EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E. Atlantic Blvd, Pomp...
FDA Recall #D-1140-2016 — Class I — December 15, 2015
Product Description
EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E. Atlantic Blvd, Pompano Beach, Florida, 33062 WWW.BEEEXTREMELYAMAZED.COM
Reason for Recall
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Recalling Firm
Bee Extremely Amazed LLC — Jewett, OH
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
N/A
Distribution
Nationwide
Code Information
All lots
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated