Product Recalls in 2017

FDA Drug Class II Terminated

PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 86 vials total (78/5mL vials and 8/50mL vials) units

FDA Drug Class I Terminated

UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, supplied in 2, 4 and 10 count packages, Distributed by AH Distribution, DelRay, Beach, FL ---- UPC Code 680474229260

April 18, 2017 Organic Herbal Supply

FDA Drug Class II Terminated

5-MTHF 10ML SDV (CALIF) 5MG/ML INJ, Injection 5mg/mL, Rx only, 10mL Glass /Single Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 3 vials units

FDA Drug Class II Terminated

TRI MIX 10/30/0.5 *5ML* MDV MCG/MG/MG/ML INJ, Injection,10mcg/30mg/0.5mg/mL, Rx only, 5 mL Glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 200 vials units

FDA Drug Class II Terminated

QUAD MIX 50/30/1/0.2 5ML MDV (CALIF) MCG/MG/MG/MG/ML INJ, Injection, 50mcg/30mg/1mg/0.2mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 1 vial units

FDA Drug Class II Terminated

VITAMIN B COMPLEX 1ML SDV NA INJ, Injection, 100mg/2mg/2mg/2mg/100mg/mL, Rx only, 1mL Glass; Single Dose, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 3 vials units

FDA Drug Class II Terminated

FOLINIC ACID MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 5 mL and10 mL glass/ Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 3 vials total units

FDA Drug Class II Terminated

HYDROXO-B12 INH PF GV 5MG/ML SOLN, Inhalation Solution, 5mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 240 mL units

FDA Drug Class II Terminated

GSH/NAC INH PV 150/50MG/ML SOLN, Inhalation Solution, 150mg/50mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 180mL units

FDA Drug Class II Terminated

5-MTHF 10ML MDV (CALIF) 5MG/ML INJ, Injection, 5mg/mL, Rx only, 10mLGlass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 6 vials units

FDA Drug Class II Terminated

TRI MIX 20/30/1 5ML MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/1mg/mL, Rx only, 5 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 3 vials units

FDA Drug Class II Terminated

PROCAINE HCL 50ML MDV (CALIF) 1% INJ, Injection, 1%, Rx only, 50mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

April 18, 2017 Key Pharmacy and Compounding Center 2 vials units

NHTSA Ongoing

Front Passenger Air Bag may Deploy Improperly

April 17, 2017 NISSAN NORTH AMERICA, INC. 30,038 units

FDA Drug Class III Terminated

Allergy Relief Diphenhydramine HCl 25 mg, Antihistamine, Dye-Free, 24 Softgels, distributed under the following labels: (a) TopCare Allergy Relief, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLA

April 17, 2017 P & L Development, LLC 369,012 cartons units

FDA Drug Class II Terminated

EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwo

April 17, 2017 Syntho Pharmaceuticals, Inc. 5,000 bottles units

FDA Food Class III Terminated

Moondance desserts gluten free Mexican Wedding Cookie 8 oz (227g) UPC 7 36211 68076 1

April 17, 2017 Moondance Heavenly Desserts, LLC 108 cases units

FDA Drug Class II Terminated

EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Ph

April 17, 2017 Syntho Pharmaceuticals, Inc. 5,000 bottles units

FDA Drug Class III Terminated

Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.

April 17, 2017 Fagron, Inc

FDA Drug Class II Terminated

ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC: 58597-8049-3), d) 25g bottle (NDC: 58597-8049-4), For Prescription Compounding, RX Only, Packed under cGMP conditions by A

April 17, 2017 American Pharmaceutical Ingredients LLC 1g=1 bottle; 5g=4 bottle; 25g=3 bottles units

NHTSA Ongoing

TREQ-VMx Mobile Tablet may Overheat

April 17, 2017 FiveCubits, Inc. 13,240 units

FDA Food Class II Terminated

Moondance desserts gluten free Chocolate Chip Cookie Bar 12 oz (340g) UPC 36211 68096 9

April 17, 2017 Moondance Heavenly Desserts, LLC 188 cases units

FDA Food Class II Terminated

Lemongrass Satay, Net: 9oz (265gr), 12units/case and 1/2 gallon, 6 units/case

April 15, 2017 TP Food Processing Inc. 4,140 units units

FDA Food Class II Terminated

Shrimp Satay Hot Dry Shrimp-Chili Sauce, Net: 6 and 9oz , 12 units/case

April 15, 2017 TP Food Processing Inc. 6,612 units units

FDA Food Class I Terminated

Decorated (sugared) holiday cookies sold in the shape of purple eggs, pink bunnies or yellow chicks. These cookies were sold in the self service cookie display.

