Barilla MEDIUM SHELLS, 1 LB (454 g), GTIN 00076808002881, packed as twelve boxes in 1 case
Barilla America NY, Inc. has recalled four types of pasta due to the presence of aluminum fragments
Barilla Pronto PENNE, 12 OZ (340 g), GTIN number 10076808005605, packed as 16 boxes per case, sold as individual units at retailer.
Barilla  PENNE, 8 X 1 LB (454 g) BOXES, [NET WT. 8 LB (3.63 kg)], GTIN 10076808034360, packed as a Multi-unit box, 8 units per case for sale at club stores.
Barilla Packaged Specifically for FoodService, PENNE RIGATE, 160 OZ (10 LBS) (4.54 kg), GTIN 1007680839242, packed as two bags per case.
Cross Valley Farms cucumbers, 24 count corrugated carton
Bulk refined sugar.  Sanding in 50 lb paper bags
Foreign material in product, small pieces of brass less than 7mm.
Manufacturing Pans 6510 and 6511.  Customer specific lot numbers as idenified in individual recall notices:  6525-5211;  6352-5218;  6546-5226;  6515-5225;  6544-5230.
Bulk refined sugar.  CON AAA in 2200 poly super totes
Manufacturing Pans 6510 and 6511.  Customer specific lot numbers as idenified in individual recall notices:  6510-5204;  6522-5210;  6513-5211;  6518-5217;  6546-5224;  6547-5225;  6572-5233.
Bulk refined sugar.  CON AA in 50lb paper bags, 2000 and 2200 poly super totes
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
CPT05 5 Ounce Pizza Dough Ball, 112 - 5 Ounce Dough Balls, Net Weight 35.0 Pounds, UPC 1 081267 0012644 4..
The Dough Shop is recalling one lot of pizza dough because a piece of vinyl glove was found in the product.
Pure Source, Inc manufactured the recalled product for Baker's Best Health Products, Inc.  They sold all of the the products to Baker's Best Health Products, Inc. in Wixom, MI who then distributed the products to their customers via catalog sales and internet sales.    Baker's Best Health Products, Inc. distributed product throughout the U.S.
Baker's Best Maximum Mind & Memory Formula, 60 capsules, Vitamin B6 75 mg.  Distributed by Baker's Best Health Products, Inc. Wixom, MI
Vitamin B6 level below percent declared on label
Helados La Tapatia ;  Granola; Net Wt. 4 oz, (113g)  UPC 6 34242 60012 6;  INGREDIENTS FOR ICE MILK BARS:  ICE CREAM MIX (CREAM, MILK, FRESH CONDENSED SKIM  MILK, SUCROSE, CORN SYRUP. DESSERT SOLIDS (WHEY,  REDUCED LACTOSE, WHEY AND NON FAT DRIED MILK) AND  STABILIZER ( GUAR GUM, MONO, AND DIGLYCERIDES),  CAI.,CIUM SORBATE, POLYSORBATE 40, CEllUlOSE GUM  AND CARRAGENAN), WATER, WHOLE ROASTED OAT FlAKES,  RAISINS, COCONUT FlAKES, SUGAR.  MAY CONTAIN ALMONDS, PEANUTS, CASHEWS,  HAZELNUTS, PECANS AND/OR WALNUTS.    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F
Product has undeclared allergens:  soy and almonds.
Helados La Tapatia Creamy Fruit Bars;  Strawberry Cream flavor; Net Wt. 3 FL oz;    UPC 6 34242 20001 2;    INGREDIENTS FOR MILK BARS:  ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP, MONO  AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM, POLYSORBATE 80,  CARRAGEENAN), STABILIZER (XANTHAN GUM, GUAR GUM, STANDARDIZED  WITH DEXTROSE) WATER, STRAWBERRIES, SUGAR, AND RED #40 (WATER,  YELLOW 5 AND BLUE 1, CITRIC ACID AND SODIUM BENZOATE (A  PRESERVATIVE)).  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS  CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS: MILK, FD&C YELLOW NO.5    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F
Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.
