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U.S. Department of Health and Human Services

Safety

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Enforcement Report for March 10, 2010

March 10, 2010                                                                                        10-09

RECALLS AND FIELD CORRECTIONS:  COSMETICS - CLASS II
___________________________________
PRODUCT
John Frieda Collection Sheer Blonde Lustrous Touch Strengthening Conditioner with Satin Finishers. Recall # F-1367-2010
CODE
Unit: Y321CE27
RECALLING FIRM/MANUFACTURER
Recalling Firm: KAO Brands Co., Cincinnati, OH, by letter on December 15, 2009.
Manufacturer: Tri Tech Laboratories, Inc., Lynchburg, VA. Firm initiated recall is ongoing.
REASON
Product is contaminated with the microorganism, Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
5,346 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  COSMETICS - CLASS III
___________________________________
PRODUCT
Family Dollar brand Baby Hair & Body Wash, 15 oz, SKU: 912028, UPC#-400910167679. Recall # F-1341-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Family Dollar Services, Inc., Charlotte, NC, by e-mail on July 29, 2009.
Manufacturer: RNA Corp., Blue Island, IL. Firm initiated recall is complete.
REASON
Incorrect directions for use; Directions for Use include instructions to apply and leave on as a moisturizer.
VOLUME OF PRODUCT IN COMMERCE
149,430 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
NutPro Macadamia Nuts. Product of South Africa. Cracked and packed by: NutPro cc, Republic of South Africa. Product is raw in a vacuum packed bag contained inside a cardboard box, boxes are each 25 lbs. Recall # F-1368-2010
CODE
Lots AD42098 and 26694
RECALLING FIRM/MANUFACTURER
Recalling Firm: Specialty Commodities, Inc., Fargo, ND, by telephone on October 22, 2009 and by letter on October 27, 2009.
Manufacturer: NutPro CC, Nelspruit, South Africa. Firm initiated recall is ongoing.  
REASON
Macadamia Nuts may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
890 – 25 lb containers (22,250 lbs)
DISTRIBUTION
AZ, CA, CO, MI, NY, OR, TX
___________________________________
PRODUCT
Sam's Club White Macadamia Nut frozen raw cookie dough, container size: 24.75 lbs/case, 240 cookies per case. UPC: 78206 23045 5. Recall # F-1369-2010
CODE
Julian date: 9 280 and 9 287 for item# 923045; 9 280 Best used by 10/7/10; 9 287 Best used by 10/14/10
RECALLING FIRM/MANUFACTURER
Countryside Baking Co., Inc., Irvine, CA, by telephone on October 22, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using macadamia nuts recalled by Specialty Commodities because they had the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,475 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Radix Polygonati Officinalis, Net Wt: 12 oz (340 g), UPC 6 941882 511458 --- INGS: Radix Polygonati Officinalis --- PRODUCT OF CHINA --- Nutrition Facts: Serving Size (50g) Servings Per Container (blank). Recall # F-1370-2010  
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sunny Lake Trading, Inc., Brooklyn, NY, press release on December 2, 2009.  
Manufacturer: Zhongshan Kaxing Industry & Trade Co., Ltd., China. NY State initiated recall is complete.
REASON
The product contained undeclared sulfites (1413 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
7 cartons (50 x 12 oz bags per carton)
DISTRIBUTION
NY State

___________________________________
PRODUCT
Cousins Products Spinach Vinaigrette, Net Wt. 16 oz (473ml), UPC: 850278001011. Recall # F-1371-2010
CODE
All codes up to and including: 002901, 06/27/10 (this is one code)
RECALLING FIRM/MANUFACTURER
Cousins Products LLC, Covington, LA, by telephone on January 29, 2010 and press release on February 3, 2010. Firm initiated recall is complete.
REASON
Undeclared egg, soy and wheat.
VOLUME OF PRODUCT IN COMMERCE
350 cases of 12
DISTRIBUTION
LA, MS, VA, IL, TX, FL

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
Honeysoy Soyaflour, 50 lbs (22.68kg) bags, 25 KG bags, 2000# totes, bulk truck, bulk railcar. Recall # F-1342-2010
CODE
Type: Lot # bulk/rail: 3109-424BC, 3259-429BC. bulk: 3179-4292BT. totes: 2999-429. 2000#: 3229-425. 50#: 2699-424, 3259-424, 3199-425, 3209-425, 3249-425, 3059-428, 3069-428, 3139-429, 3169-429, 3259-4291. 52#: 3249-429C. 25KG: 2959-424, 3159-424, 3169-4241, 3179-424, 3199-424, 2849-425, 2849-4251, 2579-425, 2859-425, 2869-425, 2969-425, 3039-425, 3069-425, 0359-425
RECALLING FIRM/MANUFACTURER
CHS Oilseed Processing, Mankato, MN, by telephone and e-mail on November 23, 2009. Firm initiated recall is ongoing.
REASON
Firm received a complaint from a direct customer who reported metal in soy flour.
VOLUME OF PRODUCT IN COMMERCE
1,351,396 lbs
DISTRIBUTION
OR, WI, MN, KS, IL
___________________________________
PRODUCT
16.5 lb blocks deep skin pin bone out Alaska Pollock, 3 blocks per case. Labeled in part: "Alaskan Pollock Frozen***Fishblocks DS PBO HC***Theragra Chalcogramma *** Product of USA*** Net Wt *** (3 X 16.5 lbs). Recall # F-1343-2010
CODE
8 production days, 6/12/09 through 6/19/09 with the following serial numbers: "09061207 through 09061923" breakdown of the code is: yy-mm-dd-hh. Production Date***Best Before***December 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Unisea Inc., Redmond, WA, by telephone and e-mail on January 28, and letter on February 3, 2010.  
Manufacturer: Unisea Inc., Dutch Harbor, AK. Firm initiated recall is ongoing.
REASON
Product is adulterated with plastic shavings.
VOLUME OF PRODUCT IN COMMERCE
1,765,648.5 lbs
DISTRIBUTION
MA, WA, WI, Canada, China, and Spain
___________________________________
PRODUCT
1) Stonewall Kitchen Chocolate Hazelnut Sauce (SKU 161312): 12 oz glass round jars. Recall # F-1344-2010;

2) Chocolate Peanut Butter: Packaged under the brand name: Stonewall Kitchen (SKU 161211), 12 oz. round glass jars; Giant Simply Enjoy and Stop & Shop Simply Enjoy Chocolate Peanut Butter Sauce 12 oz. glass square jars. Recall # F-1345-2010;

