Product Recalls in 2017

FDA Drug Class II Terminated

PF-Glutathione 200mg/ml, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 1 (877) BELLA.

August 15, 2017 Bella Pharmaceuticals, Inc. 82 vials units

FDA Drug Class II Terminated

Calcium chloride 10%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

August 15, 2017 Bella Pharmaceuticals, Inc. 5 vials units

FDA Food Class II Terminated

Rajbhog Sweet, JALEBI, Net Weight 11.2 oz. (315 grams), Distributed by Rajbhog Distributors (GA) Inc., Duluth, GA 30096.

August 15, 2017 Rajbhog Distributors GA Inc 1467 Packets units

NHTSA Ongoing

Right-Side Swingarm Pivot Pin Bolts May Loosen

August 15, 2017 BMW OF NORTH AMERICA, LLC 3,368 units

NHTSA Ongoing

Unintentional Rotation of the Ladder

August 15, 2017 KOVATCH MOBILE EQUIPMENT CORP 14 units

NHTSA Ongoing

Ladder Tip Speed may Increase Unexpectedly

August 15, 2017 KOVATCH MOBILE EQUIPMENT CORP 20 units

FDA Drug Class II Terminated

Lidocaine Ophthalmic Gel 3.5%, 15mL bottles, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1(877) BELLA.

August 15, 2017 Bella Pharmaceuticals, Inc. 6 bottles units

FDA Drug Class II Terminated

Methylcobalamin 10mg, (1mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

August 15, 2017 Bella Pharmaceuticals, Inc. 30 vials units

FDA Drug Class II Terminated

BevaDex (bevacizumab) 0.06mL Prefilled 32 g (1.25mg/1mg) Syringes, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659 (877) BELLA.

August 15, 2017 Bella Pharmaceuticals, Inc. 200 syringes units

FDA Drug Class II Terminated

Fluorescein Sodium, 5mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

August 15, 2017 Bella Pharmaceuticals, Inc. 644 vials units

FDA Drug Class II Terminated

Magnesium Chloride 200mg, 30m L vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

August 15, 2017 Bella Pharmaceuticals, Inc. 5 vials units

FDA Drug Class II Terminated

Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00

August 15, 2017 Amphastar Pharmaceuticals, Inc. 637,810 vials units

FDA Drug Class II Terminated

Sodium Bicarbonate 8.4%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

August 15, 2017 Bella Pharmaceuticals, Inc. 20 vials units

FDA Drug Class II Terminated

Phenylephrine2.5%/Tropicamide 1% Ophthalmic Solution, 15mL bottle, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

August 15, 2017 Bella Pharmaceuticals, Inc. 6 bottles units

FDA Drug Class II Terminated

MIC 25/50/50, 30mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

August 15, 2017 Bella Pharmaceuticals, Inc. 5 vials units

NHTSA Ongoing

Axle Housing may Fracture due to Fatigue

August 15, 2017 Ride The Ducks International LLC 57 units

FDA Drug Class II Terminated

G.A.C 25/100/250mg, 30 mL Vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

August 15, 2017 Bella Pharmaceuticals, Inc. 3 vials units

FDA Drug Class II Terminated

B-Complex, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659,1 (877) BELLA.

August 15, 2017 Bella Pharmaceuticals, Inc. 45 vials units

FDA Drug Class II Terminated

Mannitol 20%, 10 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.

August 15, 2017 Bella Pharmaceuticals, Inc. 10 vials units

FDA Food Class I Terminated

Scampi Butter, Net Wt. 3 OZ, packaged in clear plastic tubs. Dierbergs Kitchens

August 14, 2017 Dierbergs Markets, Inc Corporate Office 1,242 3 oz containers units

FDA Food Class II Terminated

Rainbow Carrot and Quinoa Salad, ready to eat product, packaged in one pint clear plastic deli containers, sold at random weight. UPC 252383-001604.

August 14, 2017 NEW SEASONS MARKET 21 containers units

FDA Food Class I Terminated

Cabernet Grille Butter, Net Wt. 3 OZ, packaged in clear plastic tubs. Dierbergs Kitchens

August 14, 2017 Dierbergs Markets, Inc Corporate Office 709 3 oz packages units

FDA Food Class II Terminated

(a) SEVEN SUNDAYS VANILLA CHERRY PECAN MUESLI 12oz. pouch, UPC: 8-56088-00315-6 (b) SEVEN SUNDAYS VANILLA CHERRY PECAN MUESLI 2oz. cup UPC: 8-56088-00311-8

August 14, 2017 Garden Of Light Inc. (a) 1098 cases (b) 20 cases units

FDA Food Class I Terminated

Cranberry Raisin Jete Nutritional Energy Bar, One Mother of a Bar, Net wt. 61 gram. Product is package in a cellophane sealed wrapper. UPC 6 16320 77471 4. The label is read in parts: ***Cranberry

August 13, 2017 Kelejete LLC 62 bars units

FDA Food Class I Terminated

Dark Chocolate Jete Nutritional Energy Bar, One Mother of a Bar, Net wt. 61 gram. Product is package in a cellophane sealed wrapper. UPC 6 16320 77469 1. The label is read in parts: ***Dark Chocola

August 13, 2017 Kelejete LLC 457 bars units

FDA Food Class I Terminated

Chocolate Jete Nutritional Energy Bar, One Mother of a Bar, Net wt. 61 gram. Product is package in a cellophane sealed wrapper. UPC 6 16320 77467 7. The label is read in parts: ***Chocolate***Jete