Helados La Tapatia ;  Cafe Coffee; Net Wt. 3 fl. oz.  UPC 6 34242 60013 5;  INGREDIENTS FOR ICE MILK BARS:  ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP, MONO AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM, POLYSORBATE 80, CARRAGEENAN), WATER, SUGAR, GROUND COFFEE AND STABILIZER (XANTHAN GUM, GUAR GUM, STANDARDIZED WITH DEXTROSE).   PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS MILK.           .    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F
Helados La Tapatia Creamy Fruit Bars;  Vanilla vainilla; Net Wt. 3 FL oz;   UPC 6 34242 20005 0;    INGREDIENTS FOR MILK BARS:  ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP, MONO  AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM, POLYSORBATE 80  CARRAGEENAN), WATER, SUGAR, STABILIZER (XANTHAN GUM, GUAR GUM,  STANDARDIZED WITH DEXTROSE), YELLOW 5 (WATER, FD&C YELLOW #5, FD&C RED #40,CITRIC ACID AND SODIUM BENZOATE (PRESERVATIVE)) ,AND RED 40 (WATER, YELLOW 5 AND BLUE 1, CITRIC ACID, AND SODIUM BENZOATE (A PRESERVATIVE)), NATURAL VANILLA AND RAISINS.  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS  CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS: MILK, FD&C YELLOW #5      Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F
Helados La Tapatia Creamy Fruit Bars;  Pecan Nuez; Net Wt. 3 FL oz;   UPC 6 34242 20007 4;    INGREDIENTS FOR MILK BARS:  ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN  SYRUP, MONO AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM,  POLYSORBATE 80 CARRAGEENAN), WATER, SUGAR, MAPLE BUTTER  FLAVOR (PROPYLENE GLYCOL, WATER AND GLYCERIN), STABILIZER  (XANTHAN GUM, GUAR GUM, STANDARDIZED WITH DEXTROSE),  CARAMEL COLOR AND NATURAL FRESH PECANS.  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS  CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS: MILK, PECANS      Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F
Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling..
Helados La Tapatia Creamy Fruit Bars;  All Natural Rice Arroz; Net Wt. 3 FL oz;   UPC 6 34242 20008 1;    INGREDIENTS FOR MILK BARS:  ICE CREAM MIX (CREAM, MILK, FRESH CONDENSED  SKIM MILK, SUCROSE, CORN SYRUP, DESSERT SOLIDS  (WHEY, REDUCED LACTOSE, WHEY AND NON FAT  DRIED MILK) AND STABILIZER {GUAR GUM, MONO, AND  DIGLYCERIDES), CALCIUM SORBATE, POLYSORBATE 40,  CELLULOSE GUM AND CARRAGENAN), WATER, RICE,  SUGAR, CINNAMON, AND RAISINS.  PROCESSED IN A FACILITY THAT PROCESSES NUTS.    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F
Helados La Tapatia ;  Cookies 'n' Cream Biscuits au Chocolat; Net Wt. 4 oz, (113g)  UPC 6 34242 60007 2;    INGREDIENTS FOR ICE FRUIT BARS:  ICE CREAM MIX (CREAM, MILK, FRESH CONDENSED SKIM  MILK, SUCROSE, CORN SYRUP. DESSERT SOLIDS (WHEY,  REDUCED LACTOSE, WHEY AND NON FAT DRIED MILK) AND  STABILIZER (GUAR GUM, MONO, AND DIGLYCERIDESJ,  CALCIUM SORBATE, POLYSORBATE 40, CELLULOSE GUM  AND CARRAGENAN),WATER, CHOCOLATE COOKIES AND SUGAR.  MAY CONTAIN ALMONDS, PEANUTS, CASHEWS,HAZELNUTS, PECANS AND/OR WALNUTS.    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F
Product has undeclared allergens: soy and wheat. .
