Product Recalls in 2020

FDA Drug Class III Terminated

ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0872-08

April 20, 2020 Glaxosmithkline Consumer Healthcare Holdings 288 packages units

FDA Drug Class III Terminated

ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0873-08

April 20, 2020 Glaxosmithkline Consumer Healthcare Holdings 360 packages units

FDA Food Class II Terminated

5.5 oz cans of Ocean Spray Pink Lite Cranberry Juice Drink

April 20, 2020 Ocean Spray Cranberries Inc. 206,106 cans units

NHTSA Ongoing

Pressure Relief Devices May Not Vent/FMVSS 304

April 20, 2020 ELDORADO NATIONAL - CALIFORNIA, INC. 419 units

FDA Food Class II Terminated

14", 10" Hand Stretched Whole Wheat Flour Tortillas, packaged in quantities of 1-2 dozen per package. Each package is twist-tied and placed in a box. Box is then sealed for delivery.

April 20, 2020 La Sonorense, Inc. 576 boxes containing 5 packs of 2 dozen tortillas (total) units

FDA Drug Class II Terminated

Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, N

April 20, 2020 Fresenius Kabi USA, LLC 3,497,575 vials units

NHTSA Ongoing

Seat Belts may not Restrain Occupant/FMVSS 209

April 20, 2020 TransitWorks 205 units

FDA Drug Class II Terminated

Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0

April 20, 2020 Lupin Pharmaceuticals Inc. 11,808 bottles units

FDA Food Class II Terminated

12", 10" Pressed Wheat Flour Tortillas, packaged in quantities of 1-2 dozen per package. Each package is twist-tied and placed in a box. Box is then sealed for delivery.

April 20, 2020 La Sonorense, Inc. 576 boxes containing 5 packs of 2 dozen tortillas (total) units

FDA Food Class II Terminated

16", 14", 13", 12", 10", 5" Hand Stretched Wheat Flour Tortillas, packaged in quantities of 1-2 dozen per package. Each package is twist-tied and placed in a box. Box is then sealed for delivery.

April 20, 2020 La Sonorense, Inc. 576 boxes containing 5 packs of 2 dozen tortillas (total) units

FDA Drug Class III Terminated

ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA, NDC 0573-0871-08

April 20, 2020 Glaxosmithkline Consumer Healthcare Holdings 288 packages units

FDA Drug Class I Terminated

Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11

April 18, 2020 B. Braun Medical Inc 22,488 Duplex containers units

FDA Food Class I Terminated

Wegmans brand Semi-Sweet Chocolate Nonpareils in an 18.5 oz. (524 g) plastic container, 12 plastic containers per case.

April 18, 2020 Mellace Family Brands California Inc 294 cases. units

NHTSA Ongoing

Belt Tension Sensor Malfunction

April 17, 2020 FORD MOTOR COMPANY 1,355 units

NHTSA Ongoing

Tonneau Cover May Detach From Pickup Bed

April 17, 2020 GENERAL MOTORS LLC 14,876 units

FDA Food Class I Terminated

7126763 Flounder Stuffed W/ Seafood FRZN, Net Wt LBS 3.00 (1.36 KG), 4 packages per case

April 17, 2020 Freedman Food Service, Inc dba Buckhead Meat & Seafood of Houston 180 cases with a total weight of 540.0 lbs. units

NHTSA Ongoing

Fuel Heater May Overheat and Cause Fire

April 17, 2020 NAVISTAR, INC 27,421 units

NHTSA Ongoing

Fuel Pump May Become Inoperative/Engine Stall

April 17, 2020 SUBARU OF AMERICA, INC. 188,207 units

FDA Food Class II Terminated

7075931 Flounder Stuffed W/ Seafood FRZN, Net Wt LBS 15.00 (6.80 KG), 20 packages per case

April 17, 2020 Freedman Food Service, Inc dba Buckhead Meat & Seafood of Houston 26 cases with a total weight of 390.0 lbs. units

NHTSA Ongoing

Front Tire May Contact Slide Out Bracket

April 17, 2020 FOREST RIVER, INC. 83 units

NHTSA Ongoing

Fuel Heater May Overheat and Cause Fire

April 17, 2020 NAVISTAR, INC 23,299 units

CPSC Ongoing

Polaris Recalls Model Year 2018 to 2020 Ranger XP 1000 Off-Road Vehicles Due to Fire Hazard (Recall Alert)

April 16, 2020 Polaris Industries Inc., Medina, Minn. About 80,000 units

CPSC Ongoing

Dr. Adorable Recalls Sweet Birch Essential Oil Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning; Sold Exclusively on Amazon.com (Recall Alert)

April 16, 2020 Dr. Adorable, of Chicago, Ill. About 12 units

FDA Food Class I Terminated

Whole Foods Market Queso Sauce PLU code printed on the product scale labels beginning with 74135 sold in clear plastic deli-style containers of various weights.

