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U.S. Department of Health and Human Services

Enforcement Report - Week of January 6, 2016

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Food Barilla MEDIUM SHELLS, 1 LB (454 g), GTIN 00076808002881, packed as twelve boxes in 1 case Lot Code 5745U05 Class II Barilla America NY, Inc. has recalled four types of pasta due to the presence of aluminum fragments Barilla America NY, Inc.
Food Barilla Pronto PENNE, 12 OZ (340 g), GTIN number 10076808005605, packed as 16 boxes per case, sold as individual units at retailer. Lot Codes: 5745U05 & 5755U05 Class II Barilla America NY, Inc. has recalled four types of pasta due to the presence of aluminum fragments Barilla America NY, Inc.
Food Barilla Packaged Specifically for FoodService, PENNE RIGATE, 160 OZ (10 LBS) (4.54 kg), GTIN 1007680839242, packed as two bags per case. Lot Code: 5755U05, 5765U05 Class II Barilla America NY, Inc. has recalled four types of pasta due to the presence of aluminum fragments Barilla America NY, Inc.
Food 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. Lot Code: 5755U05, 5765U05 Class II Barilla America NY, Inc. has recalled four types of pasta due to the presence of aluminum fragments Barilla America NY, Inc.
Food Cross Valley Farms cucumbers, 24 count corrugated carton 7563200 Class I Possible contamination with Salmonella. Del Monte Fresh Produce N A Inc
Food Bulk refined sugar. CON AA in 50lb paper bags, 2000 and 2200 poly super totes Manufacturing Pans 6510 and 6511. Customer specific lot numbers as idenified in individual recall notices: 6260-5219; 6394-5227; 6518-5227; 6260-5233; 6394-5233; 6515-5210; 6544-5225; 6547-5230; 6570-5233; 6511-5209; 6513-5210; 6509-5204; 6509-5209; 6515-5213; 6524-5222; 6518-5224. Class II Foreign material in product, small pieces of brass less than 7mm. Amcane Sugar Llc
Food 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. Class II Foreign material in product, small pieces of brass less than 7mm. Amcane Sugar Llc
Food Bulk refined sugar. Sanding in 50 lb paper bags 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. Class II Foreign material in product, small pieces of brass less than 7mm. Amcane Sugar Llc
Food CPT05 5 Ounce Pizza Dough Ball, 112 - 5 Ounce Dough Balls, Net Weight 35.0 Pounds, UPC 1 081267 0012644 4.. 09022015-2 Class II The Dough Shop is recalling one lot of pizza dough because a piece of vinyl glove was found in the product. The Dough Shop Pizza Dough Shop, Inc.
Food Baker's Best Maximum Mind & Memory Formula, 60 capsules, Vitamin B6 75 mg. Distributed by Baker's Best Health Products, Inc. Wixom, MI Lot #080115, Exp 01/2018 Class II Vitamin B6 level below percent declared on label Pure Source, Inc.
Food 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 UPC 6 34242 20001 2; Distributed 10-8 to 10-16-2015. lot number  282 15 01; lot number  285 15 02    Class I Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling. Helados La Tapatia, Inc.
Food 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 UPC 6 34242 20002 9; Distributed 10-8 to 10-16-2015. lot number  282 15 02  lot number  285 15 03  lot number  288 15 03   Class I Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling. Helados La Tapatia, Inc.
Food 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 UPC 6 34242 20003 6; no lot codes Distributed 10-8 to10-16-2015. lot number  281 15 03  Class I Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.. Helados La Tapatia, Inc.
Food 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 UPC 6 34242 20004 3; no lot codes Distributed 10-8 to10-16-2015. lot number  281 15 04  Class I Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.. Helados La Tapatia, Inc.
Food 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 UPC 6 34242 20005 0; Distributed 10-8 to10-16-2015. lot number  287 15 03   Class I Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling. Helados La Tapatia, Inc.
Food Helados La Tapatia Creamy Fruit Bars; Cookies "n" 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 UPC 6 34242 20010 4; Distributed 10-8 to10-16-2015. lot number  282 15 03  , lot number  288 15 02  Class I Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.. Helados La Tapatia, Inc.
Food Helados La Tapatia Creamy Fruit Bars; Esquimal eskimo; Net Wt. 3 FL oz; UPC 6 34242 20012 8; INGREDIENTS: ICE CREAM MIX (CREAM, MILK, NONFAT MILK SOLIDS, STABILIZER (LOCUST BEAN GUM, GUAR GUM)), WATER, SUGAR, VANILLA FLAVOR (PROPYLENE GLYCOL, WATER AND CARAMEL COLOR), YUKON CHOCOLATE (COCONUT OIL, SUGAR, COCOA POWDER, WHEY POWDER (MILK) SOY LECITHIN ADDED AS AN EMULSIFIER AND VANILLA), STABILIZER (XANTHAN GUM, GUAR GUM, "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 UPC 6 34242 20012 8; Distributed 10-8 to10-16-2015. lot number  289 15 04   Class I Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling. Helados La Tapatia, Inc.