August 13, 2017 Kelejete LLC 136 bars units

FDA Food Class III Terminated

Whole Foods Smoked Traditional Atlantic Salmon Portion, packed in bulk boxes. Labeling states: Smoked on: 08/09/17, Sell Through: 09/04/17. Smoked fish portions are placed inside of a box lined with

August 11, 2017 Rushing Waters Fisheries, LLC 76.5lbs units

FDA Food Class III Terminated

Whole Foods Smoked Peppered Atlantic Salmon Portion, packed in bulk boxes. Labeling states: Smoked on: 08/09/17, Sell Through: 09/04/17. Smoked fish portions are placed inside of a box lined with a

August 11, 2017 Rushing Waters Fisheries, LLC 92.13lbs units

NHTSA Ongoing

Tag Axle Hydraulic Steering Hose may Leak or Burst

August 11, 2017 Temsa Global Sanayi Ve Ticaret A.S. 205 units

FDA Food Class I Terminated

Gazab Green Raisins, 7 oz. 14 oz. packages, 20/25 packs/carton

August 11, 2017 United Trading Inc. 14oz - 27 cases (675 pcs were packaged) / 7oz  44.48 cases (1,112 pcs were packaged) units

FDA Food Class III Terminated

Whole Foods Smoked Whitefish Fillet, packed in bulk boxes. Labeling states: Smoked on: 08/09/17, Sell Through: 09/04/17. Smoked fish portions are placed inside of a box lined with a plastic bag, whi

August 11, 2017 Rushing Waters Fisheries, LLC 22.70lbs units

NHTSA Ongoing

Battery Cable may Rub Against Frame Rail

August 11, 2017 FOREST RIVER, INC. 47 units

NHTSA Ongoing

Battery Cable may Rub Against Frame Rail

August 11, 2017 NEWMAR CORPORATION 1,167 units

FDA Food Class I Terminated

OPA by Litehouse Ranch, 6/11.25 oz. glass round bottles per case. The retail label listed item #48246 and has the UPC 0 77661 15022 1. The UPC on master case outer label is 01 1 0077661 13948 3.

August 11, 2017 Litehouse Inc. 742 cases (6 bottles per case) units

NHTSA Ongoing

Wheels may Fracture Causing Rapid Air Loss

August 11, 2017 Streetcar ORV LLC 1,765 units

FDA Food Class II Terminated

4-count boxes of KIND Breakfast Dark Chocolate Cocoa Bars 1.76 oz (50g) Outer Box: UPC: 60265220102-8

August 11, 2017 KIND, LLC 26,328 consumer units (outer carton boxes) units

FDA Drug Class III Terminated

Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bo

August 11, 2017 PD-Rx Pharmaceuticals, Inc. 3440 bottles units

FDA Food Class I Terminated

Madhava Naturally Sweet Deliciously Organic MMM... Chocolate Chip Cookie Mix,, 13.8 oz. , UPC 0 78314 25105 0. Packaged in box, 6 packages per case, Ambient storage.

August 11, 2017 Madhava Honey Ltd 13,380 cases units

FDA Food Class II Terminated

Zydot Ultimate Blend Detox Drink Natural Tropical Ice Flavor 32 fl. oz. (946 ml) and 16 fl. oz. (473 ml) packaged in clear plastic bottles

August 10, 2017 Zydot Unlimited, Inc 9101 bottles units

FDA Drug Class II Terminated

Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, , Fent

August 10, 2017 SSM Health Care St. Louis DBA SSM St. Clare Health Center N/A units

FDA Drug Class II Terminated

Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton,

August 10, 2017 SSM Health Care St. Louis DBA SSM St. Clare Health Center N/A units

CPSC Ongoing

Kawasaki Recalls All-Terrain Vehicles Due to Fire Hazard

August 10, 2017 About 15,000 units

FDA Food Class II Terminated

IQF Green Beans, Keep Frozen. 11 varieties, packaged under the following brands and sizes: 1) Bountiful Harvest French Style Green Beans, 1 - 10lb carton/case; 2) GFS French Style Green Beans, 12  3

August 10, 2017 Lakeside Foods, Inc 1,856 cases (total) units

FDA Drug Class II Terminated

Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Faci

August 10, 2017 SSM Health Care St. Louis DBA SSM St. Clare Health Center N/A units

FDA Drug Class II Terminated

Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facil

August 10, 2017 SSM Health Care St. Louis DBA SSM St. Clare Health Center N/A units

FDA Drug Class II Terminated

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd., Kund

August 10, 2017 Morton Grove Pharmaceuticals, Inc. 7332 bottles units

FDA Drug Class II Terminated

Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- N

August 10, 2017 SSM Health Care St. Louis DBA SSM St. Clare Health Center N/A units

NHTSA Ongoing

Oil leak Due to Engine Oil Cooler Hose Separation

August 10, 2017 Chrysler (FCA US LLC) 1,207 units

NHTSA Ongoing

Seat Belt Mounting Studs have Inadequate Padding

August 10, 2017 HICKORY SPRINGS MANUFACTURING COMPANY 6,052 units

FDA Drug Class II Terminated

Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO.

August 10, 2017 SSM Health Care St. Louis DBA SSM St. Clare Health Center N/A units