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Showing 281–300 of 548 results

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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

Brazil Seed 2-Pack (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

Tejocote Root Supplement (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

Class IHigh

FDAFeb 9, 2024Nationwide• HandNatural

Brazil Seed Supplement (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

Brazil Seed Supplement (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

Brazil Seed 2-Pack (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

Brazil Seed Supplement (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

Brazil Seed 2-Pack (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

Brazil Seed 2-Pack (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

Brazil Seed Supplement (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

Tejocote Root Supplement (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

OralProCare Lip Treatment (Den-Mat) – Specification Deviation (2024)

CGMP Deviations: products may not conform to the labeled specifications.

Class IIModerate

FDAJan 16, 2024Nationwide• Den-Mat Holdings, LLC

Remedy Antifungal Cream (Medline) – Mislabeled Parabens (2024)

Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.

Class IIModerate

FDAJan 10, 2024Nationwide• MEDLINE INDUSTRIES, LP - Northfield

FentaNYL Citrate Large IV Solution (Denver Solutions) – Double Dose Risk (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

PHENYLephrine HCl IV Solution (Denver Solutions) – Double Dose Risk (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Vancomycin IV Bag (Denver Solutions) – Dosage Malfunction (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

FentaNYL Citrate IV Solution (Denver Solutions) – Double Dose Risk (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

VANCOmycin HCl IV Solution (Denver Solutions) – Double Dose Risk (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

PHENYLephrine HCl Lower Dose IV Solution (Denver Solutions) – Double Dose Risk (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Freskaro Magnesium Citrate Laxative Chewable (Pharma Nobis) – Bacterial Contamination (2023)

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Class IIModerate

FDADec 21, 2023Nationwide• Pharma Nobis LLC

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