Shoolin Pharma Chem LLP — Class II: SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding
Shoolin Pharma Chem LLP has initiated a Class II recall for Sildenafil Citrate USP API (NDC 85702-001-05) due to CGMP deviations identified during an FDA inspection. The recall involves 100g bags intended for prescription compounding.
This recall affects Shoolin Pharma Chem LLP, compounding pharmacies utilizing this API for prescription drug preparation, and quality assurance personnel responsible for supplier qualification of active pharmaceutical ingredients.
The classification of this recall as Class II indicates that the CGMP deviations found at the Indian manufacturing facility are significant enough that the product may cause temporary or medically reversible adverse health consequences. For regulatory professionals, this underscores the continued FDA scrutiny of international API manufacturing sites and the risks associated with raw materials used in compounding.
Procurement and Quality units should immediately verify if this specific lot of Sildenafil Citrate API is in current inventory or has been distributed to compounding pharmacies. Ensure all API suppliers are qualified via physical or remote audits that specifically address CGMP compliance at the manufacturing site.
Class II. Reason: CGMP Deviations:Noted during FDA inspection. 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. Firm: Shoolin Pharma Chem LLP (Kadi India). Status: Ongoing.
Open in openFDA / FDA.gov