D-0388-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 26, 2021
- Initiation Date
- March 24, 2021
- Termination Date
- July 16, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3894 ten-count boxes (38,940 capsules)
Product Description
Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box. Each box contains 10 capsules.
Reason for Recall
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
Distribution Pattern
Nationwide
Code Information
All lots within expiry.