D-1180-2023 Class I
Recall Details
- Product Type
- Drugs
- Report Date
- September 20, 2023
- Initiation Date
- August 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300 cartons
Product Description
WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5
Reason for Recall
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot # #18520168, Exp. date 09/30/2026 .