HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 36492
Summary
The FDA issued a Class I for HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per ca by Esupplementsales, LLC. Reason: Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approv.
Details
Source
Drug Recall
External ID
D-0561-2022
Action Date
2022-02-16
Status
Terminated
Category
drug
Product Description
HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59
Lot/Code Info: Lot: 2107, Exp July 2024
Quantity Affected: 500 cartons
Reason for Recall
Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.
Distribution
Nationwide in the USA via Amazon at www.amazon.com
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-28
Company
Reno, NV
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 104 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 (Esupplementsales, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Esupplementsales, LLC have FDA actions?
This is the only FDA action we have on record for Esupplementsales, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0561-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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