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Showing 2101–2120 of 14370 results

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Glycopyrrolate (AVKARE) – Impurity Specification Failure (2022)

Failed impurities/degradation specifications: Out of specification for unknown impurities.

Class IIModerate

FDADec 22, 2022Nationwide• AVKARE LLC

Mitomycin Ophthalmic Solution (Pharmacy Innovations) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

Scopolamine Ophthalmic Solution (Pharmacy Innovations) – sterility concern (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

Vancomycin Hydrochloride (Pfizer) – Glass Particulate Matter (2022)

Presence of Particulate Matter: Glass particulate matter detected in injectable.

FDADec 22, 2022Nationwide• Pfizer Inc.

Dutasteride (Pharmacy Innovations) – Sterility Risk (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

Tobramycin Fortified Ophthalmic Solution (Pharmacy Innovations) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

Magnesium Chloride (Pharmacy Innovations) – Sterility Risk (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

Hydroxocobalamin Injectable (Pharmacy Innovations) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

Vancomycin Ophthalmic Solution (Pharmacy Innovations) – sterility concern (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

5-Fluorouracil (Pharmacy Innovations) – Sterility Risk (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

PE1/Papaverine Combination Injectable (Pharmacy Innovations) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

Methylcobalamin Injection (Pharmacy Innovations) – sterility concern (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

Phosphatidylcholine/Deoxycholic Acid (Pharmacy Innovations) – Sterility Risk (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

Methotrexate Intravitreal Injectable (Pharmacy Innovations) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

Phenol Injection (Pharmacy Innovations) – sterility concern (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

NADH Injectable (Pharmacy Innovations) – sterility concerns (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

Glycerin Injectable (Pharmacy Innovations) – sterility concern (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

Edetate Calcium Disodium (Pharmacy Innovations) – Sterility Risk (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

Mitomycin Ophthalmic Solution (Pharmacy Innovations) – sterility concern (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

Glycerin Lidocaine Injection (Pharmacy Innovations) – sterility concern (2022)

Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.

Class IIModerate

FDADec 22, 2022Nationwide• Pharmacy Innovations

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