3) Coffee Caramel Sauce): packaged under the brand names: Stonewall Kitchen(SKU 161204), 13 oz round glass jars; Giant Simply Enjoy Brand and Stop & Shop Simply Enjoy Brand Coffee Caramel Sauce, 13 oz. square glass jars. Recall # F-1346-2010;

4) Stonewall Kitchen Dulce de Leche Sauce (SKU 161214): 12.5 oz round glass jars. Recall # F-1347-2010;

5) Barefoot Contessa Espresso Dulce de Leche Sauce (SKU 542313) 10.5 oz. round glass jars. Recall # F-1348-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Stonewall Kitchen Ltd, York, ME, by e-mail, telephone or letter and press release on January 23, 2009. Firm initiated recall is complete.
REASON
Products under recall have potential for Clostridium botulinum growth due to the pH and water activity.
VOLUME OF PRODUCT IN COMMERCE
343,441 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
1) Jamaican Me Crazy Marinade (JAMA-0002), Net Weight 45 lbs., packed in 5 gallon white pails. The recalled product is intended for beef injection or marinading of finished meat products. Recall # F-1349-2010;

2) Peach Ginger Marinade (LMC08610), Net Weight 45 lbs., packed in 5 gallon white pails. The recalled product is intended for beef infection or marinading of finished meat products. Recall # F-1350-2010
CODE
1) and 2) Lot # 09294
RECALLING FIRM/MANUFACTURER
JES Foods Celina, Inc., Celina, OH, by letter and e-mail on January 20, 2010. Firm initiated recall is ongoing.
REASON
Products contained the undeclared allergen, wheat.
VOLUME OF PRODUCT IN COMMERCE
1) 3,645 lbs; 2) 2,070 lbs
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Refrigerated cookie dough in plastic tubs in 16 oz and 32 oz sizes. Product labeled in part: "***Net Wt. 1 Lb. ***My Mom's Kitchen Chocolate Chip Cookie Dough***Keep refrigerated or freeze by date on lid. ***Ingredients: Chocolate chips (sugar, unsweetened chocolate, cocoa butter, soy lecithin***enriched wheat flour***butter, sugar". Recall # F-1364-2010;

2) Refrigerated cookie dough in plastic tubs in 16 oz size. Product labeled in part: "***Net Wt. 1 Lb. ***My Mom's Kitchen Peanut Butter Milk Chocolate Chip Cookie Dough***Keep refrigerated or freeze by date on lid.***Ingredients: Unbleached enriched wheat flour***peanuts, salt***milk chocolate, lecithin,***butter, sugar". Recall # F-1365-2010;

3) Refrigerated cookie dough in plastic tubs in 16 oz size. Product labeled in part: "***Net Wt. 1 Lb. My Mom's Kitchen Ginger Cookie Dough***Keep refrigerated or freeze by date on lid. Ingredients: Unbleached enriched wheat flour***brown sugar, butter, molasses". Recall # F-1366-2010
CODE
"12 18 09" Represents the expiration date of December 18, 2009
RECALLING FIRM/MANUFACTURER
My Mom's Kitchen, Eugene, OR,
REASON
The products list butter and lecithin as ingredients, but do not list milk and soy as the sources of the ingredients as required by FALCPA (Food Allergen Labeling and Consumer Protection Act).
VOLUME OF PRODUCT IN COMMERCE
45 – 16 oz tubs and 2 – 32 oz tubs
DISTRIBUTION
OR

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT
Jell-O Cranberry Gelatin Dessert; Net Wt. 3 Oz. (85 g); Kraft Foods Global, Inc., Northfield, IL 60093-2753 USA, Product of Canada; UPC 0 43000 20007 0. Recall # F-1255-2010
CODE
Lot 21 SEP 2011 D1 xx:xx, where the xx:xx is the military time packaged
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kraft Foods, Inc., Northfield, IL, by memo on March 31, 2009, and e-mail, fax or visit on December 3, 2009.
Manufacturer: Kraft Foods, Inc., Dover, DE. Firm initiated recall is ongoing.
REASON
The boxes of Jell-O Cranberry Gelatin Dessert actually contain Sugar Free Jell-O Cranberry Gelatin Dessert that contains aspartame, and the boxes do not bear the warning statement for phenylketonurics.
VOLUME OF PRODUCT IN COMMERCE
930 cases
DISTRIBUTION
FL, GA, IL, MI, NB, NC, ND, WI and Costa Rica
___________________________________
PRODUCT
1) Vanilla Elephant Head Sugar Cookie (Item 14064); "Dad" Vanilla Sugar Cookie (Item CS1730H / CS 1731H) 1.6oz; Empire State Building W/Face Vanilla Cookie 2.4oz; Vanilla New York Apple Sugar Cookie 2.4oz (Item HMS10760); Vanilla Pink Poodle Cookie (Item CS1736-A) 2.2oz; Vanilla Cow Sugar Cookie (Item CS 1734-A) 1.6oz; Vanilla Green Flower Sugar Cookie (Item CS1580-B) 1.0oz; Vanilla Astronaut Sugar Cookie (Item CS0074-A) 2.2 oz; Vanilla Alligator Sugar Cookie (Item CS1337) 1.5 oz; Vanilla Bone Sugar Cookie (Item CS1578-A) 1.3oz; Vanilla Scottie Dog Sugar Cookie (Item CS1579-B) 2.5oz; Vanilla Taxi Sugar Cookie (Item 15401) 2.4 oz; Spring Bugs & Flower Peiti Cookies (Item 14790) 2.9 oz; Vanilla American Flag Sugar Cookie (Item 14781) 2.2 oz; Vanilla #1 Trophy Sugar Cookie (Item 14700) 2.5 oz; Vanilla Sail Boat Sugar Cookie (Item 14700) 2.5 oz; Vanilla Diploma Sugar Cookie (Item 14652) 2.5 oz; Vanilla Black Hat Sugar Cookie (Item 14651) 1.7 oz; Vanilla "Thank You" Sign Cookie (Item 14550) 2.9 oz; Sport Mini Cookies (Item 14512) 2.2 oz; Vanilla Cupcake Sugar Cookie (Item 14258) 2.7 oz; Vanilla Birthday Cake Sugar Cookie (Item 14250) 3.2 oz. Recall # F-1256-2010;

2) Lemon Flip Flop Sugar Cookie 2.7 oz; Lemon Sun w/Sunglasses Sugar Cookie 2.3 oz; Lemon Tropical Fish Sugar Cookie; Lemon Sand Dollar Sugar Cookie (Item 15601) 3.0 oz; Beachball Lemon Sugar Cookie 2.6 oz; Lemon Ice cream Cone Sugar Cookie (Item 14765) 2.6 oz; Lemon Sand Castle Sugar Cookie (Item 14763) 2.4 oz; Lemon Flip Flop Sugar Cookie (Item 14761) 3.0 oz; Lemon Yellow Tropical Fish Sugar Cookie (Item 14759) 2.6 oz; Lemon Blue Dolphin Sugar Cookie (Item 14756) 1.7 oz; Lemon Sun w/Sunglasses Sugar Cookie (Item 14754) 2.3 oz; Lemon Girl Bathing Suit Sugar Cookie (Item 14752) 2.4 oz; Lemon Beachball Sugar Cookie (Item 14700) 3.3 oz; Lemon Watermelon Sugar Cookie (Item 14456) 1.9 oz; Lemon Strawberry Sugar Cookie (Item 14147) 2.8 oz; Lemon Butterfly Sugar Cookie (Item 14146) 2.7 oz; Lemon Frog Sugar Cookie (Item 14145); Lemon Daisy W/Ladybug Sugar Cookie (Item 14108); Lemon Daisy W/Ladybug Sugar Cookie (Item 14108) 2.5 oz. Recall # F-1257-2010
CODE
Lots 1182-1622;
RECALLING FIRM/MANUFACTURER
Monaco Baking Co., Santa Fe Springs, CA, by letter on January 29, 2010. Firm initiated recall is ongoing.
REASON
Defective butter from supplier.
VOLUME OF PRODUCT IN COMMERCE
384,547
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Honest Tea brand Mango Acai White Tea, packed in 64 oz. plastic bottles, 8 bottles per corrugated carton. Bottle UPC: 657622731043; Case UPC: 657622731050. Recall # F-1270-2010
CODE
Lot Code: AUG2510BA
RECALLING FIRM/MANUFACTURER
Recalling Firm: Honest Tea, Bethesda, MD, by e-mail and telephone on December 4, 2009.
Manufacturer: Bowman Apple Products Co., Inc., Mount Jackson, VA. Firm initiated recall is ongoing.
REASON
Bottled beverage is mislabeled in that the back panel label does not match correct label on the front of the bottle.
VOLUME OF PRODUCT IN COMMERCE
3,289 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
MasoN natural Food Supplement Fruit & Vegetable Daily DIETARY SUPPLEMENT Get the antioxidant power of fruits and vegetables in an easy-to-swallow softgel 3 servings of fruits & vegetables in one softgel 30 SOFTGELS. Supplemental Facts Serving Size 1 Softgel HI ORAC Fresh Fruit Blend, Lutein (from Marigold Extract) 6 mg, Lycopene (from tomato) 5 mg. ALLERGEN CERTIFICATION this product contains soy ingredients. Product Code: 1486-30. Recall # F-1293-2010
CODE
Lot number: 01437, expiration date September 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mason Distributors, Inc., Miami Lakes, FL, by letter on November 4, 2009.
Manufacturer: Nutra Manufacturing, Greenville, SC. Firm initiated recall is ongoing.
REASON
The product is labeled as Fruit and Vegetable Daily softgel when actually the bottle contains Dieter's Detox capsules.
VOLUME OF PRODUCT IN COMMERCE
317 bottles
DISTRIBUTION
Nationwide 2 Export Accounts

___________________________________
PRODUCT
Great Value Cheddar Broccoli Rice & Sauce, Net Wt/Peso Neto 5.7 oz (161g). Recall # F-1295-2010
CODE
Code Dates: 265P9, 266P9, 267P9, 278P9, 279P9, 280P9, 285P9, 286P9, 292P9, 293P9, 294P9, 295P9, 206P9, 207P9, 308P9, and 309P9
RECALLING FIRM/MANUFACTURER
Recalling Firm: Riviana Foods Inc., Houston, TX, by e-mail on November 13, 2009.
Manufacturer: Power Packaging, Inc., Grand Prairie, TX. Firm initiated recall is complete.  
REASON
The product is misbranded in that it contains sodium in excess of amount listed in the Nutrition Facts panel.
VOLUME OF PRODUCT IN COMMERCE
68,292 cases of 12 pouches each
DISTRIBUTION
IL, TX, FL, KY, AZ, CA, WA, TN, and PA
___________________________________
PRODUCT
Organic (Evaporated Cane Juice) Sugar, Item no. 605083; 25 lb. in poly-lined cardboard box. Recall # F-1297-2010
CODE
101409 015 28064
RECALLING FIRM/MANUFACTURER
Bergin Fruit and Nut Co., Inc., Falcon Heights, MN, by letter dated October 20, 2009. Firm initiated recall is ongoing.
REASON
Bergin Fruit and Nut Company is voluntarily recalling 25 lb cases of Organic (Evaporated Cane Juice) Sugar, item no. 605083, because the product is mislabeled. Non-organic sugar was mistakenly packed and labeled as organic sugar.
VOLUME OF PRODUCT IN COMMERCE
6 cases
DISTRIBUTION
MN, WI

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
___________________________________
PRODUCT
LIBIPOWER PLUS Capsules, Natural Male Stimulant, 650 mg herbal blend, packaged in 1 capsule blister packs. Recall # D-333-2010
CODE
Lot Numbers: XHT890, Exp. 09/2010 & FIK531, Exp. 06/2011
RECALLING FIRM/MANUFACTURER
Haloteco, Santa Monica, CA, by letters dated June 25, 2009. Firm initiated recall is complete.
REASON
Marketed without an approved NDA/ANDA: product found to contain tadalafil which is the active ingredient of an FDA approved drug for Erectile Dysfunction (ED).
VOLUME OF PRODUCT IN COMMERCE
Approximately 15,000 capsules
DISTRIBUTION
CA
___________________________________
PRODUCT
Vicks Sinex Vapo Spray (Oxymetazoline HCl ) Nasal Spray 0.05%, 15 mL bottle, OTC, UPC 3 23900 01253 0. Recall # D-348-2010
CODE
Lot # 9239028831
RECALLING FIRM/MANUFACTURER
Recalling Firm: Procter & Gamble Co., Mason, OH, by press release and letter on November 19, 2009.
Manufacturer: Procter & Gamble Gmbh & Co. Mfg. OHG, Gro-Gerau, Germany
REASON
Microbial Contamination of Non-Sterile Product: Product may be contaminated with bacteria Burkholderia cepecia. A stability sample had failed microbial content testing. The microbial content was 8560 cfu/ml for total aerobic count (specification maximum is <100 cfu/ml).
VOLUME OF PRODUCT IN COMMERCE
44,352 bottles
DISTRIBUTION
Nationwide, the United Kingdom, and Germany

