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intelliPATH HRP Detection Kit (Biocare) – Weak Staining (2024)

Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated.

Moderate

FDASep 25, 2024Nationwide• Biocare Medical, LLC

Norepinephrine Injection (Fresenius Kabi) – Manufacturing Violations (2024)

cGMP violations

Class IIModerate

FDASep 25, 2024Nationwide• Fresenius Kabi Compounding, LLC

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intelliPATH HRP Detection Kit (Biocare) – Weak Staining (2024)

Norepinephrine Injection (Fresenius Kabi) – Manufacturing Violations (2024)

Norepinephrine Injection (Fresenius Kabi) – Manufacturing Violations (2024)

Phenylephrine HCl Injection (Fresenius Kabi) – Manufacturing Violations (2024)

Epinephrine Sodium Chloride (Fresenius Kabi) – Manufacturing Violations (2024)

Phenylephrine HCl Injection (Fresenius Kabi) – Manufacturing Violations (2024)

Vancomycin HCl Injection (Fresenius Kabi) – Manufacturing Violations (2024)

Phenylephrine HCl Injection (Fresenius Kabi) – Manufacturing Violations (2024)

Phenylephrine HCl Injection (Fresenius Kabi) – Manufacturing Violations (2024)

Oxytocin Injection (Fresenius Kabi) – Manufacturing Violations (2024)

Thiamine HCl Injection (Fresenius Kabi) – Manufacturing Violations (2024)

Adult Cough Medicine (Denison) – Crystallization Issue (2024)

Kids Cough Medicine (Denison) – Crystallization Issue (2024)

Medex TranStar DPT Stopcocks (Smiths Medical) – Pressure Monitoring (2024)

Medex TranStar Single 84in Kit (Smiths Medical) – Pressure Monitoring (2024)

Medex TranStar Kids 34in Kit (Smiths Medical) – Pressure Monitoring (2024)

Medex TranStar Kids 19in Kit (Smiths Medical) – Pressure Monitoring (2024)

Medex TranStar 84in Single Set (Smiths Medical) – Pressure Monitoring (2024)

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

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