FDADecember 23, 2015drug

APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.

What to do

FDA enforcement status: Ongoing

Brands named

nuway distributorsnuway

UPCs

705105963617

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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