Product Recalls in 2020

FDA Drug Class II Terminated

ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) 10 fL oz / 295 ml bottle, UPC 6 39277 49070 4, Distributed by G

July 11, 2020 4e Brands North America, Llc 17,359,247 total bottles and pumps units

FDA Drug Class II Terminated

blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San A

July 11, 2020 4e Brands North America, Llc 17,359,247 total bottles and pumps units

FDA Drug Class I Terminated

blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% ethyl alcohol), 33.8 fl oz / 1 L bottle, Distributed in USA and Canada by: 4e Brands 4e Brands North

July 11, 2020 4e Brands North America, Llc N/A units

FDA Drug Class II Terminated

ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49069 8 b) 10 fL oz / 296 ml bottle, UPC 6 39277 49069 8, Distributed by Gee

July 11, 2020 4e Brands North America, Llc 17,359,247 total bottles and pumps units

FDA Drug Class I Terminated

blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC

July 11, 2020 4e Brands North America, Llc 17,359,247 total bottles and pumps units

FDA Drug Class II Terminated

Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made

July 11, 2020 4e Brands North America, Llc 17,359,247 total bottles and pumps units

FDA Drug Class II Terminated

blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4 b) 7.5 fl. oz./221 ml bottle, UPC 8 14266 02362 4 b) 33.8 fl. oz

July 11, 2020 4e Brands North America, Llc 17,359,247 total bottles and pumps units

FDA Drug Class I Terminated

blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4, b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4, Distribut

July 11, 2020 4e Brands North America, Llc 17,359,247 total bottles and pumps units

FDA Drug Class II Terminated

blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl oz / 532 ml bottle, UPC 8 14266 02408 9 b) 33.8 fl oz / 1L bot

July 11, 2020 4e Brands North America, Llc 17,359,247 total bottles and pumps units

FDA Drug Class II Terminated

blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4 c) 15.2 fl

July 11, 2020 4e Brands North America, Llc 17,359,247 total bottles and pumps units

FDA Drug Class II Terminated

Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59

July 10, 2020 Keryx Biopharmaceuticals, Inc. 59,820 bottles units

NHTSA Ongoing

Generator Prep May Be Incorrectly Wired

July 10, 2020 FOREST RIVER, INC. 62 units

CPSC Ongoing

Miracle Botanicals Recalls Wintergreen and Birch Essential Oils Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)

July 9, 2020 Miracle Botanicals, of Pahoa, Hawaii About 380 units

FDA Drug Class II Terminated

Shine & Clean Hand Sanitizer gel, (Ethyl Alcohol 70%), 33.81 fl oz (1L) bottle, Made in Mexico By: Maquiladora Miniara S.A. de C.V. Carrerera Teoloyucan Huehuetoca km: 22 S/N La Planada Mexico C.P.: 5

July 9, 2020 Maquiladora Miniara Sa De Cv 245,500 bottles units

NHTSA Ongoing

Lift Kits May Be Installed with Wrong Size Tires

July 9, 2020 TAP Worldwide, LLC 47 units

CPSC Ongoing

DaVinci Recalls Bassinets Due to Fall and Entrapment Hazards (Recall Alert)

July 9, 2020 About 3,000 (In addition, about 290 were sold in Canada). These bassinets were previously recalled on December 2019. units

CPSC Ongoing

Ananda Apothecary Recalls Essential Oils Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)

July 9, 2020 Ananda Apothecary, of Boulder, Colo. About 275 units

CPSC Ongoing

RH Recalls Riveted Mesh Floor Lamps Due to Fire Hazard (Recall Alert)

July 9, 2020 About 1,180 (in addition, about 54 were sold in Canada) units

CPSC Ongoing

Cooper Lighting Recalls Light Fixtures Due to Injury Hazard (Recall Alert)

July 9, 2020 Cooper Lighting, LLC, (Cooper Lighting Solutions), of Peachtree City, Georgia About 39,000 units

NHTSA Ongoing

Jack Stand May Collapse Under Load

July 8, 2020 Harbor Freight Tools 118,000 units

NHTSA Ongoing

Alternator Terminal Nut May Loosen

July 8, 2020 Kia Motors America 5,385 units

CPSC Ongoing

Pranarom Recalls Wintergreen Essential Oils Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Poisoning

July 8, 2020 Pranarom, of Minneapolis, Minn. About 960 units

CPSC Ongoing

Lidl US Recalls Silvercrest Bread Makers Due to Electric Shock Hazard

July 8, 2020 About 1,840 units

CPSC Ongoing

GloryBee Natural Sweeteners Recalls GloryBee Wintergreen Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning

July 8, 2020 GloryBee Natural Sweeteners Inc., of Eugene, Ore. About 540 units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07

July 7, 2020 Lupin Pharmaceuticals Inc. 59,568 bottles units

NHTSA Ongoing

Brand Emblem and Securing Nuts May be Projectiles

July 7, 2020 Chrysler (FCA US LLC) 925,239 units

FDA Drug Class I Terminated

ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, CareFusion El P

July 7, 2020 Carefusion 213, Llc 36 cartons units

FDA Drug Class I Terminated

ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 799

July 7, 2020 Carefusion 213, Llc 280 cartons units

FDA Food Class II Terminated

***KIND HEALTHY GRAINS***Oats & Honey Granola with Toasted Coconut***INGREDIENTS: Oats, tapioca syrup, brown rice, cane sugar, honey, millet, oat flour, coconut, canola oil, buchwheat, amaranth, molas

July 7, 2020 KIND, LLC 142,273 cases plus 484 individual pouches units

NHTSA Ongoing

Antenna Wing May Separate From Mounting Base

July 7, 2020 KEYSTONE RV COMPANY 8,313 units

NHTSA Ongoing

Engine Compartment Seal May Detach

July 7, 2020 Volkswagen Group of America, Inc. 12,964 units

FDA Drug Class I Terminated

Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50

July 7, 2020 Mylan Institutional LLC 18,480 vials units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01

July 7, 2020 Lupin Pharmaceuticals Inc. 64,344 bottles units

FDA Drug Class I Terminated

BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 799

July 7, 2020 Carefusion 213, Llc 988 cartons units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07

July 7, 2020 Lupin Pharmaceuticals Inc. 273,060 bottles units

FDA Drug Class I Terminated

BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion El Paso, TX 799

July 7, 2020 Carefusion 213, Llc 400 cartons units

FDA Drug Class II Terminated

Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09

July 7, 2020 Lupin Pharmaceuticals Inc. 95,886 bottles units

NHTSA Ongoing

Accessory Power Outlet May Overheat

July 6, 2020 HYUNDAI MOTOR AMERICA 272,126 units

NHTSA Ongoing

ESP System Software Programmed Incorrectly

July 6, 2020 MERCEDES-BENZ USA, LLC. 5,399 units

NHTSA Ongoing

Engine Compartment Flap Hinge Improperly Welded

July 6, 2020 Daimler Coaches North America 58 units

NHTSA Ongoing

Loss of Power Steering Assist

July 6, 2020 Gillig LLC 531 units

FDA Drug Class III Terminated

Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86

July 6, 2020 Sun Pharmaceutical Industries Inc. 3516 bottles units

FDA Drug Class III Terminated

Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distributed in the U.S.A. by Allergan, Irvine, CA 92612, NDC 0023-4965-02

July 6, 2020 Allergan, PLC. 4,018 bottles units

FDA Drug Class III Terminated

Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0%), 5 fl oz.; Purifying Toner (Salicylic Acid 2.0%), 6 fl oz,; Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 fl oz., Dis

July 6, 2020 Allergan, PLC. 8,555 kits units

NHTSA Ongoing

Bolts Securing Suspension Spring May Be Too Long

July 6, 2020 AIRSTREAM, INC. 145 units

FDA Food Class II Terminated

WinCo Foods Tater Bites Shaped, Shredded Potatoes, frozen product. Retail 32 oz. poly bag has UPC 0 70552 30303 4. The master case contains 12/32 oz. bags (net wt. 24 lbs.), identified as WinCo Foo

July 6, 2020 Lamb Weston Inc 558 cases (12/32 oz. Bags per case) units

FDA Drug Class II Ongoing

Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA,

July 3, 2020 Granules Pharmaceuticals Inc a) 476,073 bottles; b) 2,100 bottles units

FDA Drug Class II Terminated

D-Biotin 300 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

July 2, 2020 MasterPharm LLC 390 capsules units

FDA Drug Class II Terminated

Sildenafil 50 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

July 2, 2020 MasterPharm LLC 80 troches units

FDA Drug Class II Terminated

Estriol 8 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

July 2, 2020 MasterPharm LLC 300 capsules units