and 500-ml, 1-, 2.5-, 5-, and 25-liter, and 1-gal bottles; (6) IBA Ibamectin, 1-and 5-liter bottles; (7) Phoenix Pharmaceutical, Inc. Ivercide, 1- and 5-liter bottles; (8) AgriLabs Agri-Mectin, 5-liter bottles. Recall # V-087-2010;

12) D-Worm 60 (pyrantel pamoate) Dog Dewormer Liquid for Puppies & Dogs, containing 2.27 mg of pyrantel base as pyrantel pamoate per ml, packaged in 60-ml bottles, OTC, ANDA #200-248. Recall # V-088-2010;

13) AmTech Group, Inc. Liquid Spectam, Scour-Halt (Spectinomycin) Oral Solution for Pig Scours, each ml contains 50 mg Spectinomycin (from spectinomycin dihydrochloride pentahydrate), packaged in 240-, 500-, 1,000-ml and 1-gal bottles, OTC, NADA 033-157. Recall # V-089-2010;

14) IVX TiaGard (tiamulin) Liquid Concentrate Antibiotic for Use in Drinking Water of Swine Only, 12.3% tiamulin hydrogen fumarate, packaged in 1-qt. bottles, OTC, ANADA 200-360. Recall # V-090-2010;

15) Amprolium 9.6% Oral Solution, packaged in 32-fl. oz. bottles (TEVA brand only) and 1-gal bottles, OTC, ANADA 200-389, packaged under the following product names and labels: (1) TEVA Amprolium 9.6% Oral Solution; (2) AgriLabs Amprolium 9.6% Oral Solution; (3) AGRIpharm Cocci-Cure; (4) AmTech Group, Inc., Amprolium 9.6% Oral Solution; (5) Aspen CocciStop Solution; (6) Durvet Amprolium 9.6% Oral Solution; and (7) VEDCO Banex. Recall # V-091-2010;

16) Phoenix Scientific 20% Sulfaquinoxaline Sodium Solution, packaged in 1-gal. bottles, OTC, NADA 006-677. Recall # V-092-2010;

17) DVM ChlorhexiDerm Shampoo 2% Chlorhexidine, packaged in 1-gal. bottles labeled as Teva Animal Health, Inc., and 8- and 12-fl. oz. bottles, OTC, labeled as IVX Animal Health. Recall # V-093-2010;

18) DVM Malaseb Shampoo, Medicated Shampoo Formulation for Dogs, Cats and Horses, containing miconazole nitrate 2% and chlorhexidine gluconate 2%, packaged in 1-gal. bottles, RX, labeled as Teva Animal Health, Inc.; 8- and 12-fl. oz. bottles, OTC, labeled as IVX Animal Health. Recall # V-094-2010;

19) DVM Relief Creme Rinse, containing pramoxine hydrochloride 1%, packaged in 1-gal. bottles labeled as Teva Animal Health, Inc., and 8- and 12-fl. oz. bottles labeled as IVX Animal Health, OTC. Recall # V-095-2010;

20) DVM Maximum ChlorhexiDerm Shampoo, 4% Chlorhexidine, packaged in 1 gal, 12- and 8 fl oz bottles, OTC. Recall # V-096-2010;

21) DVM ChlorhexiDerm Flush, active ingredient Chlorhexidine Gluconate 0.22% w/w, packaged in 4- and 12 fl oz bottles, OTC. Recall # V-097-2010;

22) DVM Malaseb Flush, containing Miconazole base 0.174% w/v (equivalent to Miconazole Nitrate 02% w/v), Chlorhexidine Gluconate 0.2% w/v., packaged in 4- and 12-fl oz bottles, RX. Recall # V-098-2010;

23) DVM Malaseb Spray, containing miconazole 1.74% w/v (equivalent to 2% w/v miconazole nitrate, chlorhexidine gluconate 2% w/v, RX, packaged in 8-fl. oz. bottles. Recall # V-099-2010;

24) DVM Relief Shampoo, Pramoxine and Colloidal Oatmeal, active ingredient Pramoxine Hydrochloride 1%, packaged in 1-gal, 12- and 8 oz bottles, OTC. Recall # V-100-2010;

 25) DVM Relief Spray, containing Pramoxine Hydrochloride 1%, packaged in 8-fl oz bottles, OTC. Recall # V-101-2010;

26) T8 Solution Ear Rinse, packaged in 4- and 12-fl oz bottles, OTC, labeled under the following firms: (1) DVM T8 Solution; and (2) novopharm T8 Solution. Recall # V-102-2010;

27) DVM Malaseb Concentrate, containing Miconazole base 5.2% w/w, Chlorhexidine Gluconate 5.9% w/w, after dilution active ingredient equivalent to 0.2% Miconazole Nitrate, 0.2 % Chlorhexidine Gluconate, packaged in 32-fl oz bottles, RX. Recall # V-103-2010;

28) DVM T8 Keto Flush, containing Ketoconazole 0.1% w/w, packaged in 4- and 12-fl oz bottles, RX. Recall # V-104-2010;

29) DVM AloCetic Ear Rinse, acetic acid and aloe, packaged in 4- and 12-fl oz bottles, OTC. Recall # V-105-2010;

30) DVM CortiCalm Lotion, containing Hydrocortisone USP 1%, RX, packaged under the following product names and labels: (1) DVM CortiCalm Lotion, 3-fl oz bottles; and (2) DVM CortiCalf Lotion, 6-fl oz bottles. Recall # V-106-2010;

31) DVM LymDyp Pet Dip, containing Sulfurated Lime Solution 97.8%, packaged in 1 gallon and 16-fl oz bottles, RX.  Recall # V-107-2010;

32) DVM NuSal T Shampoo, containing Salicylic Acid 3%, Coal Tar 2% and Menthol 1%, packaged in 1 gal, 8- and 12-fl oz bottles, OTC. Recall # V-108-2010;

33) DVM OtiCalm Ear Solution, OTC, packaged under the following sizes and firm names: (1) 4-and 12-fl oz bottles; (2) 4-fl oz bottles; and (3) 12-fl oz bottles. Recall # V-109-2010;

34) DVM OtiFoam Ear Cleanser, packaged in 8-fl oz bottles, OTC. Recall # V-110-2010;

35) DVM OtiRinse Ear Cleansing/Drying Solution, Antiseptic Ear Solution for Dogs and Cats, packaged in 8-fl oz bottles, OTC. Recall # V-111-2010;

36) DVM ChlorhexiDerm Plus Scrub, containing chlorhexidine gluconate 2% solution), packaged in 1-gal bottles, OTC. Recall # V-112-2010;

37) DVM Maximum ChlorhexiDerm HC Shampoo, containing Chlorhexidine Gluconate 4% and Hydrocortisone Acetate 1%, packaged in 1-gal, 12- and 8-fl oz bottles, OTC.  Recall # V-113-2010;

38) DVM Relief HC Spray, containing Pramoxine Hydrochloride 1% and Hydrocortisone Acetate 1%, packaged in 8-fl oz bottles, OTC. Recall # V-114-2010;

39) DVM LymDyp Concentrate, containing Calcium Polysulfide 22.3% w/w equivalent to 76.9% w/w Lime Sulfur Solution, packaged in 1-gal bottles, and 16-fl oz bottles, RX. Recall # V-115-2010;

40) DVM LymDyp Spray, Ready-to-Use Solution, containing Calcium Polysulfide 0.75% w/w equivalent to 2.6% w/w Lime Sulfur Solution, packaged in 16-fl oz bottles, RX. Recall # V-116-2010;

41) DVM ChlorhexiDerm Solution, containing Chlorhexidine Gluconate 2%, packaged in 1-gal bottles, OTC. Recall # V-117-2010;

42) DVM SulfOxyDex Shampoo, containing Benzoyl Peroxide 2.5% and Sulfur 2%, packaged in 1-gal bottles; and 8- and 12-fl oz bottles, OTC. Recall # V-118-2010;

43) DVM OxyDex Shampoo, containing Benzoyl Peroxide 2.5%, packaged in 1-gal bottles; and 8- and 12-fl oz bottles, OTC. Recall # V-119-2010;

44) Pyrantel Pamoate Paste, each ml contains 226 mg pyrantel base, ANADA 200-342, OTC, packaged under the following product names and labels: (1) Farnam StrongyleCare, 18.8-g syringes; (2) AgriLabs Equi-Cide, 18.8-g syringes; (3) AmTech Group, Inc. Pyrantel Pamoate Paste, 18.8-g syringes; (4) Butler PYRANTICPASTE, 18.8-g syringes; (5) Cooper's Best Pyrantel Equine Paste Anthelmintic, 18.8-g syringes,; (6) Phoenix Pharmaceutical, Inc Pyrantel Pamoate Paste, 18.8-g syringes; (7) VEDCO EQUI-PHAR ProTal Paste, 18.8-g syringes,; and (8) Farnam TapeCare Plus, 37.6-g syringes. Recall # V-120-2010;

45) Ivermectin Paste 1.87%, ANADA 200-286, OTC, packaged under the following product names and labels: (1) AmTech Group, Inc. Phoenectin Paste, 6.08-g syringes; (2) Cooper's Best Ivermectin Paste, 6.08-g syringes; (3) Horse Health Equine Ivermectin, 6.08-g syringes; (4) Phoenix Pharmaceutical, Inc. Ivercide Equine Paste 1.87%, 6.08-g syringes,; (5) Farnam IverCare, 7.30-g syringes; and (6) Farnam Rotectin 1.87%, 7.30-g syringes. Recall # V-121-2010;

46) DVM KeraSolv Gel (Salicylic Acid 6.6%) in a 1-oz. tubes, RX. Recall # V-122-2010;

47) DVM OxyDex Gel, containing 5% Benzoyl Peroxide, packaged in 1-oz. tubes, RX. Recall # V-123-2010;

