Drug recall D-0760-2026
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 for recall
CGMP Deviations:Noted during FDA inspection
Lots and codes
Lot: TLF2506001, Date of Expiry: May 31, 2028.
Recall details
- Recalling firm
- Shoolin Pharma Chem LLP, Kadi
- Quantity
- 1KG - 100-0.1KG(100gm) bags
- Distribution
- Distributed Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 3, 2026