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Showing 201–220 of 505 results

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Carvedilol Tablets 12.5mg (Glenmark) - Nitrosamine Impurity (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Class IIModerate

FDAAug 7, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 25mg (Glenmark) - Nitrosamine Impurity (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Class IIModerate

FDAAug 7, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Carvedilol Tablets 3.125mg (Glenmark) - Nitrosamine Impurity (2025)

CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.

Class IIModerate

FDAAug 7, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Flexible Joint Formula (Formutech Nutrition) – Unapproved Claims (2025)

Unapproved Drug Claims.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Adderex XR (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Fish Oil Heart & Brain Supplement (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Quercetin (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Uric Control (Top Secret Nutrition) – Unapproved Claims (2025)

Unapproved Drug Claims.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Slimaglutide Weight Loss Aid (Hi-Tech Pharmaceuticals) – Misbranded Product (2025)

Unapproved Drug Claims and Misbranded.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Carvedilol Tablets 12.5mg (Glenmark) - Nitrosamine Excess (2025)

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class IIModerate

FDAAug 6, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Metoprolol Tablets 50mg (Westminster) - Nitrosamine Risk (2025)

CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.

Class IIModerate

FDAAug 6, 2025Nationwide• Westminster Pharmaceuticals LLC

Beta Sitosterol (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Taurine Performance (PrimeNutrition) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Phytoform Fruits & Greens (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Pine Bark (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Battle Hardener Platinum (LG Sciences) – Unapproved Claims (2025)

Unapproved Drug Claims.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Phytoform Fruits & Greens (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Joint-RX (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Carvedilol Tablets 25mg (Glenmark) - Nitrosamine Excess (2025)

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class IIModerate

FDAAug 6, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Joint Health Supplement (iFORCE Nutrition) – Unapproved Claims (2025)

Unapproved Drug Claims.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

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