Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3
Summary
The FDA issued a Class I for Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angele by NSNY Distributor Inc. Reason: Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil.
Details
Source
Drug Recall
External ID
D-0642-2021
Action Date
2021-07-07
Status
Ongoing
Category
drug
Product Description
Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010, UPC 0 40232 18144 3
Lot/Code Info: all lots
Quantity Affected: 399 capsules
Reason for Recall
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-04-08
Company
Flushing, 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 19 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
NSNY Distributor Inc has 2 FDA actions in our database, including 2 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 (NSNY Distributor Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NSNY Distributor Inc have FDA actions?
NSNY Distributor Inc has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0642-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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