Recall D-0763-2026

US Class II Ongoing · initiated 2026-08-03

Recalling firm

Shoolin Pharma Chem LLP

Product

SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-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, Mahesania, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-08.

Reason for recall

CGMP Deviations:Noted during FDA inspection

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