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
Alka-Seltzer Plus Day & Night Cold Formulas Liquid Gels is an OTC product. The Alka-Seltzer Plus Day & Night Cold Formulas (combination pack only) contains 20 liquid filled capsules per carton (12 day formulation capsules and 8 night formulation capsules) with NDC number is 0280-115--20, and the UPC number is 0-16500-53777-9. Recall # D-139-2010
CODE
Lot number 296939L (exp 5/2011)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer Healthcare, LLC, Morristown, NJ, by press release and e-mail on December8, 2009.  
Manufacturer: Accucaps Industries Limited, Windsor, Ontario, Canada. Firm initiated recall is ongoing.
REASON
Labeling: Label Mix-Up: Firm is recalling one lot of Alka Seltzer Plus Day & Night Cold Formulas Liquid Gels (combination pack only) after identifying that the label on the foil blister card of certain packages were printed with the label reversed. Therefore, the label for the green Night product appears under some of the blue Day product and vice versa. All individual liquid filled capsules are imprinted correctly
VOLUME OF PRODUCT IN COMMERCE
107,520 boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Allergy relief (diphenhydramine HCL) capsules, 25mg, 100-count bottle, OTC; NDC 11673-310-13; UPC 8 97882 00105 4; Allergy (Diphenhydramine Hydrochloride) capsules, 25 mg, 24-count blisters in a box, OTC, NDC 65905-310-31, UPC 8 43072 00353 7 Multi-Symptom Complete Allergy (Diphenhydramine HCL) capsules, 25 mg, 24-count blisters in a box, OTC; UPC 8 97882 00109 2. The product was distributed under the brand names Target, Diphendryl Allergy; Dollar General, DG Allergy; and Today's Health, Today's Health Allergy. Recall # D-342-2010
CODE
Lot number BK549
RECALLING FIRM/MANUFACTURER
Kirk Pharmaceuticals, LLC, Fort Lauderdale, FL, by e-mail, telephone and letter dated September 24, 2009. Firm initiated recall is complete.
REASON
Temperature Abuse: Kirk Pharmaceuticals is recalling Diphenhydramine Hydrochloride 25mg capsules, for sub-potent assay results due to improper storage conditions of the product during transit.
VOLUME OF PRODUCT IN COMMERCE
2,674,608 bottles and boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Intron A (Interferon alfa-2b, recombinant) Solution for Injection, 3 MIU Multidose Pen, 6 doses of 3 million IU/0.2 mL per box, Rx only, NDC 0085-1242-01. Item number 21340707. Recall # D-343-2010; 

2) Intron A (Interferon alfa-2b, recombinant) Solution for Injection, 5 MIU Multidose Pen, 6 doses of 5 million IU/0.2 mL per box, Rx only, Product of Ireland, NDC 0085-1235-01. Item number: 21340405. Recall # D-344-2010;

3) Intron A (Interferon alfa-2b, recombinant) Solution for Injection, 10 MIU Multidose Pen, 6 doses of 10 million IU/0.2 mL per box, Rx only. Product of Ireland, NDC 0085-1254-01. Item number 21341002. Recall # D-345-2010
CODE
1) Lot numbers 8-CO-2004, 9-CO-2001, 9-CO-2002, 9-CO-2003;

2) Lot numbers: 8-CO-1003, 8-CO-1004, 9-CO-1000, 9-CO-1001, 9-CO-1002, 9-CO-1003;

3) Lot numbers: 8-CO-3005, 9-CO-3000, 9-CO-3001, 9-CO-3002, 9-CO-3003
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schering Corp., Kenilworth, NJ, by letters on November 3, 2009.
Manufacturer: Schering-Plough (Brinny) Co., County Cork, Ireland. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products:Stability failure at 18 months detected impurities in Intron A (interferon alfa-2b, recombinant) Solution in Multidose Pen for Injections.
VOLUME OF PRODUCT IN COMMERCE
64,240 boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Humira (adalimumab) Pen, for subcutaneous use only, 40 mg/0.8mL, 4 single-use prefilled pens (NDC 0074-4339-02) per Psoriasis Starter Package (NDC 0074-4339-07), UPC 3 00744 33907 8, Rx only. Recall # D-347-2010  
CODE
Lot # 70266SP44, Exp SEP 2010; 74329SP41, Exp JAN 2011; 74329SP42, Exp JAN 2011; and 74329SP45, Exp JAN 2011
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by letters dated February 2, 2010. Firm initiated recall is ongoing.
REASON
Unit Dose Mispackaging: Some of the Humira Psoriasis Starter Packages may have been assembled in a configuration in which the positions of the pens within the Starter Package carton were inconsistent with the intended positions correlating to the recommended initial dosing regimen.
VOLUME OF PRODUCT IN COMMERCE
11,813 starter packages
DISTRIBUTION
Nationwide, Bermuda, Cayman Islands
___________________________________
PRODUCT
1) Daytrana (methylphenidate transdermal system), CII, 20 mg (2.2 mg/hr), 30 count carton, Rx only, NDC 54092-554-30. Recall # D-355-2010;

2) Daytrana (methylphenidate transdermal system), CII, 30 mg (3.3 mg/hr), 30 count carton, Rx only, NDC 54092-555-30. Recall # D-356-2010
CODE
1) Lot #s: 33988, exp 12/31/10; 34174, exp 12/31/10; 34175, exp 12/31/10;
2) Lot #s: 33990, exp 12/31/10; 34179, exp 12/31/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shire PLC, Wayne, PA, by press release and letter on December 3, 2009. 
Manufacturer: Noven Pharmaceuticals, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
Miscalibrated and/or Defective Delivery System: no longer meets the release liner removal specification.
VOLUME OF PRODUCT IN COMMERCE
25,886 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Dipyridamole Tablets, USP 25 mg, a) 100 count bottles - NDC 0527-1461-01, and b) 1000 count bottles, NDC 0527-1461-10; Rx Only;
CODE
Lot numbers: 2008261067 exp 6/2010 and 2008522883 exp 12/2010; b) Lot numbers: 2008261068 exp 6/2010 and 2008522884 exp 12/2010
RECALLING FIRM/MANUFACTURER
Lannett Co., Inc., Philadelphia, PA, by letter dated January 27, 2010. Firm initiated recall is ongoing.
REASON
Failed USP dissolution test requirements.
VOLUME OF PRODUCT IN COMMERCE
5,137 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Glyburide and Metformin HCl, USP, tablets, 2.5 mg/500 mg, 1000 count bottles, Rx only, NDC 55111-696-10. Recall # D-360-2010
CODE
Lot # 18007859, Exp. 4/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dr Reddy's Laboratories Inc., Bridgewater, NJ, by letters on March 4, 2010.
Manufacturer: USV Limited, Dabhel, Daman, India. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets: One batch of Glyburide and Metformin Hydrochloride Tablets 2.5 mg/500 mg may have Glyburide Metformin Hydrochloride 5 mg/500 mg tablets co-mingled in it.
VOLUME OF PRODUCT IN COMMERCE
685 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
1) Effexor XR (venlafaxine HCl) Extended Release capsules, 37.5 mg, a) 15-count bottle, N DC 0008-0837-20; b) 30-count bottle, NDC 0008-0837-21; c) 90-count bottle, NDC 0008-0837-22; Rx only. Recall # D-133-2010;

