Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC,
Summary
The FDA issued a Class I for Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count box by Ummzy, LLC. Reason: Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs f.
Details
Source
Drug Recall
External ID
D-0662-2021
Action Date
2021-07-28
Status
Terminated
Category
drug
Product Description
Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860
Lot/Code Info: All lots within expiry.
Quantity Affected: N/A
Reason for Recall
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-03-30
Company
Palisades Park, NJ
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 49 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Ummzy, LLC 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 (Ummzy, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ummzy, LLC have FDA actions?
Ummzy, LLC 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-0662-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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