Drug product
LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3 tubes per packet within a box, Produced by: Good Harvests (Asia) Trading Co., Ltd.; Imported by: Murray Int'l Trading Co., Inc., New York, NY 10013; UPC 7 67533 86925 1, remaining labeling contains Chinese characters.
D-1351-2016
Product summary
- Event
- Event 74017
- Status
- Terminated
- Classification
- Class II
- Quantity
- 178 boxes
- Official record key
drug-enforcement:D-1351-2016
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.