Esupplementsales, LLC: Drug Recall
Recall #D-0561-2022 · 01/28/2022
Class I: Dangerous
Recall Details
- Recall Number
- D-0561-2022
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Esupplementsales, LLC
- Status
- Terminated
- Date Initiated
- 01/28/2022
- Location
- Reno, NV, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 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.
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
Distribution Pattern
Nationwide in the USA via Amazon at www.amazon.com
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.