Detox Transforms Recalls iNDiGO Capsules Containing Undeclared Phenolphthalein
Detox Transforms is recalling iNDiGO capsules because they contain undeclared phenolphthalein, making the product an unapproved drug.
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
Detox Transforms is recalling 175 bottles of iNDiGO capsules, 220 mg, 60-count. The product was developed by Signature and is identified by Lot 000034 and expiration date 04/10/17.
The recall was initiated because the product was found to contain undeclared phenolphthalein. This finding means the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), classifying it as an unapproved drug.
The affected units were distributed nationwide. Consumers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00404 4.
- Manufacturer
- Detox Transforms
- Category
- Drug — Dietary Supplement
- Affected units
- 175
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 (2)
- Lot: 000034
- Exp 04/10/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Detox Transforms 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 5 products in this recall →Related recalls
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