Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Neva
Summary
The FDA issued a Class I for Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by Today The World. Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved pr.
Details
Source
Drug Recall
External ID
D-0343-2024
Action Date
2024-02-28
Status
Ongoing
Category
drug
Product Description
Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada
Lot/Code Info: Lot #: BTH:230551, Exp. Date 12.05.2026; BTH:230571, Exp. Date 14.05.2026
Quantity Affected: 7000 boxes
Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.
Distribution
Product distributed nationwide within the United States.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-06
Company
Portland, OR
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 41 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Today The World has 3 FDA actions in our database, including 3 recalls.
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 (Today The World) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Today The World have FDA actions?
Today The World has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0343-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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