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Alpha Test (Iovate) - Cathine Presence (2024)

Presence of cathine in product

FDADec 18, 2024AZ, CA, CO +27 more• Iovate Health Sciences USA Inc.

HemosIL Heparin Calibrators (Instrumentation Laboratory) – Quality Control Problem (2024)

Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.

Moderate

FDADec 18, 2024Nationwide• Instrumentation Laboratory

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Alpha Test (Iovate) - Cathine Presence (2024)

HemosIL Heparin Calibrators (Instrumentation Laboratory) – Quality Control Problem (2024)

Olympus MAJ-891 Forceps/Irrigation Plug (Olympus) – Biomaterial Retention Risk (2024)

Colchicine Capsules 0.6mg (Granules) – dissolution failure (2024)

Wicklow Gold Cheddar Nettle & Chive (Abbey) - Listeria Risk (2024)

VinFast VF 8 (VinFast) – Center Airbag Deployment Risk (2024)

Cummins B6.7 (Cummins) – Cooling System Component Failure (2024)

Cummins Power Generation Generator Set (Cummins) – Wire Lead Chafing (2024)

GlipiZIDE Extended-Release Tablets (Amerisource) – Dissolution Failure (2024)

Tesla Model 3 (Tesla) – Tire Pressure Monitor Malfunction (2024)

InVision 3-Burner Cooktop (InVision) – Burner Tube Cracking (2024)

Orgain Plant Protein (Orgain) - Peanut Allergen (2024)

Keith Valley Mustard (Clements) - Salmonella Contamination (2024)

CODMAN CERTAS Plus Valve (Integra) – Incorrect Product Labels (2024)

Medline Fluid Delivery Set (Medline) – Drip Chamber Mismatch (2024)

Mitsubishi Fuso Rizon FEC9K (Mitsubishi Fuso) – Circuit Current Damage (2024)

LithoCrushV Mechanical Lithotriptor (Olympus) – Distal Tip Tearing (2024)

FOUZEE SugarLin Herbal Capsules (Shoppers-Plaza) – Undeclared Medications (2024)

Atropine Sulfate Ophthalmic Solution (Somerset) – Impurity Specifications (2024)

Ciprofloxacin Ophthalmic Solution (FDC Limited) – Defective Container (2024)