REFA Enterprises Recalls Forever Beautiful INFINITY Capsules for Unapproved Ingredients
REFA Enterprises is recalling Forever Beautiful INFINITY capsules because FDA analysis found the product contains sibutramine and phenolphthalein without an approved NDA/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
REFA Enterprises, LLC is recalling 92 bottles of Forever Beautiful INFINITY capsules, 300mg in 60-count bottles. The product was distributed nationwide. The recall was initiated because FDA analysis found that the product contains sibutramine and phenolphthalein, and it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The product is identified by the UPC code 633090804649. The expiration date is unknown. The manufacturer is located at 900 Commonwealth Place, Ste 104, Virginia Beach, VA.
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
- Forever Beautiful INFINITY, capsules, 300mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA
- Manufacturer
- REFA Enterprises, LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 92
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)
- UPC CODE: 633090804649 Exp unknown
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by REFA Enterprises, LLC 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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