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Enoxaparin Sodium Injection (Cardinal Health) - Product Mispack (2025)

Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL

Class IIModerate

FDAAug 5, 2025KS• Cardinal Health Inc.

Sensodyne PRONAMEL (Haleon) - Labeling Mix-up (2025)

Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton

Class IIILow

FDAAug 5, 2025Nationwide• Haleon US Holdings LLC

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Enoxaparin Sodium Injection (Cardinal Health) - Product Mispack (2025)

Sensodyne PRONAMEL (Haleon) - Labeling Mix-up (2025)

Unity Accessory Devices (Alcon) – incomplete seal (2025)

Frozen Half Shell Oysters (Khee Trading) – Norovirus Risk (2025)

Frozen Half Shell Oysters (Khee Trading) – Norovirus Risk (2025)

Baby Bedtime Drops (M.O.M Enterprises) – Yeast Contamination (2025)

MediHoney Paste (Integra) – packaging failure (2025)

Ramen Noodles (Kobayashi) – Undeclared Soy (2025)

DxC 500 Analyzer (Beckman Coulter) – test processing issue (2025)

Raman Spectrometers (Wasatch Photonics) – laser safety (2025)

PhD Hemostasis Valve (Merit Medical) – manufacturing defect (2025)

Halyard CPT Basic IR Pack (AVID Medical) – seal compromise (2025)

Novum IQ Large Volume Pump (Baxter) – device correction (2025)

Novum IQ Syringe Pump (Baxter) – device correction (2025)

Epinephrine Injection (Pfizer) - Sterility Issue (2025)

Halyard ENT Pack (AVID Medical) – seal compromise (2025)

Lactated Ringer's Injection (B Braun) - Sterility Concern (2025)

Potato Salad (Hans Kissle) – Undeclared Wheat (2025)

Sodium Chloride Injection (B Braun) - Sterility Concern (2025)

Sodium Bicarbonate Injection (Pfizer) - Sterility Issue (2025)