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Showing 1421–1440 of 14370 results

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

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Class IIModerate

FDAJul 14, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Cardioplegia Solution (Central Admixture) – sterility uncertainty (2023)

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Class IIModerate

FDAJul 14, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Cardioplegia Solution (Central Admixture) – sterility concern (2023)

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Class IIModerate

FDAJul 14, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

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

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Class IIModerate

FDAJul 14, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Cardioplegia Solution (Central Admixture) – sterility concern (2023)

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Class IIModerate

FDAJul 14, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Cardioplegia Solution (Central Admixture) – sterility concern (2023)

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Class IIModerate

FDAJul 14, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Oxytocin IV Bag (Central Admixture) – sterility issue (2023)

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Class IIModerate

FDAJul 14, 2023Nationwide• Central Admixture Pharmacy Services, Inc.

Methylphenidate Tablets (Sun Pharmaceutical) – foreign substance (2023)

Presence of Foreign Substance: Metal embedded in a tablet.

Class IIModerate

FDAJul 13, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Testosterone Injection (New Vitalis) – sterility concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 13, 2023Nationwide• New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Uro Kid Support Capsules (Global Vitality) – E. Coli Risk (2023)

potential contamination with E coli

Class IIModerate

FDAJul 13, 2023CA, IN• Global Vitality Inc.

Serious Brain Enhancer Capsules (Global Vitality) – E coli contamination (2023)

potential contamination with E coli

Class IIModerate

FDAJul 13, 2023CA, IN• Global Vitality Inc.

Oxacillin Injection (Sagent) – sterility issue (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

Oxacillin Injection (Sagent) – sterility risk (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

Fingolimod Capsules (Ascend) – dissolution failure (2023)

Failed Dissolution Specifications

Class IIModerate

FDAJul 11, 2023Nationwide• Ascend Laboratories, LLC

Oxacillin Injection (Sagent) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAJul 11, 2023Nationwide• Sagent Pharmaceuticals

Succinylcholine Chloride Syringe (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

Hair-Skin-Nail Supplement (Emceta) – Labeling deficiency (2023)

FDA evaluation of Natural Systems brand HAIR - SKIN NAIL Dietary Supplement label disclosed several deficiencies to 21 CFR 101 Labeling Regulations.

FDAJul 10, 2023Nationwide• Emceta International Inc.

Tiagabine Hydrochloride Tablets (Sun Pharma) – Impurity Failure (2023)

Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing

Class IIModerate

FDAJul 10, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Rocuronium Bromide Syringe (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

Vancomycin IV Bag (Advanced Compounding) – Production Contamination (2023)

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

Class IIModerate

FDAJul 10, 2023Nationwide• New England Life Care, Inc. dba Advanced Compounding Solutions

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