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Showing 2541–2560 of 3039 results

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Pravastatin Sodium Tablets (Glenmark) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Solifenacin Succinate Tablets (Glenmark) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Prochlorperazine Maleate Tablets (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Voriconazole Tablets 50mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Acetaminophen and Ibuprofen Tablets (Glenmark) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Ranolazine Extended-Release 1000mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Indomethacin Extended-Release Capsules 75mg (Glenmark) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Frovatriptan Succinate Tablets 2.5mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Teriflunomide Tablets 14mg (Glenmark) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Solifenacin Succinate Tablets 10mg (Glenmark) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Pravastatin Sodium Tablets 20mg (Glenmark) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Nitroglycerin Sublingual Tablets 0.3mg (Glenmark) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Celsior Storage Solution (Institut Georges Lopez) – contamination risk (2025)

The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.

FDAMar 13, 2025Nationwide• INSTITUT GEORGES LOPEZ 6 ROUTE DE SAINT BONNET ST LAURENT DE CHAMOUSSET France

HeartMate Mobile Power Unit (Thoratec) – electrical component failure (2025)

Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.

FDAMar 13, 2025Nationwide• Thoratec LLC

Fluphenazine Hydrochloride Tablets 2.5mg (Glenmark) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Voriconazole Tablets 200mg (Glenmark) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Propafenone Extended-Release 225mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Lacosamide Tablets 50mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Clindamycin Hydrochloride Capsules 300mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Lacosamide Tablets 200mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

FDAMar 13, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

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