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Ezetimibe and Simvastatin Tablets (Glenmark) – Impurity Specification Failure (2025)

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.

Class IIILow

FDAMay 19, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Hummingbird EMG Kit (Neurovision Medical) – Packaging Error (2025)

Product packaging contains the wrong part number and kit contents.

Low

FDAMay 19, 2025CA• Neurovision Medical Products Inc

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Ezetimibe and Simvastatin Tablets (Glenmark) – Impurity Specification Failure (2025)

Hummingbird EMG Kit (Neurovision Medical) – Packaging Error (2025)

Vegetable Singara (South Asian Food) – Undeclared Peanut (2025)

Q-Stop Suture Device (Drs Vascular) – Unknown Issue (2025)

GE LOGIQ F R3 Ultrasound (GE Healthcare) – Fetal Weight Measurement (2025)

2025 Isuzu NRR EV (Isuzu) – Electrical System Risk (2025)

GE Versana Ultrasound (GE Healthcare) – Fetal Weight Measurement (2025)

ARTIS Angiography System (Siemens) – Dose Sensor Error (2025)

Interventional X-Ray System (Siemens) – Dose Sensor Error (2025)

2025 Volkswagen ID. Buzz (Volkswagen) – Seat Configuration (2025)

Broselow Pediatric Tape (SunMed) – Incorrect Zone Information (2025)

Beacon Tip Angiographic Catheter (Cook) – Tip Separation (2025)

2026 IC Bus CESB (IC Bus) – Parking Brake Issue (2025)

Digital Wall Clocks – Ingestion Risk (2025)

Medline Umbilical Tray (Medline) – Packaging Defect (2025)

Nutrifill Contact Lens Solution (Contamac) – Sterility Issue (2025)

Adult Portable Bed Rails (LivingCaring) – Entrapment Risk (2025)

PlayTab Rollers Tile Toys – Magnet Ingestion Risk (2025)

Ranger XP 1000 NorthStar (Polaris) – Vehicle Safety (2025)

Child Safety Gates – Entrapment Fall Risk (2025)