FDA-Drug2016-07-13Class I
Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St. #392 Columbus, IN 47203
Bee Extremely Amazed LLC
Hazard
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 Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Sold states
Nationwide
Affected count
1,104 bottles
Manufactured in
85205 Sportsmans Club Rd, N/A, Jewett, OH, United States
Products
Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St. #392 Columbus, IN 47203
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1145-2016Don't want to check this manually?
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