Product Recalls in 2018

4,897 recalls issued this year

258

CPSC

1,977

FDA Food

1,681

FDA Drug

981

NHTSA

FDA Food Class I Terminated

Baked Macaroni and Cheese, NET WT 12 OZ (340g), CONTAINS: WHEAT, MILK, EGG, Produced By BAKKAVOR USA, 2700 Westinghouse Blvd. Charlotte, NC 28273, Phone: 704-522-1977, UPC 7 61088 80502 3

November 5, 2018 Bakkavor Foods USA Inc. 92/12-oz. trays units
FDA Food Class II Terminated

Duncan Hines Classic Classic Yellow cake mix 15.25oz. 12 retail units per case 644209307494

November 5, 2018 ConAgra Foods Inc 56,645 cases units
FDA Food Class II Terminated

Apricot Chai Tea, 8 oz. Loose. UPC 41427-96317

November 5, 2018 Cedar Lake Tea 34.4 lbs. units
NHTSA Ongoing

Incorrect Low Beam Aiming/FMVSS 108

November 5, 2018 Kia Motors America 1,754 units
NHTSA Ongoing

Insufficiently Tightened Brake Caliper Bolts

November 5, 2018 FOREST RIVER, INC. 182 units
NHTSA Ongoing

Fuel Tank may Crack due to Vent Line Restriction

November 5, 2018 Suzuki Motor of America, Inc. 21,063 units
FDA Drug Class II Terminated

IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by

November 2, 2018 Golden State Medical Supply Inc. 12,502 bottles units
FDA Drug Class II Terminated

Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00

November 2, 2018 Sandoz, Inc 7817 bottles units
FDA Drug Class II Terminated

Curaplex Epi Kit NOT FOR IV USE, #8600-01120, Epi-Safe Kit 8600-01 120 contains:2 Safety-LOK Syringe, TB, 1cc w/ needle, 25 ga x5/8 , 2 Vials of epinephrine, 1mg/1mL, 4 Alcohol prep pads, 2 Adhesive b

November 2, 2018 Bound Tree Medical, LLC 339 kits (1 standard syringe / 1 IFU per kit) units
FDA Drug Class II Terminated

curaplex Epi Safe Kit, 8600-01101, contains:" 1ml Vial of Epinephrine " 1 Epi-Safe Syringe " 1 Safety Needle " 2 Alcohol Prep Pads " 1 Adhesive Dressing " 1 Insert, Rx Only. Distributed by Sarnova HC

November 2, 2018 Bound Tree Medical, LLC 7,063 kits (1 syringe per kit / 1 IFU per kit) units
FDA Drug Class II Terminated

Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00

November 2, 2018 Sandoz, Inc 1550 bottles units
FDA Drug Class II Terminated

Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01

November 2, 2018 Sandoz, Inc 18,832 bottles units
FDA Food Class III Terminated

Red Bull Energy Drink, 8.4 Fl. oz. (250 mL) Ingredient: Carbonated water, Sucrose, Glucose, Citric Acid, Taurine, Sodium Bicarbonate, Magnesium, Carbonate Caffeine, Nicainamide, Calcium Pantothena

November 2, 2018 Red Bull North America Inc BATCH # 1639377  48,456 CANS, BATCH # 1639378  146,160 CANS units
FDA Drug Class III Terminated

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz

November 2, 2018 Sandoz, Inc 14366 bottles units
FDA Food Class II Terminated

DIDGFPGB, Food Grade Pre-Gel Corn Flour. Bulk

November 2, 2018 Fairview Mills Inc 94,640 lbs units
FDA Drug Class II Terminated

IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by

November 2, 2018 Golden State Medical Supply Inc. 15,917 bottles units
FDA Drug Class II Terminated

IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-

November 2, 2018 Golden State Medical Supply Inc. 2,439 bottles units
NHTSA Ongoing

Floor Pedestal may Detach/FMVSS 210

November 2, 2018 HICKORY SPRINGS MANUFACTURING COMPANY 100 units
FDA Drug Class II Terminated

curaplex Epi Safe Administration and Training Kits, #8600-01100, Contains: 2 Epi Safe Administration Kit (8600-01101), 1 Epi Safe Training Kit (8600-01102), Rx Only, Distributed by Sarnova HC, LLC s f

November 2, 2018 Bound Tree Medical, LLC 1,283 kits (8 syringes per kit / 3 IFU's per kit) units
FDA Food Class I Terminated

16 count Smartfood Delight Variety Pack Sack

November 2, 2018 Frito-Lay, Inc 19,565 sacks (total) units
NHTSA Ongoing

Incorrect Plow Light Software//FMVSS 108

November 2, 2018 VOLVO TRUCKS NORTH AMERICA 4,625 units
NHTSA Ongoing

Incorrect Location of Water Heater Exhaust

November 2, 2018 KEYSTONE RV COMPANY 7 units
FDA Food Class I Terminated

16 count Crunch & Pop Mix Variety Pack Sack

November 2, 2018 Frito-Lay, Inc 19,565 sacks (total) units
FDA Drug Class II Terminated

Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00

November 2, 2018 Sandoz, Inc 5100 bottles units
NHTSA Ongoing

Incorrect Plow Light Software/FMVSS 108

November 2, 2018 MACK TRUCKS, INC 755 units
FDA Drug Class III Terminated

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC

November 2, 2018 Sandoz, Inc 23053 bottles units
NHTSA Ongoing

Driver Side Window Shade may Lower Without Warning

November 2, 2018 FOREST RIVER, INC. 4,790 units
FDA Drug Class II Terminated

Curaplex Epi Safe Kit, 8600-01102 TRAINING ONLY, Rx Only, Distributed by Sarnova HC, LLC s family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-a

November 2, 2018 Bound Tree Medical, LLC 2,654 kits (6 syringes per kit / 1 IFU per kit) units
FDA Food Class II Completed

Roth Kase CHEESE BLND FIREHOUSE ULTMTE 2/5lb CASE

November 1, 2018 Sysco Charlotte 56 units
FDA Food Class II Completed

WIEBE CHEESE CHEDDAR CTTNWOOD RIVER¿1/5 LBS

November 1, 2018 Sysco Charlotte 3 units
FDA Food Class II Completed

Great Lakes CHEESE SWISS A CUT

November 1, 2018 Sysco Charlotte 20 units
FDA Food Class II Completed

Sea Wings CRAB MEAT SPECIAL PAST ASIA

November 1, 2018 Sysco Charlotte 143 units
FDA Food Class II Completed

Simply Lemonade LEMONADE FRESH PLS BTL

November 1, 2018 Sysco Charlotte 36 units
FDA Food Class II Completed

Packer KUMQUAT FRESH¿

November 1, 2018 Sysco Charlotte 1 units
NHTSA Ongoing

Incorrectly Installed Mini Breaker May Cause Fire

November 1, 2018 Grand Design RV, LLC 1,765 units
FDA Food Class II Completed

ONEKOMB DRINK KOMBUCHA TRIPLE BERRY¿

November 1, 2018 Sysco Charlotte 1 units
FDA Food Class II Completed

Sea Wings CRAB MEAT PAST JMBO LUMP ASIA

November 1, 2018 Sysco Charlotte 12 units
FDA Food Class II Completed

Yoplait YOGURT VANILLA PARFAIT POUCH

November 1, 2018 Sysco Charlotte 309 units
FDA Food Class II Completed

PACKER LEMON GRASS FRESH¿

November 1, 2018 Sysco Charlotte 2 units
FDA Food Class II Completed

Wholesome Farms Classic CREAMER COFFEE WHITENR CUP ESL

November 1, 2018 Sysco Charlotte 50 units
FDA Food Class II Completed

BELGIO CHEESE MASCARPONE BELIOIOSO¿¿

November 1, 2018 Sysco Charlotte 1cs/12/8 oz pkgs units
FDA Food Class II Completed

TRADCHS CHEESE CHEDDAR SMOKEY PRCT¿ 1/9 LBS

November 1, 2018 Sysco Charlotte 3 units
FDA Food Class II Completed

Dannon YOGURT STRAWBERRY LIGHT & FIT

November 1, 2018 Sysco Charlotte 63 units
CPSC Ongoing

Pain Relief Naturally Recalls Pain and Itch Relief Creams, Sprays and Gels Due to Failure to Meet Child Resistant Closure Requirement; Risk of Poisoning (Recall Alert)

November 1, 2018 Ridge Properties, DBA Pain Relief Naturally, of Salem, Ore. About 7,000 units
FDA Drug Class II Ongoing

Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia fo

November 1, 2018 Sandoz, Inc 170 HDPE bottles units
FDA Food Class II Completed

Pacific Cove CRAB MEAT SPECIAL PAST IND

November 1, 2018 Sysco Charlotte 30 units
FDA Food Class II Completed

Rivoire CHEESE GRUYERE COMTE BLOCKS 3.5#

November 1, 2018 Sysco Charlotte 7 cs/2/3.5 lb blocks units
FDA Food Class II Completed

Great Lakes CHEESE CHDR MILD SLI .75 OZ

November 1, 2018 Sysco Charlotte 83 units
FDA Food Class II Completed

Yoplait YOGURT RASPBERRY RNBOW TRIX

November 1, 2018 Sysco Charlotte 30 units
FDA Food Class II Completed

YOGURT VAN W/M&M¿

November 1, 2018 Sysco Charlotte 4 units