STANDARDIZED WITH DEXTROSE), CORN OIL, PEANUTS AND YELLOW COLOR (WATER, FD&C YELLOW 5, FD&C RED 40, CITRIC ACID, SODIUM BENZOATE AS A PRESERVATIVE).  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS: MILK, PEANUTS AND FD&C YELLOW 5 AND SOY.    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F
Helados La Tapatia Creamy Fruit Bars;  Chocolate; Net Wt. 3 FL oz;   UPC 6 34242 20003 6;    INGREDIENTS FOR MILK BARS:  ICE CREAM MIX (MILK FAT AND NON FAT MILK. SUGAR, CORN SYRUP. MONO AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM,POLYSORBATE 80 CARRAGEENAN), WATER, SUGAR,CHOCOLATE (HIGH FRUCTOSE CORN SYRUP. CORN SYRUP. WATER, COCOA, SUGAR, CONTAINS 2% OR LESS OF: POTASSIUM SORBATE (PRESERVATIVE), SALT, MONO AND DIGLYCERIDES, XANTHAN GUM, POLYSORBATE 60, VANILLIN AND ARTIFICIAL FLAVOR) AND STABILIZER (XANTHAN GUM, GUAR GUM, STANDARDIZED WITH DEXTROSE).  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS  CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS: MILK  Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F
Helados La Tapatia Creamy Fruit Bars;  Pina Colada; Net Wt. 3 FL oz;   UPC 6 34242 20014 2;    INGREDIENTS FOR MILK BARS:  ICE CREAM MIX  (MILK  FAT AND  NON FAT MILK, SUGAR,CORN SYRUP. MONO AND DIGLYCERIDES, CELLULOSE GUM,GUAR GUM,POLYSORBATE 80 CARRAGEENAN),WATER,SUGAR,FRESH COCONUT, FRESH PINEAPPLE. COCONUT  FLAVOR (WATER,SUCROSE,VEGETABLE OIL (COCONUT), MODIFIED CORNSTARCH,ARTIFICIAL FLAVORINGS,BROMINATED VEGETABLE OIL 0.03% ANHYDROUS CITRIC ACID, SODIUM   BENZOATE   (PRESERVATIVE), PROPYLENE  GLYCOL,  AND  ANTIFOAM), PINEAPPLE FLAVOR (PROPYLENE GLYCOL  AND ETHANOL),CHERRIES,STABILIZER (XANTHAN GUM,GUAR GUM, STANDARDIZED WITH DEXTROSE),YELLOW 5 (WATER,FD&C YELLOW #5,FD&C RED #40,CITRIC ACID, AND SODIUM BENZOATE (PRESERVATIVE)),AND RED 40   (WATER,YEllOW 5 AND BLUE l,CITRIC ACID AND SODIUM BENZOATE (PRESERVATIVE)).  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS CONTAINING PEANUTS,TREE NUTS,SOY,WHEAT AND MILK.   CONTAINS:MILK AND FD&C YELLOW #5        Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F
Helados La Tapatia Creamy Fruit Bars;  Banana Platano; Net Wt. 3 FL oz;   UPC 6 34242 20004 3;    INGREDIENTS FOR MILK BARS:  ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP,  MONO AND DIGLYCERIDES,CELLULOSE GUM,GUAR GUM, POLYSORBATE  80, CARRAGEENAN), WATER, FRESH BANANAS, SUGAR, STABILIZER  (XANTHAN GUM, GUAR GUM, STANDARDIZED WITH DEXTROSE),  YELLOW 5 (WATER, YELLOW 5 AND BLUE 1, CITRIC ACID AND SODIUM  BENZOATE (A PRESERVATIVE)) AND RED 40 (WATER, FD&C YELLOW #5,  FD&C RED #40, CITRIC ACID AND SODIUM BENZOATE (PRESERVATIVE)).  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS  CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS: MILK, FD&C YELLOW #5    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F