48) Tetracyline Hydrochloride Soluble Powder, each pound contains 324 g tetracycline hydrochloride, OTC, ANADA 200-136, packaged under the following product names and labels: (1) AgriLabs Tetra-Bac 324, 5-lb. pails; (2) AgriPharm Tetracycline 324 Powder, 5-lb. pails; (3) AmTech Group, Inc. Tetracyline Hydrochloride Soluble Powder-324, 5- and 25-lb. pails; (4) durvet DURAMYCIN 324, 5-lb. pails; (5) IBA Tet 324 Powder, 5- and 25-lb. pails; and (6) VEDCO Tetracyline Hydrochloride Soluble Powder-324, 5-lb. pails; Recall # V-124-2010;

49) Oxytetracyline Hydrochloride Soluble Powder, each pouch contains 10 grams oxytetracycline HCl, packaged in 6.4-oz. foil pouches, 1 pouch per pail, ANADA 200-146, OTC, manufactured under the following product names and labels: (1) AgriLabs AGRIMYCIN POWDER; (2) AGRIpharm OXY-MYCIN 10; (3) AmTech Group, Inc. Oxytetracycline HCl Soluble Powder; and (4) Aspen Terra-Vet. Recall # V-125-2010;

50) AmTech Group, Inc. Oxytetracyline HCl Soluble Powder-343, containing 204.8 grams of oxytetracycline HCl, packaged in 9.6-oz. foil pouches, 1 pouch per pail, OTC, ANADA 200-247. Recall # V-126-2010;

51) Levamisole Hydrochloride Soluble Pig Wormer, contains 18.15 grams of levamisole hydrochloride activity, packaged in 20.17-g bottles, OTC, ANADA 200-313, packaged under the following product names and labels: (1) AgriLabs Levamisole Hydrochloride Soluble Pig Wormer; (2) AmTech Group, Inc. Levamisole Hydrochloride Soluble Pig Wormer; (3) Aspen Levamisole Hydrochloride Soluble Pig Wormer; and (4) durvet Levamisole Hydrochloride Soluble Pig Wormer. Recall # V-127-2010;

52) Lincomycin Hydrochloride Soluble Powder, containing 16 grams lincomycin hydrochloride equivalent to lincomycin, packaged in 40-g. foil pouches, 1 pouch per pail, OTC, ANADA 200-303, packaged under the following product names and labels: (1) AmTech Group, Inc., Lincomycin Hydrochloride Soluble Powder; and (2) durvet Lincomycin Hydrochloride Soluble Powder. Recall # V-128-2010;

53) Phoenix Scientific Lincomycin-Spectinomycin Water Soluble Powder, containing 16.7 grams lincomycin hydrochloride, equivalent to lincomycin, and 33.3 grams spectinomycin dihydrochloride pentahydrate, equivalent to spectinomycin, packaged in 2.65-oz. bottles, OTC, ANADA 200-345. Recall # V-129-2010;

54) DVM EctoKyl 3X Flea and Tick Shampoo, containing 0.15% pyrethrins, 1.00% piperonyl butoxide, 0.50% dicarboximide, and 0.50% Di-n-Propyl isocinchomeronate, packaged in 1-gallon, 12-fl oz and 8-fl oz bottles, OTC. Recall # V-130-2010;

55) DVM EctoKyl CA Flea & Tick Shampoo, containing 0.150% pyrethrins, 0.300% piperonyl butoxide, and 0.500% N-Octyl bicycloheptene dicarboximide, packaged in 1-gallon, 8- and 12-fl. oz. bottles, OTC. Recall # V-131-2010;

56) Dextrose 50%, each 100 ml contains 50 grams dextrose hydrate, packaged in 500-ml vials, OTC, under the following product names and labels: (1) AgriLabs Dextrose 50%; (2) AGRIpharm Dextrose; (3) AmTech Group, Inc. Dextrose Solution 50%; (4) Aspen Dextrose Solution; (5) Butler Dextrose Solution 50%; (6) durvet Dextrose 50% Sterile Solution; (7) IBA Dextrose 50%; (8) Phoenix Pharmaceutical, Inc. Dextrose Solution 50%; (9) Co Op U Dextrose Solution 50%; (10) VEDCO Dextrose 50% Solution; and (11) VET TEK Dextrose Solution 50%. Recall # V-132-2010;

57) Calcium Gluconate 23% Solution, each 100 ml contains 23 grams Calcium Gluconate (provides 2.14 grams Calcium), packaged in 500-ml. vials, OTC, under the following product names and labels: (1) AgriLabs Calcium Gluconate 23% Solution; (2) AmTech Group, Inc. Calcium Gluconate 23% Solution; (3) Butler CAL-NATE 1069; (4) IBA Hi-CAL 23%; (5) Phoenix Pharmaceutical, Inc. Calcium Gluconate 23% Solution; (6) TEVA Calcium Gluconate 23% Solution; and (7) VEDCO Calcium Gluconate 23% Solution. Recall # V-133-2010;

58) Calcium-Magnesium-Phosphorus-Potassium-Dextrose Solution, each 500 ml of sterile aqueous solution contains 10.8 g calcium (as calcium borogluconate, equivalent to calcium gluconate 23.2%), 8.0 g potassium (as potassium chloride), 2.5 g phosphorus (as sodium hypophosphite hydrate), 1.6 g magnesium (as magnesium borogluconate), and 75.0 g dextrose hydrate, packaged in 500-ml vials, RX, under the following product names and labels: (1) AgriLabs Cal-Dex CMPK Injection; (2) AmTech Group, Inc., CMPK Injection; (3) Aspen Cal Dex CMPK Injection; (4) Butler CAL-MPK 1080 Injection; (5) Phoenix Pharmaceutical Inc. Cal-Phos #2 with Potassium Injection; (6) VEDCO CMPK Solution; and (7) VET TEK C-M-P-K Injection. Recall # V-134-2010;

59) Cal-Phos #2 Injection, each 500 ml contains 10.00 g (complexed as boryl esters of gluconic acid), 2.76 g magnesium (obtained from 23.07 grams of magnesium chloride hexahydrate), 6.03 g phosphorus (obtained from 20.65 grams of sodium hypophosphite hydrate), and 75.00 g dextrose hydrate, packaged in 500-ml vials, RX, under the following product names and labels: (1) AgriLabs Cal-Phos #2 Injection; (2) AmTech Group, Inc. Cal-Phos #2 Injection; (3) Butler CAL PHOS 1000; (4) Phoenix Pharmaceutical, Inc. Cal-Phos #2 Injection; (5) VEDCO CAL-PHOS #2 Reinforced; and (6) VET TEK CAL-PHOS #2 Injection. Recall # V-135-2010;

60) Sterile saline solution 0.9%, each 100 ml of sterile aqueous solution contains 0.9 g sodium chloride, RX, packaged under the following product names: (1) AgriLabs Sterile Saline Solution 0.9%, 250-, 500-, and 1,000-ml vials; (2) AmTech Group, Inc. Saline Solution 0.9%, 250-, 500-, and 1,000-ml vials; (3) Butler Physiological Saline Solution, 250-, 500-, and 1,000-ml vials; (4) Phoenix Pharmaceutical, Inc. Saline Solution 0.9%, 250-, 500-, and 1,000-ml vials; (5) VEDCO Normal Saline Solution, 250-, 500-, and 1,000-ml vials; (6) VET TEK Sterile Saline, 250- and 1,000-ml vials; (7) Pro Labs Sterile Saline Solution 0.9%, 500-ml vials. Recall # V-136-2010;

61) Sodium Iodide 20% Injection, each 100 ml of sterile aqueous solution contains 20 grams sodium iodide, RX, packaged in 250-ml vials under the following product names and labels: (1) AgriLabs Sodium Iodide 20% Injection; (2) AmTech Group, Inc. Sodium Iodide 20% Injection; (3) A & G Sodium Iodide 20% Injection; (4) Aspen Sodium Iodide 20% Injection; (5) Butler Sodium Iodide Solution 20%; (6) Phoenix Pharmaceutical, Inc. Sodium Iodide 20% Injection; (7) RXV Sodium Iodide 20% Injectable Solution; (8) VEDCO Sodium Iodide 20% Solution; and (9) VET TEK Sodium Iodide 20% Injection. Recall # V-137-2010;

62) Sterile Water for Injection, USP, RX, packaged under the following product names and labels: (1) Butler Sterile Water for Injection, USP, 100-, 250-, 500-, and 1,000-ml vials; (2) Phoenix Pharmaceutical, Inc. Sterile Water for Injection, USP, 100- and 500-ml vials; 250- and 1,000-ml vials; (3) VEDCO Sterile Water for Injection, 100-, 250-, 500-, and 1,000-ml vials; (4) AgriLabs Sterile Water for Injection, USP, 250-, 500-, and 1,000-ml vials; (5) AmTech Group, Inc. Sterile Water for Injection, USP, 250-, 500-, and 1,000-ml vials; (6) Aspen Sterile Water for Injection, USP, 250-, 500-, and 1,000-ml vials; and (7) VET TEK Sterile Water for Injection, 250-, 500-, and 1,000-ml vials. Recall # V-138-2010

63) Electrolyte solution with dextrose, each 500 ml of sterile aqueous solution contains 12.50 g dextrose hydrate, 12.50 g sorbitol, 3.95 g sodium lactate, 2.40 g sodium chloride, 0.37 g potassium chloride, 0.21 g magnesium chloride hexahydrate, 0.19 g calcium chloride dihydrate, RX, packaged under the following product names and labels: (1) AmTech Group, Inc. Dexolyte Solution Injection, 500- and 1,000-ml vials; (2) A & G Dexolyte Solution Injection, 500-ml vials; (3) Butler Dexalyte Injection, 500- and 1,000-ml vials; (4) Phoenix Pharmaceutical, Inc. Dexolyte Solution Injection, 500- and 1,000-ml vials; (5) RXV Vetalyte Plus I.V. Solution Injection, 500-ml vials; (6) VEDCO EQUI-PHAR Electrolyte with Dextrose, 500-ml vials, and VEDCO Electrolyte Solution with Dextrose, 1,000-ml vials; (7) AgriLabs Electrolyte Solution with Dextrose Injection, 1000-ml vials; (8) Aspen Electrolyte w/Dextrose Injection, 1,000-ml vials; and (9) VET TEK Electrolyte Solution with Dextrose, 1,000-ml vials. Recall # V-139-2010;

