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Showing 2161–2180 of 29086 results

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Tobramycin Injection (Eugia US LLC) – stability specification (2024)

Failed Stability Specification: Water determination was found not complying with specification.

Class IIModerate

FDAFeb 22, 2024Nationwide• Eugia US LLC

Organic Carrot Juice (Barsotti) – Under Processed (2024)

Product was determined to be under processed.

Class IIModerate

FDAFeb 22, 2024AZ, CA, CT +7 more• Barsotti Juice Company, Inc.

Nicardipine Hydrochloride Injection (Eugia) – impurity specs (2024)

Failed Impurities/Degradation Specifications: Out of specification for organic impurities

Class IIModerate

FDAFeb 20, 2024Nationwide• Eugia US LLC

Moxifloxacin Single-Dose Vial (Denver Solutions) – glass delamination (2024)

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Class IIModerate

FDAFeb 20, 2024Nationwide• Denver Solutions, LLC DBA Leiters Health

Nicardipine Hydrochloride Injection (Eugia) – impurity specs (2024)

Failed Impurities/Degradation Specifications: Out of specification for organic impurities

Class IIModerate

FDAFeb 20, 2024Nationwide• Eugia US LLC

Lidocaine HCL Solution (Denver Solutions) – glass delamination (2024)

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Class IIModerate

FDAFeb 20, 2024Nationwide• Denver Solutions, LLC DBA Leiters Health

Methylprednisolone Acetate Injection (Eugia) – dissolution failure (2024)

Failed Dissolution Specifications

Class IIModerate

FDAFeb 20, 2024LA, MS, OH +1 more• Eugia US LLC

Moxifloxacin Balanced Salt Solution (Denver Solutions) – glass delamination (2024)

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Class IIModerate

FDAFeb 20, 2024Nationwide• Denver Solutions, LLC DBA Leiters Health