Cream; Net Wt. 3 FL oz;   UPC 6 34242 20010 4;  INGREDIENTS FOR MILK BARS:  ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP, MONO AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM, POLYSORBATE 80, CARRAGEENAN}, CHOCOLATE COOKIES (ENRICHED FLOUR (WHEAT FLOUR, NIACIN, REDUCED IRON, THIAMIN MONONITRATE (VITAMIN B1 RIBOFLAVIN (VITAMIN 82), FOLIC AOD), SOYBEAN AND PALM OIL WITH TBHQ FOR FRESHNESS, COCOA PROCESSED WITH ALKALI, INVERT SUGAR CONTAINS TWO PERCENT OF LESS OF DEGERMINATED YELLOW CORN FLOUR, CORNSTARCH, CHOCOLATE, SALT, LEAVENING BAKING SODA, MONOCALCIUM PHOSPHATE) ARTIFICIAL FLAVOR, SOY LECITHIN, WHEY), SUGAR AND STABILIZER (XANTHAN GUM, GUAR GUM,STANDARDIZED WITH DEXTROSE).  PROCESSED IN A FACILITY THAT PROCESSES PRODUCTS  CONTAINING PEANUTS, TREE NUTS, SOY, WHEAT AND MILK.  CONTAINS: MILK, WHEAT AND SOY      Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F
Helados La Tapatia Creamy Fruit Bars;  Natural Creamy All Natural Coconut Coco; Net Wt. 3 FL oz; (85g)    UPC 6 34242 20002 9;    INGREDIENTS: ICE CREAM MIX MILK, FRESH CONDENSED  SKIM MILK, SUCROSE, CORN SYRUP, DESSERT SOLIDS (WHEY, REDUCED  LACTOSE WHEY AND. NON FAT DRIED MILK) AND STABILIZER (GUAR  GUM, MONO AND DIGLYCERIDES), CALCIUM SORBATE, POLYSORBATE  40, CELLULOSE GUM AND CARRAGENAN), WATER, FRESH COCONUT,  SUGAR AND COCONUT FLAVOR.  Manufactured in a facility that produces products with almonds,  peanuts, cashews, hazel nuts, pecans and/or walnuts.    Mfg by:  Helados La Tapatia, Inc.  Fresno, CA 93772  Plant # 06-02536F
USA  (nationwide) Distribution to the states of : AL, AK, AZ, CA,  CO,  CT,  DE,  FL, GA,  ID,  IL, IN, IA, KY, ME, MA,  MN, MO, NE, NV, NJ,  NM, NY,  NC,  ND,  OH, OR,  PA,  SC, TN, TX, UT,  VA,  VT,  WA,  WI and WY., and Internationally to Canada.
Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
The firm has received 15 complaints over ten years related to the connection of the spring arm to the top horizontal arm of the lighting system that while positioning the light head enabled the spring arm and light head to fall.
4028110 - iLED Single; 4028210 - iLED duo; 4028310 - iLED trio/quad; 4038110 - TruLight single; 4038210 - TruLight duo; 4038310 - TruLight trio/quad; 1565068 - iLED single (TUSM); 1565160 - iLED duo (TUSM); 1565161 - iLED trio/quad (TUSM); 1574759 - TruLight single (TUSM); 1574850 - TruLight duo (TUSM); 1574851 - TruLight trio/quad (TUSM)
TATE'S BAKE SHOP CHOCOLATE CHIP COOKIES, NET WT. 7 OZ (198 G), UPC Code 810291001002, product is packed in plastic which is inserted into green paper wrapping, DISTRIBUTED BY: TATE'S BAKE SHOP 43 NORTH SEA RD. SOUTHAMPTON NY 11968 631-780-6511, WWW.TATEBAKESHOP.COM, MADE IN THE U.S.A.
Tate's Bake Shop has recalled Chocolate Chip Cookies and Ginger Zinger Cookies due to the presence of undeclared walnuts.
Outer Case Code 15.09.22 - BEST BY MAR 20 2016
TATE'S BAKE SHOP Cookies GINGER ZINGER GLUTEN FREE, NET WT. 7 OZ (198 G), UPC Code 810291001095, product is packed in plastic which is inserted into a mint green paper wrapper, DISTRIBUTED BY: TATE'S BAKE SHOP 43 NORTH SEA RD. SOUTHAMPTON NY 11968 631-780-6511, WWW.TATEBAKESHOP.COM, MADE IN THE U.S.A.
Outer Case Code 15.07.08 - BEST BY JAN 04 2016
Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Cefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Piperacillin/Tazobactam (Zosyn)  Accuflo bag, a) 18 g/NS 275 mL  b) 4.5 g/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Dextrose 5% and 0.9% Sodium Chloride injection bag a) 1000 mL,  b) 3000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Milrinone 0.375 mcg/kg/min D5W bag a) 365 mL, b) 400 mL c) 430 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Cefazolin in Accuflo bags, a) 1g/NS 25 mL, b) 2g/NS 25 mL, c) 8g/NS 275 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 Lack
Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Vancomycin Injection in NS, Accuflo bag, a) 500 mg/NS 100 mL, b)1G/NS 100 mL, c) Vancomycin 1G/NS 250 mL, d) 1.5G/NS 250 mL e) 750 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Insulin Regular (Human) syringe, a)15 unit/0.15 mL, b) 24 unit/0.24mL syringe, c) 50 unit/0.5 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
IVIG Gammagard injection bag, a) 13 gm, b) 20 gm, c) 73 gm, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Sodium Ascorbate (Vitamin C) syringe, a) 500 mg/1 mL syringe, b)1000 mg/2 mL c) 800 mg/1.6 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Clindamycin injection, Accuflo bag, a) 500 mg/NS 50 mL  b) 900 mg/NS 100 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
0.9% Sodium Chloride injection bag, a) 500 mL, b)1000 mL c)2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Famotidine injection syringe a) 10 mg/1 mL  b) 80 mg/8 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Dextrose 5% and 0.45% Sodium Chloride with KCl 20 mEq 1000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Heparin injection, Preservative Free, a) 280 units/0.28 mL, b) 350 units/0.35 mL syringe, c) 440 units/0.44 mL, d) 500 units/0.5 mL syringe, e) Heparin 800 units/0.8 f) Heparin 2300 units/2.3 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045
Worldwide Distribution - US Distribution including Puerto Rico., and to the states of : CA, CO, FL, IL, MA, MI, MO, NY, OH, SC, TX, VA, WI, WV and Hawaii.,  and to the countries of :  Australia, Germany, France, Greece, Northern Mariana Islands, Taiwan and Uruguay.
Radiographic Transparency for Certain and External Connection Tapered Implants.  Images that assist with measurements for dental implants.
Images contained within radiographic transparency ART 1036 are undersized.
Model Number:  ART 1036, Rev. C 03/13; Purchase Order # 184427.
Distributed in the states of IL, NC, and VT.
Merge Hemo with software versions 10.0 LA.    Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.
Merge Hemo with software versions 10.0 LA
Merge Cardio with software version 10.1 LA.
Merge Cardio with software version 10.1 LA.    Merge Cardio is intended to allow users to review diagnostic and non-diagnostic quality images.
Distribution to ALDI distribution centers for their stores only.  U.S. distribution to the following; IL, PA, TX, MD, MN, IN, FL, OH, GA, TN, WI, MO, KS, NC, PA, CT, NY, MI
Friendly Farms   Greek   Peach Parfait  Nonfat Yogurt  net wt. 5.3 oz (150g)    Distributed by ALDI Inc., Batavia, IL 60510
Ehrmann Arizona Dairy, LLC is recalling Friendly Farm Greek Peach Parfait due to the cups displaying gluten free logo when the ingredients state that the granola contains wheat flakes.
Valve XS Atrium Retractor  FC429R  52154756    The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery.
Product Information All lots affected  	Product Description  FC424R	Valve XS Atrium Lift Ret. Blade50X35  FC425R	Valve XS Atrium Lift Ret. Blade60X35  FC426R	Valve XS Atrium Lift Ret. Blade70X35  FC428R	Valve XS Atrium Lift Ret. Blade50X45  FC429R	Valve XS Atrium Lift Ret. Blade60X45  FC430R	Valve XS Atrium Lift Ret. Blade70X45  FC431R	Valve XS Atrium Lift Ret. Blade25X20  FC432R	Valve XS Atrium Lift Ret. Blade25X25  FC433R	Valve XS Atrium Lift Ret. Blade40X25  FC434R	Valve XS Atrium Lift Ret. Blade50X25  FC435R	Valve XS Atrium Lift Ret. Blade25X40  FC436R	Valve XS Atrium Lift Ret. Blade25X50  FC420R	Valve XS Atrium Lift Ret. Blade Complete Set
Raley's Sweet Pumpkin Ravioli;  Fresh egg pasta with a pumpkin & Amaretti Biscuits filling.  Net Wt. 10 oz. (284 g);  Ingredients: Filling- pumpkin, bread crumbs (wheat flour, natural yeast, salt), Butter Amaretti Biscuits (sugar, apricot kernels, egg whites, lactose, milk protein, leavening- sodium hydrogen carbonate(, salt..  Pasta - soft wheat flour, pasteurized eggs, durum wheat seminola:  Contains eggs, milk, wheat, gluten;    Proudly distributed by Raley's West Sacramento, CA  Product of Italy.
Raley's was notified by the manufacturer that their Pumpkin Ravioli may contain undeclared cashew and almond.
US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
Granada Biphasic Broth    The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
Worldwide Distribution - USA (nationwide) Distribution and to the countries of :  Austria, Belgium, Brazil, Canada, Germany, Italy, Japan, Kazakhstan, Kuwait, Mexico, Myanmar, Netherlands, Norway, Panama, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Thailand and United Kingdom.
MicroScan Pos Breakpoint Combo Panel Type 23, Part No. B1017-206    MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
Beckman Coulter has confirmed falsely negative results for Voges-Proskauer (VP) (pale-pink/brown/colorless) with Quality Control (QC) American Type Culture Collection (ATCC) organism Staphylococcus aureus ATCC 29213 in a portion of affected lots of MicroScan Pos Combo and MicroScan Pos Breakpoint Combo panels. The expected result is positive.
MicroScan Pos Breakpoint Combo Panel Type 20, Part No. B1017-202    MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
MicroScan Pos Combo Panel Type 34, Part No. B1017-214    MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
MicroScan Pos Combo Panel Type 21, Part No. B1017-201    MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
MicroScan Pos Combo Panel Type 33, Part No. B1017-211    MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
Santee Cosmetics is recalling Santee Diamond Color Mascara because it has the potential to be contaminated with mold, Bacillus lentus, Pseudomonas putida, and Achromobacter xylosoxidans.
Worldwide Distribution: US (nationwide) including states of: AK, AZ, AR, CA, CO, CT, DE DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, ,MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WY; and countries of:  Antiqua & Barbuda, Australia, Austria, Bahama, Bahrain, Canada, Czech Republic, Germany, Hungary, Saudi Arabia, Sweden, Turkey, & United Kingdom.
MOSAIQ Oncology Information System    MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
US Distribution to the states of : CA  and  FL.
RenovoCath RC 120;  Temporary Intravascular Occluding Catheter  Model number: MMRC120-DB-1111;  Rx only.    Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system.
Incorrect version of Instructions for Use were shipped to two US customers.
Model number: MMRC120-DB-1111;  Lot number: B2456974A; Expiry 2016-07.  Lot B2457150A - all 72 units were either used or returned prior to initiation of recall.
Simply Enjoy Shrimp and Lobster Ravioli, 9 oz, refrigerated packaged in plastic tray. Distributed by Foodhold USA, Landover, MD.  UPC Code: 68826743926
Shrimp and Lobster Ravioli back panel incorrectly identifies Spinach and Roasted Garlic ravioli ingredients
Lot code 15309  Use by Date December 20, 2015
Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.
Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.
Catalog Reference #367842; Lot numbers 5089731 and   5175923
Catalog Reference #368047; Lot number 5154647
Catalog Reference #367844; Lot number 5154624    Catalog Reference #367862; Lot numbers 5089771 and 5187753    Catalog Reference #368021; Lot number 5089820
Worldwide Distribution- US Distribution including the states of AZ, CA, CO, IL IN, MI, MN, NY, OH, OK, SD, TX, WI, and the countries of CANADA, CHINA, CZECH REPUBLIC, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, PORTUGAL, ROMANIA, SOUTH AFRICA, SWITZERLAND, TURKEY.
GE Healthcare, 3.0T 6 Channel Phased Array  Flex Coil, M0050SS.    Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.
GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners.    Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue.
Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer.