Drug product
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
D-0388-2026
Product summary
- Event
- Event 98258
- Status
- Ongoing
- Classification
- Class I
- Quantity
- N/A
- Official record key
drug-enforcement:D-0388-2026
Official wording
Reason: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Code information: All lots within expiry
Distribution pattern: USA nationwide
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.