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Showing 1081–1100 of 2326 results

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Rizatriptan Benzoate Tablets (Glenmark) – Nitrosamine Impurity (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 10, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Duloxetine Capsules (Preferred) – Nitrosamine Contamination (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAMay 10, 2024CA, CT, FL +2 more• Preferred Pharmaceuticals, Inc.

Rizatriptan Benzoate Tablets (Glenmark) – Nitrosamine Impurity (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 10, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Sicilian Semolina (Della Fattoria) – undeclared sesame (2024)

Missing the declaration of sesame seeds from the "Contains" statement.

Class IIModerate

FDAMay 8, 2024CA• Della Fattoria, LLC

Della Fattoria Seeded Wheat – Missing Sesame Declaration (2024)

Missing the declaration of sesame seeds from the "Contains" statement.

Class IIModerate

FDAMay 8, 2024CA• Della Fattoria, LLC

Losartan Hydrochlorothiazide (Macleods) – Plastic Contamination (2024)

Presence of foreign substance: plastic-like substance.

Class IIModerate

FDAMay 7, 2024Nationwide• MACLEODS PHARMA USA, INC

Zilretta Injection (Pacira) – Stability Specification Failure (2024)

Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.

Class IIModerate

FDAMay 7, 2024Nationwide• PACIRA PHARMACEUTICALS INC

Metoprolol Tablets (Rubicon) – Metal Contamination (2024)

Presence of Foreign Substance: metal in tablet

Class IIModerate

FDAMay 6, 2024Nationwide• Rubicon Research Private Limited

Magnesium Citrate (Pharma Nobis) – Bacterial Contamination (2024)

Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria

Class IIModerate

FDAMay 1, 2024Nationwide• Pharma Nobis LLC

Magnesium Citrate (Pharma Nobis) – Bacterial Contamination (2024)

Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria

Class IIModerate

FDAMay 1, 2024Nationwide• Pharma Nobis LLC

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAApr 29, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAApr 29, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Duloxetine Capsules (Breckenridge) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAApr 29, 2024Nationwide• Breckenridge Pharmaceutical, Inc

H-E-B Creamy Creations Chocolate Ice Cream (H-E-B) – Metal Contamination (2024)

Potential metal contamination

Class IIModerate

FDAApr 27, 2024TX• H-E-B San Antonio Retail Support Center (SARSC)

H-E-B Creamy Creations Homemade Ice Cream (H-E-B) – Metal Contamination (2024)

Potential metal contamination

Class IIModerate

FDAApr 27, 2024TX• H-E-B San Antonio Retail Support Center (SARSC)

H-E-B Creamy Creations Lime/Orange Ice Cream (H-E-B) – Metal Contamination (2024)

Potential metal contamination

Class IIModerate

FDAApr 27, 2024TX• H-E-B San Antonio Retail Support Center (SARSC)

Tramadol Tablets (Rubicon) – Foreign Tablet Presence (2024)

Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol

Class IIModerate

FDAApr 26, 2024Nationwide• Rubicon Research Private Limited

Methylprednisolone Injection (Sagent) – Particulate Matter (2024)

Presence of Particulate Matter: Potential for black particulates in the drug product.

Class IIModerate

FDAApr 25, 2024Nationwide• Sagent Pharmaceuticals

Crustless Chicken Potato Pot Pie (Nutrition Corp) – Listeria Risk (2024)

Possible contamination with Listeria monocytogenes

Class IIModerate

FDAApr 25, 2024Nationwide• Nutrition Corp

Haloperidol Injection (Somerset) – Foreign Substance (2024)

Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).

Class IIModerate

FDAApr 24, 2024Nationwide• SOMERSET THERAPEUTICS LLC

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