April 16, 2020 Whole Foods Market 9 pounds units

CPSC Ongoing

MTD Southwest Recalls Trimmers and Polesaws Due to Laceration Hazard

April 16, 2020 MTD Southwest Inc., of Tempe, Ariz. About 2,660 units

CPSC Ongoing

Polaris Recalls Model Year 2019 to 2020 Ranger XP 1000 Off-Road Vehicles Due to Fire Hazard (Recall Alert)

April 16, 2020 Polaris Industries Inc., Medina, Minn. About 7,000 units

CPSC Ongoing

Polaris Recalls PRO XD and Ranger Utility Vehicles Due to Injury Hazard (Recall Alert)

April 16, 2020 Polaris Industries Inc., Medina, Minn. About 10,100 (In addition, 400 units were sold in Canada) units

CPSC Ongoing

The Vitamin Shoppe Recalls Energy Formula Multivitamins Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)

April 16, 2020 The Vitamin Shoppe, of Secaucus, N.J. About 2,800 units

CPSC Ongoing

Wyndmere Naturals Recalls Birch Sweet Essential Oil and Aches & Pains Synergistic Essential Oil Blend Due to Failure to Meet Child Resistant Packaging Requirement; Risk of Poisoning

April 16, 2020 Wyndmere Naturals Inc., of New Hope, Minn. About 2,850 units

NHTSA Ongoing

License Plate Lamp Incorrectly Installed/FMVSS 108

April 16, 2020 SPARTAN MOTORS, INC. 50 units

FDA Drug Class I Terminated

KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By Summitt Labs, UPC 8 5765000812 8, www.KOREORGANIC.com 833.810.KORE.

April 15, 2020 Summitt Labs 236 bottles units

FDA Food Class III Terminated

Hearts of Romaine. Product is fresh and packaged in 9 ounce (255g) plastic bags.

April 15, 2020 Dole Fresh Vegetables Inc 6 bags per case X 80 cases= 480 bags (units) units

FDA Drug Class II Terminated

Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count b

April 15, 2020 H J Harkins Company Inc dba Pharma Pac 9,000 tablets units

NHTSA Ongoing

Reflective Tape May be Partially Covered/FMVSS 108

April 15, 2020 Daimler Trucks North America LLC 63,175 units

FDA Drug Class II Terminated

Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15

April 15, 2020 Amneal Pharmaceuticals of New York, LLC. 11258 bottles units

FDA Food Class III Terminated

Dole "Classic Kit Light Cesar" fresh salad mix. Salad and topping Net Wt.7.7 OZ (218g), Dressing Net 2.2 FL OZ (65ml), Total Net Wt. 10 OZ (283g), Thoroughly Washed, Perishable/Keep Refrigerated.

April 15, 2020 Dole Fresh Vegetables Inc 6 units per case, recalling 118 cases= 708 units units

FDA Drug Class II Terminated

Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC

April 15, 2020 Lupin Pharmaceuticals Inc. 4,518 bottles units

FDA Food Class II Ongoing

Absorb Health Advanced Joint Relief Joint Health; 510mg; 90 CAPSULES; Manufactured for: Absorb Health, 106 Countryside St NW, Supply, NC 28462 UPC 79056992863

April 15, 2020 Absorb Health LLC 70 bottles units

FDA Drug Class I Terminated

Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded Product Not for Resale, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419.

April 14, 2020 MasterPharm LLC 7260 capsules units

FDA Drug Class II Terminated

Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 8

April 14, 2020 B & B Pharmaceuticals, Inc. 3,825 grams units

NHTSA Ongoing

Driver Frontal Air Bag Inflator May Rupture

April 13, 2020 Takata (TK Global LLC) 1,318,212 units

FDA Food Class II Terminated

Roasted/Salted Deluxe Mixed Nuts; Net Wt. 10 oz./284 g, Clear plastic container UPC 65143370994 Cashews, Almonds, Brazil Nuts, Hazelnuts, Pecan Halves, Macadamia Nuts, Canola Oil, salt. Contai

April 11, 2020 DSD Merchandisers, Inc. 170 cases(12 x 10 oz. containers per case) units

NHTSA Ongoing

Incorrect GAWR on Certification Label/FMVSS 120

April 10, 2020 Daimler Trucks North America LLC 89 units

FDA Food Class I Terminated

Whole Foods Market Minestrone Soup PLU code printed on the product scale labels beginning with 248529 for soup sold in clear plastic deli-style containers of various weight and 246691 for soup sold in

April 10, 2020 Whole Foods Market 1615 units units

NHTSA Ongoing

Possible Unintended Vehicle Movement

April 10, 2020 HYUNDAI MOTOR AMERICA 11,870 units

FDA Food Class I Terminated

Lake Champlain CHOCOLATES, COIN DARK BULK ORG, NET WT 48 OZ (1.3 kg), APPROX 186 PIECES, INGREDIENTS: DARK CHOCOLATE (SUGAR, CHOCOLATE LIQUOR, COCOA BUTTER, COCOA POWDER (PRESSED WITH ALKALI), AND VAN

April 10, 2020 Champlain Chocolate Company 9 cases (1,674 pieces) units

NHTSA Ongoing

Improper Lubrication of Engine Components/Stall

April 10, 2020 YAMAHA MOTOR CORPORATION, USA 17 units

NHTSA Ongoing

Incorrect Cylinder Label/FMVSS 304

April 10, 2020 Winkelmann Flowform Technology LP 5 units

NHTSA Ongoing

Wire Harness May Chafe and Damage Circuits

April 9, 2020 FOREST RIVER, INC. 6 units

CPSC Ongoing

Pass & Seymour Recalls Commercial-Grade Electrical Receptacles Due to Burn Hazard

April 9, 2020 About 685,000 units