The Recall Desk
SevereFDA (Drugs)·D-1347-2016·Announced 2016-07-20

FUCONPO Capsule Recalled for Marketing Without Approved NDA or ANDA

Murray International Trading Co. is recalling FUCONPO Capsules because they are marketed as dietary supplements but bear 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 rating (score 4) per the rubric, as the product is an unapproved drug marketed with drug claims.

Plain-English summary

Murray International Trading Co., Inc. is recalling FUCONPO Capsules, which are packaged in 30-count bottles within boxes. The remaining labeling on the product contains Chinese characters. The recall covers all lots of the product.

The recall was initiated because the product is marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Although the product is marked as a dietary supplement, its labeling bears drug and disease claims. This classification makes the product an unapproved drug under FDA regulations.

The product was distributed nationwide and in Puerto Rico. Consumers who have purchased FUCONPO Capsules should stop using the product and contact the recalling firm for further instructions.

The recalled product

Product
FUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeling contains Chinese characters.

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 →