64) Lactated Ringers Injection, each 100 ml contains 600 mg sodium chloride, 310 mg sodium lactate, 30 mg potassium chloride, and 20 mg calcium chloride dihydrate, RX, packaged in 1,000-ml vials under the following product names and labels: (1) AgriLabs Lactated Ringers Injection; (2) AmTech Group, Inc. Lactated Ringers Injection; (3) A & G Lactated Ringers Injection; (4) Butler Lactated Ringers Injection SC; (5) Phoenix Pharmaceutical, Inc. Lactated Ringers Injection; (6) RXV Lactated Ringers Injection; (7) VEDCO Lactated Ringers Injection; and (8) VET TEK Lactated Ringers. Recall # V-140-2010;

65) Vitamin B12, each ml of sterile aqueous solution contains 1,000 mcg cyanocobalamin (B12), RX, packaged under the following product names and labels: (1) AmTech Group, Inc. Vitamin B12 1000 mcg, 100-, 250-, and 500-ml vials; (2) A & G Vitamin B12 1000 mcg, 100-ml vials; (3) VEDCO Vitamin B12, 100- and 500-ml vials; and (4) Phoenix Pharmaceutical, Inc. Vitamin B12 Injection, 250-ml vials. Recall # V-141-2010;

66) Vitamin B12, each ml of sterile aqueous solution contains 3,000 mcg cyanocobalamin (B12), RX, packaged under the following product names and labels: (1) AmTech Group, Inc. Vitamin B12 3000 mcg, 100-ml vials; and (2) TEVA Vitamin B12 3000 mcg, 250-ml vials. Recall # V-142-2010;

67) Vitamin B12, each ml of sterile aqueous solution contains 5,000 mcg cyanocobalamin (B12), RX, packaged in 100-ml vials under the following product names and labels: (1) AmTech Group, Inc. Vitamin B12 5000 mcg; and (2) VEDCO Vitamin B12 5000 mcg. Recall # V-143-2010;

68) Xylazine HCl Injection, each ml contains xylazine (base equivalent) 100 mg (present as the hydrochloride), RX, ANDA 200-139, packaged in 50-ml vials under the following product names and labels: (1) AmTech Group, Inc., Xylazine HCl Injection; (2) Butler X-Ject E; (3) Fort Dodge Sedazine; (4) Phoenix Pharmaceutical, Inc. Xyla-Ject; (5) Pro Labs Xylazine HCl Injection; (6) RXV Xylazine Injection; (7) VEDCO TranquiVed; and (8) VET TEK Xylazine HCl Injection. Recall # V-144-2010;

69) Hypertonic Saline Solution 7.2%, each 100 ml of sterile aqueous solution contains 7.2 g sodium chloride, RX, packaged in 1,000-ml vials under the following product names and labels: (1) AgriLabs Hypertonic Saline Solution 7.2%; (2) AmTech Group, Inc., Hypertonic Saline Solution 7.2%; (3) Aspen Hypertonic Saline Solution 7.2%; (4) Butler Hypersaline Solution 8X; (5) Phoenix Pharmaceutical, Inc. Hypertonic Saline Solution 7.2%; (6) RXV Hypertonic Saline Solution 7.2%; (7) VEDCO EQUI-PHAR EQUINE 7 HSS; and (8) VET TEK Hypertonic Saline Solution 7.2%. Recall # V-145-2010;

70) Dexamethasone Solution, each ml contains 2 mg dexamethasone, RX, ANDA 200-108, packaged in 100-ml multiple dose vials under the following product names and labels: (1) AgriLabs Dexamethasone Solution; (2) AmTech Group, Inc. Dexamethasone Solution; (3) Aspen Dexamethasone Solution; (4) Butler Dexaject; (5) Phoenix Pharmaceutical, Inc. Dexamethasone Solution; (6) VEDCO Dexamethasone Solution; and (7) VET TEK Dexamethasone Solution. Recall # V-146-2010;

71) Iron Dextran Injection (Iron Hydrogenated Dextran), contains ferric hydroxide in complex with a low molecular weight dextran fraction equivalent to 100 mg elemental iron per ml, OTC, ANDA 200-254, packaged in 100-ml vials under the following product names and labels: (1) Aspen Iron Dextran Injection-100; (2) Phoenix Scientific Iron Dextran Injection; (3) Co op U Iron Dextran Injection; and (4) VEDCO Iron Dextran Injection. Recall # V-147-2010;

72) Gentamicin Sulfate Solution, each ml contains gentamicin sulfate equivalent to 100 mg gentamicin base, RX, ANDA 200-137, packaged under the following product names and labels: (1) AgriLabs LEGACY, 100- and 250-ml multiple dose vials; (2) AmTech Group, Inc. GentaMax 100, 100- and 250-ml multiple dose vials; (3) Butler GENTAFUSE, 100- and 250-ml multiple dose vials; (4) Phoenix Pharmaceutical, Inc. GentaMax 100, 100- and 250-ml multiple dose vials; (5) Schering-Plough Animal Health Gentozen, 100-ml multiple dose vial; (6) VEDCO GentaVed 100, 100- and 250-ml multiple dose vials; (7) VET TEK Gentamicin Sulfate Solution, 100- and 250-ml multiple dose vial; and (8) RXV Gentamicin Sulfate Solution, 250-multiple dose vials. Recall # V-148-2010;

73) Phenylbutazone 20% Injection, each ml contains 200 mg phenylbutazone, RX, ANDA 200-128, packaged in 100-ml. vials under the following product names and labels: (1) AmTech Group, Inc. Phenylbutazone 20% Injection; (2) A & G Phenylbutazone 20% Injection; (3) Butler BUTAJECT; (4) Phoenix Pharmaceutical, Inc. Phenylbute Injection 20%; and (5) VEDCO EQUI-PHAR Phenylbutazone Injection. Recall # V-149-2010;

74) Vitamin K1 Injection, each ml contains 10 mg phytonadione, RX, packaged in 100-ml vials under the following product names and labels: (1) AmTech Group, Inc., Vitamin K1 Injection; (2) Butler K-Ject; (3) RXV VITA-JEC; (4) VEDCO VEDA-K1; and (5) VET TEK Vitamin K1 Injection. Recall # V-150-2010; 

75) d-Panthenol Injection, each ml contains 250 mg dexpanthenol, RX, packaged in 100-ml vials under the following labels: (1) AmTech Group, Inc.; and (2) RXV. Recall # V-151-2010;

76) Oxytetracycline Injection, each ml contains 200 mg of oxytetracycline base as oxytetracycline amphoteric, OTC, ANDA 200-123, packaged under the following product names and labels: (1) AmTech Group, Inc. Maxim-200, 100-, 250-, and 500-ml vials; (2) Aspen Oxytetracycline Injection 200 mg/ml, 100- and 250-ml vials; and Aspen Terra-Vet 200, 500-ml vials; (3) Butler Oxybiotic 200, 100-, 250-, and 500-ml vials; (4) durvet Duramycin 72-200, 100-, 250-, and 500-ml vials; (5) Phoenix Pharmaceutical, Inc. Maxim-200, 100-, 250-, and 500-ml vials; (6) VEDCO OxyCure 200, 100-, 250-, and 500-ml vials; and (7) IBA Tetra-Span 200, 250- and 500-ml vials. Recall # V-152-2010;

77) Flunixin Meglumine Injection, each ml contains 50 mg flunixin meglumine equivalent to flunixin, RX, ANDA 200-124, packaged under the following product names and labels: (1) Butler FLUNIXIJECT, 100- and 250-ml vials; (2) Phoenix Pharmaceutical, Inc. FluMeglumine, 100- and 250-ml vials; (3) Phoenix Scientific Flunixin Meglumine, 100-and 250-ml vials; (4) VEDCO VedaGesic, 100- and 250-ml vials; (5) VET TEK Flunixin Meglumine, 100- and 250-ml vials; and (6) Aspen VetaMeg, 250-ml vials. Recall # Recall # V-153-2010;

78) Oxytetracycline Hydrochloride Injection, each ml contains 100 mg oxytetracycline base (as HCl), OTC, ANDA 200-068, packaged in 500-ml vials under the following product names and labels: (1) AgriLabs AGRIMYCIN 100; (2) AGRIpharm OXY-MYCIN 100; (3) AmTech Group, Inc. MAXIM 100; (4) Aspen Terra-Vet 100 Injectable; (5) Butler OXYBIOTIC 100; (6) durvet Duramycin-100; (7) IBA OXY-BIOTIC 100 Injection; (8) Phoenix Pharmaceutical, Inc. Promycin 100; and (9) VEDCO OxyCure-100. Recall # V-154-2010;

79) Calcium/dextrose/magnesium/phosphorus injectable solution, RX, packaged in 500-ml. vials under the following product names and labels: (1) Pfizer Norcalciphos Parenteral Solution; (2) Pfizer Norcalciphos; (3) Pfizer Norcalciphos Solucion parenteral Inyectable; (4) Pfizer Norcalciphos Solucion Parenteral; and (5) Pfizer Cal-D-Mag Forte Mineral, Pfizer, Inc. Recall # V-155-2010;

80) Tripelennamine Hydrochloride Injection, each ml of sterile aqueous solution contains 20 mg tripelennamine hydrochloride USP, RX, ANDA 200-162, packaged under the following product names and labels: (1) Fort Dodge Re-Covr Injection, 250- and 500-ml vials; (2) AgriLabs Tripelennamine Hydrochloride, 500-ml vials; (3) Aspen Tripelennamine Hydrochloride, 500-ml vials; (4) Butler Tripelenject, 500-ml vials; (5) Pro Labs Tripelennamine Hydrochloride, 500-ml vials; (6) RXV Triple Histamine, 500-ml vials; (7) VEDCO Rally-20, 500-ml vials; and (8) VET TEK Tripelennamine Hydrochloride, 500-ml vials. Recall # V-156-2010;

