Drug product
SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peoples Republic of China, remaining labeling contains Chinese characters.
D-1348-2016
Product summary
- Event
- Event 74017
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 bottles
- Official record key
drug-enforcement:D-1348-2016
Official wording
Reason: Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Code information: All lots
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.