The Recall Desk
SevereFDA (Drugs)·D-1349-2016·Announced 2016-07-20

FDA Recalls Crocodile Bile Pills Marketed as Unapproved Asthma Drug

Murray International Trading Co. is recalling Crocodile Bile Pills for Asthma because they are marketed as dietary supplements but contain drug claims, making them unapproved drugs.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, which corresponds to a Severe severity score per the rubric, as it involves a product marketed without an approved NDA/ANDA.

Plain-English summary

Murray International Trading Co., Inc. is recalling Crocodile Bile Pills for Asthma. The product is packaged in 100-count bottles within a box, and the remaining labeling contains Chinese characters. The recall involves 48 bottles and covers all lots.

The FDA is recalling this product because it is marketed as a dietary supplement but has labeling that bears drug and disease claims. This makes the product an unapproved drug, as it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

The product was distributed nationwide and in Puerto Rico. Consumers who have this product should stop using it and contact the recalling firm for instructions on how to return it or dispose of it safely.

The recalled product

Product
CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, remaining labeling contains Chinese characters.
Affected units
48

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 →