JaDera Weight Loss Supplement Recalled for Undeclared Sibutramine
Dolphin Intertrade Corporation is recalling JaDera weight loss capsules because they contain undeclared sibutramine, a drug removed from the U.S. market for safety reasons.
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
Dolphin Intertrade Corporation is recalling 998 boxes of JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle. The product was distributed nationwide. The recall involves bottles with manufacturing codes 10.06.2011 and expiration dates of 09.06.2013.
The FDA is recalling these products because they were marketed without an Approved NDA/ANDA and were found to 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 this product should stop using it and contact the recalling firm for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle
- Manufacturer
- Dolphin Intertrade Corporation
- Category
- Drug — Weight Loss Supplement
- Affected units
- 998
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)
- Manufacturing Codes: 10.06.2011 Exp. 09.06.2013
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 →Related recalls
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