81) Potassium chloride for injection concentrate, each ml of sterile aqueous solution contains 2mEq potassium chloride, RX, packaged under the following product names and labels: (1) Butler Potassiject, 10- and 20-ml vials; (2) Phoenix Pharmaceutical, Inc. Potassium Chloride for Inj. Concentrate, USP, 10- and 20-ml vials; (3) VEDCO Potassium Chloride for Inj. Concentrate, USP, 10-ml vials. Recall # V-157-2010;

82) Sulfadimethoxine Injection 40%, each ml contains 400 mg sulfadimethoxine, OTC, ANDA 200-177, packaged in 250-ml multiple dose vials under the following product names and labels: (1) AgriLabs DI-METHOX; (2) AGRIpharm Sulfadimethoxine Injection-40%; (3) AmTech Group, Inc., Sulfadimethoxine Injection-40%; (4) Aspen Sulfadimethoxine Injection-40%; (5) Butler Sulfabiotic; (6) durvet Sulfadimethoxine Injection 50%; (7) Phoenix Pharmaceutical, Inc. SDM Injection; and (8) VEDCO SulfadiVed 40% Injection. Recall # V-158-2010;

83) Ivermectin injection for cattle and swine, containing 1% ivermectin, OTC, ANDA 200-228, packaged under the following product names and labels: (1) AgriLabs AGRI-MECTIN, 50-, 200- and 500-ml. vials; (2) AmTech Group, Inc. Phoenectin, 50-, 200-, 500- and 1,000-ml vials; (3) Aspen Ivermectin, 50-, 200-, 500- and 1,000-ml vials; (4) Butler Parid LA, 50-, 200- and 500-ml vials; (5) durvet Ivermectin, 50-, 200-, 500- and 1,000-ml vials; (6) Phoenix Pharmaceutical, Inc., Ivercide, 50-, 200-, and 500-ml vials; (7) Ivermax, 50-, 200- and 500-ml vials; and (7) VEDCO ProMectin Injection, 50-, 200-, 500- and 1,000-ml vials. Recall # V-159-2010;

84) Atropine Sulfate Injection 1/120 grain, each ml contains 0.54 mg atropine sulfate, RX, packaged in 100-ml multiple dose vials under the following product names and labels: (1) AmTech Group, Inc. Atropine Sulfate Injection 1/120 Grain; (2) Butler ATROJECT SA; (3) Phoenix Pharmaceutical, Inc. Atropine Sulfate Injection 1/120-Grain; and (4) VEDCO Atropine Sulfate Injection 1/120 Grain. Recall # V-160-2010;

85) Epinephrine Injection USP 1:1000, each ml contains 1 mg epinephrine, RX, packaged in 30-ml multiple dose vials under the following product names and labels: (1) AmTech Group, Inc. Epinephrine Injection USP; (2) Butler EPINJECT; (3) NEOGEN Vet Epinephrine 1:1000; (4) Phoenix Pharmaceutical, Inc. Epinephrine Injection USP; (5) RXV Epinephrine Injection, USP; (6) VEDCO Epinephrine Injection 1:1000; and (7) VET TEK Epinephrine Injection USP. Recall # V-161-2010;

86) Iron dextran injection, containing ferric hydroxide in complex with a low molecular weight dextran fraction equivalent to 200 mg elemental iron per ml, OTC, ANDA 200-256, packaged in 100-ml vials under the following product names: (1) AgriLabs FERRODEX 200; (2) AGRIpharm Anem-X 200; (3) Aspen Iron Dextran Injection-200; (4) durvet Iron Dextran-200; (5) Phoenix Pharmaceutical, Inc. Iron Dextran Injection-200; (6) Phoenix Scientific Iron Dextran Injection-200; (7) VEDCO HemaJect 200; and (8) Co Op U Iron Dextran Injection-200. Recall # V-162-2010;

87) AmTech Group, Inc. SPECTAM Injectable, each ml contains 100 mg spectinomycin (from spectinomycin dihydrochloride pentahydrate), OTC, NADA 040-040, packaged in 500-ml vials. Recall # V-163-2010;

88) Life Science P-Bloc, an injectable source of the volatile salts of Pitcher Plant (Sarraceniaceae) with 5% w/v ethanol as a solution aide and 0.75% w/v benzyl alcohol as a preservative, RX, packaged in 100-ml vials. Recall # V-164-2010;

89) Mannitol injection, each 100 ml contains 20 g mannitol USP, RX, packaged in 100-ml vials under the following product names and labels: (1) AmTech Group, Inc. Mannitol Injection 20%; (2) Butler Manniject; and (3) VEDCO Mannitol Injection 20%. Recall # V-165-2010;

90) DVM Malaseb Pledgets, Medicated Pads for Dogs, Cats and Horses, each pledget applicator (2.25 in. diameter 70% rayon, 30% polyester) contains approximately 17.4 mg Miconazole (equivalent to 20 mg Miconazole Nitrate) and 20 mg Chlorhexidine Gluconate, 60 pledgets per container. Recall # V-166-2010;

91) IVX Malaseb Towelettes, Medicated Pads for Dogs, Cats and Horses, each individually wrapped towelette applicator (6 inches x 6 inches, 60% polypropylene, 40% cellulose fibers) contains approximately 63 mg of miconazole (equivalent to 72 mg miconazole nitrate), 72 mg of chlorhexidine gluconate, packaged in 12- and 60-ct shelf packs, RX. Recall # V-167-2010;

92) AgriLabs Prohibit (Levamisole Hydrochloride) Soluble Drench Powder, contains 46.8 grams of levamisole hydrochloride activity, packaged in 1.8-oz. packets, OTC, ANADA 200-386. Recall # V-168-2010
CODE
1) Lots 8070508, exp. Feb10; 9020109, 9020111, and 9020113, exp. Aug-10;
2) Lots 8010072, Exp. Jan-10 and 8070514, Exp. Jul-10;
3) Lots 8070518, exp. Jan-10; and 9010043, exp. Jul-10;
4) Lots 8060441, exp. Dec-09, and 8120894, exp Jun-10;
5) 1 gal. - Lots 6091559, exp. Sep-09; 6101735, exp. Oct-09; 7010102, exp. Jan-10; 7050790, exp. May-10; and 8010023, exp. Jan-11. 1 pt. - Lots 6101735, exp Oct-09; 6121993, exp Dec-09; 7030397, exp Mar-10; 7050744, exp. May-10; and 7070995, exp. Jul-10;

6) 1-pt - Lots 6091512, 6101725, 6111879, 6122014, 7010014, 7020210, 7020243, 7030398, 7040583, 7081122, 7091305, 7101365, 7121603, 7121604, 8010054, 8010059, 8020141, 8090653, 8090663, 8100750, and 8110798, with exp. dates between Mar-10 and Nov-11. 75-ml - Lots 6101758, exp. Oct-09; 7081182; exp. Aug-10; and 8030279, exp. Mar-11. 300-ml - Lot 6101758, exp. Oct-09. 900-ml - Lots 6101758, exp. Oct-09; 7081182, exp. Aug-10; and 8040352, exp. Apr-11;

7) Lot 9010044, exp. Jan-11;

8) Lot numbers 7091239, 7091240, 7091241, 7091242, 7091243, 7091244, 7091245, 7091246, 7091247, 7091248, 7101366, 7101367, 7101368, 7101369, 7101370, 7101371, 7101443, 7111461, 7111517, 7111518, 7111519, 7111520, 7111521, 7111554, 7121591, 7121592, 7121593, 7121601, 7121602, 8010013, 8010014, 8010015, 8010049, 8010050, 8010060, 8020100, 8040315, 8040316, 8040317, 8040320, 8040321, 8040322, 8040323, 8040324, 8040340, 8040341, 8040342, 8040347, 8040348, 8040359, 8040360, 8050382, 8050383, 8050384, 8050387, 8060427, 8060428, 8060429, 8060438, 8060439, 8070490, 8070500, 8070507, 8070522, 8070523, 8070526, 8070527, 8070531, 8070532, 8080575, 8080576, 8080577, 8080588, 8080597, 8090633, 8090638, 8090643, 8090649, 8090664, 8090669, 8090670, 8100674, 8100717, 8100726, 8100744, 8100745, 8100754, 8110802, 8110803, 8110811, 8120858, 8120859, 8120864, 8120879, 8120881, and 8120887 with exp. dates Sep-09 thru Dec-10;

9) Lot numbers 7121605, 8010040, 8030285, 8030286, 8060426, 8070488, 8070489, 8090652, 8110769, 8120885, and 8120886 with exp. dates between Dec-09 thru Dec-10;

10) Lot numbers 7091249, 7101377, 7101435, 7101452, 7101453, 7101454, 7111522, 7111533, 7121607, 8010057, 8010069, 8060435, 8070499, 8070502, 8070505, 8070506, 8070520, 8080567, 8080572, 8080573, 8080578, 8080579, 8080585, and 8090639, exp. dates Sep-09 thru Sep-10;

