FDA recalls, October 2019: 202 published

76 different companies appear this month.

Risk classification: Class I: 68 · Class II: 127 · Class III: 7

Same month, other agencies:CPSC 18 recallsFSIS 4 recallsNHTSA 103 recalls

Recalls this month

DateProduct
October 16, 2019Neonatal Cap Change Kit DT20315Z-0082-2020Centurion Medical Products Corporation
October 16, 2019Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c …Z-0042-2020Roche Diagnostics Operations, Inc.
October 16, 2019Popchips Sour Cream & Onion Potato Popped Chips; 5 oz. bag and 8 oz. bag UPC: 0 82666…F-0027-2020SONORA MILLS FOODS INC DBA POPCH
October 16, 2019CVC BUNDLE WITHOUT CATH CVI4600Z-0079-2020Centurion Medical Products Corporation
October 16, 2019Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx…D-0131-2020Teva Pharmaceuticals USA
October 16, 2019Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC L…D-0135-2020Epic Pharma, LLC
October 16, 2019Consider Bardwell Farm brand Experience Handmade Cow Cheese - Ingredients Pasteurized Cow…F-0039-2020Consider Bardwell Farm, LLC
October 16, 2019Fresh Grab brand Ham & Cheese, refrigerated 5 oz. wheat bread wedge cut sandwich, with U…F-0043-2020Lipari Foods Operating Company, LLC.
October 16, 2019Fresh Grab brand Turkey No Cheese, refrigerated 5 oz. wheat bread wedge cut sandwich, wi…F-0044-2020Lipari Foods Operating Company, LLC.
October 16, 2019CVC BUNDLE MULTIMED, 3L, 20CM ECVC6060Z-0093-2020Centurion Medical Products Corporation
October 16, 2019BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Truc…Z-0074-2020Becton, Dickinson and Company, BD Biosciences
October 16, 2019CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355Z-0096-2020Centurion Medical Products Corporation
October 16, 2019Ritter Sport KAFFEESPLITTER Chocolate with caramelized coffee beans; Net Weight: 3.5oz / …F-0021-2020STARK INC.
October 16, 2019Tep Say Crispy Tiny Shrimp Snack, Net Wt. 7 oz. in plastic jar UPC 7 37483 77926 9 Dist…F-0033-2020Vinh Sanh Trading Corp
October 16, 2019Fetting's Family Breads, White Bread, 4-1 lb. loaves. Net Wt. 4 lbs. (1.81 kg) UPC code…F-0017-2020Fetting's Frozen Foods LLC
October 16, 2019Chef Pierre ¿ SMALL WHOLE GRAIN BANANA MUFFINS NET WT 12 LB (5.44kg) 4 TRAYS/24/2 oz WHOL…F-0040-2020Sara Lee Frozen Bakery
October 16, 2019BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Truco…Z-0066-2020Becton, Dickinson and Company, BD Biosciences
October 16, 2019CVC BUNDLE, 20CM, 3L, PI ECVC5120Z-0091-2020Centurion Medical Products Corporation
October 16, 2019OR VANTEX 7FR 3L 16CM CVC ECVC6665Z-0100-2020Centurion Medical Products Corporation
October 16, 2019Popchips Sea Salt Potato Popped Chips; 5 oz. bag, 0.8 oz. bag UPC: 0 82666 50080 3 - 5…F-0026-2020SONORA MILLS FOODS INC DBA POPCH
October 16, 2019Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle,…D-0126-2020GCP Laboratories Inc
October 16, 2019Cap Change Kit DT20310Z-0081-2020Centurion Medical Products Corporation
October 16, 2019PEDIATRIC PICC INSERTION TRAY CVI4450AZ-0077-2020Centurion Medical Products Corporation
October 16, 2019DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a…D-0133-2020Unipharma, Llc.
October 16, 2019Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe Fo…D-0138-2020GUERBET LLC
October 16, 2019Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sando…D-0128-2020Sandoz, Inc
October 16, 2019Madrona Market Delicatessen Hot Cocoa Mix, Net Wt. 2 lb (907 g), Distributed by Food Serv…F-0030-2020Diamond Crystal Brands Inc
October 16, 2019Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz…D-0127-2020Sandoz, Inc
October 16, 2019Premo and Fresh Grab brands Egg Salad, refrigerated 5 oz. wheat bread wedge cut sandwich…F-0046-2020Lipari Foods Operating Company, LLC.
October 16, 201910% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx …D-0136-2020Pfizer Inc.
October 16, 2019Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) b…D-0130-2020Morton Grove Pharmaceuticals, Inc.
October 16, 2019Chef's Companion Instant Chocolate Mousse Mix Net Wt. 1 lb 14 oz (851 g), Dist by Diamond…F-0031-2020Diamond Crystal Brands Inc
October 9, 2019Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage:…Z-2767-2019WOM World of Medicine AG
October 9, 2019TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829Z-0037-2020Quality Electrodynamics LLC
October 9, 2019Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monit…Z-2765-2019Roche Diabetes Care, Inc.
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F 110CM AL20, REF SA6AL20A. for cardiovascular useZ-2611-2019Medtronic Vascular
October 9, 2019Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton…D-0119-2020Alkermes, Inc.
October 9, 2019C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care Pharmacy, 51…D-0004-2020Colonia Care Pharmacy
October 9, 2019Valencia Sopaipilla and Fry Bread Mix, 25 lbs, packaged in Paper bags with polyliners. UP…F-0014-2020Valencia Flour Mill, Ltd.
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL1.5, .070", REF SA6SAL15. for cardiovascular u…Z-2741-2019Medtronic Vascular
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F ALR1-2 SH, .070", REF SA6ALR12SH. for cardiovascu…Z-2689-2019Medtronic Vascular
October 9, 2019Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 …D-0072-2020KRS Global Biotechnology, Inc
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU4.5, .070", REF SA6EBU45. for cardiovascular u…Z-2633-2019Medtronic Vascular
October 9, 2019Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS G…D-0057-2020KRS Global Biotechnology, Inc
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F JR6.0 SH, .070", REF SA6JR60SH. for cardiovascula…Z-2739-2019Medtronic Vascular
October 9, 2019PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 m…D-0087-2020KRS Global Biotechnology, Inc
October 9, 2019SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75, .070", REF SA6AL75. for cardiovascular useZ-2641-2019Medtronic Vascular
October 9, 2019TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525Z-0035-2020Quality Electrodynamics LLC
October 9, 2019C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 Inman Ave., S…D-0033-2020Colonia Care Pharmacy
October 9, 2019Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Bio…D-0090-2020KRS Global Biotechnology, Inc

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