FoodNov 9, 2016
Rikki USA Hollandaise Sauce, sold as Sallere Classic Sauces and Butters recall — FDA F-0377-2017
Hollandaise Sauce was recalled due to presence of mold.
Class IIIFDA: TerminatedRikki USA, Inc.
Latest records
Latest recalls — page 1770
The newest recall records with useful source details are listed here.
FoodNov 9, 2016
JJBL The Stone Ground Peanut Butter Chocolate Bar, Net wt recall — FDA F-0320-2017
The Stone Ground Peanut Butter Chocolate Bar is recalled due to undeclared soy lecithin.
Class IIFDA: TerminatedJJBL LLC
FoodNov 9, 2016
Roland Foods, LLC NET WT recall — FDA F-0369-2017
The product contains undeclared sulfites based on sampling and analysis by New York State Department of Agriculture and Markets and private laboratory testing.
Class IIFDA: TerminatedRoland Foods, LLC.
DrugNov 9, 2016
Par Pharmaceutical Gildess 1/20 recall — FDA D-0120-2017
Subpotent Drug; Ethinyl Estradiol
Class IIIFDA: CompletedPar Pharmaceutical, Inc.
DrugNov 9, 2016
Par Pharmaceutical Gildess FE 1.5/30 recall — FDA D-0122-2017
Subpotent Drug; Ethinyl Estradiol
Class IIIFDA: CompletedPar Pharmaceutical, Inc.
DrugNov 9, 2016
Par Pharmaceutical Gildess 1.5/30 recall — FDA D-0119-2017
Subpotent Drug; Ethinyl Estradiol
Class IIIFDA: CompletedPar Pharmaceutical, Inc.
DrugNov 9, 2016
Par Pharmaceutical Gildess 24 FE 1.5/30 recall — FDA D-0123-2017
Subpotent Drug; Ethinyl Estradiol
Class IIIFDA: CompletedPar Pharmaceutical, Inc.
DrugNov 9, 2016
Actavis Laboratories, FL Ramipril Capsules, USP, 1.25 mg, 30-count bottle recall — FDA D-0118-2017
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Class IIIFDA: OngoingActavis Laboratories, FL, Inc.
DrugNov 9, 2016
Pharmedium Services Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials recall — FDA D-0125-2017
Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
Class IIFDA: TerminatedPharmedium Services, LLC
DrugNov 9, 2016
Desoximetasone Cream USP, 0.05% 100 g recall — FDA D-0117-2017
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Class IIFDA: TerminatedTaro Pharmaceuticals, Inc.
DrugNov 9, 2016
Par Pharmaceutical Gildess FE 1/20 recall — FDA D-0121-2017
Subpotent Drug; Ethinyl Estradiol
Class IIIFDA: CompletedPar Pharmaceutical, Inc.
DrugNov 9, 2016
Desoximetasone Cream USP, 0.25% 100 g recall — FDA D-0116-2017
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Class IIFDA: TerminatedTaro Pharmaceuticals, Inc.
Medical DeviceNov 2, 2016
Roche Diagnostics Operations cobas 6800/8800 system Hepatitis Viral B DNA Detection Product recall — FDA Z-0110-2017
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been…
Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.
Medical DeviceNov 2, 2016
Roche Diagnostics Operations cobas p 312 Pre-Analytical System calculator/data processing recall — FDA Z-0109-2017
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been…
Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.
Medical DeviceNov 2, 2016
Roche Diagnostics Operations cobas 8000 Modular Analyzer Series c8000, Chemistry recall — FDA Z-0097-2017
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been…
Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.
Medical DeviceNov 2, 2016
Hospira Symbiq One Channel Infuser recall — FDA Z-0305-2017
Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior to…
Class IIFDA: TerminatedHospira Inc.
Medical DeviceNov 2, 2016
Siemens Healthcare Diagnostics IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay recall — FDA Z-0320-2017
Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceNov 2, 2016
Becton Dickinson & Co PhoenixSpec Calibrator & Kit is used to calibrate the PhoenixSpec & recall — FDA Z-0311-2017
BD has determined that the BBL PhoenixSpec Calibrator kits referenced in this recall from the following lots (5364776, 5345796 ) are labeled with an incorrect expiration date (year). The…
Class IIIFDA: TerminatedBecton Dickinson & Co.
Medical DeviceNov 2, 2016
St Jude Medical Fortify VR, Model No recall — FDA Z-0115-2017
St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery…
Class IFDA: TerminatedSt Jude Medical Inc.
Medical DeviceNov 2, 2016
Roche Diagnostics Operations Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A recall — FDA Z-0098-2017
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been…
Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.
Medical DeviceNov 2, 2016
Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry recall — FDA Z-0100-2017
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been…
Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.
Medical DeviceNov 2, 2016
Lumenis FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip recall — FDA Z-0301-2017
The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.
Class IIFDA: TerminatedLumenis Limited
Medical DeviceNov 2, 2016
TZ Medical Neptune Plus (Hemostatic Pad), Part Numbers: 8870-03 Neptune Pad is used to recall — FDA Z-0298-2017
Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER . This statement should not appear on label.
Class IIFDA: TerminatedTZ Medical, Inc.
Medical DeviceNov 2, 2016
Roche Diagnostics Operations cobas 6000 Series system c6000, Chemistry recall — FDA Z-0096-2017
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been…
Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.
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