D-0001-2022 Class I Ongoing
FDA drug recall D-0001-2022 was initiated by Alpha-Tek LLC on July 16, 2021 and is designated Class I. Reason for recall: Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil The recall status is ongoing. Affected quantity: Unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- October 13, 2021
- Initiation Date
- July 16, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Unknown
Product Description
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)
Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Distribution Pattern
Nationwide in the US
Code Information
All lots within expiry