Drug product
ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)
D-0001-2022
Product summary
- Firm
- Alpha-Tek LLC
- Event
- Event 88335
- Status
- Ongoing
- Classification
- Class I
- Quantity
- Unknown
- Official record key
drug-enforcement:D-0001-2022
Official wording
Reason: Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Code information: All lots within expiry
Distribution pattern: Nationwide in the US
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil