WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar
Summary
The FDA issued a Class I for WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brook by Hua Da Trading, Inc. dba Wefun Inc.. Reason: 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.
Details
Source
Drug Recall
External ID
D-1180-2023
Action Date
2023-09-20
Status
Terminated
Category
drug
Product Description
WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5
Lot/Code Info: Lot # #18520168, Exp. date 09/30/2026 .
Quantity Affected: 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.
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-25
Company
Brooklyn, NY
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 32 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hua Da Trading, Inc. dba Wefun Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hua Da Trading, Inc. dba Wefun Inc. have FDA actions?
This is the only FDA action we have on record for Hua Da Trading, Inc. dba Wefun Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1180-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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