2) Effexor XR (venlafaxine HCl) Extended-Release capsules, 75 mg, a) 15-count bottle (NDC 0008-0833-20); b) 30-count bottle (NDC 0008-0833-21); c) 90-count bottle (NDC 0008-0833-22); d) 100-count carton of 10 Redipak blister strips of 10 capsules each (NDC 0008-0833-03); Rx only. Recall # D-340-2010;

3) Effexor XR (venlafaxine HCl) Extended-Release capsules, 150 mg, a) 15-count bottle,  NDC 0008-0836-20; b) 30-count bottle, NDC 0008-0836-21; c) 90-count bottle, NDC 0008-0836-22; d) 100-count carton of 10 Redipak blister strips of 10 capsules each, NDC 0008-0836-03; Rx only. Recall # D-341-2010
CODE
1) a) Lot Numbers C24657, C79353, C59181, Exp 10/10 -12/10; b) Lot Numbers C30317, C87427, D44262, Exp 08/10 -10/11; c) Lot numbers C30329, C59182 ,C79360, C98393, Exp 07/10-02/11;

2) a) Lot # C94009, C024262, Exp 03/11-07/11; b) Lot # C35138, C35139, C41328, C41329, C50306, C50307, C59523, C59524,C59526, C59530, C70592, C87937, C95682, C95699, D13622, D15930, D15931, D15932, D24603, D29149, Exp 08/11-10/11; c) Lot Numbers C40448, C40449, C40451, C46681, C46685. C46688, C46861, C51385S,C59184, C72564, C79438, C87911, C87912, C87913, C87914, D07619,D07620, D07621, D29150, D029151, D44256, D44259, D47414, D66746,D68004, D74751, D86901 Expiration Date 08/10 - 05/12; d) Lot Numbers D44210, D55950, Exp 10/10;

3) a) Lot Numbers C46773, C83940, Exp 8/10 and 12/10; b) Lot numbers C23201, C23205, C30294, C30298, C36097, C40978, C41039, C41066, C46797, C46799, C59189, C79426, C79427, C87825, C87827, C87848, C87853, C87859, C87860, D07625, D07626, D07627, D07629, D29069, D29153, D29154, D29155, D34439, D37378, D37380, D88962, Exp 07/10-02/12; c) Lot Numbers C28511S, C28512S, C28513S, C28514S, C28515S, C28517S, C36428S, C47303S, C47304S, C47305S, C47306S, C47307S, C47308S, C51439S, C51440S, C5144IS, C51442S, C51443S, C51444S, C70036S, C70037S, C70328S, C79627S, C79628S, C79629S, C79630S, C7963IS, C79632S,C88186S, C88187S, C88188S, C88189S, C88190S, C88192S, C88193S, C88195S, C95708S, C95862S, C95862S, C95863S, D03417S, D03422S, D03424S, D22794S, D281165S, D28166S, D28197S, D29003S, D37029S, D65167S, D65170S, D65171S, C95854S, C88194S, Exp 07/10-03/12; d) Lot Number C81860 Exp Date 01/11
RECALLING FIRM/MANUFACTURER
Wyeth Pharmaceuticals Co., Guayama, PR, by letter dated November 9, 2009. Firm initiated recall is ongoing.
REASON
Cross Contamination With Other Products: Firm is recalling Effexor extended release lots because of a potential cross-contamination issue at one of their API suppliers.
VOLUME OF PRODUCT IN COMMERCE
10,554,952 bottles and cartons
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Zmax (azithromycin) extended release for oral suspension, 2 g per bottle, packed in a box, Rx only, NDC 0069-4170-21. Recall # D-331-2010
CODE
Lot #17178VF, Exp 11/2011; Lot #V090373, Exp 11/2011; Lot V090374, Exp 11/2011
RECALLING FIRM/MANUFACTURER
Pfizer Inc, New York, NY, by letter on November 18, 2009. 
Manufacturer: Pfizer Pharmaceuticals LLC, Vega Baja, PR. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: Zmax is being recalled because it was determined that certain lots did not meet dissolution specifications on stability.
VOLUME OF PRODUCT IN COMMERCE
67,872 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Clear Nicotine (nicotine) Transdermal System patch, 7 mg delivered over 24 hours, 14-count patches per box, OTC, Manufactured by: Aveva Drug Delivery Systems, Miramar, FL 33025; Rugby, UPC 3 0536-5894-88 3; equate, NDC 49035-894-88, UPC 6 81131 18741 1; equaline, NDC 41163-894-88, UPC 0 41163 45820 8; (Bulk Product) Nicotine Transdermal System, 7 mg delivered over 24 hours, 1 patch per pouch, 4001080 is packaged in 540-count pouches per box. Product was sold under Equate, Rugby, and Equaline brands. Recall # D-346-2010
CODE
Lot # 37264
RECALLING FIRM/MANUFACTURER
AVEVA Drug Delivery Systems, Inc., Miramar, FL, by letter on January 5, 2010 and by telephone on January 12, 2010. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Product tested out of specification for two degradants, myosmine and beta-nicotyrine.
VOLUME OF PRODUCT IN COMMERCE
384,384 patches (27,456 14-count boxes)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Clindamycin Injection, USP, (150 mg/mL) 300 mg/2 mL Single Dose Vial, Rx only, Material Code 28202, NDC 63323-282-02. Recall # D-349-2010;

2) Clindamycin Injection, USP, (150 mg/mL) 600 mg/4 mL Single Dose Vial, Rx only, Material Code 28204, NDC 63323-282-04. Recall # D-350-2010;

3) Clindamycin Injection, USP, (150 mg/mL) 900 mg/6 mL Single Dose Vial, Rx only, Material Code 28206, NDC 63323-282-06. Recall # D-351-2010;

4) Clindamycin Injection, USP, (150 mg/mL) 9 grams/60 mL vial, Pharmacy Bulk Package, Rx only, Material Code 28260, NDC 63323-282-60. D-352-2010
CODE
1) Lot# 405220; Exp 2/28/2010; Lot # 406688, Exp 12/31/2010; and Lot # 406689 Exp 12/31/2010;

