D-0686-2021 Class I Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 28, 2021
- Initiation Date
- March 29, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
Reason for Recall
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.
Distribution Pattern
USA Nationwide
Code Information
all lots within expiry