FDAFDA · Food and drugs·Recall number D-0686-2021
Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Published July 28, 2021 · Recall initiated: March 29, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an FDA approved drug making this an unapproved drug for which the safety and efficacy has not been established and therefore subject to recall.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Nuri Trading LLC
- Distributor
- USA Nationwide
- Lot
- all lots within expiry
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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