Product Recalls in 2020

FDA Food Class I Terminated

Iron Drops (UPC 729609000098) liquid Dietary Supplement, 1 oz/30 mL amber glass bottle packaged in an individual product carton that includes a 1 mL oral syringe dispenser.

July 24, 2020 Wellements LLC 27,557 bottles units

FDA Food Class I Terminated

Iron Drops Sampler (UPC 729609000098) liquid Dietary Supplement, 1 oz/30 mL, (2 mL fill) amber glass bottle packaged in an individual product carton that includes a 1 mL oral syringe dispenser.

July 24, 2020 Wellements LLC 20,964 bottles units

FDA Drug Class II Terminated

VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg hyoscyamine sulfate), Rx Only, 100 Capsules per Bottle, Manufactured for

July 24, 2020 Vilvet Pharmaceuticals Inc. 11,640 bottles units

FDA Drug Class II Terminated

VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg hyoscyamine sulfate and 32.4 mg phenyl salicylate), Rx Only, 90 Tablets per B

July 24, 2020 Vilvet Pharmaceuticals Inc. 1,716 bottles units

FDA Food Class I Terminated

Iron (III) Hydroxide Polysaccharides Complex in 25kg polyethylene drums manufactured by Chaitanya Biologicals Pvt. Ltd, Buldhana, India

July 24, 2020 Advanced Compounds International, Inc. 60 drums (25Kg/drum); 1500Kg total units

FDA Food Class II Terminated

Rosemary Garlic French Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, net weight 14 oz (400 g). UPC 0 08613 10008 7. The product la

July 23, 2020 San Francisco Street Bakery Inc. 36 units units

FDA Food Class II Terminated

Desem Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, net weight 22 oz. UPC 0 08613 10001 8. The product label read: "***desem ***Ing

July 23, 2020 San Francisco Street Bakery Inc. 14 loaves units

FDA Food Class II Terminated

Olive Levain Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, net weight 16 oz (454 g). UPC 0 088613 10014 8. The product label is rea

July 23, 2020 San Francisco Street Bakery Inc. 16 loaves units

FDA Food Class II Terminated

Garlic Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product l

July 23, 2020 San Francisco Street Bakery Inc. 20 bagels units

FDA Food Class I Terminated

UpSpring Baby Iron + Immunity MULTI + IRON + ZINC Promotes nutrition For Healthy Growth + Immune System Support For Infants 4 months + Natural Grape Flavor Easy To Use Dropper Dietary Supplement NET W

July 23, 2020 Upspring,ltd 10,328 units units

CPSC Ongoing

Willis Electric Recalls Home Accents Holiday Artificial Christmas Trees Due to Burn Hazard; Sold Exclusively at Home Depot

July 23, 2020 Willis Electric Co. Ltd., of Taiwan About 99,000 (another 5,100 were sold in Canada) units

CPSC Ongoing

Polaris Recalls Ranger Off-Road Vehicles and PRO XD and Bobcat Utility Vehicles Due to Crash Hazard (Recall Alert)

July 23, 2020 Polaris Industries Inc., of Medina, Minn. About 13,200 (In addition, 515 units were sold in Canada) units

CPSC Ongoing

Bulk Apothecary Recalls Nature's Oil Wintergreen and Birch Essential Oils Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)

July 23, 2020 Bulk Apothecary, of Aurora, Ohio About 20,240 units

FDA Food Class II Terminated

Italian Farm Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, net weight 23 oz (652 g). UPC 0 08613 10005 6. The product label is read

July 23, 2020 San Francisco Street Bakery Inc. 34 loaves units

FDA Food Class II Terminated

Pesto Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product la

July 23, 2020 San Francisco Street Bakery Inc. 55 bagels units

FDA Food Class II Terminated

Cheddar Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product

July 23, 2020 San Francisco Street Bakery Inc. 52 bagels units

FDA Food Class II Terminated

Sesame Seed Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk prod

July 23, 2020 San Francisco Street Bakery Inc. 24 bagels units

FDA Food Class II Terminated

Plain Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product la

July 23, 2020 San Francisco Street Bakery Inc. 48 units units

FDA Drug Class II Terminated

BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packaged as a) 9.5 FL OZ (280 mL) bottle, UPC 8 40038 21462 4: b) 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3; and c) 34 FL

July 23, 2020 Real Clean Distribuciones SA de CV 975,720 bottles units

FDA Drug Class II Terminated

scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL, Distributed by Scent Theory Products, LLC New York, NY 10018, Made in Mexico, UPC 8 40038 21434 1

July 23, 2020 Real Clean Distribuciones SA de CV 504,000 pieces units

NHTSA Ongoing

Inadequate Back Camera View/FMVSS 111

July 23, 2020 Tropos Technologies, Inc. 66 units

FDA Food Class II Terminated

Everything Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk produ

July 23, 2020 San Francisco Street Bakery Inc. 48 bagels units

FDA Drug Class II Terminated

LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, Distributed by: Procurement Services, LLC Nashville, TN 37215, Product of Mexico. NDC 74882-007-02

July 23, 2020 Real Clean Distribuciones SA de CV 90,288 bottles units

FDA Drug Class II Terminated

scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcohol 70%), 16.9 FL OZ/500 mL bottle, Distributed by Scent Theory Products, LLC New York, NY 10018. Made in Mexico, UPC 8 4003

July 23, 2020 Real Clean Distribuciones SA de CV 917,280 bottles units

NHTSA Ongoing

Dinette Seat Belts too Short/FMVSS 208, 209

July 23, 2020 THOR MOTOR COACH 49 units

FDA Drug Class I Terminated

BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 FL OZ (500 mL) bottle, UPC 8 40038 21456 3, Made in Mexico; Distributed by Scent Theory Products, LLC, New York, NY 10018.