11) 250-ml - Lot numbers 6091464, 6101700, 7020328, 7060911, 9010047, exp. dates Sep-09 thru Jan-12; 500-ml - Lot numbers 6091464, 7020328, 7060911, 8060421, 6091462, 6101699, 7020329, 7050765, 7060910, exp. dates Sep-09 thru Jun-10; 1-liter - Lot numbers 7111537, 7111538, 8050368, 8060463, 9010047, 9010048, exp. dates Nov-10 thru Jan-12; 1-gal - Lot numbers 6101697, 7040611, 7071033, 8060421, 8120850, exp. dates Oct-09 thru Dec-11; 5-liter - 6091464, 6101700, 6101701, 6101702, 6101703, 6111833, 6111834, 6111835, 6111836, 6111837, 7040607, 7040608, 7040609, 7040610, 7050766, 7050767, 7050768, 7050769, 7050770, 7050771, 7050772, 7050773, 7050774, 7050775, 7060906, 7060907, 7060908, 7060909, 7081155, 7081156, 7081169, 7081170, 7081171, 7081183, 7081184, 7081185, 7081186, 7081187, 7091253, 7091254, 7091255, 7091256, 7091257, 7091258, 7091276, 7091277, 7091278, 7091279, 7091280, 7091281, 7091282, 7091283, 7091308, 7101388, 7101418, 7101419, 7101420, 7101456, 7111493, 7111496, 7111497, 7111524, 7111525, 7111526, 7111527, 7111528, 7121585, 7121586, 7121587, 7121588, 7121589, 7121608, 7121609, 7121610, 7121611, 7121612, 8020142, 8030244, 8030245, 8030246, 8030247, 8030248, 8030249, 8030250, 8030251, 8030252, 8030253, 8040307, 8040308, 8040309, 8040310, 8070467, 8070468, 8070469, 8070470, 8070471, 8070472, 8070473, 8070474, 8070475, 8070476, 8070509, 8070510, 8070511, 8070512, 8070513, 8080537, 8080538, 8080539, 8080540, 8080541, 8080542, 8080543, 8080544, 8080545, 8080546, 8090616, 8090617, 8090618, 8090619, 8090620, 8090621, 8090622, 8090623, 8090624, 8090625, 8090667, 8100692, 8100701, 8100702, 8100703, 8100704, 8100705, 8110788, 8110789, 8110790, 8120845, 8120846, 8120847, 8120848, 8120849, 9010049, 9010050, 9020131, and 9020132, exp. dates Sep-09 thru Feb-12; 25-liter - Lot numbers 6091471, 6091472, 7050778, 7081162, 7111536, 8090615, 8090626, 8090627, 8100691, 9020130, and 9030203, exp dates Sep-09 thru Feb-12; 2.5-liter - Lot numbers 6091463, 6101698, 7030456, 7050766, 7060942, 7060946, 7071020, 7111543, 8060422, 8100690, and 9020129, exp. dates Sep-09 thru Feb-11;

12) Lot numbers 7091251, 7101379, 8010041, 8030287, 8030288, 8040346, 8060424, 8060425, 8090650, 8090651, and 9010041, exp. date Sep-09 thru Jan-11;

13) 240-ml - Lot numbers 6111918, 7071006, 8050394, and 8120868, exp. Nov-09 thru Dec-11; 500-ml - Lot number 8080596, exp Aug-11; 1,000-ml - Lot numbers 6091515, 6121991, 7010127, 7020231, 7020305, 7040595, 8010058, 8060458, 8080594, 8100679, and 8120876, exp dates Sep-09 thru Dec-11; 1-gal - 6091515, 6121991, 7010127, 7020231, 7020305, 7040595, 8010058, 8060458, 8080594, 8100679, and 8120876, exp. dates Feb 10 thru Nov-11;

14) Lot numbers 7091252, 7101380, 7101433, 7111535, 8010070, 8030255, 8030256, 8030257, 8030258, 8030259, 8030260, 8030261, 8030262, 8030263, 8030264, 8040311, 8040312, 8040361, 8040362, 8050376, 8050377, 8050378, 8050379, 8050388, 8050389, 8050390, 8050391, 8050392, and 8050393, exp. Sep-09 thru May-10;

15) 32 fl. oz - Lot number 8120893, exp. date Dec-10; 1-gal - Lot numbers 8010038, 8010039, 8030266, 8030269, 8030270, 8030271, 8050386, 8060423, 8060432, 8060448, 8060449, 8060450, 8070497, 8070498, 8080569, 8080570, 8080571, 8080593, 8090630, 8090631, 8090654, 8090662, 8100711, 8100714, 8110766, and 8110772, exp. Jan-10 thru Nov-10;

16) Lot number 8060457, exp. date Jun-10;

17) 8-fl. oz. - Lot numbers 7091267, exp. date Sep-10; 8020179, exp date Feb-11; and 8090665, exp. date Sep-11. 12-fl. oz - Lot numbers 7101415, exp. date Oct-10; 8010083, exp. date Jan-11; and 8090668, exp. date Sep-11. 1-gal - Lot numbers 8060447, exp. date Jun-11; and 9010067, exp date Jan-12.

18) 8 fl oz - Lot numbers 7101444, 7101445, 8010056, 8010067, 8030268, 8060460, 8060461, 8080600, 8100757, 9010051, 9030220, and 9040230, exp. dates Oct-09 thru Apr-11; 12-fl oz - Lot numbers 7101436, 7101442, 7121619, 8010016, 8030267, 8040353, 8070521, 8070524, 8100755, 8110814, 8110815, 9040225, and 9040228, exp. dates Oct-09 thru Apr-11; and 1-gal - 7121618, 8020168, 8070503, 8070504, 8110760, 8110763, and 8120861, exp. dates Dec-09 thru Dec-10;

19) 8 fl oz - Lot number 8050401, exp. date May-10; 12 fl oz - Lot number 8050399, exp. date May-10; and 1-gal - Lot number 8020167, exp. date Feb-10;

20) 1 gal: Lots 7121615 & 8090634; 12 fl oz: Lots 7121606, 8030274, 8050395 & 8100731; 8 fl oz: Lots 7111529, 8090635 & 9010061 -- with exp dates Dec 09 - Jan 11;

21) 4 fl oz: Lots 8020177 & 8080583; 12 fl oz: Lots 7091307, 7101455, 8040349 & 8070528 -- with exp dates Sep 09 - Aug 10;

22) 4 fl oz bottles: Lots 7091288, 7111523 & 8100721; 12 fl oz bottles: Lots 7111523 & 8080568 with exp dates from Sep 09 to Oct 10;

23) Lot numbers 8010045, 8010046, 8090666, 8100689, 8110813, and 8120843 with exp dates Jan-10 thru Dec -11;

24) 1 gallon: Lots 7111555, 8010048 & 8040354; 12 fl oz: 7121590, 8010047, 8020158, 8050402, 8080574 & 9020074; 8 fl oz: 7091292, 8010047, 8020157, 8080590 & 8110795 with exp dates Sep 09 to Feb 11;

25) Lots 7121600 & 8050385 with exp dates of Dec 09 and May 10;

26) 4 fl oz: Lots 8020140 & 8080601; 12 fl oz: Lots 8020140 & 8080601 w/ exp dates Feb 10 & Aug 10;

27) Lot 8010084, exp date Jan 10;

28) 4 fl oz: 7091275, 8010018, 8060431, 8100706, 8120820, 9010038 & 9030210; 12 fl oz: 7101421, 8010017, 8040339, 8060455, 8090644, 8090647, 8120862, 8120863 & 9030202 with exp dates Sep 09 to Mar 11;

29) 4 fl oz: Lots 080523926 & 082745836; 12 fl oz: Lots 080523925 & 082745837 with exp dates Mar 10 and Oct 10;

30) 3-fl oz: Lots 3289, 3369, 3389 & 3462; 6 oz: Lots 3339, 3405, 3428 and 3476 with exp dates of Sep 09 to Mar 10;

31) 1 gal: G375, H015 & H145; 16-fl oz:, H175, D205, E295 & F075 with exp dates Apr 10 to Aug 10;

32) 1 gal: Lots 081684808, 081764884, 090190123 & 090850682; 12-fl oz: Lots 081684811, 081764883, 090190125 & 090850683; 8-fl oz: Lots 081684812, 081764882, 090190126 with exp dates Jul 10 to Jun 11;

33) 4-fl oz: Lots 700121A, 701101A, 801201A, 801201B, 801210B, 801240A, 805150A, 805150B. 809180A, 900240A, 905010A & 906120A; 12-fl oz: Lots 709011A, 709011B, 801210A, 801240B, 803210A, 804090A, 807250A, 808201A, 808201B, 809180B, 802030A, 904150A, 906120B & 906120C with exp dates Oct 09 to May 11;

34) Lots 800201A, 804020A & 806160A with exp dates of Feb 10 to Oct 10;

35) Lots 703021A, 801190A, 801220A, 802021A, 802070A, 803011A, 803260A, 806080A, 807121A, 808130A, 809210A & 809221A with exp dates Jan 10 to Dec 10;

36) Lots 801-1026-054, 808-1026-055, 810-1026-056 & 903-1026-057 with exp dates Dec 09 to Feb 11;

37) 1 gallon: Lots 8120882 & 8120883; 12-fl oz: Lot 8120882; and 8-fl oz: Lot 8120883 with exp dates Dec 10;

38) Lots 8030275 & 8060465 with exp dates Mar 10 & Jun 10;

39) 1 gallon: Lot 083126144; 16 oz: 072572649 & 083126142 with exp dates Sep 09 & Nov 10;

40) Lots 082485554 & 090790628 with exp dates Oct 10 and Apr 11;

41) Lots 7111532, 8040343, 8060437, 8070501, 8110770 and 8120892 with exp dates Apr 10 to Dec 10;

 42) 1-gallon: Lots 8040319, 8060451, 8080580 & 8100720; 12-fl oz: Lots 8060451 &8100720; 8-fl oz: Lots 8040319, 8060451 & 8080580 with exp dates Oct 09 to Dec 10;

43) 1 gallon: Lots 8030289 & 8070529; 12 oz: Lots 8030289 & 8070529; 8 oz: Lot 8030289 with exp dates Mar 10 and Jul 10;

44) 18.8 gm: Lots 7111490, 7111491, 7111512, 7111513, 7111550, 8030191, 8030192, 8030193, 8030282, 8030283, 8100697, 8100698, 8100699, 8100700, 8110761, 8110791, 8110792, 9030200, 9030201, 7121565, 7121566, 7121567, 7121568, 7121620, 8110793, 8120851, and 9030212; 37.6 gm: Lots 7091259, 7091260, 7101391, 7101392, 7101393, 7101437, 7101438, 8010036, 8010037, 8020121, 8020122, 8020123, 8020124, 8020178, 8020181, 8040290, 8040291, 8070517, 8070530, 8080563 and 8080564 with exp dates Sep 09 to Mar 11;