2) Lot# 406127, Exp 8/31/2010; Lot# 406711, Exp 12/31/2010; and Lot# 406743, Exp 12/31/2010;

3) Lot# 406201, Exp 8/31/2010; Lot # 406712, Exp 12/31/2010; and 406744, Exp 12/31/2010;

4) Lot# 405174, Exp 02/28/2010; and Lot # 406686, Exp 12/31/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: APP Pharmaceuticals LLC, Schaumburg, IL, by letters dated January 6, 2010. 
Manufacturer: APP Pharmaceuticals, LLC, Grand Island, NY. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: This product is being recalled because the lots have failed or have the potential to fail the Total Impurities specification before expiration.
VOLUME OF PRODUCT IN COMMERCE
628,814 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Coats Aloe Natural Sun Protection (titanium Dioxide 6%/zinc oxide 2.2%) SPF 30+ Lotion provided Broad-Spectrum UVA and UVB Protection Untinted, 1 Liter; Lot Number 05308G Coats Aloe Natural Sun Protection (titanium Dioxide 6%/zinc oxide 2.2%) SPF 30+ Lotion with UVA and UVB Protection, Color Free, 4 Fl oz Rhonda Allison (titanium Dioxide 6%/zinc oxide 2.2%), SPF 30 SUNSCREEN, Color Free Sun Protection, 1 Fl. oz.  Recall # D-358-2010;

2) Natural Sun Protection (titanium Dioxide 6%/zinc oxide 2.2%) SPF 30+ Lotion provided Broad-Spectrum UVA and UVB Protection, 32 oz/946 mL; Lot Number 05308G Coats Aloe Int'l Natural Sun Protection (titanium Dioxide 6%/zinc oxide 2.2%) SPF 30+ Lotion with UVA and UVB Protection, 4 Fl oz Rhonda Allison (titanium Dioxide 6%/zinc oxide 2.2%), SPF 30 SUNSCREEN, Tinted Sun Protection, 1 Fl. oz. Recall # D-359-2010
CODE
1) Lot number 05308G;
2) Lot numbers: 00308F, and 05508G
RECALLING FIRM/MANUFACTURER
Coats International Holdings, Inc., Dallas, TX, by certified letter on January 29, 2010. Firm initiated recall is ongoing.
REASON
Product was distributed without proper stability data to support the 2 year shelf-life.
VOLUME OF PRODUCT IN COMMERCE
8,170 tubes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I
___________________________________
PRODUCT
1) BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100. Recall # Z-0750-2010;

2) BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101. Recall # Z-0751-2010;

3) BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102. Recall # Z-0752-2010;

4) BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108. Recall # Z-0753-2010;

5) MPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte, REF 385150. Recall # Z-0754-2010;

6) MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151. Recall # Z-0755-2010;

7) MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164. Recall # Z-0756-2010;

8) BD Nexiva Closed IV Catheter System, REF 383530, 24GA 0.56IN. Recall # Z-0829-2010;

9) BD Nexiva Closed IV Catheter System, REF 383531, 24GA 0.75IN. Recall # Z-0830-2010;

10) BD Nexiva Closed IV Catheter System, REF 383532, 22GA 1.00IN. Recall # Z-0831-2010;

11) BD Nexiva Closed IV Catheter System, REF 383533, 20GA 1.00IN. Recall # Z-0832-2010;

12) BD Nexiva Closed IV Catheter System, REF 383534, 20GA 1.25IN. Recall # Z-0833-2010;

13) BD Nexiva Closed IV Catheter System, REF 383536, 20GA 1.00IN. Recall # Z-0834-2010;

14) BD Nexiva HF Closed IV Catheter System, REF 383537, 20GA 1.25IN. Recall # Z-0835-2010;

15) BD Nexiva Closed IV Catheter System, REF 383538, 20GA 1.75IN. Recall # Z-0836-2010;

16) BD Nexiva Closed IV Catheter System, REF 383539, 18GA 1.25IN. Recall # Z-0837-201;

17) BD Nexiva Closed IV Catheter System, REF 383540, 18GA 1.75IN. Recall # Z-0838-2010;

18) BD Nexiva Closed IV Catheter System, REF 383647, 20GA 1.25IN. Recall # Z-0839-2010;

19) BD Nexiva Closed IV Catheter System, REF 383649, 18GA 1.25IN. Recall # Z-0840-2010
CODE
1) Lot Numbers 8268863, 8269020, 8275798, 8308321, 8308323, 8309553, 8331937, 8331940, 8354558, 9007921, 9009643, 9009646, 9028838, 9035029, 99035032;

2) Lot numbers: 8305510, 8331944;

3) Lot numbers: 8305511, 8308330, 8354561, 9012072;

4) Lot numbers: 9007918, 9035042, 9035044;

5) Lot numbers: A1967, A1979, A2056;

6) Lot numbers: A1950, A2399;

7) Lot number: A1951;

8) Lot numbers: 8238450, 8319936, 8345957, 9013868;

9) Lot numbers: 8284049, 8284050, 8305438, 8308349, 8345951, 9013867, 9026722;

10) Lot numbers: 8248349, 8259950, 8295761, 8296792, 8296793, 8309299, 8309662, 8311150, 8319961, 8322609, 8331771, 8338737, 8338738, 8358628, 9020033;

11) Lot numbers: 8291980, 8330279;

12) Lot number: 8331763;

13) Lot number: 8248355, 8249034, 8249035, 8269338, 8270576, 8274565, 8275207, 8275210, 8283964, 8311167, 8312211, 8319016, 8347056, 9007360, 9015539, 9022039;

14) Lot numbers: 8263294, 8270579, 8347058, 9013864;

15) Lot number: 8312220;

16) Lot number: 8263293, 8274555, 8275429, 8290311, 8340308, 9016819;

17) Lot number: 8340302;

18) Lot Number: 9034319;

19) Lot Number: 9041552
RECALLING FIRM/MANUFACTURER
Becton Dickinson Medical Systems, Sandy, UT, by letters on October 28, 2009 and February 8, 2010. Firm initiated recall is ongoing.
REASON
Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
VOLUME OF PRODUCT IN COMMERCE
1,275,200 units (Q-Syte US), 2,651,680 units (Nexiva)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT
1) AC power cords used with either Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505, 750 and 775 Indicated for hyper- or hypothermic patients or normothermic patients, for whom induced hyper- hypothermia or localized temperature therapy is clinically indicated. In addition, the temperature management systems can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients. Recall # Z-0895-2010;

