Product Recalls in 2018

4,897 recalls issued this year

258

CPSC

1,977

FDA Food

1,681

FDA Drug

981

NHTSA

FDA Drug Class I Terminated

Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01

December 11, 2018 Asclemed USA Inc. dba Enovachem
FDA Drug Class I Terminated

Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0755-01

December 11, 2018 Asclemed USA Inc. dba Enovachem
FDA Drug Class II Terminated

Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50

December 11, 2018 KVK-Tech, Inc. 156 bottles units
NHTSA Ongoing

Incorrect Brake Hose/Sensor Wire Routing

December 11, 2018 KAWASAKI MOTORS CORP., U.S.A. 1,173 units
NHTSA Ongoing

T-Fitting Failure Causing Air Leak/FMVSS 121, 106

December 11, 2018 Elgin Sweeper Company Inc. 1,230 units
NHTSA Ongoing

Passenger Air Bag Module Damaged During Assembly

December 11, 2018 GENERAL MOTORS LLC 154 units
NHTSA Ongoing

Improperly Secured Fuel Line may cause Fuel Leak

December 11, 2018 Volkswagen Group of America, Inc. 516 units
FDA Food Class II Terminated

DrNatura Flora Protect¿ Probiotics

December 10, 2018 Mylan Pharmaceuticals Inc. 2378 Bottles units
FDA Food Class II Terminated

DrNatura Toxinout Kit Broad Spectrum Detoxification Program

December 10, 2018 Mylan Pharmaceuticals Inc. 800 Kits units
FDA Drug Class III Terminated

Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.

December 10, 2018 CBI Laboratories, Inc. 5363 tubes units
FDA Drug Class II Terminated

Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31

December 10, 2018 Dr. Reddy's Laboratories, Inc. 4,404 (30 count blister packs) units
FDA Drug Class III Terminated

Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 oz./128 g tube, Mfg. For Credentials Skincare Fort Worth, TX 76155

December 10, 2018 CBI Laboratories, Inc. 2055 tubes units
FDA Drug Class II Terminated

Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.

December 10, 2018 Gordon Laboratories 1,155 boxes units
NHTSA Ongoing

Auxiliary Heater Connector may Overheat

December 10, 2018 Volkswagen Group of America, Inc. 845 units
NHTSA Ongoing

Air Compressor Belt Slippage Reducing Output

December 10, 2018 CUMMINS, INC. 381 units
NHTSA Ongoing

Insufficiently Tightened Brake Caliper Bolts

December 10, 2018 NEWMAR CORPORATION 308 units
NHTSA Ongoing

Improperly Secured Fuel Line may cause Fuel Leak

December 10, 2018 Volkswagen Group of America, Inc. 1,104 units
NHTSA Ongoing

Shifter Return Spring may Break

December 10, 2018 YAMAHA MOTOR CORPORATION, USA 11,240 units
NHTSA Ongoing

Radiator Hose may Crack and Leak Coolant

December 10, 2018 YAMAHA MOTOR CORPORATION, USA 16,760 units
FDA Food Class II Terminated

The Salty Nutty Toffee Bar, brand ALMA, net weight 1.85 oz. UPC on individual bar: 8 58533 00602 8 UPC on master case 0 108585 330060 2 The label is read in parts: "***INGREDIENTS: Salty Nutty

December 7, 2018 Moonstruck Chocolate Company 323 bars units
FDA Food Class I Terminated

Tamy Pop 18 pieces Net Wt. 1 lb. 15.7 oz. packaged in a clear plastic jar, 6 jars per case

December 7, 2018 Procesadora de Dulces Tipicos, S.A. de C.V. 417 cases units
FDA Food Class II Terminated

Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count, item number PF0003; 90 count - Item number PF0002; 180 count, Item number PF0106 and 90 + 90 count, PF 7013 white plastic bottles. Propri

December 7, 2018 Threshold Enterprises Ltd 16, 542 units units
FDA Food Class I Terminated

FLECHAZO 36 pieces Net Wt. 1 lb. 12.5 oz. packaged in a clear plastic jar, 6 jars per case

December 7, 2018 Procesadora de Dulces Tipicos, S.A. de C.V. 87 cases units
FDA Food Class I Terminated

El Super Leon Jabalina Xtreme 50 pieces Net Wt. 2 lb. (3.2 oz.) Cont. Net. 1 kg packaged in a clear plastic jar, 6 jars per case

December 7, 2018 Procesadora de Dulces Tipicos, S.A. de C.V. 690 cases units
FDA Food Class I Terminated

1) PICA-BOLA 50 pieces Cont. Net 1 kg Net Wet. 2 lb 3.2 oz., packaged in a clear plastic ja, 6 jars per case and 2) PICA-BOLA 40 pieces Net Wet. 1 lb. 12.2 oz. packaged in a plastic bag, 11 bags per

