Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
Summary
The FDA issued a Class II for Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS by Loud Muscle Science. Reason: Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims..
Details
Source
Drug Recall
External ID
D-1339-2022
Action Date
2022-07-27
Status
Terminated
Category
drug
Product Description
Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375.
Lot/Code Info: Lot# C07172101, Exp date: 07/2024; 2022054, Exp date: 03/2025
Quantity Affected: 2,495 60-count bottles
Reason for Recall
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
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 II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-1339-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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