Drug Enforcement D-1180-2023

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.

Status

Completed

Classification

Class I

Report Date

September 20, 2023

Termination Date

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Product Information

Product description
WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5
Product quantity
300 cartons
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.
Recall initiation reason
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Initial firm notification
Press Release
Distribution pattern
Distributed Nationwide in the USA

Location & Firm

Recalling firm
Hua Da Trading, Inc. dba Wefun Inc.
Address
6306 20th Ave

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-1180-2023
Event ID
92979
Recall initiation date
August 25, 2023
Center classification date
September 29, 2023
Code info
Lot # #18520168, Exp. date 09/30/2026 .
More code info
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