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

CGMP Deviations

Class IIModerate

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

Lacosamide Tablets 150mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

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

Lacosamide Tablets 100mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

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

Carvedilol Tablets 12.5mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

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

Colesvelam Tablets 625mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

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

Metformin Extended-Release Tablets (Glenmark) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

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

Propafenone Extended-Release 325mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

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

Nitroglycerin Sublingual Tablets 0.4mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

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

Saxagliptin Tablets 5mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

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

Naproxen Sodium Tablets 550mg (Glenmark) – CGMP Issues (2025)

CGMP Deviations

Class IIModerate

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

Rosuvastatin Tablets 40mg (Glenmark) – CGMP Deviations (2025)

CGMP Deviations

Class IIModerate

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

Proactiv Emergency Blemish Relief (Alchemee) – Benzene Contamination (2025)

Chemical contamination: Presence of benzene

Class IIModerate

FDAMar 12, 2025Nationwide• Alchemee, LLC

B Natural Organics Sunscreen (Kabana) – cGMP Deviations (2025)

cGMP deviations

Class IIModerate

FDAMar 12, 2025FL, MI, NJ• KABANA SKIN CARE

Erin's Faces Mineral SPF 32 (Kabana) – cGMP Deviations (2025)

cGMP deviations

Class IIModerate

FDAMar 12, 2025FL, MI, NJ• KABANA SKIN CARE

In Your Face Mineral Tint SPF 31 (Kabana) – cGMP Deviations (2025)

cGMP deviations

Class IIModerate

FDAMar 12, 2025FL, MI, NJ• KABANA SKIN CARE

Proactiv Skin Smoothing Exfoliator (Alchemee) – Benzene Contamination (2025)

Chemical contamination: Presence of benzene

Class IIModerate

FDAMar 12, 2025Nationwide• Alchemee, LLC

GreenScreen Sunscreen (Kabana) – cGMP Deviations (2025)

cGMP deviations

Class IIModerate

FDAMar 12, 2025FL, MI, NJ• KABANA SKIN CARE

Ciprofloxacin Ophthalmic Solution (FDC) – Defective Container (2025)

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

Class IIModerate

FDAMar 11, 2025Nationwide• FDC Limited

Walgreens Acne Treatment Cream (Fruit of Earth) – Benzene Contamination (2025)

Chemical contamination: presence of benzene

Class IIModerate

FDAMar 11, 2025Nationwide• Fruit Of The Earth, Inc.

CVS Health Acne Treatment Cream (Fruit of Earth) – Benzene Contamination (2025)

Chemical contamination: presence of benzene

Class IIModerate

FDAMar 11, 2025Nationwide• Fruit Of The Earth, Inc.

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