45) 6.08 gm: Lots 7091274, 7101402, 7111492, 8020125, 8020126, 8020163, 8020164, 8020182, 8030194, 8030195, 8040344, 8050374, 8050375, 8050398, 8060419, 8060420, 8060454, 8070491, 8070492, 8070493, 8070494, 8070515, 8070516, 8080559, 8080560, 8080561, 8080562, 8080586, 8080591, 8080592, 8090605, 8090606, 8090607, 8090608, 8090645, 8090646, 8100693, 8100694, and 8100695; 7.30 gm: Lots 7111511, 7111553, 7121594, 7121595, 8010034, 8010035, 8030278, 8030281, 8030284, 8040292, 8040293, 8040336, 8040337, 8040350, 8040351, 8050372, 8050373, 8050396, 8050397, 8060416, 8060417, 8060418, 8060452, and 8060453 with exp dates Sep 09 to Oct 10;

46) Lots 60905, 70165, 70353, 71137 and 80708 with exp dates Oct 09 to Jul 11;

47) Lots 71136 & 80707 with exp dates of Feb 10 and Aug 10;

48) 5 lb: Lots 7091293, 7091294, 7091295, 7091296, 7091309, 7091310, 7091311, 7091312, 7101425, 7101426, 7101427, 7101428, 7101429, 7101430, 7101431, 7101432, 7101447, 7101448, 7101449, 7101450, 7111462, 7111463, 7111464, 7111465, 7111466, 7111467, 7111468, 7111469, 7111470, 7111471, 7111472, 7111473, 7111474, 7111475, 7111476, 7111477, 7111499, 7111500, 7111501, 7111502, 7111503, 7111504, 7111505, 7111506, 7111507, 7111508, 7111544, 7111545, 7111546, 7111547, 7111548, 7111549, 7121575, 7121576, 7121577, 7121578, 7121579, 7121580, 7121581, 7121582, 7121583, 7121584, 7121616, 7121617, 8010024, 8010025, 8010026, 8010027, 8010028, 8010029, 8010030, 8010031, 8010032, 8010033, 8010074, 8010075, 8010076, 8010077, 8010078, 8010079, 8010080, 8010081, 8010085, 8010086, 8010087, 8010088, 8020101, 8020102, 8020103, 8020104, 8020105, 8020106, 8020107, 8020108, 8020109, 8020110, 8020111, 8020112, 8020113, 8020114, 8020115, 8020116, 8020117, 8020118, 8020119, 8020120, 8020169, 8020170, 8020171, 8020172, 8020173, 8020174, 8020175, 8020176, 8020183, 8020184, 8020185, 8020186, 8030196, 8030197, 8030198, 8030199, 8030200, 8030201, 8030202, 8030203, 8030204, 8030205, 8030206, 8030207, 8030208, 8030209, 8030210, 8030226, 8030227, 8030228, 8030229, 8030230, 8030231, 8030232, 8030233, 8030234, 8030235, 8030236, 8030237, 8030238 ,8030239, 8030240, 8030241, 8030242, 8040325, 8040326, 8040327, 8040328, 8040329, 8040330, 8040331, 8040332, 8040333, 8090657, 8090658, 8090659, 8090660, 8110773, 8110774, 8110776 and 8110777; 25 lb: Lots 7111514, 7111530, 7111531, 7121596, 7121597, 8040334, 8040335, 8100746, 8100747 and 8120837 with exp dates of Sep 09 to Dec 10;

49) Lots 7101407, 7101408, 7101451, 7121569, 8020143, 8030276, 8060410, 8060411, 8060412, 8060413, 8060456, 8060464, 8080547, 8080548, 8080549, 8090655, 8090656, 8100683, 8100684, 8100722, 8110782, 8110783, 8110784, 8120838, 8120839, 8120840, 8120841, 9010017, 9020115 and 9020116 with exp dates Oct 09 to Feb 12;

50) Lots 7091290, 7121570, 8030243, 8120842 and 9010040 with exp dates Sep 09 to Jan 11.

51) Lot numbers 7091284, exp date Sep-09; 7111551 and 7111552, exp date Nov-09; and 7121613 and 7121614, exp date Dec-09;

52) Lots 7091261, 7091298, 7091299, 7091300, 7101403, 7101404, 7101405, 7101406, 7111478, 7111479, 7111509, 7111510, 7111539, 7111540, 7111541, 7111542, 7121571, 7121572, 7121573, 7121574, 8010005, 8010006, 8010007, 8010008, 8010019, 8010020, 8010021, 8010022, 8010062, 8010063, 8010064, 8010065, 8010066, 8020144, 8020145, 8020146, 8020147, 8020148, 8020149, 8030213, 8030214, 8030215, 8030216, 8030217, 8030218, 8030280, 8040294, 8040295, 8040296, 8040297, 8040298, 9010064, 9010065, 9010066, 9020102 and 9020103 with exp dates of Sep 09 to Feb 12;

53) Lots 7091297, 8020151, 8030277, 8040299, 9010052 and 9010053 with exp dates Sep 09 to Jan 11;

54) 1 gallon: Lots 41102, 50601, 50602, 50603, 60828, 61209 & 61210; 12 oz: Lots 50528, 41223B, 61114B and 61207B; 8 oz: Lots 50529, 61208 and 61207A with exp dates Dec 09 to Dec 11;

55) 1 gallon: Lots 07209A, 08051A and 08140A; 12 oz: Lots 08291, 23364, 07209A; and 8 oz: Lot 23361 with exp dates Aug 11 Nov 13;

56) Lot numbers 6091535, 6091536, 609304F, 609305F, 609307F, 609309F, 609310F, 609313F, 610314F, 610315F, 610316F, 610323F, 610324F, 610325F, 610333F, 610334F, 610335F, 611347F, 611350F, 611352F, 611354F, 611355F, 611356F, 612364F, 612365F, 612366F, 612367F, 612368F, 612369F, 612376F, 612378F, 701001F, 701002F, 701003F, 701004F, 701005F, 701013F, 701015F, 701016F, 701017F, 701021F, 701022F, 701023F, 702029F, 702031F, 702034F, 702038F, 702050F, 702056F, 704125F, 704127F, 704129F, 704131F, 704133F, 704135F, 704137F, 704139F, 704141F, 704143F, 704145F, 705147F, 705179F, 705193F, 705195F, 706197F, 706237F, 707239F, 707241F, 707247F, 707249F, 707251F, 708279F, 708281F, 708283F, 708284F, 708285F, 708286F, 708287F, 708288F, 708289F, 708290F, 708292F, 708294F, 708296F, 708298F, 708301F, 708303F, 708305F, 708307F, 708308F, 708309F, 709339F, 709341F, 709343F, 709345F, 709347F, 709349F, 709351F, 710353F, 710355F, 710357F, 710359F, 710361F, 710368F, 710370F, 710372F, 710374F, 710376F, 710380F, 710382F, 711384F, 711386F, 711388F, 711390F, 711392F, 712433F, 712434F, 712435F, 801011F, 801012F, 801013F, 801014F, 801015F, 805030F, 805031F, 806063F, 807064F, 807065F, 807066F, 810140F, 810141F, 810146F, 812172F, 812173F, and 812176F with exp dates Sep-09 thru Dec-11;

57) Lot numbers 805034F, 805035F, 805036F, 805037F, 805038F, 805039F, 805040F, 805041F, 805041F-03-B, 805042F, 806053F, 806054F, 806055F, 806056F, 806057F, 807080F, 807080F-03-B, 807080F-03-C, 807080F-03-D, 808083F, 808083F-03-B, 808084F, 808084F-03-B, 808084F-03-C, and 901006F with exp. dates between Nov-09 thru Jul-10;

58) Lot numbers 610318F, 610322F, 610336F, 610337F, 611346F, 612371F, 612374F, 612377F, 612380F, 612381F, 701006F, 701007F, 701020F, 702032F, 702036F, 702037F, 702041F, 702047F, 702048F, 704115F, 704121F, 704123F, 705169F, 705171F, 705173F, 705175F, 705177F, 705181F, 706213F, 706215F, 706217F, 708291F, 708293F, 708295F, 709320F, 709321F, 709322F, 710352F, 710354F, 710356F, 710358F, 710360F, 710379F, 710381F, 710383F, 711385F, 711387F, 711399F, 711401F, 711403F, 711405F, 711407F, 806043F, 806044F, 806045F, 806046F, 806047F, 806058F, 806059F, 806060F, 806061F, 806062F, 808096F, 810139F, and 901008F with exp. dates between 10/9/2009 thru 1/1/2012;

59) Lot numbers 611359F, 612360F, 701018F, 702046F, 705183F, 705185F, 705187F, 705189F, 705191F, 709342F, 709344F, 709346F, 709348F, 709350F, 711410F, 711411F, 712425F, 806048F, 806049F, 806050F, 806051F, 806052F, 808097F, 808098F, 808099F, 808100F, 810134F, 810135F, 810136F, 810137F, and 810138F with exp. dates between Nov-09 thru Oct-11;

60) 250 ml - Lot numbers 609302F, 609303F, 610339F, 701011F, 702040F, 703080F, 703082F, 703090F, 707257F, 707259F, 707261F, 710363F, 710365F, 710367F, 712428F, 712429F, 712430F, 712431F, 712432F, 807073F, 807075F, 809120F, 809121F, 809122F, and 812168F with exp. dates between Sep-09 thru Dec-11; 500 ml - Lot numbers 610331F, 703092F, 707260F, 707267F, 707269F, 710362F, 710364F, 710366F, 808101F, 808102F, 808103F, and 812171F with exp dates between Oct-09 thru Aug-11; and 1,000-ml - Lot numbers 703059F, 703061F, 703073F, 708280F, 708282F, 711394F, 711396F, and 811152F with exp. dates between Mar-10 thru Nov-11;

61) Lot numbers 610338F, 707253F, 707255F, 710377F, 712427F, 809116F, 809118F, and 812170F with exp. dates between Oct-09 thru Dec-11;
 
62) Lot numbers 6101727, 7030361, 7060836, 610340F, 701010F, 702039F, 703084F, 703086F, 703088F, 707263F, 709325F, 709327F, 709329F, 709331F, 710369F, 710371F, 710373F, 710375F, 807067F, 807068F, 807069F, 807070F, 807071F, 810124F, 610327F, 610332F, 612373F, 702044F, 703058F, 703064F, 703070F, 703076F, 704119F, 706211F, 707254F, 707256F, 711408F, 712416F, 712426F, 801021F, 801022F, 801023F, 809110F, 901022F, 902027F, 702049F, 702051F, 702053F, 703085F, 703097F, 704113F, 708274F, 708276F, 708278F, 710378F, 901018F, 901019F, and 902023F with exp. dates between Oct-09 thru Feb-12;

