FDA recall D-0561-2022

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.

Distribution

Nationwide in the USA via Amazon at www.amazon.com

Key facts

Status

Terminated

Initiation date

2022-01-28

Report date

2022-02-16

Termination date

2022-08-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reno, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0561-2022