D-0662-2021 Class I Terminated
FDA drug recall D-0662-2021 was initiated by Ummzy, LLC on March 30, 2021 and is designated Class I. 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 est… The recall status is terminated (terminated June 9, 2022). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- July 28, 2021
- Initiation Date
- March 30, 2021
- Termination Date
- June 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Distribution Pattern
USA Nationwide
Code Information
All lots within expiry.