FDA recalls, November 2019: 314 published

81 different companies appear this month.

Risk classification: Class I: 56 · Class II: 243 · Class III: 15

Same month, other agencies:CPSC 18 recallsFSIS 8 recallsNHTSA 70 recalls

Recalls this month

DateProduct
November 20, 2019Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at Home. Double Chocolate with…F-0142-2020California New foods
November 20, 2019Viatrexx-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark,…D-0345-20208046255 Canada Inc. DBA Viatrexx
November 20, 2019Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium…D-0311-2020Novitium Pharma LLC
November 20, 2019Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium …D-0310-2020Novitium Pharma LLC
November 20, 2019RANDOX NEFA (Non-Esterified Fatty Acids) FA115 Lot 485343, GTIN: 5055273203066.Z-0367-2020Randox Laboratories, Limited
November 20, 2019Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newa…D-0348-20208046255 Canada Inc. DBA Viatrexx
November 20, 2019Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distribut…D-0316-2020Apotex Inc.
November 20, 2019WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (NDC 0363-140…D-0324-2020Sato Pharmaceutical Inc.
November 20, 2019Tony's Columbia Gorge Salmon, Skinless and boneless salmon, packaged in a metal can, Net …F-0154-2020Tonys Smoke House and Cannery Inc
November 20, 2019Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at Home. Peanut Butter Chocola…F-0144-2020California New foods
November 20, 2019Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at Home. Oatmeal Raisin Net W…F-0140-2020California New foods
November 20, 2019Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.…Z-0363-2020Implant Direct Sybron Manufacturing, LLC
November 20, 2019Viatrexx-Prolo, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark…D-0336-20208046255 Canada Inc. DBA Viatrexx
November 20, 2019Viatrexx-Connectissue, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated,…D-0326-20208046255 Canada Inc. DBA Viatrexx
November 20, 2019Viatrexx-Collagen, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, New…D-0335-20208046255 Canada Inc. DBA Viatrexx
November 20, 2019Country Baking Company; Pre-scooped & Ready to Bake: Happy Trails Cookie Dough All Natu…F-0147-2020California New foods
November 20, 2019ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK C…Z-0383-2020Orthofix Srl
November 20, 2019Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by Sat…D-0323-2020Sato Pharmaceutical Inc.
November 20, 2019ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT…Z-0390-2020Orthofix Srl
November 20, 2019Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, New…D-0332-20208046255 Canada Inc. DBA Viatrexx
November 20, 2019Viatrexx-Ouch, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark,…D-0328-20208046255 Canada Inc. DBA Viatrexx
November 20, 2019Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at Home. Chocolate Chip Net …F-0139-2020California New foods
November 20, 2019Viatrexx-GI, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, D…D-0339-20208046255 Canada Inc. DBA Viatrexx
November 20, 2019TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label…Z-0355-2020TriMed Inc.
November 20, 2019Viatrexx-Infla, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark…D-0334-20208046255 Canada Inc. DBA Viatrexx
November 20, 2019TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm…Z-0357-2020TriMed Inc.
November 20, 2019Food Lion Creamy Chocolate Frosting, Net Wt 16 OZ, Distributed by Food Lion, LLC, Salisbu…F-0149-2020Gilster-Mary Lee Corp.
November 20, 2019Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, N…D-0343-20208046255 Canada Inc. DBA Viatrexx
November 20, 2019ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, …Z-0378-2020Orthofix Srl
November 20, 2019Viatrexx-Neuro 3, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newa…D-0333-20208046255 Canada Inc. DBA Viatrexx
November 20, 2019TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on t…Z-0356-2020TriMed Inc.
November 20, 2019TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is …Z-0358-2020TriMed Inc.
November 20, 2019Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, N…D-0338-20208046255 Canada Inc. DBA Viatrexx
November 20, 2019Viatrexx-Lymph 1, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newa…D-0337-20208046255 Canada Inc. DBA Viatrexx
November 20, 2019Visual-ICE Cryoablation System, FPRCH6000. The cryoablation system is a mobile console s…Z-0404-2020Galil Medical, Inc.
November 20, 2019THE FRESH MARKET Mint Chip OLD FASHIONED ICE CREAM 1.5 QT (1.42 L) container DISTRIBUTED …F-0153-2020Harris Teeter Supermarkets, LLC dba Hunter Farms
November 13, 2019S-LIDOCAINE HCL 1% / PHENYLEPHRINE1.5% (PF) INJ SOLN, 1ml syringe, Red Mountain Compoundi…D-0235-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019Wedge Chicken Salad, Tuscan Sun brand, is a ready to eat sandwich. Net wt. 9.3 oz (263g)…F-0124-2020Jumbo Foods, Inc.
November 13, 2019Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bot…D-0183-2020Dr. Reddy's Laboratories, Inc.
November 13, 2019S-TRIMIX (15MG/0.5MG/10MCG/ML) INJ, Rx Only, 5ml glass vial, Red Mountain Compounding Rx.D-0254-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019S-MIC 25/50/50MG/ML B12A1MG/ML MDV INJ SOLN; Rx Only, a) 10ML b) 30ML glass vial. Red Mou…D-0275-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019Low Level Output Cable Interface to Philips Monitor For Use With Cardiosave and CS300 I…Z-0266-2020Datascope Corp.
November 13, 2019S-FOLIC ACID 10MG/ML MDV INJ; packaged in 30ml glass vials, Rx Only, Red Mountain Compoun…D-0220-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC …D-0175-2020Dr. Reddy's Laboratories, Inc.
November 13, 2019Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by:…D-0189-2020Basic Reset Inc.
November 13, 2019S-SODIUM SELINITE 0.219% INJ, 19ml glass vials, Rx only, Red Mountain Compounding RxD-0250-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019S-VIT B COMPLEX (1/3/5/6/12A) MDV INJ 100/2/2/100/1MG/ML, 30 ML glass vial. Red Mountain…D-0255-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019S-HCG/B12A 1000U/5MG/ML MDV INJ, packaged in a) 5ML b) 10 ML glass vials, Rx Only, Red Mo…D-0266-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019S-LIDOCAINE HCL 2% MDV INJ SOLN, packaged in 50ML vial, Red Mountain Compounding Rx,D-0270-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy
November 13, 2019S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RXD-0229-2020First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

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