RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Summary
The FDA issued a Class I for RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, AS by Positive Health. Reason: Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatme.
Details
Source
Drug Recall
External ID
D-0645-2022
Action Date
2022-03-02
Status
Terminated
Category
drug
Product Description
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Lot/Code Info: Lot # 48658908, Exp. date 09/09/2023
Quantity Affected: 5,500 cartons
Reason for Recall
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Distribution
Product was distributed nationwide via the internet through Amazon Marketplace.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-10
Company
Wilmington, DE
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 98 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 (Positive Health) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Positive Health have FDA actions?
This is the only FDA action we have on record for Positive Health in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0645-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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