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
USSILDENAFIL 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
Recalling Firm: Shoolin Pharma Chem LLP
Reason for Recall / Hazard
CGMP Deviations:Noted during FDA inspection
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Kadi |
| Event id | 99547 |
| Address 1 | 408 B/H Ratnamani Tubes |
| Address 2 | Block/Survey No; Nr Maruti Inox |
| Code info | Batch SDC2505001, Date of Expiry: April 30, 2030. |
| Postal code | N/A |
| Report date | 20260819 |
| Product type | Drugs |
| Product quantity | 25KG, 250-1gm bags |
| Reason for recall | CGMP Deviations:Noted during FDA inspection |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260803 |
| Center classification date | 20260813 |
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Overview
- Recalling FirmShoolin Pharma Chem LLP
- StatusOngoing
- Risk LevelClass II
- DistributionDistributed Nationwide in the USA
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🚨 SAFETY ALERT: 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 Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 382715, India, (CAS NO. 171599-83-0) NDC 85702-001-05 Check if your household is affected: https://therecallfile.com/recalls/sildenafil-citrate-usp-0-100-kg-100-gm-bag-net-wt-rx-only-for-prescrip/FDA-D-0759-2026
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