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.
Reason for recall: Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Recall initiated: 20160420
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated