Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860
Reported: July 28, 2021 Initiated: March 30, 2021 #D-0662-2021
Product Description
Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860
Reason for Recall
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Details
- Recalling Firm
- Ummzy, LLC
- Units Affected
- N/A
- Distribution
- USA Nationwide
- Location
- Palisades Park, NJ
Frequently Asked Questions
What product was recalled? ▼
Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860. Recalled by Ummzy, LLC. Units affected: N/A.
Why was this product recalled? ▼
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 28, 2021. Severity: Critical. Recall number: D-0662-2021.
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