Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
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.
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.
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.
Distributed in the states of IL, NC, and VT.
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
US Distribution to states of: CA, GA, IN, MA, MN, MO, NY, OH and PA.
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.
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.
US Distribution to the states of : CA and FL.
Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.
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.

Product Description
Barilla MEDIUM SHELLS, 1 LB (454 g), GTIN 00076808002881, packed as twelve boxes in 1 case
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
Bulk refined sugar. CON AAA in 2200 poly super totes
Bulk refined sugar. CON AA in 50lb paper bags, 2000 and 2200 poly super totes
CPT05 5 Ounce Pizza Dough Ball, 112 - 5 Ounce Dough Balls, Net Weight 35.0 Pounds, UPC 1 081267 0012644 4..
Baker's Best Maximum Mind & Memory Formula, 60 capsules, Vitamin B6 75 mg. Distributed by Baker's Best Health Products, Inc. Wixom, MI
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
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
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
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
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
Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5
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 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.
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
Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants.
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.
Merge Cardio with software version 10.1 LA.
Friendly Farms Greek Peach Parfait Nonfat Yogurt net wt. 5.3 oz (150g) Distributed by ALDI Inc., Batavia, IL 60510
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.
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.
Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.
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.
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 Diamond Color Mascara, Item No. ST081, Net Wt. 10g Product Measurements: 5.5 x 1 x 1
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.
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.
Simply Enjoy Shrimp and Lobster Ravioli, 9 oz, refrigerated packaged in plastic tray. Distributed by Foodhold USA, Landover, MD. UPC Code: 68826743926
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.
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

Reason for Recall
Barilla America NY, Inc. has recalled four types of pasta due to the presence of aluminum fragments
Foreign material in product, small pieces of brass less than 7mm.
The Dough Shop is recalling one lot of pizza dough because a piece of vinyl glove was found in the product.
Vitamin B6 level below percent declared on label
Product has undeclared allergens: soy and almonds.
Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.
Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling..
Product has undeclared allergens: soy and wheat. .
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.
Tate's Bake Shop has recalled Chocolate Chip Cookies and Ginger Zinger Cookies due to the presence of undeclared walnuts.
Images contained within radiographic transparency ART 1036 are undersized.
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.
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.
AAG received a customer complaint that corrosion had been found by a hospitals central sterile service department on the ball joint of an FC424R blade. Investigation revealed that the corrosion was due to incorrect material used in the manufacturing of the disk spring of the ball joint by the supplier
Raley's was notified by the manufacturer that their Pumpkin Ravioli may contain undeclared cashew and almond.
FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States.
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.
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.
Incorrect version of Instructions for Use were shipped to two US customers.
Shrimp and Lobster Ravioli back panel incorrectly identifies Spinach and Roasted Garlic ravioli ingredients
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.
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.
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer.

Code Info
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.
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.
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)
Outer Case Code 15.09.22 - BEST BY MAR 20 2016
Outer Case Code 15.07.08 - BEST BY JAN 04 2016
Model Number: ART 1036, Rev. C 03/13; Purchase Order # 184427.
Merge Hemo with software versions 10.0 LA
Merge Cardio with software version 10.1 LA. Merge Cardio is intended to allow users to review diagnostic and non-diagnostic quality images.
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
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.
Lot code 15309 Use by Date December 20, 2015
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