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Showing 2021–2040 of 14370 results

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QuadMix Plus (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

Mitomycin Injection (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

TriMix Plus PGE1/Papaverine (Northern VA Compounders) – sterility concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

TriMix Injection (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

TriMix Injection (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

TriMix Injection PGE1/Papaverine (Northern VA Compounders) – sterility concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

TriMix Injection PGE1/Papaverine (Northern VA Compounders) – sterility concern (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

QuadMix Super 002 (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

Methylcobalamin Injection (Northern VA Compounders) – Sterility Issue (2022)

Lack of Assurance of Sterility

Class IIModerate

FDADec 30, 2022Nationwide• Northern VA Compounders PLLC

Heparin Sodium 2,000 Units (Pfizer) – potential leakage (2022)

Lack of assurance of sterility: Bags have the potential to leak.

Class IIModerate

FDADec 29, 2022Nationwide• Pfizer Inc.

Rasagiline Mesylate Tablets (Ascend Labs) – foreign substance (2022)

Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.

Class IIModerate

FDADec 28, 2022CA, FL, GA +18 more• Ascend Laboratories, LLC

Acyclovir Sodium Injection (Eugia US) – particulate matter (2022)

Presence of Particulate Matter: Customer complaint of dark particles found inside the vial

Class IIModerate

FDADec 28, 2022Nationwide• Eugia US LLC

Vancomycin IV Bag (Sentara) – Sterility Issue (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

TPN Nutritional Bag (Sentara) – Sterility Problem (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Ondansetron 8MG (Sentara) – Sterility Concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Milrinone IV Bag (Sentara) – Sterility Concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Levothyroxine 25MCG (Sentara) – Sterility Concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Fluconazole 200mg IV Bag (Sentara) – Sterility Concern (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Dobutamine IV Bag (Sentara) – Sterility Issue (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

Pantoprazole Syringe (Sentara) – Sterility Risk (2022)

Lack of sterility assurance

Class IIModerate

FDADec 27, 2022Nationwide• Sentara Infusion Services

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