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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 4

DrugsSource: FDA (drug) · Date: 2026-08-19

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
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 / hazard
CGMP Deviations:Noted during FDA inspection
Classification
Class II
Status
Ongoing
Distribution / sold at
Distributed Nationwide in the USA
Recall initiated
2026-08-03
Code info
Batch SDC2505001, Date of Expiry: April 30, 2030.
Product quantity
25KG, 250-1gm bags
Voluntary mandated
Voluntary: Firm initiated
City
Kadi
Country
India
Event id
99547
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