Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.
Summary
The FDA issued a Class I for Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661 by Loud Muscle Science. Reason: Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment o.
Details
Source
Drug Recall
External ID
D-1337-2022
Action Date
2022-07-27
Status
Terminated
Category
drug
Product Description
Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864.
Lot/Code Info: Lot # 2022104, Exp. Date 04/2025
Quantity Affected: 1000 10-count tins
Reason for Recall
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Distribution
The product was distributed nationwide in the USA and Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-27
Company
Hauppauge, 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 115 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Loud Muscle Science has 6 FDA actions in our database, including 6 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 (Loud Muscle Science) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Loud Muscle Science have FDA actions?
Loud Muscle Science has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1337-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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