LiDa DAIDAIHUA capsules recalled for undeclared sibutramine and phenolphthalein
Blue Square Market, Inc. is recalling LiDa DAIDAIHUA capsules nationwide because they contain undeclared sibutramine and phenolphthalein and were marketed without an approved NDA or ANDA.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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
Blue Square Market, Inc. is recalling LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG) capsules. The product is packaged in 1.6oz boxes containing 30 capsules each. The recall covers 25 boxes and all lots of the product.
The recall is being conducted because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product contains undeclared sibutramine and phenolphthalein. The product was distributed nationwide.
Consumers who have purchased this product should stop using it immediately. They should return the product to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- Product
- LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged in 1.6oz box 30 capsules per box, Kunming Dali Industry & Trade Co., Ltd
- Manufacturer
- Blue Square Market, Inc.
- Affected units
- 25
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 Blue Square Market, 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.
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