The Recall Desk
ModerateFDA (Drugs)·D-1357-2016·Announced 2016-07-20

FDA Recalls Te Xiao BaiNeiTing Herbal Supplement for Unapproved Drug Claims

Murray International Trading Co. is recalling 17 boxes of Te Xiao BaiNeiTing Herbal Supplement because the product is marketed with drug claims without an approved NDA or ANDA.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.

Plain-English summary

Murray International Trading Co. is recalling 17 boxes of Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid. The product, produced by Good Harvests (Asia) Trading Co., Ltd, is packaged in a bottle within a box and bears the UPC 7 67533 86115 6. The remaining labeling contains Chinese characters.

The recall is being conducted because the product is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Although labeled as a dietary supplement, the product bears drug and disease claims, which classifies it as an unapproved drug under FDA regulations.

The affected units were distributed nationwide and in Puerto Rico. Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.

The recalled product

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
Affected units
17

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 14 recalled by Murray International Trading Co., Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →