HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Mal...
FDA Recall #D-0561-2022 — Class I — January 28, 2022
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.
Recalling Firm
Esupplementsales, LLC — Reno, NV
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
500 cartons
Distribution
Nationwide in the USA via Amazon at www.amazon.com
Code Information
Lot: 2107, Exp July 2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated