FDAFDA · Food and drugs·Recall number D-0561-2022
HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59
Published February 16, 2022 · Recall initiated: January 28, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Esupplementsales, LLC
- Distributor
- Nationwide in the USA via Amazon at www.amazon.com
- Lot
- Lot: 2107, Exp July 2024
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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