D-0561-2022 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 16, 2022
- Initiation Date
- January 28, 2022
- Termination Date
- August 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 500 cartons
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
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 Pattern
Nationwide in the USA via Amazon at www.amazon.com
Code Information
Lot: 2107, Exp July 2024