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Atorvastatin Tablets (Nivagen) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.

Class IIModerate

FDASep 24, 2024Nationwide• Nivagen Pharmaceuticals Inc

Ryaltris Nasal Spray (Glenmark) – Clogged Delivery System (2024)

Defective Delivery System: The dip tube is clogged causing the spray not to work.

Class IIModerate

FDASep 24, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

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Atorvastatin Tablets (Nivagen) – Foreign Tablet Contamination (2024)

Ryaltris Nasal Spray (Glenmark) – Clogged Delivery System (2024)

Medex TranStar OR Set (Smiths Medical) – Pressure Monitoring (2024)

Medex TranStar Monitoring Kit (Smiths Medical) – Pressure Monitoring (2024)

Medex TranStar Stopcock (Smiths Medical) – Pressure Monitoring (2024)

Percept RC Neurostimulator (Medtronic) – Programming Compatibility (2024)

Fitbone Trochanteric Nail (Orthofix) – Potential Bending (2024)

KLS Martin Battery Pack (Pro-Dex) – Tyvek Shavings (2024)

Pluvicto Injection (Advanced Accelerator) – Manufacturing Deviations (2024)

Eleos Male-Female Midsection (Onkos Surgical) – Assembly Challenge (2024)

Surgical Strip (Integra) – Endotoxin Levels (2024)

Halyard Pacemaker Instrument Pack (AVID Medical) – Metal Flake Risk (2024)

Halyard Ortho Pack (AVID Medical) – Metal Flake Risk (2024)

Halyard Open Heart Pack (AVID Medical) – Metal Flake Risk (2024)

Halyard D & C Pack (AVID Medical) – Metal Flake Risk (2024)

Halyard IR Biopsy Pack (AVID Medical) – Metal Flake Risk (2024)

Halyard Eye Plastic Tray (AVID Medical) – Metal Flake Risk (2024)

Halyard Pacemaker Pack (AVID Medical) – Metal Flake Risk (2024)

Halyard Endovascular Kit (AVID Medical) – Metal Flake Risk (2024)

Surgical Strip (Integra) – Endotoxin Levels (2024)