FDA recalls, October 2018: 228 published

83 different companies appear this month.

Risk classification: Class I: 15 · Class II: 192 · Class III: 21

Same month, other agencies:CPSC 32 recallsFSIS 20 recallsNHTSA 95 recalls

Recalls this month

DateProduct
October 17, 2018THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Lioth…D-0013-2019Syntec Pharma Corp
October 17, 2018Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 …Z-0094-2019Widex A/S
October 17, 2018Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a…D-0088-2019GLAXOSMITHKLINE NEBRASKA
October 17, 2018Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manuf…D-0011-2019Jubilant Cadista Pharmaceuticals, Inc.
October 17, 2018Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distrib…D-0010-2019Pfizer Inc.
October 17, 2018Lic's REESE'S OREO, ONE QUART (946 mL), packed in Plastic quart containerF-0027-2019Lloyd'S Ice Cream Inc
October 17, 2018Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipl…D-0012-2019InvaGen Pharmaceuticals, Inc.
October 17, 2018OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.Z-0083-2019Orthosensor, Inc.
October 17, 2018Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg…D-0026-2019Takeda Development Center Americas, Inc.
October 17, 2018Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, Thyroid Pow…D-0008-2019Alkano Chemicals, Inc
October 17, 2018THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine (corre…D-0014-2019Syntec Pharma Corp
October 17, 2018Ube Cookies & Cream (cookies); A Sarap Asian Fusion Product; NET WT. 65 G/Cookie; Co…F-0026-2019Sarap Asian Fusion
October 17, 2018Colpo-Pneumo Occluder, Part CPO-6Z-0098-2019CooperSurgical, Inc.
October 10, 2018CE17TKCD CONT EPIDURAL ANESTHESIA KIT, Material Number 332229 Connection device used …Z-3367-2018B. Braun Medical, Inc.
October 10, 2018Oregon Heritage Farms Family Blend Apple Cider, 100% Juice, 1 gallon plastic container, U…F-0006-2019Oregon Heritage Developments Inc dba Oregon Heritage Farms
October 10, 2018Ultrasonic Bronchoscope BF-UC160F-OL8Z-3303-2018Olympus Corporation of the Americas
October 10, 2018EVERYBURGER - Burger-Shaped Chocolate Cookies: NET WT. 2.32 oz. (66 g) There are 2 pack…F-0017-2019Wismettac Asian Foods (USA) dba Nishimoto Trading Co Ltd
October 10, 2018robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed …D-0009-2019Endo Pharmaceuticals, Inc.
October 10, 2018CCE18HK10L CONT EPIDURAL TRAY, Material Number 332264 Connection device used by physi…Z-3377-2018B. Braun Medical, Inc.
October 10, 2018Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 …Z-0016-2019COVIDIEN LLC
October 10, 2018Capnostream20 M ADULT ICU (CPM), CS08654RAZ-0045-2019Oridion Medical 1987 Ltd.
October 10, 2018CNB200TKU NON-STIM CATH FULL KIT, Material Number 332127 Connection device used by ph…Z-3345-2018B. Braun Medical, Inc.
October 10, 2018CE17TKFCY 17GA SAFETY TUOHY NEEDLE TRAY, Material Number 332075 Connection device use…Z-3330-2018B. Braun Medical, Inc.
October 10, 2018CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF, Material Number 332097 Connection device use…Z-3343-2018B. Braun Medical, Inc.
October 10, 2018Bronchofiberscope F-1T160Z-3284-2018Olympus Corporation of the Americas
October 10, 2018Coconut & Cheese Pastry. The product is packed in a cardboard box. The firm marks the Co…F-0014-2019Baker's Service of South Florida, Inc.
October 10, 2018CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY, Material Number 332077 Connection device used…Z-3331-2018B. Braun Medical, Inc.
October 10, 2018Bronchovideoscope F-1TQ180Z-3288-2018Olympus Corporation of the Americas
October 10, 2018CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658Z-0040-2019Oridion Medical 1987 Ltd.
October 10, 2018ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, …Z-0008-2019Endologix
October 10, 2018VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266Z-0058-2019Ortho Clinical Diagnostics Inc
October 10, 2018EPID PAED FULL KIT 24GA CT NG CATH LF, Material Number 332292 Connection device used …Z-3383-2018B. Braun Medical, Inc.
October 10, 2018CE17TKFSDTD EPID TRAY W/17GA FIXED WING, Material Number 332095 Connection device use…Z-3341-2018B. Braun Medical, Inc.
October 10, 2018Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657Z-0034-2019Oridion Medical 1987 Ltd.
October 10, 2018Bronchovideoscope BF-XP160FZ-3305-2018Olympus Corporation of the Americas
October 10, 2018smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 2…Z-0073-2019Smiths Medical ASD Inc.
October 10, 2018VITROS Sodium Slides, Catalog # 837 9034Z-3280-2018Ortho-Clinical Diagnostics
October 10, 2018Guava Pastry. The product is packed in a cardboard box. The firm marks the Guava Pastry …F-0007-2019Baker's Service of South Florida, Inc.
October 10, 2018CONTIPLEX TUOHY ULTRA 2 IN CONT. PNB SET, Material Number 331673 Connection device us…Z-3316-2018B. Braun Medical, Inc.
October 10, 2018Meijer Taco Seasoning Mix, Net wt. 4.5 oz.F-0020-2019McCormick & Company, Inc. - Flavor Manufacturing Center
October 10, 2018Formed Hash Brown Patties, packaged in cardboard trays covered with plastic film, frozen …F-0001-2019Lamb Weston Inc
October 10, 2018Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Dis…D-0005-2019Pfizer Inc.
October 10, 2018smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring …Z-0075-2019Smiths Medical ASD Inc.
October 10, 2018CE17TKPS CONTINUOUS EPIDURAL ANES TRAY, Material Number 332233 Connection device used…Z-3370-2018B. Braun Medical, Inc.
October 10, 2018CE17TKFCPS EPIDURAL FULL TRAY, Material Number 332078 Connection device used by physi…Z-3332-2018B. Braun Medical, Inc.
October 10, 2018smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 …Z-0071-2019Smiths Medical ASD Inc.
October 10, 2018Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in …D-0007-2019Dr. Reddy's Laboratories, Inc.
October 10, 2018CE17TKFSDT EPID TRAY W/17GA FIXED WING, Material Number 332093 Connection device used…Z-3340-2018B. Braun Medical, Inc.
October 10, 2018CE18TKCD CONT EPIDURAL TRAY, Material Number 332211 Connection device used by physici…Z-3356-2018B. Braun Medical, Inc.
October 10, 2018NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml…D-0002-2019BioLyte Laboratories, LLC

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