The Recall Desk
CriticalFDA (Drugs)·D-1250-2014·Announced 2014-04-30

Dolphin Intertrade Recalls XIYOUJI QINGZHI CAPSULES Due to Undeclared Sibutramine

Dolphin Intertrade Corporation is recalling XIYOUJI QINGZHI CAPSULES because they contain undeclared sibutramine, a substance removed from the U.S. market for safety reasons.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Dolphin Intertrade Corporation is recalling XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box. The recall involves 8 bottles distributed nationwide. All lots are affected.

The FDA has classified this as a Class I recall because the products were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contain undeclared sibutramine. Sibutramine was previously removed from the U.S. market for safety reasons, which makes these products unapproved new drugs.

Consumers who have purchased these products should stop using them immediately and contact the recalling firm for instructions on how to return the product or obtain a refund.

The recalled product

Product
XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box
Affected units
8

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.

Part of a larger recall action

This product is one of 2 recalled by Dolphin Intertrade Corporation 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 2 products in this recall →

Same manufacturer · Dolphin Intertrade Corporation

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