 2) AC power cords used with Ranger Blood/Fluid Warming Unit: Model 245. Intended to warm blood, blood products and liquids. Part number 502221 Model 90024. Recall # Z-0896-2010;

3) AC power cords used with Ranger Irrigation Fluid Warming Unit; Model 247. Intended to warm irrigation fluids. Part number 502221 Model 90024. Recall # Z-0897-2010;

4) AC power cords used with Ranger Pressure Infusion Power Pack; Model 90033. To provide power to pressure infusers. Part number 502221 Model 90024. Recall # Z-0898-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Arizant Inc., Eden Prairie, MN, by letter dated December 17, 2009. Firm initiated recall is ongoing. 
REASON
This recall is being issued in response to a small number of customer reports of melting, smoking or fire within the power cord plug. However, the potential risks from this power cord failure include electric shock, delay in setup and therapy, interruption of therapy, device failure, and fires.
VOLUME OF PRODUCT IN COMMERCE
84,537 nationwide; 7,380 internationally
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat, Size D, Left. 00-5750-014-01. Recall # Z-0915-2010
CODE
Lot number: 61369812
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by letters on January 12, 2010 and January 27, 2010. Firm initiated recall is ongoing.
REASON
The package should contain the left knee component but actually contains the right knee component. Delay in completing surgery may result, and a new or different implant may need to be identified.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide, Korea
___________________________________
PRODUCT
1) 9200 Advisor Vital Signs Monitor utilizes the power cord WW3005. Recall # Z-0918-2010;

2) BCI 3180 Pulse Oximeter utilizes the power cord WW3005. Recall # Z-0919-2010;

3) 8400 Capnocheck Capnometer utilizes the power cord 8404 for its battery charger 330. Recall # Z-0920-2010
CODE
1) Power cord # WW3005;
2) Power cord # WW3005;
3) Power cord # 8404
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc., Waukesha, WI, by letter dated January 12, 2010. Firm initiated recall is ongoing.
REASON
Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II Capnometer(Human or Veterinary) and V6400 Invasive Pressure Monitor (Veterinary). The affected Electri-Cord AC power cords are equipped with a plug that has prong and ground-pin insert design and a black plastic bridge connecting the terminal prongs on the plug. The FDA has reported that two medical device manufactures have reported incidents of sparking, charring, and fires from the affected power cords used with their devices. Smiths medical has received no reports of incidents regarding the use of the affected Electric-Cord power cords with their devices.
VOLUME OF PRODUCT IN COMMERCE
1358 cords for all devices
DISTRIBUTION
Nationwide, and Internationally
___________________________________
PRODUCT
1) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDICAL/TIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422221, FOR CEMENTED USE ONLY, QTY: (1), STERILE.
Recall # Z-0924-2010;

2) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 42 MM, M/L 25 MM, REF 71422222, FOR CEMENTED USE ONLY, QTY: (1), STERILE R.  Recall # Z-0925-2010;

3) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 46MM, M/L 27 MM, REF 71422223, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0926-2010;

4) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 49 MM, M/L 29 MM, REF 71422224, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0927-2010;

5) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422225, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0928-2010;

6) JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 55 MM, M/L 32 MM, REF 71422226, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0929-2010;

7) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 42 MM, M/L 25 MM, REF 71422232, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0930-2010;

8) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422233, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0931-2010;

9) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 49 MM, M/L 29 MM, REF 71422234, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0932-2010;

10) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422235, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0933-2010;

11) JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 55 MM, M/L 32 MM, REF 71422236, FOR CEMENTED USE ONLY, QTY: (1), STERILE R. Recall # Z-0934-2010;

12) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422241, QTY: (1), STERILE EO. Recall # Z-0935-2010;

13) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422243, QTY: (1), STERILE EO. Recall # Z-0936-2010;

14) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/RIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422244, QTY: (1), STERILE EO. Recall # Z-0937-2010;

15) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422245, QTY: (1), STERILE EO. Recall # Z-0938-2010;

16) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422246, QTY: (1), STERILE EO. Recall # Z-0939-2010;

17) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422247, QTY: (1), STERILE EO. Recall # Z-0940-2010;

18) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422248, QTY: (1), STERILE EO. Recall # Z-0941-2010;

19) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422251, QTY: (1), STERILE EO. Recall # Z-0942-2010;

20) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422252, QTY: (1), STERILE EO. Recall # Z-0943-2010;

21) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422253, QTY: (1), STERILE EO. Recall # Z-0944-2010;

22) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422254, QTY: (1), STERILE EO. Recall # Z-0945-2010;

23) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422255, QTY: (1), STERILE EO. Recall # Z-0946-2010;

24) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422256, QTY: (1), STERILE EO. Recall # Z-0947-2010;

25) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422257, QTY: (1), STERILE EO. Recall # Z-0948-2010;

26) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71422258, QTY: (1), STERILE EO. Recall # Z-0949-2010;

27) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422261, QTY: (1), STERILE EO. Recall # Z-0950-2010;

28) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422262, QTY: (1), STERILE EO. Recall # Z-0951-2010;

29) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422263, QTY: (1), STERILE EO. Recall # Z-0952-2010;

30) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422264, QTY: (1), STERILE EO. Recall # Z-0953-2010;

31) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422265, QTY: (1), STERILE EO. Recall # Z-0954-2010;

32) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422266, QTY: (1), STERILE EO. Recall # Z-0955-2010;

33) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422267, QTY: (1), STERILE EO. Recall # Z-0956-2010;

34) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422268, QTY: (1), STERILE EO. Recall # Z-0957-2010;

35) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933296, QTY: (1), STERILE EO. Recall # Z-0958-2010;

36) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933297, QTY: (1), STERILE EO. Recall # Z-0959-2010;

37) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933298, QTY: (1), STERILE EO. Recall # Z-0960-2010;

38) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 46 MM, M/L 27 MM, REF 71933299, QTY: (1), STERILE EO. Recall # Z-0961-2010;

39) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933300, QTY: (1), STERILE EO. Recall # Z-0962-2010;

40) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933301, QTY: (1), STERILE EO. Recall # Z-0963-2010;

41) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933302, QTY: (1), STERILE EO. Recall # Z-0964-2010;

42) JOURNEY " UNI TIBIAL INSERT RIGHT MEDIAL/ LEFT LATERAL, A/P 52 MM, M/L 30 MM, REF 71933303, QTY: (1), STERILE EO. Recall # Z-0965-2010;

43) JOURNEY " UNI TIBIAL BASEPLATE RIGHT MEDIAL/ LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422231, FOR CEMENTED USE ONLY, QTY: (1), STERILE. Recall # Z-0966-2010;

