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Showing 1541–1560 of 14370 results

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FentaNYL Syringe Injection (Apollo Care) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Norepinephrine Dextrose (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Norepinephrine Sodium Chloride Injection (Apollo Care) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

VANComycin Sodium Chloride Injection (Apollo Care) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Fentanyl Ropivacaine Injection (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Ketamine Injection (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Vancomycin Sodium Chloride (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

Succinylcholine Injection (Apollo Care) – Sterility Assurance Lack (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

VANComycin Sodium Chloride Injection (Apollo Care) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 2, 2023MO• Apollo Care, LLC

LORazepam Injection 2mg (RemedyRepack) – Quality Program Issue (2023)

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Class IIModerate

FDAMay 1, 2023IN, PA• RemedyRepack Inc.

Norepinephrine Dextrose (Central Admixture) – Sterility Concerns (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Neonatal TPN Starter Bag 4% (Central Admixture) – sterility risk (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

MSA MSG Comp Solution (Central Admixture) – Sterility Concerns (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Cardioplegia Solution Low Potassium (Central Admixture) – sterility risk (2023)

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Class IIModerate

FDAApr 28, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

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