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Technetium Tc 99m Mertiatide Kit (Sun Pharmaceutical) – dissolution specification failure (2025)

Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.

Class IIModerate

FDASep 3, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Chlorpromazine Hydrochloride 10mg Tablets (Zydus) – N-Nitroso impurity (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

FDASep 3, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

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Technetium Tc 99m Mertiatide Kit (Sun Pharmaceutical) – dissolution specification failure (2025)

Chlorpromazine Hydrochloride 10mg Tablets (Zydus) – N-Nitroso impurity (2025)

Chlorpromazine Hydrochloride 50mg Tablets (Zydus) – N-Nitroso impurity (2025)

Chlorpromazine Hydrochloride Tablets (Zydus) – CGMP impurity risk (2025)

Chlorpromazine Hydrochloride Tablets (Zydus) – CGMP impurity risk (2025)

Chlorpromazine Hydrochloride Tablets (Zydus) – CGMP impurity risk (2025)

Allura Xper FD20/20 (Philips) – Component Deterioration (2025)

Allura Xper FD20/15 (Philips) – Battery Depletion Risk (2025)

Chlorpromazine Hydrochloride 50mg Tablets (Zydus) – N-Nitroso impurity (2025)

FlexLab System (Inpeco) – Sample Integrity Issue (2025)

Peanut Butter Crush Bar (Zingerman's) – Undeclared Cashew (2025)

Ultra Whey Protein Powder (New Spirit) – Undeclared Milk (2025)

Artegraft Collagen Vascular Grafts (LeMaitre) – Raw Material Issue (2025)

Digital Radiography System (Canon Medical) – ROI Default Issue (2025)

Tribio Implant (Berkeley Advanced Biomaterials) – Incorrect Label (2025)

Mazda CX-70 (Mazda) – Fuel Gauge Malfunction (2025)

Kenworth W990 (Kenworth) – Display Failure (2026)

Norgestimate and Ethinyl Estradiol (AvKARE) – Content uniformity issue (2025)

Sulfamethoxazole and Trimethoprim (Major) – Foreign substance packaging (2025)

NES 0.9mm RX Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)