April 15, 2017 Whole Foods Market 9936 cookies units

FDA Food Class II Terminated

Decorated (iced) holiday cookies sold in the shape of eggs. These cookies were sold in the self service cookie displays. Individual cookies are 1.3 oz.. each. Cookie labels identify the cookies as

April 15, 2017 Whole Foods Market 216 cookies units

FDA Food Class II Terminated

Kemps Sweet Me Creamery Vanilla Bean, One Pint, UPC 41483-04142

April 14, 2017 Kemps, LLC 91,672 units Ice Cream units

FDA Food Class II Terminated

Kemps YO2 Frozen Yogurt Very Vanilla, One Pint, UPC 41483-04124

April 14, 2017 Kemps, LLC 469,568 units Frozen Yogurt units

FDA Food Class II Terminated

Kemps Sweet Me Creamery Chocolate Peanut Butter Pretzel, One Pint, UPC 41483-04144

April 14, 2017 Kemps, LLC 91,672 units Ice Cream units

FDA Food Class II Terminated

Kemps YO2 Frozen Yogurt Chocolate Peanut Butter Fudge, One Pint, UPC 41483-04126

April 14, 2017 Kemps, LLC 469,568 units Frozen Yogurt units

FDA Food Class II Terminated

Kemps YO2 Frozen Yogurt Raspberry Cheesecake, One Pint, UPC 41483-04127

April 14, 2017 Kemps, LLC 469,568 units Frozen Yogurt units

FDA Food Class II Terminated

Kemps YO2 Frozen Yogurt Salty Caramel Cookie Crunch, One Pint, UPC 41483-04123

April 14, 2017 Kemps, LLC 469,568 units Frozen Yogurt units

FDA Food Class II Terminated

Kemps YO2 Frozen Yogurt Mudslide, One Pint, UPC 41483-04121

April 14, 2017 Kemps, LLC 469,568 units Frozen Yogurt units

NHTSA Ongoing

Seat Belt Pretensioners may not Function Properly

April 14, 2017 MERCEDES-BENZ USA, LLC. 12,743 units

NHTSA Ongoing

Incorrect Torque on Steering Coupling

April 14, 2017 MERCEDES-BENZ USA, LLC. 10,832 units

FDA Food Class II Terminated

Kemps Sweet Me Creamery Salted Caramel Brownie, One Pint, UPC 41483-04141

April 14, 2017 Kemps, LLC 91,672 units Ice Cream units

FDA Food Class II Terminated

Kemps Sweet Me Creamery Strawberry Rhubarb Cobbler, One Pint, UPC 41483-04145

April 14, 2017 Kemps, LLC 91,672 units Ice Cream units

FDA Food Class II Terminated

Kemps YO2 Frozen Yogurt Cold Brewed Coffee, One Pint, UPC 41483-04122

April 14, 2017 Kemps, LLC 469,568 units Frozen Yogurt units

NHTSA Ongoing

Steering Coupling Bolt may be Loose

April 14, 2017 MERCEDES-BENZ USA, LLC. 168 units

FDA Food Class II Terminated

Kemps Sweet Me Creamery Creamy Dark Chocolate Mint, One Pint, UPC 41483-04143

April 14, 2017 Kemps, LLC 91,672 units Ice Cream units

FDA Food Class II Terminated

Kemps Sweet Me Creamery Maple Toffee Blondie, One Pint, UPC 41483-04146

April 14, 2017 Kemps, LLC 91,672 units Ice Cream units

FDA Food Class II Terminated

Kemps Sweet Me Creamery Expresso Mocha, One Pint, UPC 41483-04140

April 14, 2017 Kemps, LLC 91,672 units Ice Cream units

FDA Food Class I Terminated

7-ELEVEN CAESAR SIDE SALAD 3 oz. packaged in clear plastic container

April 13, 2017 Del Monte Fresh Produce N.A., Inc. HQ 740 units units

CPSC Ongoing

Bosch Solar Services Recalls Solar Panels Due To Fire Hazard

April 13, 2017 About 28,000 units

FDA Food Class I Terminated

Beyond Beef Feisty Crumble Vegan Gluten-free Non-GMO Weight: 10 lbs. (2) 5 lb. bags UPC: 10852629004412 KEEP FROZEN 111 Main Street El Segundo, CA 90245 866-756-4112 [email protected] www.beyond

April 13, 2017 BEYOND MEAT 4665 cases (3856 retail packages/8366 food service packages) units

CPSC Ongoing

Polaris Recalls Ranger 900 Recreational Off-Highway Vehicles Due to Fire and Burn Hazards

April 13, 2017 Polaris Industries Inc., of Medina, Minn. About 51,000 units

NHTSA Ongoing

Short Wheel Nuts may cause Wheel Separation

April 13, 2017 PROLine Products LLC 54 units

FDA Drug Class I Terminated

Hyland's Baby Teething Tablets [Calcarea Phosporica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated)] Quick-Dissolving Tablets, packaged

April 13, 2017 Standard Homeopathic Company 10,263,585 bottles units

CPSC Ongoing

Target Recalls Water Absorbing Toys Due to Serious Ingestion Hazard

April 13, 2017 About 560,000 units

FDA Drug Class I Terminated

Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X

April 13, 2017 Standard Homeopathic Company 692,115 bottles units

NHTSA Ongoing

Loose Ball Joints may cause Loss of Steering

April 13, 2017 FORETRAVEL, INC. 81 units