63) Lot numbers 609311F, 609312F, 610326F, 612362F, 706229F, 706231F, 706235F, 712436F, 712437F, 801001F, 801002F, 808088F, 808089F, 808090F, 901004F, 703091F, 703093F, 703095F, 705180F, 705182F, 705184F, 705186F, 705188F, 705192F, 705194F, 707252F, 707266F, 707270F, 707272F, 708297F, 708299F, 708300F, 708302F, 708304F, 811153F, 811154F, and 812162F with exp. dates between Sep-09 thru Dec-11;

64) Lot numbers 702055F, 703057F, 703063F, 703069F, 703071F, 703075F, 703079F, 703081F, 703083F, 703087F, 703089F, 704124F, 704126F, 704128F, 705164F, 705168F, 705170F, 705172F, 705174F, 705176F, 706214F, 706216F, 706218F, 706220F, 706222F, 706224F, 706226F, 811157F, 812159F, and 812160F with exp. dates between Feb-10 thru Dec-11;

65) 100-ml - Lot 8100710; 250-ml - Lot 8100752; and 500-ml - Lot 8100730, exp. date Oct-10;

66) 100-ml - Lot 9020120, exp. Feb-11; and 250-ml - Lot 8100715, exp. date Oct-10;

67) Lot number 8100712, exp. date Oct-10;

68) Lot numbers 7030446, exp. date Sep-09; 7040665, exp. date Oct-09; 7050703, exp. date Nov-09; 7071044, exp. date Jan-10; 7081089, exp. date Feb-10; 54016LC, exp. date Dec-10; 54016TT, exp. date Jan-11; and 540171T, exp. date Jan-11;

69) Lot numbers 703099F, 703102F, 703103F, 703104F, 703105F, 704106F, 704107F, 704108F, 704109F, 704112F, 704114F, 704116F, 704118F, 704120F, 704122F, 704130F, 704132F, 704134F, 704136F, 704138F, 704140F, 705146F, 705148F, 705150F, 705152F, 705154F, 705156F, 705158F, 705160F, 705162F, 705166F, 705178F, 705190F, 706196F, 706198F, 706200F, 706202F, 706204F, 706206F, 706208F, 706210F, 706212F, 706228F, 706234F, 706236F, 707238F, 707240F, 707242F, 707244F, 707246F, 707248F, 707250F, 711398F, 711400F, 711402F, 711404F, 711406F, 811158F, 812165F, and 812166F with exp. dates between Mar-10 thru Dec-11;

70) Lot numbers 6091494, 6091500, 6091557, 6101693, 6101739, 6121971, 6121995, 6122038, 6122061, 7010042, 7010122, 7020201, 7020233, 7020327, 7040552, 7050705, and 7081090 with exp. dates between Sep-09 thru Aug-10;

71) Lot numbers 6091495, 6091503, 6091520, 6091564, 6091602, 6101619, 6111874, 6121935, 7010046, 7010097, 7010169, 7020185, 7020209, 7020298, 7040556, 7060841, and 7070968 with exp. dates between Sep-09 thru Jul-10;

72) 100-ml - Lot numbers 6091521, 6101676, 6111866, 6111928, 6122047, 7010112, 7030374, 7030469, 7040557, 7050721, and 7060842 with exp. dates between Sep-09 thru Jun-10; and 250-ml - Lot numbers 6091441, 6091522, 6091550, 6101620, 6101677, 6101710, 6111821, 6111905, 6121975, 7010004, 7010170, 7020204, 7030375, 7030458, 7030489, 7040558, 7040559, 7050711, 7050712, 7060843, 7060844, 7070969, 7070970, 7070971, and 7081097 with exp. dates between Sep-09 thru Aug-10;

73) Lot numbers 6121970, exp. date Dec-09; 7020205, exp. date Feb-10; 7030472, exp. date Mar-10; and 7050814, exp. date May-10;

74) Lot numbers 6101746, exp. date Oct-09; 7010150, exp. date Jan-10; 7020300, exp. date Feb-10; 7050713, exp. date May-10; 7070972, exp. date Jul-10; and 8110801, exp. date Nov-11;

75) Lot number 8110808, exp. date Nov-10;

76) 100-ml - Lot numbers 6101726, exp. date Oct-09; 7020234, exp. date Feb-10; 7040561, exp. date Apr-10; and 7060847, exp. date Jun-10; 250-ml - Lot numbers 6091551, exp. date Sep-09; 6101781, exp. date Oct-09; 7070973, exp. date Jul-10; and 500-ml - Lot numbers 6091524, 6101726, 6101766, 6111868, 6121976, 6122008, 7010113, 7020234, 7040560, 7040561, 7050714, 7060847, 7060848, and 7070974, with exp. dates between Sep-09 thru Jul-10;

77) 100-ml - Lot numbers 6091502, exp. date Sep-09; 6091552, exp. date Sep-09; 6122088, exp. date Dec-09; and 7010151, exp. date Jan-10; 540159V, exp. date Mar-11; and 540159W, exp. date Apr-11. 250-ml - Lot numbers 6091451, 6121978, 6122036, 6122037, 6122048, 7010006, 7010048, 7010114, 7020235, 7020323, 7030377, 7030495, 7040562, 54015P8, 540161R, 54016TP, and 54018LP with exp. dates between Sep-09 thru Oct-10;

78) Lot numbers 6091452, 6091504, 6091523, 6091553, 6101623, 6101624, 6101765, 6101780, 6111908, 6121979, 6122009, 6122049, 7010007, 7010049, 7010115, 7020187, 7020206, 7020271, 7020301, 7030378, 7030379, 7030487, 7040563, 7040564, 7040667, 7060850, 7060851, 7060852, 7070976, 7070977, and 7081101 with exp. dates between Sep-09 thru Aug-10;

79) Lot numbers 610317F, 611343F, 611349F, 612363F, 701009F, 701012F, 702042F, 702054F, 706199F, 706201F, 706203F, 706205F, 706207F, 706209F, 707243F, 707245F, 707271F, 707273F, 708275F, 708277F, 709323F, 709324F, 709326F, 709328F, 709330F, 709332F, 709334F, 709336F, 709338F, 709340F, 711389F, 711391F, 711393F, 711395F, 711397F, 711412F, 711413F, 711414F, 711415F, 809106F, 809107F, 809108F, 809109F, 809111F, 809112F, 809113F, 809114F, 810129F, 810130F, 810131F, 810132F, 810133F, 902033F, 902034F, 902035F, 902036F, 902041F, and 903043F with exp. dates between Oct-09 thru Mar-12;

80) 250-ml - Lot number 7030457, exp. date Mar-10; 500-ml - Lot numbers 6091573, 6101680, 6121932, 6122050, 7010116, 7020356, 7030485, 7050719, 7050720, and 7070980 with exp. dates between Sep-09 thru Jul-10;

81) 10-ml vials - Lot numbers 6101692, 7010008, 7020326, 7050722, 7081107, 8100741, 8100742, and 8100749 with exp. dates between Oct-09 thru Oct-11; 20-ml vials - Lot numbers 6101752, exp. date Oct-09; 7030381, exp. date Mar-10; and 8100751, exp. date Oct-11;

82) Lot numbers 6091505, 6091526, 6091554, 6101625, 6101681, 6101763, 6111824, 6111870, 6111910, 6111927, 6121980, 6122010, 6122023, 7010009, 7010010, 7010050, 7010117, 7010171, 7020236, 7030383, 7030490, 7040567, 7050723, 7060855, 7070981, 7070982, and 7081108 with exp. dates between Sep-09 thru Aug-10;

83) 500-ml - Lot numbers 6091506, 6101745, 6122051, 7010166, 7020272, and 7040568 with exp. dates between Sep-09 thru Apr-10; 1,000-ml - Lot numbers 6111869, 6111888, 7010091, 7010121, 7010174, 7030384, and 7070983 with exp. dates between Nov-09 thru Jul-10; 50-ml - Lot numbers 6091490, 6101626, 6101745, 6122011, 7010154, 7020188, 7030385, 7050724, 7060856, and 7070984 with exp. dates between Sep-09 thru Jul-10; 200 ml - Lot numbers 6101751, exp. date Oct-09; 6122011, exp date Dec-09; 7040645, exp. Apr-10; and 7050725, exp. date May-10;

84) Lot numbers 6101742, 6121931, 7020242, 7030473, 7060831, 8100677, and 8100707 with exp. dates between Oct-09 thru Oct-11;

85) Lot numbers 6101720, exp. date Oct-09; and 7010140, exp. date Jan-10;

86) Lot numbers 6091456, 6091509, 6091555, 6091576, 6091586, 6091601, 6101629, 6101682, 6101708, 6101721, 6111829, 6111843, 6111889, 6111894, 6121974, 6122005, 6122077, 7010003, 7010096, 7010111, 7020186, 7020203, 7020269, 7020270, 7020299, 7030391, 7030392, 7030393, 7030476, 7040575, 7040576, 7040577, 7050734, 7050737, 7060865, 7060866, 7060867, 7070990, 7070991, 7070992, 7081116, 7081117, 5401562, 5401563, 5401564, 54015J7, 5401673, 54016N8, 54016N9, 54016NC, 54016PG, 54016TV, 54016TX, 54016VO, 540171N, 540171X, 540174N, 5401769, 540176J, 54017WG, 54017WJ, 540182C, and 54018CJ with exp. dates between Sep-09 thru Sep-11;

87) Lot numbers 6091556, 6111873, 6122080, 7030395, 7040647, 7060868, 7071046, and 7081120 with exp. dates between Sep-09 thru Aug-10;

88) Lot number 7010106, exp. date Jan-10;

