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Cefazolin Injection (Sandoz) – Labeling Mix-Up (2025)

Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin

Class IHigh

FDAJun 27, 2025Nationwide• Sandoz Inc

Rich Bar (Rich Ice Cream) – Listeria contamination (2025)

Listeria

Potential Listeria Monocytogenes Contamination

Class IIModerate

FDAJun 27, 2025AL, AZ, CA +20 more• Rich Ice Cream Co

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Cefazolin Injection (Sandoz) – Labeling Mix-Up (2025)

Rich Bar (Rich Ice Cream) – Listeria contamination (2025)

Sprinter Cart Infusion Pole (Maquet) – Labeling Requirement (2025)

Breathing Circuit Set (Hamilton Medical) – Tubing Crack (2025)

Pitavastatin Tablets 2mg (AvKARE) – Impurity Specification Failure (2025)

RAPIDPoint 500 Wash Cartridge (Siemens) – Manufacturing Error (2025)

Black Fungus Slice (Wei-Chuan) – Salmonella Risk (2025)

UIBC Assay (Beckman Coulter) – Hemoglobin Interference (2025)

VITEK 2 Gram-Negative AST (bioMerieux) – Test Result Risk (2025)

Pitavastatin Tablets 1mg (AvKARE) – Impurity Specification Failure (2025)

DxI 800 Immunoassay Analyzer (Beckman Coulter) – Software Issue (2025)

UniCel DxI 800 Analyzer (Beckman Coulter) – Software Issue (2025)

FARAWAVE Ablation Catheter (Boston Scientific) – Electrode Band Crack (2025)

NobelBiocare Tri-Lobe Titanium Base (Preat) – Positioning Error (2025)

UniCel DxI 600 Analyzer (Beckman Coulter) – Software Issue (2025)

Shredded Tofu (Danshi) – Undeclared Sesame (2025)

DxI 600 Immunoassay Analyzer (Beckman Coulter) – Software Issue (2025)

DASH SARS-CoV-2 & Flu Test (Nuclein) – Diagnostic Accuracy (2025)

Lithium Orotate (Aceto) – Concentration Variance (2025)

Lithium Orotate 1MG (Enjoy Nutrition) – Potency Issue (2025)