The Recall Desk
ModerateFDA (Drugs)·D-1350-2016·Announced 2016-07-20

Murray International Recalls Tien Ma Tou Tong Wan Pills for Unapproved Drug Claims

Murray International Trading Co. is recalling Tien Ma Tou Tong Wan pills because they bear drug claims despite being marketed as dietary supplements.

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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is regulatory (unapproved drug claims) rather than a direct physical safety defect with reported harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Murray International Trading Co., Inc. is recalling 96 bottles of Tien Ma Tou Tong Wan (Condensed pills). The product is packaged in 100-count bottles within a box and was manufactured by Kwangchow First Chinese Medicine Factory in Kwangchow, China. The remaining labeling on the product contains Chinese characters.

The recall was initiated because the products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Although marketed as dietary supplements, the labeling bears drug or disease claims, which classifies them as unapproved drugs under FDA regulations.

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

The recalled product

Product
Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within a box, Kwangchow First Chinese Medicine Factory, Kwangchow, China; remaining labeling contains Chinese characters.
Affected units
96

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 →