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Showing 3081–3100 of 11714 results

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Metformin ER Tablets 500mg (Granules) – foreign tablet found (2024)

Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.

Class IIModerate

FDADec 30, 2024IN, OH• Granules Pharmaceuticals Inc.

Duloxetine Capsules 20mg (Rising Pharma) – CGMP impurity risk (2024)

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIModerate

FDADec 30, 2024Nationwide• Rising Pharma Holding, Inc.

Duloxetine Capsules 60mg (Rising Pharma) – CGMP impurity risk (2024)

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Class IIModerate

FDADec 30, 2024Nationwide• Rising Pharma Holding, Inc.

NeiMed NasoGel (Neilmed) – Spray Stability Failure (2024)

Due to nasal spray stability failure for bioburden.

FDADec 28, 2024Nationwide• Neilmed Pharmaceuticals Inc

Progesterone Injection 500mg (Eugia) – glass piece contamination (2024)

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

Class IIModerate

FDADec 27, 2024Nationwide• Eugia US LLC

Regard Newborn Kit (ROi CPS) – Pressure Loss Risk (2024)

There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP pressure ranges impacting effective ventilation of the patient..

FDADec 26, 2024MO• ROi CPS LLC

AnchorFast Guard Select Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

FDADec 23, 2024Nationwide• Hollister Incorporated

Centurion Infusion Catheter (Medline) – Mislabeling (2024)

Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.

FDADec 23, 2024FL, IL, KS +4 more• MEDLINE INDUSTRIES, LP Northfield

Medline Arterial Line Pack (Medline) – Mislabeling (2024)

Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.

FDADec 23, 2024FL, IL, KS +4 more• MEDLINE INDUSTRIES, LP Northfield

AnchorFast Oral Endotracheal Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

FDADec 23, 2024Nationwide• Hollister Incorporated

VDR4 Phasitron Breathing Circuit (Percussionaire) – Venturi Component Stuck (2024)

Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.

FDADec 23, 2024Nationwide• Percussionaire Corporation

Lev5 Susceptibility Discs (Oxoid) – Mislabeling Risk (2024)

Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.

FDADec 23, 2024CA, FL, MA +4 more• Oxoid Limited Wade Road Basingstoke United Kingdom

AnchorFast SlimFit Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

FDADec 23, 2024Nationwide• Hollister Incorporated

Astagraf XL 0.5mg (Astellas) – empty capsules risk (2024)

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

FDADec 23, 2024Nationwide• Astellas Pharma US Inc.

Ultra Repair Cream (First Aid Beauty) – distribution error (2024)

CGMP Deviations; product intended for quarantine was inadvertently distributed

Class IIModerate

FDADec 23, 2024Nationwide• First Aid Beauty Ltd

Prograf 0.5mg (Astellas) – empty capsules risk (2024)

Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules

FDADec 23, 2024Nationwide• Astellas Pharma US Inc.

AnchorFast Guard Tube Fastener (Hollister) – Skin Barrier Wear Time (2024)

Hollister received reports of decreased skin barrier wear time which could can lead to tube migration

FDADec 23, 2024Nationwide• Hollister Incorporated

ETHIBOND EXCEL Polyester Suture (Ethicon) – Packaging Seal Defect (2024)

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

FDADec 20, 2024Nationwide• Ethicon, LLC

Smart Drive MX2+ SpeedControl Dial (Max Mobility) – Circuit Board Fault (2024)

Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of device potentially resulting in minor and major injuries.

FDADec 20, 2024AL, AK, AZ +49 more• Max Mobility LLC

PERMA-HAND Silk Suture (Ethicon) – Packaging Seal Defect (2024)

Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.

FDADec 20, 2024Nationwide• Ethicon, LLC

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