WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www....
FDA Recall #D-1180-2023 — Class I — August 25, 2023
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.
Recalling Firm
Hua Da Trading, Inc. dba Wefun Inc. — Brooklyn, NY
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
300 cartons
Distribution
Distributed Nationwide in the USA
Code Information
Lot # #18520168, Exp. date 09/30/2026 .
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated