DrugJan 16, 2019
Cefdinir for Oral Suspension USP, 250mg/5mL recall — FDA D-0376-2019
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
January 2019 recalls — page 5
These records include useful source details for the selected month.
DrugJan 16, 2019
Heritage Pharmaceuticals Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials recall — FDA D-0352-2019
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
Class IIFDA: TerminatedHeritage Pharmaceuticals, Inc.
DrugJan 16, 2019
Estradiol Vaginal Inserts, USP, 10 mcg recall — FDA D-0350-2019
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Class IIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugJan 16, 2019
Cefdinir for Oral Suspension USP, 125mg/5mL recall — FDA D-0375-2019
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.
Class IIFDA: TerminatedLupin Pharmaceuticals Inc.
Medical DeviceJan 9, 2019
ORTHO-CLINICAL DIAGNOSTICS VITROS HBeAg Reagent, Cat recall — FDA Z-0688-2019
The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower…
Class IIFDA: OngoingORTHO-CLINICAL DIAGNOSTICS
Medical DeviceJan 9, 2019
R & D Systems Quantikine IVD ELISA, Human sTfR Immunoassay kit recall — FDA Z-0691-2019
The Human sTfR Quantikine IVD ELISA Kit, catalog # DTFR1, lot P180151 was packed with the incorrect control data card number 750228.4.
Class IIIFDA: TerminatedR & D Systems, Inc.
Medical DeviceJan 9, 2019
ORTHO-CLINICAL DIAGNOSTICS VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For recall — FDA Z-0687-2019
The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower…
Class IIFDA: OngoingORTHO-CLINICAL DIAGNOSTICS
Medical DeviceJan 9, 2019
ORTHO-CLINICAL DIAGNOSTICS VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in recall — FDA Z-0689-2019
The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower…
Class IIFDA: OngoingORTHO-CLINICAL DIAGNOSTICS
Medical DeviceJan 9, 2019
Ultradent Products Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose recall — FDA Z-0690-2019
Dental varnish has the possibility of having an unpleasant and off flavor.
Class IIFDA: TerminatedUltradent Products, Inc.
Medical DeviceJan 9, 2019
Medtronic Navigation StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation recall — FDA Z-0552-2019
An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.
Class IFDA: TerminatedMedtronic Navigation, Inc.
DrugJan 9, 2019
Hiers Enterprises, LLC dba Northwest Compounding Lidocaine/Epinepherine liquid 1%/ 1:1000 recall — FDA D-0398-2019
Lack of sterility assurance.
Class IIFDA: TerminatedHiers Enterprises, LLC dba Northwest Compounding…
DrugJan 9, 2019
Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle recall — FDA D-0346-2019
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Class IIFDA: TerminatedLUPIN SOMERSET
Medical DeviceJan 2, 2019
Hologic I-View Contrast Enhanced Digital Mammography, ASY-08109 recall — FDA Z-0685-2019
Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
Class IIFDA: TerminatedHologic, Inc.
Medical DeviceJan 2, 2019
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only recall — FDA Z-0683-2019
Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system…
Class IIFDA: OngoingMedtronic Inc.
Medical DeviceJan 2, 2019
Abbott Ireland Diagnostics Division Alinity i 25-OH Vitamin D Reagent Kit, List Number recall — FDA Z-0669-2019
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is…
Class IIFDA: TerminatedAbbott Ireland Diagnostics Division
Medical DeviceJan 2, 2019
Abbott Ireland Diagnostics Division Alinity i TSH Reagent Kit, List Number 07P4830 recall — FDA Z-0664-2019
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is…
Class IIFDA: TerminatedAbbott Ireland Diagnostics Division
Medical DeviceJan 2, 2019
Medical Action Industries Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' recall — FDA Z-0681-2019
Potential compromise of product sterility due to breach of sterile barrier.
Class IIFDA: TerminatedMedical Action Industries Inc.
Medical DeviceJan 2, 2019
Tosoh Bioscience AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for recall — FDA Z-0671-2019
Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays
Class IIFDA: TerminatedTosoh Bioscience Inc.
Medical DeviceJan 2, 2019
ICU Medical Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit recall — FDA Z-0662-2019
Potential for leakage due to defect in the thermoset check valve component.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceJan 2, 2019
ICU Medical Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per recall — FDA Z-0661-2019
Potential for leakage due to defect in the thermoset check valve component.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceJan 2, 2019
Elekta MOSAIQ Oncology Information System Version 2.64 recall — FDA Z-0686-2019
If a Setup field (CT, kV, MV or MVCT) is created by COPYING a treatment field or another setup field, then the copied field will have the same isocenter as the parent and that isocenter may…
Class IIFDA: TerminatedElekta, Inc.
Medical DeviceJan 2, 2019
Abbott Ireland Diagnostics Division Alinity i Free T4 Reagent Kit, List Number 07P7030 recall — FDA Z-0665-2019
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is…
Class IIFDA: TerminatedAbbott Ireland Diagnostics Division
Medical DeviceJan 2, 2019
Abbott Ireland Diagnostics Division Alinity i Estradiol Reagent Kit, List Number 07P5020 recall — FDA Z-0667-2019
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is…
Class IIFDA: TerminatedAbbott Ireland Diagnostics Division
Medical DeviceJan 2, 2019
Tosoh Bioscience ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY recall — FDA Z-0674-2019
ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers.…
Class IIFDA: TerminatedTosoh Bioscience Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.