HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59
Reported: February 16, 2022 Initiated: January 28, 2022 #D-0561-2022
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.
Details
- Recalling Firm
- Esupplementsales, LLC
- Units Affected
- 500 cartons
- Distribution
- Nationwide in the USA via Amazon at www.amazon.com
- Location
- Reno, NV
Frequently Asked Questions
What product was recalled? ▼
HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59. Recalled by Esupplementsales, LLC. Units affected: 500 cartons.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 16, 2022. Severity: Critical. Recall number: D-0561-2022.
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