FDA Recalls iNSANE Bee Pollen Capsules Containing Unapproved Drugs
The FDA is recalling iNSANE Bee Pollen capsules because they contain undeclared phenolphthalein and fluoxetine, making them unapproved drugs.
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 corresponds to a Critical severity score of 5 according to the rubric.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling iNSANE Bee Pollen capsules, 200 mg, 60-count bottles. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The manufacturer is Detox Transforms, and the product was developed by Signature.
The recall was initiated because the product was found to contain undeclared phenolphthalein and fluoxetine. The presence of these undeclared ingredients makes iNSANE an unapproved drug. The specific lot number is 0000:02, with an expiration date of 06/20/17. The product was distributed nationwide.
Consumers who have purchased this product should stop using it and return it to the place of purchase for a refund or contact the recalling firm for instructions.
The recalled product
- Product
- iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00408 2.
- Manufacturer
- Detox Transforms
- Category
- Drug — Dietary Supplement
- Affected units
- 200
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: 0000:02
- Exp 06/20/17
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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