Recall D-0762-2026

US Class II Ongoing · initiated 2026-08-03

Recalling firm

Shoolin Pharma Chem LLP

Product

TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, (CAS NO 171596-29-5), NDC 85702-001-08

Reason for recall

CGMP Deviations:Noted during FDA inspection

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