Drug product

GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFACTORY OF CHINA. GANSU CHINA; remaining labeling contains Chinese characters.

D-1353-2016

April 20, 2016

Class II

Product summary

Firm: Murray International Trading Co., Inc.
Event: Event 74017
Status: Terminated
Classification: Class II
Quantity: Unknown
Official record key: drug-enforcement:D-1353-2016

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
reason.no_named_rule · v1.0.0

Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.