44) JOURNEY " UNI TIBIAL INSERT LEFT MEDIAL/ LEFT LATERAL, A/P 38 MM, M/L 24 MM, REF 71422242, Qty: (1), Sterile EO. Recall # Z-0967-2010
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Memphis, TN, by letter on December 23, 2009 and by e-mail and telephone on January 23, 2010. Firm initiated recall is ongoing.
REASON
The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken base plate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct.
VOLUME OF PRODUCT IN COMMERCE
38,750 units
DISTRIBUTION
Nationwide, Argentina, Switzerland, Australia, Canada, Belgium, Italy, Spain, Thailand, Austria; PROC, Finland, Germany, Malaysia, Portugal, Netherlands, Singapore, and England

___________________________________
PRODUCT
BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number 440476, packed in shelfpack unit of 100 swabs. Recall # Z-0969-2010
CODE
Lot 7016132, Exp date 01/17/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Sparks, MD, by letter on September 18, 2009.
Manufacturer: Becton Dickinson Vascular Access S.A. de C.V., Nogales, Sonora, Mexico. Firm initiated recall is ongoing.
REASON
Product was shipped beyond its expiration date.
VOLUME OF PRODUCT IN COMMERCE
242 packages
DISTRIBUTION
Nationwide and Australia
___________________________________
PRODUCT
Sigma-Aldrich Histopaque-1077, Ref. 10771, packaged in 500-ml. bottles. This medium facilitates rapid recovery of viable mononuclear cells from small volumes of blood. The Histopaque-1077 procedure is suitable for studying cell-mediated lympholysis and for human lymphocyte antigen (HLA) typing. It may also be employed as the initial isolation step prior to enumeration of T-, B- and "null" lymphocytes. Recall # Z-0974-2010
CODE
Lot #038K6170, Exp. 2011-04
RECALLING FIRM/MANUFACTURER
Sigma-Aldrich Mfg LLC, Saint Louis, MO, by letter dated September 4, 2009. Firm initiated recall is ongoing.
REASON
Some of the product was contaminated with Pseudomonas mendocina.
VOLUME OF PRODUCT IN COMMERCE
6,808/500-ml. bottles
DISTRIBUTION
Nationwide, Great Britain, France, China, Germany, Australia, Canada, Mexico, Korea, Singapore, India, Japan, Colombia, Hong Kong, Peru, Taiwan, and Venezuela
___________________________________
PRODUCT
Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic. Recall # Z-1017-2010
CODE
Lot number 09061AA exp 2010-03-02
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated June 16, 2009. Firm initiated recall is complete.
REASON
Incorrect result: patient sample BUN results reported may be higher or lower than actual level.
VOLUME OF PRODUCT IN COMMERCE
1,254 cartons
DISTRIBUTION
Nationwide, Australia, Canada, Germany, Japan, and Korea
___________________________________
PRODUCT
1) SmartInfuser PainPump, part numbers P49230, P49220, P49224-D, P49224N, P49230-D and P49234. Recall # Z-1021-2010;

2) SmartBlock Pain Management System, Part numbers P49524, P49534, P49624, and P49634.  Recall # Z-1022-2010
CODE
All models and all lot codes in the USA received 1/1/2007 through 1/22/2009;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hsmg, Inc., D/b/a Smartinfuser USA, Houston, TX, by letters on January 8, 2009 and January 22, 2009.
Manufacturer: Medical Flow Systems, LTD, Shlomi, Israel. Firm initiated recall is ongoing.
REASON
Product leaks associated with a new pump reservoir, and incident related to regulator fast priming feature.
VOLUME OF PRODUCT IN COMMERCE
6,837 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL. Recall # Z-1030-2010;

2) Exacta Mix TPN (total parenteral nutrition) Bag, Model 739, 1000mL. Recall # Z-1031-2010;

3) Exacta Mix TPN (total parenteral nutrition) Bag, Model 740, 2000. Recall # Z-1032-2010
CODE
1) Lot numbers: 738391, 738392;

2) Lot Numbers: 736779, 736780, 738175, 738176, 738254;

3) Lot Numbers: 735020, 735134, 735135, 735136, 735137, 735138, 735139, 737607, 738007
RECALLING FIRM/MANUFACTURER
Baxa Corp., Englewood, CO, by letter on November 12, 2009 and November 17, 2009. Firm initiated recall is ongoing.
REASON
TPN bags may leak fluid due to inadequate sealing.
VOLUME OF PRODUCT IN COMMERCE
5,513 cases (US) 353 cases (International)
DISTRIBUTION
Nationwide, Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Panama, Peru, Singapore, South Korea, Taiwan, and Uruguay
___________________________________
PRODUCT
Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30. Recall # Z-1040-2010
CODE
All lot and serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Telefelx Medical, Durham, NC, by letter on/about January 12, 2010.
Manufacturer: Teleflex Medical, Inc., Tecate, B.C., Mexico.  Firm initiated recall is ongoing. 
REASON
When turned on, the Neptune heater may cause an artifact on the patient's heart monitor.
VOLUME OF PRODUCT IN COMMERCE
15,134 units
DISTRIBUTION
Nationwide, Canada, India, Japan, Puerto Rico, Germany, France, Italy and Ireland

RECALLS AND FIELD CORRECTIONS:  VETERINARY - CLASS II
___________________________________
PRODUCT
Brand of Lincomycin-Spectinomycin soluble powder, Water Soluble Powder, For use in Chickens only, Antibacterial and Antimycoplasmal. Packaged under the following 2 labels: 1. Agripharm Lincomycin S 50, Item Number 1LIN022; 2. Bimeda SpecLinx-50, Item Number 1LIN009. This packet contains: Lincomycin hydrochloride Equivalent to lincomycin 16.7 grams, Spectinomycin dihydrochloride pentahydrate, Equivalent to spectinomycin 33.3 grams Total Antibiotic Activity 50.0 grams. Net Weight: 75 g (2.65oz) ANDA 200-380. Recall # V-043-2010
CODE
Lot 54360025, EXP 11/10, and 54360026, EXP 2/11
RECALLING FIRM/MANUFACTURER
Bimeda, Inc., Le Sueur, MN, by letter beginning January 14, 2010 and a corrected letter on January 22, 2010.
Firm initiated recall is ongoing.
REASON
Bimeda, Inc. has voluntarily initiated a recall of SpecLinx-50 and AGRIpharm Lincomycin S 50, brand of Lincomycin-Spectinomycin Soluble Powder, because these lots were discovered to have high mold counts.
VOLUME OF PRODUCT IN COMMERCE
14,946 pouches
DISTRIBUTION
Nationwide                                                          

END OF ENFORCEMENT REPORT FOR MARCH 10, 2010