DrugJan 31, 2024
Benzonatate Capsules, USP, 100 mg, 100 Capsules recall — FDA D-0257-2024
Superpotent drug: Assay results were slightly above specification at the time zero point.
Class IIIFDA: OngoingAmerisource Health Services LLC
January 2024 recalls — page 3
These records include useful source details for the selected month.
DrugJan 31, 2024
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg recall — FDA D-0271-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Febuxostat Tablets 40mg recall — FDA D-0264-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Febuxostat Tablets 80 mg recall — FDA D-0265-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Niacin Extended-Release Tablets, USP 1000mg recall — FDA D-0269-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Niacin Extended-Release Tablets, USP 500mg recall — FDA D-0270-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Lurasidone Hydrochloride Tablets 120mg recall — FDA D-0267-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Cinacalcet Tablets 60mg recall — FDA D-0263-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet recall — FDA D-0268-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg recall — FDA D-0272-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugJan 31, 2024
Lurasidone Hydrochloride Tablets 60mg recall — FDA D-0266-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: CompletedSUN PHARMACEUTICAL INDUSTRIES Inc.
VehicleJan 30, 2024
Tesla instrument cluster/panel recall — NHTSA campaign 24V051000
Tesla, Inc. (Tesla) is recalling certain 2012-2023 Model S, 2016-2024 Model X, 2017-2023 Model 3, 2019-2024 Model Y, and 2024 Cybertruck vehicles. An incorrect font size is displayed on the…
instrument cluster/panelTesla, Inc.
Medical DeviceJan 24, 2024
Abbott Diabetes Care FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System recall — FDA Z-0734-2024
If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive…
Class IIFDA: CompletedAbbott Diabetes Care, Inc.
Medical DeviceJan 24, 2024
Becton Dickinson & Company PosiFlush Prefilled Saline Syringe with General Pump recall — FDA Z-0736-2024
An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this…
Class IIFDA: OngoingBecton Dickinson & Company
Medical DeviceJan 24, 2024
Johnson & Johnson Surgical Vision TECNIS Toric II OptiBlue IOL Models ZCW recall — FDA Z-0735-2024
Due to intraocular lens containing an angle out of specification (OOS). The cylinder axis marks do not meet product specifications for the allowable angle between Low Power Meridian (LPM)…
Class IIFDA: OngoingJohnson & Johnson Surgical Vision, Inc.
Medical DeviceJan 24, 2024
Oakworks Ultrasound EA (Ergonomic Advantage) table versions recall — FDA Z-0727-2024
Backrest platform stress fracture - the table is not operational in an inclined position
Class IIFDA: OngoingOakworks Inc.
Medical DeviceJan 24, 2024
Smiths Medical Asd Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R recall — FDA Z-0742-2024
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate…
Class IIFDA: OngoingSmiths Medical Asd Inc.
Medical DeviceJan 24, 2024
Getinge Usa Sales Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII recall — FDA Z-0762-2024
A potential for a light system to fall in the operating room.
Class IIFDA: OngoingGetinge Usa Sales Inc.
Medical DeviceJan 24, 2024
Randox Laboratories Calibration Serum Level 3 recall — FDA Z-0751-2024
There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and…
Class IIFDA: OngoingRandox Laboratories Ltd.
Medical DeviceJan 24, 2024
Smiths Medical Asd 20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR recall — FDA Z-0745-2024
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate…
Class IIFDA: OngoingSmiths Medical Asd Inc.
Medical DeviceJan 24, 2024
Olympus Corporation of the Americas Soltive SuperPulsed Laser System TFL FIBER CLEAVER recall — FDA Z-0717-2024
The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile…
Class IIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceJan 24, 2024
Smiths Medical Asd Medex LOGICAL CATH LAB KIT, List Number M20754 recall — FDA Z-0739-2024
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate…
Class IIFDA: OngoingSmiths Medical Asd Inc.
Medical DeviceJan 24, 2024
PHASE SCIENTIFIC INTERNATIONAL INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040 recall — FDA Z-0738-2024
COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could produce…
Class IIFDA: OngoingPHASE SCIENTIFIC INTERNATIONAL LIMITED
Medical DeviceJan 24, 2024
Sarnova HC Curaplex Field Cric Kit with ET Tube, Item Number 36611 recall — FDA Z-0720-2024
It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy procedure, leaving practitioners without the necessary means to secure…
Class IIFDA: OngoingSarnova HC, LLC
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.