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Showing 5161–5180 of 14370 results

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Methylcobalamin Injectable (RXQ Compounding) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 19, 2019Nationwide• RXQ Compounding LLC

Lidocaine HCL Injection (RXQ Compounding) – sterility concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 19, 2019Nationwide• RXQ Compounding LLC

Buffered Lidocaine with Epinephrine (RXQ Compounding) – sterility concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 19, 2019Nationwide• RXQ Compounding LLC

Procaine HCL Injectable Solution (RXQ Compounding) – sterility concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 19, 2019Nationwide• RXQ Compounding LLC

Vitamin B Complex Injection (RXQ Compounding) – sterility concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 19, 2019Nationwide• RXQ Compounding LLC

Buffered Lidocaine HCL Injection (RXQ Compounding) – sterility concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 19, 2019Nationwide• RXQ Compounding LLC

Hydrogen Peroxide Injectable 3% (RXQ Compounding) – Sterility Issue (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 19, 2019Nationwide• RXQ Compounding LLC

Edetate Disodium 15% Injectable (RXQ Compounding) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 19, 2019Nationwide• RXQ Compounding LLC

Methylcobalamin Injection 10 MG/ML (RXQ Compounding) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 19, 2019Nationwide• RXQ Compounding LLC

Vitamin B Complex Injection (RXQ) – Sterility Risk (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 19, 2019Nationwide• RXQ Compounding LLC

Mitomycin Irrigation (Premier Pharmacy Labs) – sterility risk (2019)

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Class IIModerate

FDAJun 18, 2019Nationwide• Premier Pharmacy Labs Inc

Neostigmine Methylsulfate Syringe (Premier Pharmacy) – sterility risk (2019)

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Class IIModerate

FDAJun 18, 2019Nationwide• Premier Pharmacy Labs Inc

Isoproterenol HCL in D5W (Premier Pharmacy Labs) – sterility risk (2019)

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Class IIModerate

FDAJun 18, 2019Nationwide• Premier Pharmacy Labs Inc

Droperidol Injectable Solution (Premier Pharmacy) – sterility concern (2019)

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Class IIModerate

FDAJun 18, 2019Nationwide• Premier Pharmacy Labs Inc

Lidocaine/Phenylephrine INJ (Premier Pharmacy Labs) – sterility risk (2019)

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Class IIModerate

FDAJun 18, 2019Nationwide• Premier Pharmacy Labs Inc

Dexamethasone Sodium Phosphate (Premier Pharmacy Labs) – sterility risk (2019)

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Class IIModerate

FDAJun 18, 2019Nationwide• Premier Pharmacy Labs Inc

Atropine Sulfate INJ (Premier Pharmacy Labs) – sterility risk (2019)

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Class IIModerate

FDAJun 18, 2019Nationwide• Premier Pharmacy Labs Inc

Sodium Bicarbonate INJ (Premier Pharmacy Labs) – sterility risk (2019)

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Class IIModerate

FDAJun 18, 2019Nationwide• Premier Pharmacy Labs Inc

Succinylcholine Chloride Syringe Large (Premier Pharmacy) – sterility risk (2019)

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Class IIModerate

FDAJun 18, 2019Nationwide• Premier Pharmacy Labs Inc

Naloxone HCL INJ (Premier Pharmacy Labs) – sterility risk (2019)

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

Class IIModerate

FDAJun 18, 2019Nationwide• Premier Pharmacy Labs Inc

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