July 23, 2020 Real Clean Distribuciones SA de CV N/A units

FDA Food Class I Terminated

Chantilly Key Lime Tartlets Net Wt 1 oz. individually packaged in plastic clamshell containers with Whole Foods Market scale labels, a PLU code of 268564

July 23, 2020 Whole Foods Market 165 Units units

NHTSA Ongoing

Converter Breaker May Cause Fire

July 23, 2020 THOR MOTOR COACH 934 units

FDA Food Class II Terminated

Poppy Seed Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk produ

July 23, 2020 San Francisco Street Bakery Inc. 14 bagels units

FDA Food Class II Terminated

Salt Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product lab

July 23, 2020 San Francisco Street Bakery Inc. 16 bagels units

FDA Food Class II Terminated

Sourdough Rye Bread, San Francisco Street Bakery brand, keep at ambient temperature. Sold as an individual unit through on-site retail store bulk display, net weight unknown. No UPC.

July 23, 2020 San Francisco Street Bakery Inc. 2 units units

FDA Food Class II Terminated

Stick-E Fingers Barbecue All Purpose Rub is a dry rub, packaged in 13.2 oz plastic jar, UPC 8 60003 24004 5. No company's address listed on the label. The product label is read in parts: "***STICK

July 23, 2020 Stick E Fingers BBQ LLC 181 jars units

FDA Food Class II Terminated

Pain Au Levain Bread, San Francisco Street Bakery brand, keep at ambient temperature. Individually packaged in flex poly bag, net weight 16 oz (454 g). UPC 0 08613 10013 1. The product label is re

July 23, 2020 San Francisco Street Bakery Inc. 62 loaves units

FDA Food Class II Terminated

Cinnamon Raisin Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk

July 23, 2020 San Francisco Street Bakery Inc. 13 bagels units

FDA Food Class II Terminated

French Bread, San Francisco Street Bakery brand, keep at ambient temperature. French Bread sold as an individual unit through the firm's on-site retail store, net weight unknown. No UPC.

July 23, 2020 San Francisco Street Bakery Inc. 10 loaves units

FDA Food Class II Terminated

Onion Bagel, San Francisco Street Bakery brand, keep at ambient temperature. Packaged in flex poly bags for bulk or various quantities specific to customer order. No UPC. The bagel bulk product la

July 23, 2020 San Francisco Street Bakery Inc. 24 bagels units

CPSC Ongoing

BioMed Balance Recalls Wintergreen and Sweet Birch Essential Oils Due to Failure to Meet Child Resistant Packaging Requirements; Risk of Poisoning

July 22, 2020 BioMed Balance, of Kent, Wash. About 60 units

CPSC Ongoing

Manhattan Toy Recalls 'Manhattan Ball' Activity Toys Due to Choking Hazard; Sold Exclusively at Target

July 22, 2020 About 22,100 units

CPSC Ongoing

DownEast Outfitters Recalls Folding Mattresses Due to Violation of Federal Mattress Flammability Standard

July 22, 2020 Relux Mattress Co. Ltd., of China About 1,600 units

CPSC Ongoing

Cookware Company Recalls Greenpan SimmerLite Dutch Ovens Due to Burn and Injury Hazards

July 22, 2020 About 11,160 units

FDA Drug Class III Terminated

Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724, NDC 0054-4497-10

July 22, 2020 West-Ward Columbus Inc 2300 bottles units

FDA Drug Class I Terminated

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL

July 22, 2020 Fresenius Kabi USA, LLC 25,100 bottles units

NHTSA Ongoing

Potential Loss of Steering Control

July 22, 2020 Kia Motors America 104 units

FDA Drug Class I Terminated

Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only, Manufactured for: AMRING PHARMACEUTICALS INC., Berwyn, PA 19312, NDC 69918-501-05

July 21, 2020 Ferring Pharmaceuticals Inc 184,325 nasal sprays units

NHTSA Ongoing

Uncontrolled Boom Movement

July 21, 2020 ALTEC INDUSTRIES INC. 141 units

NHTSA Ongoing

Damaged Circuit Board May Affect Lighting Function

July 21, 2020 NEWMAR CORPORATION 3,202 units

FDA Drug Class I Terminated

STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Behring LLC, King of Prussia, PA 19406-0901; By: Ferring GmbH, Kiel, Germany, NDC

July 21, 2020 Ferring Pharmaceuticals Inc 29,371 nasal sprays units

FDA Drug Class II Terminated

Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of

July 21, 2020 Lupin Pharmaceuticals Inc. 560,922 Pouches units

NHTSA Ongoing

Damaged Circuit Board May Affect Lighting Function

July 21, 2020 THOR MOTOR COACH 2,417 units

FDA Drug Class I Terminated

DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 USA, NDC 55566-2500-0

July 21, 2020 Ferring Pharmaceuticals Inc 15,175 nasal sprays units