Product Recalls in 2020

December 10, 2020 About 7,805 in the U.S. (6,940 Luminary Jack and 865 Bless This Home Warmers) (In addition, about 200 Luminary Jack and about 60 Bless This Home Warmers in Canada) units

FDA Drug Class II Terminated

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-

December 10, 2020 Fresenius Kabi USA, LLC 4411 trays units

NHTSA Ongoing

Lighting and HVAC Display May Lock Up

December 10, 2020 Spartan Fire, LLC 193 units

NHTSA Ongoing

Rear Toe Links May Fracture

December 10, 2020 GENERAL MOTORS LLC 220,006 units

NHTSA Ongoing

Steering May Lock Up

December 10, 2020 Icon Vehicle Dynamics, LLC 102 units

NHTSA Ongoing

48V Battery Connection Misassembled

December 10, 2020 BMW OF NORTH AMERICA, LLC 812 units

NHTSA Ongoing

Sewer Termination Bracket May Fail

December 10, 2020 FOREST RIVER, INC. 2,828 units

NHTSA Ongoing

Terminal Cover Can Compromise 12-Volt Power Supply

December 10, 2020 Volkswagen Group of America, Inc. 2,355 units

CPSC Ongoing

Goal Zero Recalls Power Supplies Due to Fire Hazard

December 9, 2020 About 4,500 units

CPSC Ongoing

Black & Decker Recalls CRAFTSMAN 10-Inch Corded Chain Saws Due to Laceration Hazard

December 9, 2020 About 82,000 units

CPSC Ongoing

Burley Recalls Child Bicycle Seats Due to Crash Hazard

December 9, 2020 About 780 units

CPSC Ongoing

Fiskars Brands Recalls 16 Foot Pole Saw/Pruners Due to Laceration Hazard

December 9, 2020 About 467,680 (In addition, about 95,000 were sold in Canada) units

CPSC Ongoing

GrillBlazer Recalls Propane Torch Guns Due to Fire Hazard

December 9, 2020 About 10,000 units

CPSC Ongoing

L G Sourcing Recalls to Repair Electric Fireplaces Due to Fire Hazard; Sold Exclusively at Lowe's Stores

December 9, 2020 Easy Top Enterprises LTD, of China About 48,000 units

CPSC Ongoing

Neptune Benson Recalls Delta Ultra-Violet Generators For Pools and Spas Due to Fire Hazard

December 9, 2020 Neptune Benson, of Warwick, Rhode Island (after August 2016) About 4,560 units

CPSC Ongoing

Spirit Halloween Recalls Children's Flashlights Due to Fire and Burn Hazards

December 9, 2020 About 6,100 (In addition, about 380 units were sold in Canada) units

CPSC Ongoing

Washington Shoe Company Recalls Western Chief Toddler Boots Due to Choking Hazard; Sold Exclusively at Target

December 9, 2020 Washington Shoe Company, of Kent, Wash. About 77,400 units

FDA Drug Class II Terminated

Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured for: Biogen Inc., Cambridge, MA 02142, NDC 64406-020-01

December 9, 2020 Biogen MA Inc. 5,307 bottles units

FDA Drug Class II Terminated

Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 599

December 9, 2020 Akebia Therapeutics dba Keryx Biopharmaceutials, Inc 2,170 bottles units

FDA Drug Class II Terminated

Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove

December 9, 2020 Morton Grove Pharmaceuticals, Inc. 127,392 bottles units

NHTSA Ongoing

Exposed Wire in Engine Harness Can Cause Stall

December 9, 2020 NISSAN NORTH AMERICA, INC. 7,583 units

NHTSA Ongoing

Pusher Axles Operation Position Not Listed

December 9, 2020 McNeilus Truck & Manufacturing, Inc. 7 units

NHTSA Ongoing

Stove Saddle Valves may Leak Gas

December 9, 2020 Grand Design RV, LLC 352 units

FDA Drug Class II Terminated

Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.

December 8, 2020 Shilpa Medicare Limited 2611 bottles units

FDA Drug Class II Terminated

Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare L

December 8, 2020 Shilpa Medicare Limited 2,064 vials units

FDA Drug Class II Terminated

Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Di

December 8, 2020 Shilpa Medicare Limited 35,931 vials units

FDA Drug Class II Terminated

Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.

December 8, 2020 Shilpa Medicare Limited 4166 bottles units

FDA Drug Class II Terminated

Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas

December 8, 2020 Shilpa Medicare Limited 6,560 vials units

NHTSA Ongoing

Operator's Manual Inaccurate and/or Incomplete

December 8, 2020 Daimler Vans USA, LLC 9 units

NHTSA Ongoing

Potential Fracture of 2" Shank

December 8, 2020 Curt Manufacturing LLC 761 units

NHTSA Ongoing

Driveshaft Can Break

December 8, 2020 NISSAN NORTH AMERICA, INC. 2,708 units

FDA Drug Class II Terminated

Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pha

December 8, 2020 Shilpa Medicare Limited 2008 vials units

FDA Drug Class I Terminated

TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10

December 7, 2020 AVKARE Inc. 14368 bottles units

FDA Drug Class II Terminated

Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.