December 7, 2018 Procesadora de Dulces Tipicos, S.A. de C.V. 686 cases units
FDA Drug Class III Terminated

Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutica

December 7, 2018 Sun Pharmaceutical Industries Inc. 47,520 prescription packs units
FDA Drug Class II Terminated

Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22

December 7, 2018 US Pharmaceuticals Inc. 19752 units units
FDA Drug Class II Terminated

Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for

December 7, 2018 US Pharmaceuticals Inc. 7020 units units
FDA Drug Class II Terminated

Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes, Distributed by: Walgreen Co. 200 Wilmot Rd. Deerfield, IL 60015, NDC 0363-0237-03

December 7, 2018 US Pharmaceuticals Inc. 67848 units units
NHTSA Ongoing

Insufficient Grease on Bearings may cause Failure

December 7, 2018 GULF STREAM COACH INC. 16 units
NHTSA Ongoing

CNG Tank Valve Stem may Eject from Valve Body

December 7, 2018 Luxfer Canada Ltd. 1,607 units
NHTSA Ongoing

CNG Tank Valve Stem may Eject from Valve Body

December 7, 2018 McNeilus Truck & Manufacturing, Inc. 199 units
NHTSA Ongoing

Clearance Lights may be Inoperative/FMVSS 108

December 7, 2018 FOREST RIVER, INC. 5 units
CPSC Ongoing

Kawasaki USA Recalls Off-Highway Utility Vehicles Due to Injury Hazard (Recall Alert)

December 6, 2018 About 1,000 units
CPSC Ongoing

Meijer Recalls Children's Hooded Jackets Due to Choking Hazard

December 6, 2018 About 25,000 units
CPSC Ongoing

Skip Hop Recalls Convertible High Chairs Due to Injury and Fall Hazards

December 6, 2018 About 32,300 (In addition, about 8,600 were sold in Canada) units
FDA Food Class II Terminated

Salmon packaged in a plastic container; HELLO QUALITY PACIFIC SILVERSIDE SALMON Hello FRESH NET WT. 10oz (283g) with Case Label: keep Frozen (0F or below) FARMED COHO SALMON 10 oz (283g) 2 X 5 oz por

December 6, 2018 Mariner Seafood, LLC 1636 cases / 32720 trays units
FDA Drug Class II Terminated

Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, NDC 60793-855-01

December 6, 2018 Pfizer Inc. 1996 bottles units
NHTSA Ongoing

Timing Chain Tensioner may Loosen and Leak Oil

December 6, 2018 DUCATI NORTH AMERICA 1,502 units
NHTSA Ongoing

Spindle Weld Failure may cause Wheel Separation

December 6, 2018 KEYSTONE RV COMPANY 169 units
NHTSA Ongoing

Reflectors may not be Installed/FMVSS 108

December 6, 2018 HEARTLAND RECREATIONAL VEHICLES, LLC 847 units
NHTSA Ongoing

Missing Edge Protection on Liquid Propane Lines

December 6, 2018 WINNEBAGO INDUSTRIES, INC. 152 units
FDA Food Class I Terminated

LIGHT & FIT¿ GREEK CRUNCH NONFAT YOGURT & TOPPINGS S MORES FLAVOR, 5 oz Preformed cups with a topper, Refrigeration required between 36F and 45F, UPC 36632 03825

December 5, 2018 Danone Waters of America, Inc 3,521 cases units
FDA Food Class II Terminated

DR. JACKSON'S RELAX TEA (ANTI-ANXIETY) 500mL Net Wt 49g; UPC Code: 5 060309 140239. Tea bags are packaged in a glass jar.

December 5, 2018 Dr Jackson 320 jars units
FDA Drug Class II Terminated

Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL total volume in a 150 mL Intravia Bag, Rx Only,PharMEDium Services, LLC. 913 N. D

December 5, 2018 Pharmedium Services, LLC 295 100 mL in 150 mL Intravia bags units
FDA Drug Class II Terminated

Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis

December 5, 2018 Pharmedium Services, LLC 295 50 ml in 60 ml syringes units
FDA Food Class II Terminated

1 lb salted combo modjeskas

December 4, 2018 Bauer's Candies, Inc. 4 lbs units
FDA Food Class II Terminated

QVC 3/8 oz bags for Christmas

December 4, 2018 Bauer's Candies, Inc. 5 lbs units
FDA Food Class II Terminated

ROOT 23 CUCUMBER HABANERO SIMPLE SYRUP 375 ml

December 4, 2018 Root 23 LLC 390 Units units
CPSC Ongoing

Foremost Recalls Shower Doors and Panels Due to Injury and Impact Hazards (Recall Alert)

December 4, 2018 Foca Sanitaryware Co. LTD., of China About 700 units