D-0759-2026 Class II Ongoing
FDA drug recall D-0759-2026 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: 25KG, 250-1gm 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
- 25KG, 250-1gm bags
Product Description
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
Reason for Recall
CGMP Deviations:Noted during FDA inspection
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Batch SDC2505001, Date of Expiry: April 30, 2030.