DrugMar 20, 2024
Optikem International TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 recall — FDA D-0382-2024
Lack of Assurance of Sterility
Class IIFDA: OngoingOptikem International, Inc.
March 2024 recalls — page 5
These records include useful source details for the selected month.
DrugMar 20, 2024
Micro Labs Telmisartan Tablets, USP 40mg recall — FDA D-0388-2024
Failed Stability Specifications: Out of specification for blend uniformity.
Class IIFDA: TerminatedMicro Labs Limited
DrugMar 20, 2024
Optikem International TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 recall — FDA D-0383-2024
Lack of Assurance of Sterility
Class IIFDA: OngoingOptikem International, Inc.
DrugMar 20, 2024
Optikem International TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic recall — FDA D-0381-2024
Lack of Assurance of Sterility
Class IIFDA: OngoingOptikem International, Inc.
DrugMar 20, 2024
Broncochem Cold & Tea recall — FDA D-0387-2024
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class IIFDA: OngoingGlobal Corporation
DrugMar 20, 2024
Febuxostat Tablets 40mg recall — FDA D-0368-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugMar 20, 2024
Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL recall — FDA D-0371-2024
cGMP Deviations: Products were stored outside the drug label specifications.
Class IIFDA: TerminatedMckesson Medical-Surgical Inc. Corporate Office
DrugMar 20, 2024
Febuxostat Tablets 80mg recall — FDA D-0369-2024
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class IIFDA: OngoingSUN PHARMACEUTICAL INDUSTRIES Inc.
DrugMar 20, 2024
Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package recall — FDA D-0385-2024
Failed Stability Specification: Water determination was found not complying with specification.
Class IIFDA: TerminatedEugia US LLC
DrugMar 20, 2024
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag recall — FDA D-0370-2024
Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.
Class IIFDA: TerminatedB. Braun Medical Inc.
DrugMar 20, 2024
Mckesson Medical-Surgical Inc. Corporate Office Bicillin L-A (Penicillin G Benzathine) 1.2 recall — FDA D-0373-2024
cGMP Deviations: Products were stored outside the drug label specifications.
Class IIFDA: TerminatedMckesson Medical-Surgical Inc. Corporate Office
DrugMar 20, 2024
Global Broncochem Cold & Flu Syrup Kids recall — FDA D-0386-2024
Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Class IIFDA: OngoingGlobal Corporation
VehicleMar 14, 2024
Ram ProMaster wiring recall — NHTSA campaign 24V197000
Chrysler (FCA US, LLC) (Stellantis) is recalling certain 2021-2022 Ram ProMaster vehicles. The wiring harness may have a poor connection, which can cause the left taillight and left turn…
wiringChrysler (FCA US, LLC) (Stellantis)
VehicleMar 14, 2024
Chrysler (FCA US, LLC) driver clockspring/spiral cassette recall — NHTSA campaign 24V199000
Chrysler (FCA US, LLC) (Stellantis) is recalling certain 2023-2024 Ram 1500, Jeep Wrangler, Jeep Wagoneer, Jeep Grand Wagoneer, Chrysler Pacifica, Ram 3500, Ram 3500 cab chassis, Ram 2500,…
driver clockspring/spiral cassetteChrysler (FCA US, LLC) (Stellantis)
Medical DeviceMar 13, 2024
Ortho-Clinical Diagnostics VITROS XT 3400 Chemistry System, Catalog No. 6844458 recall — FDA Z-1232-2024
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined,…
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
Medical DeviceMar 13, 2024
Canon Medical System, USA MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550 recall — FDA Z-1248-2024
For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG…
Class IIFDA: OngoingCanon Medical System, USA, Inc.
Medical DeviceMar 13, 2024
Ortho-Clinical Diagnostics VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 recall — FDA Z-1229-2024
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined,…
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
Medical DeviceMar 13, 2024
Synthes (USA) Products TFNA Femoral Nail 11mm, right, 130, L 235mm-Intended for temporary recall — FDA Z-1240-2024
Products not sterilized, sterility cannot be confirmed
Class IIFDA: OngoingSynthes (USA) Products LLC
Medical DeviceMar 13, 2024
Waldemar Link GmbH & Co. KG Embrace Drill Tower, Standard/Lateral (25mm) recall — FDA Z-1258-2024
The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the…
Class IIFDA: OngoingWaldemar Link GmbH & Co. KG (Mfg Site)
Medical DeviceMar 13, 2024
Micro Therapeutics The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible recall — FDA Z-1252-2024
European version of microcatheter were distributed within US which contain a different "Indications for Use".
Class IIFDA: OngoingMicro Therapeutics, Inc.
Medical DeviceMar 13, 2024
Ortho-Clinical Diagnostics VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and recall — FDA Z-1225-2024
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous…
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
Medical DeviceMar 13, 2024
Ortho-Clinical Diagnostics VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and recall — FDA Z-1231-2024
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined,…
Class IIFDA: OngoingOrtho-Clinical Diagnostics, Inc.
Medical DeviceMar 13, 2024
FUJIFILM Healthcare Americas Synapse PACS - Version 7.2.200 recall — FDA Z-1272-2024
Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
Class IIFDA: OngoingFUJIFILM Healthcare Americas Corporation
Medical DeviceMar 13, 2024
Synthes (USA) Products RIA Tube Assembly, minimum 520 mm length, sterile- intended for use recall — FDA Z-1237-2024
Products not sterilized, sterility cannot be confirmed
Class IIFDA: OngoingSynthes (USA) Products 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.