Drug product
Ginseng Power-X , 1800 mg, 1 capsule per pack , 24 single packs per box.
D-0103-2017
Product summary
- Firm
- SOS Telecom Inc.
- Event
- Event 74144
- Status
- Terminated
- Classification
- Class I
- Quantity
- N/A
- Official record key
drug-enforcement:D-0103-2017
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: 7788965; Best use by: 10/15/2018
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