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Showing 1261–1280 of 14370 results

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Cardioplegia Solution (CAPS) – Sterility Validation (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Neonatal TPN 3.5% Bag (CAPS) – Sterility Validation (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Cardioplegia Solution (Central Admixture) – Sterility Concern (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Neonatal TPN 3.5% Low Bag (CAPS) – Sterility Validation (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Neonatal TPN Starter Bag (Central Admixture) – Sterility Concern (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Phenylephrine Sodium Chloride Syringe (Central Admixture) – Sterility Concern (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Vancomycin Sodium Chloride IV Bag (Central Admixture) – Sterility Concern (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Cardioplegia High K Solution (CAPS) – Sterility Validation (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Epinephrine IV Bag (Central Admixture) – Sterility Concern (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Neonatal TPN Starter Bag (Central Admixture) – Sterility Concern (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Diltiazem Sodium Chloride IV Bag (Central Admixture) – Sterility Concern (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

dilTIAZem IV Bag (Central Admixture) – sterility concern (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Epinephrine IV Bag (Central Admixture) – sterility concern (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Oxytocin Sodium Chloride IV Bag (Central Admixture) – Sterility Concern (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Epinephrine Dextrose IV Bag (Central Admixture) – Sterility Concern (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Phenylephrine Sodium Chloride IV Bag (Central Admixture) – Sterility Concern (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Neonatal TPN Starter Bag (Central Admixture) – Sterility Concern (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Cardioplegia Solution (Central Admixture) – Sterility Concern (2023)

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

Class IIModerate

FDAAug 17, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Nexlizet (Esperion) – dissolution specification failure (2023)

Failed dissolution specifications: below specification results at stability 12-month

FDAAug 16, 2023Nationwide• Esperion

Biotin Supplement (Pharma-Natural) – Low Biotin Content (2023)

FDA sample analysis of Pharma Natural Biotin 5000 mcg Maximum Strength (30 tablets, Lot: PN10686, Exp. Date 01/24), found the biotin content was below the detection limit.

FDAAug 15, 2023PR• Pharma-Natural Inc.

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