89) Lot numbers 8110804, exp. date Nov-10; and 9010070, exp. date Jan-11;

90) Lot numbers 8010061, 8010082, 8050369, 8050370, 8050371, 8100688, 8120844, and 9010025 with exp. dates between Jan-10 thru Jan-12;

91) 60-ct. - Lot numbers 5597, exp. date Dec-09; and 5695, exp. date Jan-10; 12-ct. - Lot numbers 5644, 5662, 5665, 5684, and 5712, exp. Jan-10; lot number 5827, exp. date;

92) Lot numbers 7091262, 7091263, 7091264, and 7091265, exp date Sep-09
RECALLING FIRM/MANUFACTURER
TEVA Animal Health Inc., Saint Joseph, MO, by letters dated September 4, 2009 and October 26, 2009. Firm initiated recall is ongoing.
REASON
The products were not manufactured in conformance with GMP's.
VOLUME OF PRODUCT IN COMMERCE
Amount too numerous to list
DISTRIBUTION
Nationwide, Israel, Hong Kong, Canada, Taiwan, and China

RECALLS AND FIELD CORRECTIONS:  VETERINARY - CLASS III
___________________________________
PRODUCT
1) Procaine Penicillin G in Aqueous Suspension, Injectable, each ml contains 300,000 units of procaine penicillin, OTC, NADA 65-110, packaged under the following product names, labels, and sizes: (1) AmTech Group Inc. Pen-G Max, 100-, 250-, and 500-ml vials; (2) Aspen Penicillin G Procaine, 100-, 250-, and 500-ml vials; (3) Butler Penject, 100- and 250-ml vials; (4) Phoenix Pharmaceutical, Inc. Pen-G, 100- and 250-ml vials; (5) VEDCO Aquacillin, 100-, 250-, and 500-ml vials; (6) novopharm Penicillin G Procaine Injectable Suspension, 250- and 500-ml vials; and (7) CSR Company, Inc. Penicillin-G, 500-ml vials. Recall # V-070-2010;

2) Penicillin G Benzathine and Penicillin G Procaine in Aqueous Suspension, each ml contains 150,000 units penicillin G benzathine and 150,000 units penicillin G procaine, OTC, NADA 65-498, packaged under the following product names, labels, and sizes: (1) AgriLabs Twin Pen, 100-, 250-, and 500-ml vials; (2) AmTech Group, Inc. Pen BP-48, 100-, 250-, and 500-ml. vials; (3) Aspen Penicillin G Benzathine and Penicillin G Procaine, 100-, 250-, and 500-ml. vials; (4) Butler Penject + B, 100- and 250-ml. vials; (5) durvet Dura-Pen, 100- and 250-ml. vials; (6) Phoenix Pharmaceutial, Inc. Dual-Cillin, 100- and 250-ml. vials; and (7) VEDCO Durapen, 100- and 250-ml. vials. Recall # V-071-2010;

3) AmTech Group, Inc. Penicillin G Potassium USP, Antibiotic for Drinking Water, packaged in jars containing 0.500 billion units and 1.0 billion units Penicillin G Potassium, OTC, ANADA 200-347. Recall # V-072-2010;

4) AmTech Group, Inc. Griseofulvin Powder Microsize, contains 2.5 g griseofulvin, packaged in 15-gram pouches, RX, ANDA 200-391. Recall # V-073-2010
CODE
1) 100-ml. vials - BL710137; BL710138; BL805068; BL812175; and BL902014 with exp. dates between Oct-09 and Feb-11. 250-ml. vials - BL709117; BL709120; BL803016; BL803017; BL803018; BL803019; BL804036; BL804037; BL804048; BL804051; BL805072; and BL806074 with exp. dates between Sep-09 and Jun-10. 500-ml. vials - BL710122; BL803022; BL803024; BL804043; BL804045; BL804052; BL804055; BL805069; BL805070; BL805071; BL812178; BL901002; and BL902015 with exp. dates between Oct-09 and Feb-11;

2) 100-ml vials - BL710136; BL710139; BL811162; BL811165; BL812176; and BL901003 with exp. dates between Oct-09 and Jan-11. 250-ml. vials - BL709118; BL710134; BL711142; BL711143; BL711144; BL711145; BL711148; BL712150; BL712151; BL712152; BL808128; BL809130; BL809134; BL811164; BL812179; BL901004; and BL901013 with exp. dates between Sep-09 and Jan-11. 500-ml vials - BL710121; BL711141; BL809129; BL811163; and BL812177 with exp. dates between Oct-09 and Dec-10;

3) Lots .5000 BIU - BL710123; BL710124; BL710125; BL710126; BL710127; BL710128; BL710129; BL710130; BL710131; BL710132; BL710133; BL801002; BL801003; BL801004; BL801005; BL801006; BL801007; BL801008; BL801009; BL801010; BL801011; BL801012; BL802025; BL802026; BL802027; BL802028; BL802029; BL802030; BL802031; BL802032; BL803038; BL803039; BL803040; BL803041; BL804042; BL804044; BL804046; BL804047; BL804049; BL804050; BL804053; BL804054; BL805056; BL805057; BL805058; BL805059; BL805060; BL805061; BL805062; BL805063; BL805064; BL805065; BL805066; BL805067; and BL806081, with exp. dates between Oct-09 and Jun-10. 1 BIU - BL802033; BL802034; BL802035; BL806076; BL806077; BL806078; BL806079; BL806080; BL806082; BL806083; BL806084; BL806085; BL806086; BL806087; BL806088; BL806089; BL806090; BL807091; BL807092; BL807093; BL807094; BL807095; BL807096; BL807097; BL807098; BL807099; BL807100; BL807101; BL807102; BL807103; BL807104; BL807105; BL808107; BL808108; BL808109; BL808110; BL808111; BL808112; BL808113; BL808114; and BL808115, with exp. dates between Feb-10 and Aug-10;

4) Lot BL805073, exp. date May-10
RECALLING FIRM/MANUFACTURER
Recalling Firm: TEVA Animal Health Inc., Saint Joseph, MO, by letters dated September 18, 2009.
Manufacturer: TEVA Animal Health Inc., Fort Dodge, IA. Firm initiated recall is ongoing.
REASON
The products were not manufactured in conformance with GMP's.
VOLUME OF PRODUCT IN COMMERCE
259,852/100-ml. vials; 297,654/250-ml. vials; 120,680/500-ml. vials; 134,554/.5000 BIU jars; 48,642/1 BIU jars; and 7,807/15-gram pouches
DISTRIBUTION
Nationwide and Canada

___________________________________
PRODUCT
1) ADM Alliance Nutrition, Freeman FDLT Past RU, E7837CCF, Medicated, Net Weight 50 lb (22.67 kg). Recall # V-169-2010;

2) ADM Alliance Nutrition, Special Range Breeder Cube N-20, 11519AL, Net Weight 50 lb (22.67 kg) or as invoiced. Recall # V-170-2010;

3) ADM Alliance Nutrition, SW 20 Range Cube, 53501AAA, Net Weight 50 lb (22.67 kg) or as invoiced. Recall # V-171-2010;

4) ADM Alliance Nutrition, 37% Protein Cube, 53073AAA, Net Weight 50 lb (22.67 kg) or as invoiced. Recall # V-172-2010;

5) ADM Alliance Nutrition, 062209 Tuls Cow Dairy Mnl, Net Weight 50 lb (22.67 kg) or as invoiced. Recall # V-173-2010;

6) ADM Alliance Nutrition, NF Prospector 32 Silver, 50119AAA, ADM Alliance Nutrition, Inc., Net Weight 50 lb (22.67 kg) or as invoiced. Recall # V-174-2010;

7) ADM Alliance Nutrition, Fruita Coop Feedlot Base RU, E5397CDL, Medicated, Net Weight 50 lb (22.67 kg) or as invoiced. Recall # -175-2010;

8) ADM Alliance Nutrition, Everett Feedlot DDG CM RU, Grower E4457CCR, Medicated, Net Weight 50 lb (22.67 kg) or as invoiced. Recall # V-176-2010;

9) ADM Alliance Nutrition, CTC 10G, 859600, Medicated, Net Weight 50 lb (22.67 kg) or as invoiced. Recall # V-177-2010;

10) ADM Alliance Nutrition, CJ Feedlot DC Balancer 0.6, E6472GFO, Medicated, ADM, Net Weight 50 lb (22.67 kg) or as invoiced. Recall # V-178-2010;

11) ADM Alliance Nutrition, 062209 Lost Trail 509 Dairy Lact, MNL F0585AAA, ADM, Net Weight 50 lb (22.67 kg) or as invoiced. Recall # V-179-2010;

12) ADM Alliance Nutrition, Custom Feedlot Premix BT, W&C Land Ltd. D1165BKI, Medicated, Net Weight 50 lb (22.67 kg) or as invoiced. Recall # -180-2010;

13) ADM Alliance Nutrition, Bogle CM Feedlot FY RU Grower, E5805NME, Medicated, Net Weight 50 lb (22.67 kg) or as invoiced. Recall # 181-2010;

14) ADM Alliance Nutrition, Custom Feedlot Premix RU, W&C Land Ltd. D8999GAR, Medicated, Net Weight 50 lb (22.67 kg) or as invoiced. Recall # V-182-2010
CODE
1) HR018949, HR018985, HR019014;
2) HR018953, HR018963, HR018972, and HR019022;
3) HR019856, HR018975, HR018991, HR018900, and HR019005;
4) HR018959 and HR018997;
5)  HR018965;
6)  HR018968, HR018994, and HR019025;
7) HR018977;
8) HR018979;
9) HR018982;
10) HR018987;
11) HR019002;
12) HR019007;
13) HR019009;
14) HR019011
RECALLING FIRM/MANUFACTURER
ADM Alliance Nutrition, Hereford, TX, by telephone on March 2, 2010. Firm initiated recall is ongoing.
REASON
Product may contain metal fragments.
VOLUME OF PRODUCT IN COMMERCE
490.72 tons
DISTRIBUTION
TX, CO, OK, NM, and KS

END OF ENFORCEMENT REPORT FOR APRIL 21, 2010

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