TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, 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 171596-29-5), NDC 85702-002-04.
USTADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, 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 171596-29-5), NDC 85702-002-04.
Recalling Firm: Shoolin Pharma Chem LLP
Reason for Recall / Hazard
CGMP Deviations:Noted during FDA inspection
Product Description & Identification
TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, 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 171596-29-5), NDC 85702-002-04.
Affected Products
TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, 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 171596-29-5), NDC 85702-002-04.
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 TLF2506001, Date of Expiry: May 31, 2028. |
| Postal code | N/A |
| Report date | 20260819 |
| Product type | Drugs |
| Product quantity | 20 KG, 40 X 0.500KG(500gm) 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 - TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, 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 171596-29-5), NDC 85702-002-04. Check if your household is affected: https://therecallfile.com/recalls/tadalafil-usp-0-500-kg-0-500kg-500gm-bag-rx-only-for-prescription-comp/FDA-D-0761-2026
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