Food 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 UPC 6 34242 20014 2; Distributed 10-8 to10-16-2015. lot number  288 15 01   Class I Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling. Helados La Tapatia, Inc.
Food 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 UPC 6 34242 20007 4; Distributed 10-8 to10-16-2015. lot number  287 15 01  Class I Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.. Helados La Tapatia, Inc.
Food 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 UPC 6 34242 20008 1; Distributed 10-8 to10-16-2015. lot number  285 15 01   Class I Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling. Helados La Tapatia, Inc.
Food 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 UPC 6 34242 60007 2; lot number  286 15 15  lot number  286 15 16  . Class I Product has undeclared allergens: soy and wheat. . Helados La Tapatia, Inc.
Food 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 UPC 6 34242 60012 6; lot numbers 286 15 06 and 286 15 07 . Class I Product has undeclared allergens: soy and almonds. Helados La Tapatia, Inc.
Food 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 UPC 6 34242 20013 5; lot numbers 281 15 02 and 289 15 03 . Class I Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling. Helados La Tapatia, Inc.
Devices Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5 4028110 - iLED Single; 4028210 - iLED duo; 4028310  ...
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Class II 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. Trumpf Medical Systems, Inc.
Food 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. Outer Case Code 15.09.22 - BEST BY MAR 20 2016 Class I Tate's Bake Shop has recalled Chocolate Chip Cookies and Ginger Zinger Cookies due to the presence of undeclared walnuts. Tate's Wholesale, Llc.
Food 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 Class I Tate's Bake Shop has recalled Chocolate Chip Cookies and Ginger Zinger Cookies due to the presence of undeclared walnuts. Tate's Wholesale, Llc.
Drugs Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 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 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 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 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 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 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 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 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 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 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 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 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 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 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 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 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 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 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 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 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 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 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs Cefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 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 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 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 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Drugs 3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 All lots within expiry. Class II Lack of Assurance of Sterility Walgreens Infusion Services
Devices Radiographic Transparency (for Certain and External Connection Tapered Implants) Images that assist with measure for Implants. Model Number: ART 1036, Rev. C 03/13; Pruchase Order # 184427. Class II Images contained within radiographic transparency ART 1036 are undersized. Biomet 3i, LLC
Devices 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 Hemo with software versions 10.0 LA Class II 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 Healthcare, Inc.
Devices 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. Class II 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 Healthcare, Inc.
Food Friendly Farms Greek Peach Parfait Nonfat Yogurt net wt. 5.3 oz (150g) Distributed by ALDI Inc., Batavia, IL 60510 Batch #, Best By Date 6047, 11/9/2015 7673, 11/15/2015 9708, 11/23/2015 1093, 11/29/2015 3117, 12/7/2015 4476, 12/13/2015 5679, 12/19/2015 7698, 12/27/2015 9371, 1/3/2016 Class II 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. Ehrmann Arizona Dairy Llc
Devices 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  ...
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Class II 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 Aesculap, Inc.
Food 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. UPC 046567021218; All lots Class I Raley's was notified by the manufacturer that their Pumpkin Ravioli may contain undeclared cashew and almond. Raley's
Devices Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens. REF 42722 - Lot Numbers 896, 897 & 899 Class II FDA has determined that the product requires 510(k) clearance to continue marketing/distribution in the United States. Biomerieux Inc
Devices 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. 2016-05-05 Part No. B1017-201 Class II 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. Beckman Coulter Inc.
Devices 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. 2016-04-29 2016-05-04 Part No. B1017-211 Class II 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. Beckman Coulter Inc.
Devices 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. 2016-04-29 2016-05-06 Part No. B1017-214 Class II 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. Beckman Coulter Inc.
Devices 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. 2016-04-30 Part No. B1017-202 Class II 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. Beckman Coulter Inc.
Devices 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. 2016-05-06 Part No. B1017-206 Class II 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. Beckman Coulter Inc.
Cosmetics SANTEE Diamond Color Mascara, Item No. ST081, Net Wt. 10g Product Measurements: 5.5 x 1 x 1 UPC 849609004381 Class II Santee Cosmetics is recalling Santee Diamond Color Mascara because it has the potential to be contaminated with mold. Santee Cosmetics
Devices 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. Versions 2.50 and higher Class II Incorrect drug dosage due to "Age Limit" and patient weight data item issue. Elekta, Inc.
Devices 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. Model number: MMRC120-DB-1111; Lot number: B2456974A; Expiry 2016-07. Class II Incorrect version of Instructions for Use were shipped to two US customers. RenovoRx, Inc.
