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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

Tortilla Chip Green (La Mexicana) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

Class IIModerate

FDAMar 13, 2025TX• La Mexicana Tortilla Factory, Inc.

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

CGMP Deviations

Class IIModerate

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

GreenScreen Sunscreen (Kabana) – cGMP Deviations (2025)

cGMP deviations

Class IIModerate

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

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

Chemical contamination: Presence of benzene

Class IIModerate

FDAMar 12, 2025Nationwide• Alchemee, LLC

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

cGMP deviations

Class IIModerate

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

B Natural Organics Sunscreen (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

ChlorproMAZINE Tablets 100mg (Glenmark) – CGMP Deviations (2025)

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.

Class IIModerate

FDAMar 11, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

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

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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