DrugOct 11, 2023
Central Admixture Pharmacy Services fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% recall — FDA D-0016-2024
Lack of assurance of sterility:
Class IIFDA: TerminatedCentral Admixture Pharmacy Services Inc.
October 2023 recalls — page 6
These records include useful source details for the selected month.
DrugOct 11, 2023
Dr. Berne's Whole Health Products Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle recall — FDA D-0033-2024
CGMP Deviations
Class IIFDA: OngoingDr. Berne's Whole Health Products
DrugOct 11, 2023
Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL), 10 mL recall — FDA D-0041-2024
Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial.
Class IIFDA: OngoingEugia US LLC
DrugOct 11, 2023
Dr. Berne's Whole Health Products Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle recall — FDA D-0036-2024
CGMP Deviations
Class IIFDA: OngoingDr. Berne's Whole Health Products
DrugOct 11, 2023
Amerisource Health Services HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets recall — FDA D-0039-2024
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Class IIIFDA: TerminatedAmerisource Health Services LLC
DrugOct 11, 2023
Central Admixture Pharmacy Services fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% recall — FDA D-0015-2024
Lack of assurance of sterility:
Class IIFDA: TerminatedCentral Admixture Pharmacy Services Inc.
DrugOct 11, 2023
Dr. Berne's Whole Health Products Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle recall — FDA D-0034-2024
CGMP Deviations
Class IIFDA: OngoingDr. Berne's Whole Health Products
DrugOct 11, 2023
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) recall — FDA D-0038-2024
Failed Dissolution Specifications
Class IIFDA: TerminatedZydus Pharmaceuticals (USA) Inc.
DrugOct 11, 2023
Dr. Berne's Whole Health Products Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 recall — FDA D-0035-2024
CGMP Deviations
Class IIFDA: OngoingDr. Berne's Whole Health Products
DrugOct 11, 2023
Central Admixture Pharmacy Services fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% recall — FDA D-0017-2024
Lack of assurance of sterility:
Class IIFDA: TerminatedCentral Admixture Pharmacy Services Inc.
VehicleOct 11, 2023
Model X electrical system recall — NHTSA campaign 23V679000
Tesla, Inc. (Tesla) is recalling certain 2021-2023 Model X vehicles. The vehicle controller may fail to detect low brake fluid and will not display a warning light. As such, these vehicles…
electrical systemTesla, Inc.
VehicleOct 6, 2023
Explorer driveshaft recall — NHTSA campaign 23V675000
Ford Motor Company (Ford) is recalling certain 2020-2022 Explorer vehicles. The rear axle horizontal mounting bolt may fracture and cause the driveshaft to disconnect.
driveshaftFord Motor Company
Medical DeviceOct 4, 2023
Wolf, Henke Sass, Gmbh Henke-Ject-2 part luer sterile single use syringes - used for recall — FDA Z-2642-2023
Sterile barrier might be damaged compromising the sterility of the device.
Class IIFDA: OngoingWolf, Henke Sass, Gmbh
Medical DeviceOct 4, 2023
3M Company - Health Care Business 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack recall — FDA Z-2639-2023
Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam…
Class IIFDA: Ongoing3M Company - Health Care Business
Medical DeviceOct 4, 2023
Fresenius Kabi USA Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and recall — FDA Z-2635-2023
Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the…
Class IIFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceOct 4, 2023
3M Company - Health Care Business 3M Attest Super Rapid Readout Steam Challenge Pack, REF recall — FDA Z-2638-2023
Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam…
Class IIFDA: Ongoing3M Company - Health Care Business
Medical DeviceOct 4, 2023
3M Company - Health Care Business 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack recall — FDA Z-2640-2023
Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam…
Class IIFDA: Ongoing3M Company - Health Care Business
Medical DeviceOct 4, 2023
Covidien Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cm recall — FDA Z-2632-2023
Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling…
Class IIFDA: OngoingCovidien LP
Medical DeviceOct 4, 2023
B. Braun Medical B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver recall — FDA Z-2643-2023
The sterile blister packaging may be damaged, and sterility may be compromised
Class IIFDA: OngoingB. Braun Medical, Inc.
Medical DeviceOct 4, 2023
Inmar Supply Chain Solutions Various Medical Products stored on pallets, including but not recall — FDA Z-2634-2023
Various medical devices potentially exposed to rodent and rodent activity. In addition, medical devices may have been subjected to temperatures in excess of storage requirements on product…
Class IIFDA: OngoingInmar Supply Chain Solutions, LLC
Medical DeviceOct 4, 2023
Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data recall — FDA Z-2628-2023
Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device combust…
Class IIFDA: OngoingAmbu Inc.
Medical DeviceOct 4, 2023
Exocad GmbH exoplan version 3.1 Rijeka Software -A medical software, intended to support the recall — FDA Z-2633-2023
A software library filtering error has been discovered which occurs when users are using the Step-by-Step Full Drill Protocol export functionality of exoplan 3.1 Rijeka. When a guided…
Class IIFDA: OngoingExocad GmbH
Medical DeviceOct 4, 2023
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) recall — FDA Z-2647-2023
Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceOct 4, 2023
B. Braun Medical B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to recall — FDA Z-2644-2023
The sterile blister packaging may be damaged, and sterility may be compromised
Class IIFDA: OngoingB. Braun Medical, 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.