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Shoolin Pharma Chem LLP: TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H

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
TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-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 1715996-29-5), NDC 85702-002-02.
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
Lot: TLF2506001, Date of Expiry: May 31, 2028.
Product quantity
1KG - 100-0.1KG(100gm) bags
Voluntary mandated
Voluntary: Firm initiated
City
Kadi
Country
India
Event id
99547
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