December 7, 2020 AVKARE Inc. 38715 bottles units

NHTSA Ongoing

Tire Information Missing/FMVSS 110

December 7, 2020 MERCEDES-BENZ USA, LLC. 26 units

NHTSA Ongoing

Outdoor Grill Can be Stowed While Lit

December 7, 2020 FOREST RIVER, INC. 115 units

FDA Drug Class II Terminated

Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17

December 7, 2020 Hikma Pharmaceuticals USA Inc. 1,324,072 vials units

FDA Food Class I Terminated

Holiday Cookie Platter packaged in plastic container 20 OZ (1.25 LB) 567g. UPC 41415 88690

December 5, 2020 George DeLallo Co. Inc. New Stanton Warehouse and Production 2000 units units

FDA Food Class I Terminated

Market of Choice brand Sour Cherry Baked Brie is wrapped in a plastic shrink wrap and has a white adhesive store label. UPC 0 217241 414996. The label is read in parts: "*SOUR CHERRY BAKED BRIE

December 4, 2020 Market of Choice Inc 444 units units

FDA Food Class III Terminated

Darlington's Soft Baked Cookies, Sugar Free Net Wt. 0.75 oz (21 g), Darlington, Noblesville, IN

December 4, 2020 HS Baking Enterprises LLC DBA Darlington Manufacturing 503 cases (106 cookies per case) units

NHTSA Ongoing

LCD Display Unit May Malfunction

December 4, 2020 E-One Incorporated 195 units

CPSC Ongoing

Recreational Off-Highway Vehicles Recalled by American Honda Due to Crash and Injury Hazards (Recall Alert)

December 3, 2020 American Honda Motor Co., Inc., of Torrance, Calif. About 118,600 units

Driver Side Power Window Switch May Fail

Drive Shaft May Corrode and Fail

BCM Software Malfunction/FMVSS 103/111

Incorrect Federal Placard/FMVSS 120

Rearview Camera may Shut Down/FMVSS 111

Engine Hood Improperly Installed

Homfa Cabinets Recalled Due to Tip-Over and Entrapment Hazards; Made by Shenzhen Luosi Ge Trading Co. (Recall Alert)

Thermo Tents Recalls Mór Series Tents Due to Fire Hazard; Tents are Mislabeled as Fire Retardant (Recall Alert)

Scentsy Recalls Electrical Oil Warmers Due to Fire Hazard (Recall Alert)

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-

Lighting and HVAC Display May Lock Up

Rear Toe Links May Fracture

Steering May Lock Up

48V Battery Connection Misassembled

Sewer Termination Bracket May Fail

Terminal Cover Can Compromise 12-Volt Power Supply

Goal Zero Recalls Power Supplies Due to Fire Hazard

Black & Decker Recalls CRAFTSMAN 10-Inch Corded Chain Saws Due to Laceration Hazard

Burley Recalls Child Bicycle Seats Due to Crash Hazard

Fiskars Brands Recalls 16 Foot Pole Saw/Pruners Due to Laceration Hazard

GrillBlazer Recalls Propane Torch Guns Due to Fire Hazard

L G Sourcing Recalls to Repair Electric Fireplaces Due to Fire Hazard; Sold Exclusively at Lowe's Stores

Neptune Benson Recalls Delta Ultra-Violet Generators For Pools and Spas Due to Fire Hazard

Spirit Halloween Recalls Children's Flashlights Due to Fire and Burn Hazards

Washington Shoe Company Recalls Western Chief Toddler Boots Due to Choking Hazard; Sold Exclusively at Target

Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured for: Biogen Inc., Cambridge, MA 02142, NDC 64406-020-01

Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 599

Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove

Exposed Wire in Engine Harness Can Cause Stall

Pusher Axles Operation Position Not Listed

Stove Saddle Valves may Leak Gas

Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.

Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare L

Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, Jadcherla, 509301, India, Di

Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.

Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas

Operator's Manual Inaccurate and/or Incomplete

Potential Fracture of 2" Shank

Driveshaft Can Break

Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pha

TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10

Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.

Tire Information Missing/FMVSS 110

Outdoor Grill Can be Stowed While Lit

Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17

Holiday Cookie Platter packaged in plastic container 20 OZ (1.25 LB) 567g. UPC 41415 88690

Market of Choice brand Sour Cherry Baked Brie is wrapped in a plastic shrink wrap and has a white adhesive store label. UPC 0 217241 414996. The label is read in parts: "***SOUR CHERRY BAKED BRIE**

Darlington's Soft Baked Cookies, Sugar Free Net Wt. 0.75 oz (21 g), Darlington, Noblesville, IN

LCD Display Unit May Malfunction

Recreational Off-Highway Vehicles Recalled by American Honda Due to Crash and Injury Hazards (Recall Alert)

Market of Choice brand Sour Cherry Baked Brie is wrapped in a plastic shrink wrap and has a white adhesive store label. UPC 0 217241 414996. The label is read in parts: "*SOUR CHERRY BAKED BRIE