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Showing 3341–3360 of 29086 results

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Pin-Away Pyrental Pamoate (Denison) – Non-Food Grade Lubricant (2023)

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Class IIModerate

FDAMay 3, 2023Nationwide• Denison Pharmaceuticals, LLC

Buprenorphine Sublingual Tablets (Sun Pharma) – CGMP Issues (2023)

CGMP Deviations

Class IIModerate

FDAMay 3, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Colic Calm (Denison) – Non-Food Grade Lubricant (2023)

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Class IIModerate

FDAMay 3, 2023Nationwide• Denison Pharmaceuticals, LLC

Safe Tussin PM (Denison) – Non-Food Grade Lubricant (2023)

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Class IIModerate

FDAMay 3, 2023Nationwide• Denison Pharmaceuticals, LLC

Safe Tussin DM (Denison) – Non-Food Grade Lubricant (2023)

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

Class IIModerate

FDAMay 3, 2023Nationwide• Denison Pharmaceuticals, LLC

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

PHENYLephrine HCl 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

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