FDA recalls, December 2018: 128 published

75 different companies appear this month.

Risk classification: Class I: 23 · Class II: 88 · Class III: 17

Same month, other agencies:CPSC 19 recallsFSIS 10 recallsNHTSA 59 recalls

Recalls this month

DateProduct
December 26, 2018Milk Chocolate Maltballs: NET Wt. 15 lbs. Item number 992 Case UPC 00797817-00992-9 …F-0726-2019Marich Confectionery Company, Inc.
December 26, 2018Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 inten…Z-0627-2019Covidien LLC
December 26, 2018Dyural-80 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharm…D-0354-2019Asclemed USA Inc. dba Enovachem
December 26, 2018ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high …Z-0620-2019Clark Laboratories, Inc. (dba,Trinity Biotech USA)
December 26, 2018Wegmans Roasted Corn and Bean Salad; 13 oz. Plastic Container, 40 oz. Plastic Container…F-0741-2019ASK Foods Inc
December 26, 2018IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-6…Z-0645-2019Deerfield Imaging, Inc.
December 26, 2018Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,D…D-0339-2019Pfizer Inc.
December 26, 2018Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, H…D-0343-2019Pharm D Solutions, LLC
December 26, 2018Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottl…D-0360-2019Results RNA, LLC
December 26, 2018Taste of Inspirations Rotini Salad, Net Wt. 13 oz., Pre-pack Container sold to consumer b…F-0742-2019ASK Foods Inc
December 26, 2018Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 …D-0336-2019Tris Pharma Inc.
December 26, 2018Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL …D-0319-2019GE Healthcare Inc. Life Sciences
December 26, 2018Luckyberry Cold-Pressed Juice, Merc Blend, 16 FL OZ, Manufactured at Luckyberry Juice Caf…F-0769-2019Luckyberry
December 26, 2018Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chl…D-0334-2019Pharmedium Services, LLC
December 26, 2018TURKEY HILL Vanilla Bean Premium Ice Cream #501 3 GAL (11.36L) paper carton CONTAINS: MIL…F-0731-2019Harris Teeter Supermarkets, LLC dba Hunter Farms
December 26, 2018RT-5100 Refractor, a component of the Epic-5100 System.Z-0655-2019Nidek Inc.
December 26, 2018infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 m…D-0335-2019Tris Pharma Inc.
December 26, 2018Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharm…D-0353-2019Asclemed USA Inc. dba Enovachem
December 26, 2018Inspired Organic Peanut Butter 16oz. plastic jar, 6 per case UPC #: 863669742588 refri…F-0778-2019Lipari Foods Operating Company, LLC
December 26, 2018Kitchen Cravings Strawberry Parfait, Net Wt 8.25 oz (234g) Creamy Parfait Base, Strawber…F-0739-2019Kwik Trip, Inc.
December 26, 2018Luckyberry Cold-Pressed Juice, NoCoast, Kale, Cucumber, Green Apple, Celery, Lemon, Ginge…F-0766-2019Luckyberry
December 26, 2018Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplica…Z-0616-2019Siemens Healthcare Diagnostics, Inc.
December 26, 2018ASK Foods Inc. Rigatoni Casserole, 5 lb. Aluminum Tray Pan sold on Hot Bar at RetailerF-0744-2019ASK Foods Inc
December 26, 2018Raw Tahini sold under the following brand names: Baron's raw Tahini, 454g, UPC: 816412010…F-0728-2019Achdut
December 26, 2018ASK Foods Inc. Naturally Creative Firecracker Slaw, 3.75 lb. Bulk Container sold from the…F-0746-2019ASK Foods Inc
December 26, 2018Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5…D-0341-2019CBI Laboratories, Inc.
December 26, 2018Luckyberry Cold-Pressed Juice, Reset, Carrot, Apple, Ginger, Lemon, 16 FL OZ, Manufacture…F-0767-2019Luckyberry
December 26, 2018Inspired Organic Tahini Butter 16oz. plastic jar, 6 per case UPC #: 863669742564 refri…F-0777-2019Lipari Foods Operating Company, LLC
December 26, 2018Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Ver…Z-0641-2019GE Healthcare, LLC
December 26, 2018The Salty Nutty Toffee Bar, brand ALMA, net weight 1.85 oz. UPC on individual bar: 8 58…F-0750-2019Moonstruck Chocolate Company
December 26, 2018Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 …D-0337-2019Tris Pharma Inc.
December 26, 2018Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx onl…D-1207-2019Sun Pharmaceutical Industries, Inc.
December 26, 2018Organic Tahini sold under the following brand names: Pepperwood organic tahini, 428g, UPC…F-0727-2019Achdut
December 26, 2018LIGHT & FIT¿ GREEK CRUNCH NONFAT YOGURT & TOPPINGS S MORES FLAVOR, 5 oz Preformed cups wi…F-0740-2019DANONE WATERS OF AMERICA INC
December 26, 2018VITEK¿ 2 Systems Software Version 9.01 Update Kit.Z-0639-2019bioMerieux, Inc.
December 26, 2018Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC…D-0297-2019Epic Pharma, LLC
December 19, 2018Imperial Taste Fried Garlic, Tu Phi; 24 x 8oz. Item #1763 UPC Code: 741861017638; 24 x…F-0701-2019Gemini Food Corporation Inc
December 19, 2018Gatorade, Grape, 20.3 FL OZ, Cont. Neto (600 mL)F-0710-2019The Gatorade Puerto Rico Co
December 19, 2018Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx on…D-0295-2019QuVa Pharma, Inc.
December 19, 2018Gatorade, Orange, 20.3 FL OZ, Cont. Neto (600 mL)F-0707-2019The Gatorade Puerto Rico Co
December 19, 2018Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6…D-0330-2019Mylan Laboratories Limited, (Nashik FDF)
December 19, 2018PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 …Z-0583-2019GE Healthcare, LLC
December 19, 2018Baraka Mild Curry Powder packed in 7 oz. Plastic JarF-0716-2019U.B.C. Food Distributors INC.
December 19, 2018Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394Z-0590-2019Zimmer Biomet, Inc.
December 19, 2018Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Steril…Z-0577-2019Leoni Fiber Optics GmbH
December 19, 2018Salmon fillets packaged inside Styrofoam boxes fully surrounded and covered in ice, which…F-0735-2019K & T Oriental Imports Inc.
December 19, 2018Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-For…Z-0581-2019Leoni Fiber Optics GmbH
December 19, 2018Gatorade, Melon, 20.3 FL OZ, Cont. Neto (600 mL)F-0708-2019The Gatorade Puerto Rico Co
December 19, 2018Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for…D-0314-2019Mylan Pharmaceuticals Inc.
December 19, 2018Cap'n Crunch's Peanut Butter Crunch Cereal packaged in 17.1 ounce and 16.5 ounce cardboar…F-0718-2019Quaker Manufacturing, LLC

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