HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59

FDA recall notice · announced February 16, 2022 · Esupplementsales

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Nationwide in the USA via Amazon at www.amazon.com
Lot/code information: Lot: 2107, Exp July 2024
Quantity: 500 cartons
Status: Terminated
Products in this recall event:
- HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59 (D-0561-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.