BtRiM Max capsules recalled for undeclared phenolphthalein
Detox Transforms is recalling BtRiM Max 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Detox Transforms is recalling 173 bottles of BtRiM Max capsules. The product is sold in 60-count bottles and was distributed nationwide by WV who.
The recall was initiated because the product was found to contain undeclared phenolphthalein. This finding means that BtRiM Max is considered an unapproved drug, as it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Consumers who have purchased BtRiM Max capsules with Lot 00002 and an expiration date of 04/27/17 should stop using the product and contact the recalling firm for instructions on how to return it.
The recalled product
- Product
- BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00406 8.
- Manufacturer
- Detox Transforms
- Category
- Drug — Dietary Supplement
- Affected units
- 173
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: 00002
- Exp 04/27/17
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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