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Quick Touch Alcohol Prep Pads (Yangzhou Yulou) – Manufacturing Deviation (2025)

cGMP Deviations

FDAJul 21, 2025Nationwide• YANGZHOU YULOU PAPER PRODUCTS CO., LTD

Belsomra Tablets (Merck) – Dissolution Performance (2025)

Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.

Class IIModerate

FDAJul 21, 2025Nationwide• Merck & Co. Inc

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Quick Touch Alcohol Prep Pads (Yangzhou Yulou) – Manufacturing Deviation (2025)

Belsomra Tablets (Merck) – Dissolution Performance (2025)

Amlodipine Olmesartan Tablets (Ascend) – Dissolution Failure (2025)

DermaKleen Antiseptic Soap (DermaRite Industries) – Microbial Contamination (2025)

DermaSarra Analgesic (DermaRite Industries) – Microbial Contamination (2025)

Duloxetine Capsules (Breckenridge Pharmaceutical) – Impurity Concern (2025)

Sucralfate Tablets (Nostrum Laboratories) – Quality Program Disruption (2025)

Bicillin L-A Injection (Pfizer) – Particulate Inspection Problem (2025)

Bicillin L-A Injection (Pfizer) – Particulate Inspection Problem (2025)

Tropicamide Ophthalmic Solution (Imprimis NJOF) – Potency Concern (2025)

Rizatriptan Tablets (Ascend Laboratories) – Impurity Detection (2025)

Epinephrine Lidocaine HCL (Imprimis NJOF) – Sub-Potent Drug (2025)

Cinacalcet Tablets 90mg (Strides Pharma) – Failed Dissolution (2025)

Rizatriptan Benzoate Tablets (Ascend) – CGMP Impurity (2025)

Timolol Maleate Ophthalmic Solution (FDC) – Defective Container (2025)

Amlodipine Benazepril Capsules (Lupin) – Incorrect Expiration (2025)

Peripheral Parenteral Nutrition (CAPS) – Processing Controls (2025)

Duloxetine Capsules (Breckenridge) – CGMP Impurity (2025)

Budesonide Inhalation Suspension (Cipla) – Sterility Issue (2025)

Omeprazole Capsules (Dr. Reddy's) – Foreign Tablets (2025)