FDA Recalls in 2016

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 wit

Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.

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.

Barilla Pronto PENNE, 12 OZ (340 g), GTIN number 10076808005605, packed as 16 boxes per case, sold as individual units at retailer.

Barilla America NY, Inc. has recalled four types of pasta due to the presence of aluminum fragments

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 Tapa

Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.

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

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 S

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; 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 (WAT

Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.

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.

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 CONTAIN

Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling..

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.

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 CONTAIN

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; 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), PROPYLEN

Product was produced with an ice cream mix that contains eggs that is not included in the ingredient labeling.

Meropenem 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

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

Lack of Assurance of Sterility

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

Lack of Assurance of Sterility

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

Lack of Assurance of Sterility

Remicade (Infliximab) injection, 5 mg/kg bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

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

Lack of Assurance of Sterility

3-in-1 TPN formula daily+overfill Bag, 2000 mL, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

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

Lack of Assurance of Sterility

Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

Ceftriaxone 2g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

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

Lack of Assurance of Sterility

Nafcillin 12 gm in NS 500 mL bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

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

Lack of Assurance of Sterility

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

Lack of Assurance of Sterility

IVIG Gamunex 40 gm (400 mL) Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

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

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

Lack of Assurance of Sterility

Folic Acid 1 mg/0.2 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

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

Lack of Assurance of Sterility

Primaxin (Imipenem-Cilastatin) 500 mg/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

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

Lack of Assurance of Sterility

Tobramycin 620 mg/NS 100 mL Accuflo, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

L-Cysteine 800 mg (16 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

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

Lack of Assurance of Sterility

Gentamicin 14.4 mg/sodium chloride 0.9% 30 mL Prefilled syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

Phytonadione (Vitamin K) 1 mg/0.1mL Syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

Invanz 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

Oxacillin 12 g/NS 270 mL-24 hr Accuflo bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

0.9% Sodium Chloride/MVI injection 2000 mL Bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

0.9% NaCl 1000 mL with Ca 4.65 meq bag, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

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

Lack of Assurance of Sterility

Cefepime 1 g/NS 100 mL Minibag Plus, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

Teflaro 600 mg in 100 mL NS Minibag Plus,Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

Thiamine 100 mg (1 mL) syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045

Lack of Assurance of Sterility

Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting position.

Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.

Invacare sent an Urgent Patient Safety Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their wheelchair povider to have their joystick replaced. Customers with questions were instructed to call their provider at Invacare's recall support line at 877-413-6008. Go to www.invacare.com/joystickrecall for more information regarding this recall

Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.

The labeling is missing the size/diameter information.

DJO Surgical sent an Urgent Field Safety Notice dated September 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter requested the consignees complete and return a response card and return affected devices for replacement. For further questions call (512) 832-6302.

15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.

The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.

Baxter sent an Urgent Product Recall letter dated May 30, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. The recalling firm is instructing their customers to remove all affected products from their facility and quarantine the product subject to the recall. Customers are instructed to return the affected product to Baxter and receive a credit or replacement. For questions contact the Center for One Baxter at 1-800-422-9837.

MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.

The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer.

Mentor sent an Important Labeling Correction letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm plans to follow-up with sales representative visits. The recall letter notifies the customer of the issue, but does not instruct them to return the product. Should the customer chose to return the product, all returned product will be tagged to denote no further distribution. The recalled units under firm control have been placed on hold in the inventory system. If you have any questions related to this notice, please contact your local Mentor Sales Representative, or Mentor Customer Service at 1-800-235-5731.