D-0762-2026 Class II Ongoing
FDA drug recall D-0762-2026 was initiated by Shoolin Pharma Chem LLP on August 3, 2026 and is designated Class II. Reason for recall: CGMP Deviations:Noted during FDA inspection The recall status is ongoing. Affected quantity: 1KG - 20 X 1KG(1000gm) bags.
Recall Details
- Product Type
- Drugs
- Report Date
- August 19, 2026
- Initiation Date
- August 3, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1KG - 20 X 1KG(1000gm) bags
Product Description
TADALAFIL USP, 1.00 KG, 1KG(1000gm)-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 85702-001-08
Reason for Recall
CGMP Deviations:Noted during FDA inspection
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Batch TLF2506001, Date of Expiry: May 31, 2028.