Food Simply Enjoy Shrimp and Lobster Ravioli, 9 oz, refrigerated packaged in plastic tray. Distributed by Foodhold USA, Landover, MD. UPC Code: 68826743926 Lot code 15309 Use by Date December 20, 2015 Class II Shrimp and Lobster Ravioli back panel incorrectly identifies Spinach and Roasted Garlic ravioli ingredients Nuovo Pasta Productions, Ltd
Devices BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA The Vacutainer Brand PLUS (Plastic) Tube with EDTA Vacutainer® Brand Serum Tube are evacuated blood collection tubes which provide a means of collecting, transporting, separating and processing blood in a plastic tube. Catalog Reference #367842; Lot numbers 5089731 and 5175923 Class II BD is conducting a voluntary recall of the BD Vacutainer K2 EDTA (K2E) Plus Blood Collection Tubes. A portion of the affected tube lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a potential delay of treatment. No adverse events have been reported for this issue. BD has identified root cause and has taken corrective actions to address this issue. Becton Dickinson & Company
Devices BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA BD Vacutainer® tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory.The BD Vacutainer® Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. Catalog Reference #368047; Lot number 5154647 Class II BD is conducting a voluntary recall of the BD Vacutainer K2 EDTA (K2E) Plus Blood Collection Tubes. A portion of the affected tube lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a potential delay of treatment. No adverse events have been reported for this issue. BD has identified root cause and has taken corrective actions to address this issue. Becton Dickinson & Company
Devices BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA BD Vacutainer® tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer® Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. Catalog Reference #368054; Lot numbers 5089827, 5210514, 5154646, 5210511. Catalog Reference #367856; Lot number 5064666 Class II BD is conducting a voluntary recall of the BD Vacutainer K2 EDTA (K2E) Plus Blood Collection Tubes. A portion of the affected tube lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a potential delay of treatment. No adverse events have been reported for this issue. BD has identified root cause and has taken corrective actions to address this issue. Becton Dickinson & Company
Devices BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Tan) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA BD Vacutainer® tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer® Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. Catalog Reference #367855; Lot numbers 5064684, 5120653, 5154643, 5175930, 5210765, 5237787 Class II BD is conducting a voluntary recall of the BD Vacutainer K2 EDTA (K2E) Plus Blood Collection Tubes. A portion of the affected tube lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a potential delay of treatment. No adverse events have been reported for this issue. BD has identified root cause and has taken corrective actions to address this issue. Becton Dickinson & Company
Devices BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 4.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 7.2mg Sterile IVD BD, Made in USA BD Vacutainer® tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer® Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. Catalog Reference #367844; Lot number 5154624 Catalog Reference #367862; Lot numbers 5089771 and 5187753 Catalog Reference #368021; Lot number 5089820 Class II BD is conducting a voluntary recall of the BD Vacutainer K2 EDTA (K2E) Plus Blood Collection Tubes. A portion of the affected tube lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a potential delay of treatment. No adverse events have been reported for this issue. BD has identified root cause and has taken corrective actions to address this issue. Becton Dickinson & Company
Devices 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. Mfg Lot or Serial # System ID 00000001140049 BMDACCMR1 00000001140050 BMDACCMR1 0000011-4-0050 BMDACCMR1 0000011-4-0009 920568MR3T 0000011-4-0015 920568MR3T 0000011-4-0017 602406IMR 0000011-4-0018 602406IMR 0000011-4-0024 602406IMR 0000014-4-0007 602406IMR 0000011-4-0028 626359MR3 0000011-4-0032 626359MR3 0000011-4-0046 MSK68MR4 0000011-4-0047 MSK68MR4 0000028-3-0011 MSK68MR4 0000044-4-0046 MSK68MR4 0000011-4-0064 415CB3TW 0000011-4-0065 415CB3TW 0000011-4-0066 415723SHAW12 0000011-4-0067 415723SHAW12 0000011-4-0075 616267IMRI 0000011-4-0076 616267IMRI 011-4-0085 616267IMRI 011-4-0170 616267IMRI 0000011-4-0094 330344MR750W 011-4-0118 330344MR750W 0000011-4-0101 713792CMR1 0000011-4-0102 713792CMR1 0000011-4-0107 317887MR3 0000011-4-0108 317887MR3 0000011-4-0114 309655MR750W 0000011-4-0115 309655MR750W 011-4-0117 517353DVMR 011-4-0172 517353DVMR 011-4-0119 614293MR9 011-4-0120 614293MR9 011-4-0124 MR229050 077-4-0123 MR229050 011-4-0125 6053223TMR 011-4-0126 6053223TMR 011-4-0129 6053223TMR 011-4-0130 6053223TMR 011-4-0146 480342MR3 011-4-0149 480342MR3 011-4-0154  ...
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Class II 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. GE Medical Systems, LLC
Drugs 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 Lot# B14D26, Exp 02/16 Class II cGMP Deviations PD-Rx Pharmaceuticals, Inc.
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