FDA Recall D-0561-2022
Esupplementsales, LLC · Reno, NV
Class I — life-threatening Terminated 201 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59
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.
Recall record
- Recall number
D-0561-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the USA via Amazon at www.amazon.com
- Recall initiated
- 2022-01-28
- Classified by FDA Center
- 2022-02-15
- FDA published
- 2022-02-16
- Terminated
- 2022-08-17
- Recalling firm
- Esupplementsales, LLC
- Firm location
- Reno, NV