Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas
Summary
The FDA issued a Class I for Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distri by Stop Clopez Corp. Reason: Marketed Without An Approved NDA/ANDA.
Details
Source
Drug Recall
External ID
D-0494-2024
Action Date
2024-05-22
Status
Terminated
Category
drug
Product Description
Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV.
Lot/Code Info: Lot 2108; EXP 10/31/2024
Quantity Affected: 5 boxes
Reason for Recall
Marketed Without An Approved NDA/ANDA
Distribution
Distribution worldwide via amazon.com
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-22
Company
Miramar, FL
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 37 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 (Stop Clopez Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stop Clopez Corp have FDA actions?
This is the only FDA action we have on record for Stop Clopez Corp in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0494-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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