RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
Summary
The FDA issued a Class I for RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00 by Celebrate Today. Reason: Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products fo.
Details
Source
Drug Recall
External ID
D-0638-2022
Action Date
2022-02-23
Status
Terminated
Category
drug
Product Description
RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
Lot/Code Info: Lot # DK1027, Exp. 08/01/2023
Quantity Affected: 500 cartons
Reason for Recall
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Distribution
Product was distributed nationwide in the USA via Amazon Marketplace
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-08
Company
Brentwood, 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 60 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 (Celebrate Today) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Celebrate Today have FDA actions?
This is the only FDA action we have on record for Celebrate Today in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0638-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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