Drug product
Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box
D-0101-2017
Product summary
- Firm
- SOS Telecom Inc.
- Event
- Event 74144
- Status
- Terminated
- Classification
- Class I
- Quantity
- N/A
- Official record key
drug-enforcement:D-0101-2017
Official wording
Reason: Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements
Code information: Lot No: 9236999; Best use by: 12/16/2016
Distribution pattern: NY
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: FDA sample analyses revealed the presence of undeclared sildenafil and/or its analogs in products marketed as dietary supplements