Recall D-0759-2026

US Class II Ongoing · initiated 2026-08-03

Recalling firm

Shoolin Pharma Chem LLP

Product

SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05

Reason for recall

CGMP Deviations:Noted during FDA inspection

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