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Estradiol Patch (Zydus) – Specification Failure (2024)

Failed Impurities/Degradation Specifications.

FDAMay 16, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Pregabalin Capsules (Rising Pharma) – Foreign Tablet Found (2024)

Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.

Class IIILow

FDAMay 16, 2024Nationwide• Rising Pharma Holding, Inc.

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Estradiol Patch (Zydus) – Specification Failure (2024)

Pregabalin Capsules (Rising Pharma) – Foreign Tablet Found (2024)

Estradiol Patch (Zydus) – Specification Failure (2024)

Cephalexin Suspension 250mg (Bryant Ranch) – Incorrect Labeling (2024)

Cephalexin Suspension 250mg (Bryant Ranch) – Incorrect Labeling (2024)

Cephalexin Suspension 250mg (Bryant Ranch) – Incorrect Labeling (2024)

Cephalexin Suspension 125mg (Bryant Ranch) – Incorrect Labeling (2024)

Cephalexin Suspension 125mg (Bryant Ranch) – Incorrect Labeling (2024)

Sirolimus Tablets (Dr. Reddy's) – Impurity Specification Failure (2024)

Xelpros (Sun Pharmaceutical) – Failed Particulate Test (2024)

Epinephrine-Lidocaine HCl Solution (Imprimis) – Assay Specification (2024)

Abilify 15mg Tablets (Otsuka) – Product Contamination (2024)

Abilify 10mg Tablets (Otsuka) – Product Contamination (2024)

Abilify 5mg Tablets (Otsuka) – Product Contamination (2024)

Abilify 30mg Tablets (Otsuka) – Product Contamination (2024)

Peach Pie (Robeson) – missing ingredient details (2024)

Dot's Potato Bake (Robeson) – missing ingredient details (2024)

Hashbrown Casserole (Robeson) – missing ingredient list (2024)

Sweet Potato Casserole (Robeson) – missing ingredient list (2024)

Strawberry Pie (Robeson Enterprises) – missing sub-ingredients (2024)