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Showing 1521–1540 of 14370 results

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Ceftriaxone 2g Injection (Astral SteriTech) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 15, 2023Nationwide• Astral SteriTech Private Ltd.

Piperacillin Tazobactam 3.375g Injection (Astral SteriTech) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 15, 2023Nationwide• Astral SteriTech Private Ltd.

Cefepime 2g Injection (Astral SteriTech) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 15, 2023Nationwide• Astral SteriTech Private Ltd.

Ceftriaxone 500mg Injection (Astral SteriTech) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 15, 2023Nationwide• Astral SteriTech Private Ltd.

Ampicillin Injection (Astral SteriTech) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 15, 2023Nationwide• Astral SteriTech Private Ltd.

Ceftriaxone 250mg Injection (Astral SteriTech) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 15, 2023Nationwide• Astral SteriTech Private Ltd.

Ceftriaxone 1g Injection (Astral SteriTech) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 15, 2023Nationwide• Astral SteriTech Private Ltd.

Ampicillin-Sulbactam Injection 1.5g (Astral SteriTech) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 15, 2023Nationwide• Astral SteriTech Private Ltd.

Ampicillin and Sulbactam Injection (Astral SteriTech) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 15, 2023Nationwide• Astral SteriTech Private Ltd.

Ceftriaxone Pharmacy Bulk Injection (Astral SteriTech) – Sterility Concerns (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 15, 2023Nationwide• Astral SteriTech Private Ltd.

Ampicillin-Sulbactam Injection 3g (Astral SteriTech) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 15, 2023Nationwide• Astral SteriTech Private Ltd.

Ampicillin Injection 250mg (Astral SteriTech) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 15, 2023Nationwide• Astral SteriTech Private Ltd.

Cefepime Injection (Astral SteriTech) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 15, 2023Nationwide• Astral SteriTech Private Ltd.

Ascorbic Acid Injection (Empower Pharmacy) – Mislabeling Concern (2023)

Mislabeling: preservative free product labeled as preserved.

Class IIModerate

FDAMay 12, 2023Nationwide• Empower Clinic Services LLC dba Empower Pharmacy

Tirzepatide Solution (Revive Rx) – Sub-potent Drug (2023)

Sub-potent Drug

Class IIModerate

FDAMay 11, 2023Nationwide• Revive Rx LLC dba Revive Rx Pharmacy

Lorazepam Injection (Hikma) – Impurity Specification Failure (2023)

Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.

Class IIModerate

FDAMay 11, 2023Nationwide• Hikma Pharmaceuticals USA Inc.

HYDROmorphone HCl (SSM Health) – CGMP Program Discontinuation (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 9, 2023IN, MO• SSM Health Care St. Louis DBA SSM St. Clare Health Center

Bupropion Hydrochloride Tablets (Sun Pharma) – Failed Dissolution Test (2023)

Failed Dissolution Specifications; during stability testing

Class IIModerate

FDAMay 9, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Methylprednisolone Acetate (Amneal) – Labeling Error (2023)

Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.

FDAMay 8, 2023Nationwide• Amneal Pharmaceuticals of New York, LLC

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

CGMP Deviations

Class IIModerate

FDAMay 3, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

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