Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.
Summary
The FDA issued a Class I for Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA 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-0664-2021
Action Date
2021-07-28
Status
Terminated
Category
drug
Product Description
Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.
Lot/Code Info: All lots within expiry.
Quantity Affected: 163 boxes/10 capsules per box
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-0664-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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