Drug product

Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, Net Wt. 15ml, packaged in a bottle 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 86115 6, remaining labeling contains Chinese characters.

D-1357-2016

April 20, 2016

Class II

Product summary

Firm: Murray International Trading Co., Inc.
Event: Event 74017
Status: Terminated
Classification: Class II
Quantity: 17 boxes
Official record key: drug-enforcement:D-1357-2016

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.