FDAHealthAugust 3, 2026
Shoolin Pharma Chem LLP — 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 Maru
⚠️ CGMP Deviations:Noted during FDA inspection
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 3, 2026
Distributed Nationwide in the USA
What's affected?
- 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
- Lot code
- Batch SDC2505001, Date of Expiry: April 30, 2030.
Additional details
Batch SDC2505001, Date of Expiry: April 30, 2030.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 25KG, 250-1gm bags.
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